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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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• Open access
• Published: 30 April 2021

Ethics review of big data research: What should stay and what should be reformed?

• Agata Ferretti   ORCID: orcid.org/0000-0001-6716-5713 1 ,
• Marcello Ienca 1 ,
• Mark Sheehan 2 ,
• Alessandro Blasimme 1 ,
• Edward S. Dove 3 ,
• Bobbie Farsides 4 ,
• Phoebe Friesen 5 ,
• Jeff Kahn 6 ,
• Walter Karlen 7 ,
• Peter Kleist 8 ,
• S. Matthew Liao 9 ,
• Camille Nebeker 10 ,
• Gabrielle Samuel 11 ,
• Mahsa Shabani 12 ,
• Minerva Rivas Velarde 13 &
• Effy Vayena 1  

BMC Medical Ethics volume  22 , Article number:  51 ( 2021 ) Cite this article

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Ethics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.

In this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.

Conclusions

We believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large.

Peer Review reports

The debate about the adequacy of the Ethics Review Committee (ERC) as the chief oversight body for big data studies is partly rooted in the historical evolution of the ERC. Particularly relevant is the ERC’s changing response to new methods and technologies in scientific research. ERCs—also known as Institutional Review Boards (IRBs) or Research Ethics Committees (RECs)—came to existence in the 1950s and 1960s [ 1 ]. Their original mission was to protect the interests of human research participants, particularly through an assessment of potential harms to them (e.g., physical pain or psychological distress) and benefits that might accrue from the proposed research. ERCs expanded in scope during the 1970s, from participant protection towards ensuring valuable and ethical human subject research (e.g., having researchers implement an informed consent process), as well as supporting researchers in exploring their queries [ 2 ].

Fast forward fifty years, and a lot has changed. Today, biomedical projects leverage unconventional data sources (e.g., social media), partially inscrutable data analytics tools (e.g., machine learning), and unprecedented volumes of data [ 3 , 4 , 5 ]. Moreover, the evolution of research practices and new methodologies such as post-hoc data mining have blurred the concept of ‘ human subject’ and elicited a shift towards the concept of data subject —as attested in data protection regulations. [ 6 , 7 ]. With data protection and privacy concerns being in the spotlight of big data research review, language from data protection laws has worked its way into the vocabulary of research ethics. This terminological shift further reveals that big data, together with modern analytic methods used to interpret the data, creates novel dynamics between researchers and participants [ 8 ]. Research data repositories about individuals and aggregates of individuals are considerably expanding in size. Researchers can remotely access and use large volumes of potentially sensitive data without communicating or actively engaging with study participants. Consequently, participants become more vulnerable and subjected to the research itself [ 9 ]. As such, the nature of risk involved in this new form of research changes too. In particular, it moves from the risk of physical or psychological harm towards the risk of informational harm, such as privacy breaches or algorithmic discrimination [ 10 ]. This is the case, for instance, with projects using data collected through web search engines, mobile and smart devices, entertainment websites, and social media platforms. The fact that health-related research is leaving hospital labs and spreading into online space creates novel opportunities for research, but also raises novel challenges for ERCs. For this reason, it is important to re-examine the fit between new data-driven forms of research and existing oversight mechanisms [ 11 ].

The suitability of ERCs in the context of big data research is not merely a theoretical puzzle but also a practical concern resulting from recent developments in data science. In 2014, for example, the so-called ‘emotional contagion study’ received severe criticism for avoiding ethical oversight by an ERC, failing to obtain research consent, violating privacy, inflicting emotional harm, discriminating against data subjects, and placing vulnerable participants (e.g., children and adolescents) at risk [ 12 , 13 ]. In both public and expert opinion [ 14 ], a responsible ERC would have rejected this study because it contravened the research ethics principles of preventing harm (in this case, emotional distress) and adequately informing data subjects. However, the protocol adopted by the researchers was not required to undergo ethics review under US law [ 15 ] for two reasons. First, the data analyzed were considered non-identifiable, and researchers did not engage directly with subjects, exempting the study from ethics review. Second, the study team included both scientists affiliated with a public university (Cornell) and Facebook employees. The affiliation of the researchers is relevant because—in the US and some other countries—privately funded studies are not subject to the same research protections and ethical regulations as publicly funded research [ 16 ]. An additional example is the 2015 case in which the United Kingdom (UK) National Health Service (NHS) shared 1.6 million pieces of identifiable and sensitive data with Google DeepMind. This data transfer from the public to the private party took place legally, without the need for patient consent or ethics review oversight [ 17 ]. These cases demonstrate how researchers can pursue potentially risky big data studies without falling under the ERC’s purview. The limitations of the regulatory framework for research oversight are evident, in both private and public contexts.

The gaps in the ERC’s regulatory process, together with the increased sophistication of research contexts—which now include a variety of actors such as universities, corporations, funding agencies, public institutes, and citizens associations—has led to an increase in the range of oversight bodies. For instance, besides traditional university ethics committees and national oversight committees, funding agencies and national research initiatives have increasingly created internal ethics review boards [ 18 , 19 ]. New participatory models of governance have emerged, largely due to an increase in subjects’ requests to control their own data [ 20 ]. Corporations are creating research ethics committees as well, modelled after the institutional ERC [ 21 ]. In May 2020, for example, Facebook welcomed the first members of its Oversight Board, whose aim is to review the company’s decisions about content moderation [ 22 ]. Whether this increase in oversight models is motivated by the urge to fill the existing regulatory gaps, or whether it is just ‘ethics washing’, is still an open question. However, other types of specialized committees have already found their place alongside ERCs, when research involves international collaboration and data sharing [ 23 ]. Among others, data safety monitoring boards, data access committees, and responsible research and innovation panels serve the purpose of covering research areas left largely unregulated by current oversight [ 24 ].

The data-driven digital transformation challenges the purview and efficacy of ERCs. It also raises fundamental questions concerning the role and scope of ERCs as the oversight body for ethical and methodological soundness in scientific research. Footnote 1 Among these questions, this article will explore whether ERCs are still capable of their intended purpose, given the range of novel (maybe not categorically new, but at least different in practice) issues that have emerged in this type of research. To answer this question, we explore some of the challenges that the ERC oversight approach faces in the context of big data research and review the main strengths and weaknesses of this oversight mechanism. Based on this analysis, we will outline possible solutions to address current weaknesses and improve ethics review in the era of big data science.

Strengths of the ethics review via ERC

Historically, ERCs have enabled cross disciplinary exchange and assessment [ 27 ]. ERC members typically come from different backgrounds and bring their perspectives to the debate; when multi-disciplinarity is achieved, the mixture of expertise provides the conditions for a solid assessment of advantages and risks associated with new research. Committees which include members from a variety of backgrounds are also suited to promote projects from a range of fields, and research that cuts across disciplines [ 28 ]. Within these committees, the reviewers’ expertise can be paired with a specific type of content to be reviewed. This one-to-one match can bring timely and, ideally, useful feedback [ 29 ]. In many countries (e.g., European countries, the United States (US), Canada, Australia), ERCs are explicitly mandated by law to review many forms of research involving human participants; moreover, these laws also describe how such a body should be structured and the purview of its review [ 30 , 31 ]. In principle, ERCs also aim to be representative of society and the research enterprise, including members of the public and minorities, as well as researchers and experts [ 32 ]. And in performing a gatekeeping function to the research enterprise, ERCs play an important role: they recognize that both experts and lay people should have a say, with different views to contribute [ 33 ].

Furthermore, the ERC model strives to ensure independent assessment. The fact that ERCs assess projects “from the outside” and maintain a certain degree of objectivity towards what they are reviewing, reduces the risk of overlooking research issues and decreases the risk for conflicts of interest. Moreover, being institutionally distinct—for example, being established by an organization that is distinct from the researcher or the research sponsor—brings added value to the research itself as this lessens the risk for conflict of interest. Conflict of interest is a serious issue in research ethics because it can compromise the judgment of reviewers. Institutionalized review committees might particularly suffer from political interference. This is the case, for example, for universities and health care systems (like the NHS), which tend to engage “in house” experts as ethics boards members. However, ERCs that can prove themselves independent are considered more trustworthy by the general public and data subjects; it is reassuring to know that an independent committee is overseeing research projects [ 34 ].

The ex-ante (or pre-emptive) ethical evaluation of research studies is by many considered the standard procedural approach of ERCs [ 35 ]. Though the literature is divided on the usefulness and added value provided by this form of review [ 36 , 37 ], ex-ante review is commonly used as a mechanism to ensure the ethical validity of a study design before the research is conducted [ 38 , 39 ]. Early research scrutiny aims at risk-mitigation: the ERC evaluates potential research risks and benefits, in order to protect participants’ physical and psychological well-being, dignity, and data privacy. This practice saves researchers’ resources and valuable time by preventing the pursuit of unethical or illegal paths [ 40 ]. Finally, the ex-ante ethical assessment gives researchers an opportunity to receive feedback from ERCs, whose competence and experience may improve the research quality and increase public trust in the research [ 41 ].

All strengths mentioned in this section are strengths of the ERC model in principle. In practice, there are many ERCs that are not appropriately interdisciplinary or representative of the population and minorities, that lack independence from the research being reviewed, and that fail to improve research quality, and may in fact hinder it. We now turn to consider some of these weaknesses in more detail.

Weaknesses of the ethics review via ERC

In order to assess whether ERCs are adequately equipped to oversee big data research, we must consider the weaknesses of this model. We identify two categories of weaknesses which are described in the following section and summarized in Fig.  1 :

Persistent weaknesses : those existing in the current oversight system, which could be exacerbated by big data research

Novel weaknesses : those brought about by and specific to the nature of big data projects

Within this second category of novel weaknesses, we further differentiate between:

Purview weaknesses : reasons why some big data projects may bypass the ERCs’ purview

Functional weaknesses : reasons why some ERCs may be inadequate to assess big data projects specifically

Weaknesses of the ERCs

We base the conceptual distinction between persistent and novel weaknesses on the fact that big data research diverges from traditional biomedical research in many respects. As previously mentioned, big data projects are often broad in scope, involve new actors, use unprecedented methodologies to analyze data, and require specific expertise. Furthermore, the peculiarities of big data itself (e.g., being large in volume and from a variety of sources) make data-driven research different in practice from traditional research. However, we should not consider the category of “novel weaknesses” a closed category. We do not argue that weaknesses mentioned here do not, at least partially, overlap with others which already exist. In fact, in almost all cases of ‘novelty’, (i) there is some link back to a concept from traditional research ethics, and (ii) some thought has been given to the issue outside of a big data or biomedical context (e.g., the problem of ERCs’ expertise has arisen in other fields [ 42 ]). We believe that by creating conceptual clarity about novel oversight challenges presented by big data research, we can begin to identify tailored reforms.

Persistent weaknesses

As regulation for research oversight varies between countries, ERCs often suffer from a lack of harmonization. This weakness in the current oversight mechanism is compounded by big data research, which often relies on multi-center international consortia. These consortia in turn depend on approval by multiple oversight bodies demanding different types of scrutiny [ 43 ]. Furthermore, big data research may give rise to collaborations between public bodies, universities, corporations, foundations, and citizen science cooperatives. In this network, each stakeholder has different priorities and depends upon its own rules for regulation of the research process [ 44 , 45 , 46 ]. Indeed, this expansion of regulatory bodies and aims does not come with a coordinated effort towards agreed-upon review protocols [ 47 ]. The lack of harmonization is perpetuated by academic journals and funding bodies with diverging views on the ethics of big data. If the review bodies which constitute the “ethics ecosystem” [ 19 ] do not agree to the same ethics review requirements, a big data project deemed acceptable by an ERC in one country may be rejected by another ERC, within or beyond the national borders.

In addition, there is inconsistency in the assessment criteria used within and across committees. Researchers report subjective bias in the evaluation methodology of ERCs, as well as variations in ERC judgements which are not based on morally relevant contextual considerations [ 48 , 49 ]. Some authors have argued that the probability of research acceptance among experts increases if some research peer or same-field expert sits on the evaluation committee [ 50 , 51 ]. The judgement of an ERC can also be influenced by the boundaries of the scientific knowledge of its members. These boundaries can impact the ERC’s approach towards risk taking in unexplored fields of research [ 52 ]. Big data research might worsen this problem since the field is relatively new, with no standardized metric to assess risk within and across countries [ 53 ]. The committees do not necessarily communicate with each other to clarify their specific role in the review process, or try to streamline their approach to the assessment. This results in unclear oversight mandates and inconsistent ethical evaluations [ 27 , 54 ].

Additionally, ERCs may fall short in their efforts to justly redistribute the risks and benefits of research. The current review system is still primarily tilted toward protecting the interests of individual research participants. ERCs do not consistently assess societal benefit, or risks and benefits in light of the overall conduct of research (balancing risks for the individual with collective benefits). Although demands on ERCs vary from country to country [ 55 ], the ERC approach is still generally tailored towards traditional forms of biomedical research, such as clinical trials and longitudinal cohort studies with hospital patients. These studies are usually narrow in scope and carry specific risks only for the participants involved. In contrast, big data projects can impact society more broadly. As an example, computational technologies have shown potential to determine individuals’ sexual orientation by screening facial images [ 56 ]. An inadequate assessment of the common good resulting from this type of study can be socially detrimental [ 57 ]. In this sense, big data projects resemble public health research studies, with an ethical focus on the common good over individual autonomy [ 58 ]. Within this context, ERCs have an even greater responsibility to ensure the just distribution of research benefits across the population. Accurately determining the social value of big data research is challenging, as negative consequences may be difficult to detect before research begins. Nevertheless, this task remains a crucial objective of research oversight.

The literature reports examples of the failure of ERCs to be accountable and transparent [ 59 ]. This might be the result of an already unclear role of ERCs. Indeed, the ERCs practices are an outcome of different levels of legal, ethical, and professional regulations, which largely vary across jurisdictions. Therefore, some ERCs might function as peer counselors, others as independent advisors, and still others as legal controllers. What seems to be common across countries, though, is that ERCs rarely disclose their procedures, policies, and decision-making process. The ERCs’ “secrecy” can result in an absence of trust in the ethical oversight model [ 60 ].This is problematic because ERCs rely on public acceptance as accountable and trustworthy entities [ 61 ]. In big data research, as the number of data subjects is exponentially greater, a lack of accountability and an opaque deliberative process on the part of ERCs might bring even more significant public backlash. Ensuring truthfulness of the stated benefits and risks of research is a major determinant of trust in both science and research oversight. Researchers are another category of stakeholders negatively impacted by poor communication and publicity on the part of the ERC. Commentators have shown that ERCs often do not clearly provide guidance about the ethical standards applied in the research review [ 62 ]. For instance, if researchers provide unrealistic expectations of privacy and security to data subjects, ERCs have an institutional responsibility to flag those promises (e.g., about data security and the secondary-uses of subject data), especially when the research involves personal and high sensitivity data [ 63 ]. For their part, however, ERCs should make their expectations and decision-making processes clear.

Finally, ERCs face the increasing issue of being overwhelmed by the number of studies to review [ 64 , 65 ]. Whereas ERCs originally reviewed only human subjects research happening in natural sciences and medicine, over time they also became the ethical body of reference for those conducting human research in the social sciences (e.g., in behavioral psychology, educational sciences, etc.). This increase in demand creates pressure on ERC members, who often review research pro bono and on a voluntary basis. The wide range of big data research could exacerbate this existing issue. Having more research to assess and less time to accomplish the task may negatively impact the quality of the ERC’s output, as well as increase the time needed for review [ 66 ]. Consequently, researchers might carry out potentially risky studies because the relevant ethical issues of those studies were overlooked. Furthermore, research itself could be significantly delayed, until it loses its timely scientific value.

Novel weaknesses: purview weaknesses

To determine whether the ERC is still the most fit-for-purpose entity to oversee big data research, it is important to establish under which conditions big data projects fall under the purview of ERCs.

Historically, research oversight has primarily focused on human subject research in the biomedical field, using public funding. In the US for instance, each review board is responsible for a subtype of research based on content or methodology (for example there are IRBs dedicated to validating clinical trial protocols, assessing cancer treatments, examining pediatric research, and reviewing qualitative research). This traditional ethics review structure cannot accommodate big data research [ 2 ]. Big data projects often reach beyond a single institution, cut across disciplines, involve data collected from a variety of sources, re-use data not originally collected for research purposes, combine diverse methodologies, orient towards population-level research, rely on large data aggregates, and emerge from collaboration with the private sector. Given this scenario, big data projects may likely fall beyond the purview of ERCs.

Another case in which big data research does not fall under ERC purview is when it relies on anonymized data. If researchers use data that cannot be traced back to subjects (anonymized or non-personal data), then according to both the US Common Rule and HIPAA regulations, the project is considered safe enough to be granted an ethics review waiver. If instead researchers use pseudonymized (or de-identified) data, they must apply for research ethics review, as in principle the key that links the de-identified data with subjects could be revealed or hacked, causing harm to subjects. In the European Union, it would be left to each Member State (and national laws or policies at local institutions) to define whether research using anonymized data should seek ethical review. This case shows once more that current research ethics regulation is relatively loose and disjointed across jurisdictions, and may leave areas where big data research is unregulated. In particular, the special treatment given anonymized data comes from an emphasis on risk at the individual level. So far in the big data discourse, the concept of harm has been mainly linked to vulnerability in data protection. Therefore if privacy laws are respected, and protection is built into the data system, researchers can prevent harmful outcomes [ 40 ]. However, this view is myopic as it does not include other misuses of data aggregates, such as group discrimination and dignitary harm. These types of harm are already emerging in the big data ecosystem, where anonymized data reveal health patterns of a certain sub-group, or computational technologies include strong racial biases [ 67 , 68 ]. Furthermore, studies using anonymized data should not be deemed oversight-free by default, as it is increasingly hard to anonymize data. Technological advancements might soon make it possible to re-identify individuals from aggregate data sets [ 69 ].

The risks associated with big data projects also increase due to the variety of actors involved in research alongside university researchers (e.g., private companies, citizen science associations, bio-citizen groups, community workers cooperatives, foundations, and non-profit organizations) [ 70 , 71 ]. The novel aspect of health-related big data research compared with traditional research is that anyone who can access large amounts of data about individuals and build predictive models based on that data, can now determine and infer the health status of a person without directly engaging with that person in a research program [ 72 ]. Facebook, for example, is carrying out a suicide prediction and prevention project, which relies exclusively on the information that users post on the social network [ 18 ]. Because this type of research is now possible, and the available ethics review model exempts many big data projects from ERC appraisal, gaps in oversight are growing [ 17 , 73 ]. Just as corporations can re-use publicly available datasets (such as social media data) to determine life insurance premiums [ 74 ], citizen science projects can be conducted without seeking research oversight [ 75 ]. Indeed, participant-led big data research (despite being increasingly common) is another area where the traditional overview model is not effective [ 76 ]. In addition, ERCs might consider research conducted outside academia or publicly funded institutions to be not serious. Thus ERCs may disregard review requests from actors outside the academic environment (e.g., by the citizen science or health tech start up) [ 77 ].

Novel weaknesses: functional weaknesses

Functional weaknesses are those related to the skills, composition, and operational activities of ERCs in relation to big data research.

From this functional perspective, we argue that the ex-ante review model might not be appropriate for big data research. Project assessment at the project design phase or at the data collection level is insufficient to address emerging challenges that characterize big data projects – especially as data, over time, could become useful for other purposes, and therefore be re-used or shared [ 53 ]. Limitations of the ex-ante review model have already become apparent in the field of genetic research [ 78 ]. In this context, biobanks must often undergo a second ethics assessment to authorize the specific research use on exome sequencing of their primary data samples [ 79 ]. Similarly, in a case in which an ERC approved the original collection of sensitive personal data, a data access committee would ensure that the secondary uses are in line with original consent and ethics approval. However, if researchers collect data from publicly accessible platforms, they can potentially use and re-use data for research lawfully, without seeking data subject consent or ERC review. This is often the case in social media research. Social media data, which are collected by researchers or private companies using a form of broad consent, can be re-used by researchers to conduct additional analysis without ERC approval. It is not only the re-use of data that poses unforeseeable risks. The ex-ante approach might not be suitable to assess other stages of the data lifecycle [ 80 ], such as deployment machine learning algorithms.

Rather than re-using data, some big data studies build models on existing data (using data mining and machine learning methods), creating new data, which is then used to further feed the algorithms [ 81 ]. Sometimes it is not possible to anticipate which analytic models or tools (e.g., artificial intelligence) will be leveraged in the research. And even then, the nature of computational technologies which extract meaning from big data make it difficult to anticipate all the correlations that will emerge from the analysis [ 37 ]. This is an additional reason that big data research often has a tentative approach to a research question, instead of growing from a specific research hypothesis [ 82 ].The difficulty of clearly framing the big data research itself makes it even harder for ERCs to anticipate unforeseeable risks and potential societal consequences. Given the existing regulations and the intrinsic exploratory nature of big data projects, the mandate of ERCs does not appear well placed to guarantee research oversight. It seems even less so if we consider problems that might arise after the publication of big data studies, such as repurposing or dual-use issues [ 83 ].

ERCs also face the challenge of assessing the value of informed consent for big data projects. To re-obtain consent from research subjects is impractical, particularly when using consumer generated data (e.g., social media data) for research purposes. In these cases, researchers often rely on broad consent and consent waivers. This leaves the data subjects unaware of their participation in specific studies, and therefore makes them incapable of engaging with the research progress. Therefore, the data subjects and the communities they represent become vulnerable towards potential negative research outcomes. The tool of consent has limitations in big data research—it cannot disclose all possible future uses of data, in part because these uses may be unknown at the time of data generation. Moreover, researchers can access existing datasets multiple times and reuse the same data with alternative purposes [ 84 ]. What should be the ERCs’ strategy, given the current model of informed consent leaves an ethical gap in big data projects? ERCs may be tempted to focus on the consent challenge, neglecting other pressing big data issues [ 53 ]. However, the literature reports an increasing number of authors who are against the idea of a new consent form for big data studies [ 5 ].

A final widely discussed concern is the ERC’s inadequate expertise in the area of big data research [ 85 , 86 ]. In the past, there have been questions about the technical and statistical expertise of ERC members. For example, ERCs have attempted to conform social science research to the clinical trial model, using the same knowledge and approach to review both types of research [ 87 ]. However, big data research poses further challenges to ERCs’ expertise. First, the distinct methodology of big data studies (based on data aggregation and mining) requires a specialized technical expertise (e.g., information systems, self-learning algorithms, and anonymization protocols). Indeed, big data projects have a strong technical component, due to data volume and sources, which brings specific challenges (e.g., collecting data outside traditional protocols on social media) [ 88 , 89 ]. Second, ERCs may be unfamiliar with new actors involved in big data research, such as citizen science actors or private corporations. Because of this lack of relevant expertise, ERCs may require unjustified amendments to research studies, or even reject big data projects tout-court [ 36 ]. Finally, ERCs may lose credibility as an oversight body capable of assessing ethical violations and research misconduct. In the past, ERCs solved this challenge by consulting independent experts in a relevant field when reviewing a protocol in that domain. However, this solution is not always practical as it depends upon the availability of an expert. Furthermore, experts may be researchers working and publishing in the field themselves. This scenario would be problematic because researchers would have to define the rules experts must abide by, compromising the concept of independent review [ 19 ]. Nonetheless, this problem does not disqualify the idea of expertise but requires high transparency standards regarding rule development and compliance. Other options include ad-hoc expert committees or provision of relevant training for existing committee members [ 47 , 90 , 91 ]. Given these options, which one is best to address ERCs’ lack of expertise in big data research?

Reforming the ERC

Our analysis shows that ERCs play a critical role in ensuring ethical oversight and risk–benefit evaluation [ 92 ], assessing the scientific validity of a project in its early stages, and offering an independent, critical, and interdisciplinary approach to the review. These strengths demonstrate why the ERC is an oversight model worth holding on to. Nevertheless, ERCs carry persistent big data-specific weaknesses, reducing their effectiveness and appropriateness as oversight bodies for data-driven research. To answer our initial research question, we propose that the current oversight mechanism is not as fit for purpose to assess the ethics of big data research as it could be in principle. ERCs should be improved at several levels to be able to adequately address and overcome these challenges. Changes could be introduced at the level of the regulatory framework as well as procedures. Additionally, reforming the ERC model might mean introducing complementary forms of oversight. In this section we explore these possibilities. Figure  2 offers an overview of the reforms that could aid ERCs in improving their process.

Reforms overview for the research oversight mechanism

Regulatory reforms

The regulatory design of research oversight is the first aspect which needs reform. ERCs could benefit from new guidance (e.g., in the form of a flowchart) on the ethics of big data research. This guidance could build upon a deep rethinking of the importance of data for the functioning of societies, the way we use data in society, and our justifications for this use. In the UK, for instance, individuals can generally opt out of having their data (e.g., hospital visit data, health records, prescription drugs) stored by physicians’ offices or by NHS digital services. However, exceptions to this opt-out policy apply when uses of the data are vital to the functioning of society (for example, in the case of official national statistics or overriding public interest, such as the COVID-19 pandemic) [ 93 ].

We imagine this new guidance also re-defining the scope of ERC review, from protection of individual interest to a broader research impact assessment. In other words, it will allow the ERC’s scope to expand and to address purview issues which were previously discussed. For example, less research will be oversight-free because more factors would trigger ERC purview in the first place. The new governance would impose ERC review for research involving anonymized data, or big data research within public–private partnerships. Furthermore, ERC purview could be extended beyond the initial phase of the study to other points in the data lifecycle [ 94 ]. A possible option is to assess a study after its conclusion (as is the case in the pharmaceutical industry): ERCs could then decide if research findings and results should be released and further used by the scientific community. This new ethical guidance would serve ERCs not only in deciding whether a project requires review, but also in learning from past examples and best practices how to best proceed in the assessment. Hence, this guidance could come in handy to increase transparency surrounding assessment criteria used across ERCs. Transparency could be achieved by defining a minimum global standard for ethics assessment that allows international collaboration based on open data and a homogenous evaluation model. Acceptance of a global standard would also mean that the same oversight procedures will apply to research projects with similar risks and research paths, regardless of whether they are carried on by public or private entities. Increased clarification and transparency might also streamline the review process within and across committees, rendering the entire system more efficient.

Procedural reforms

Procedural reforms might target specific aspects of the ERC model to make it more suitable for the review of big data research. To begin with, ERCs should develop new operational tools to mitigate emerging big data challenges. For example, the AI Now algorithmic impact assessment tool, which appraises the ethics of automated decision systems, and informs decisions about whether or not to deploy the systems in society, could be used [ 95 ]. Forms of broad consent [ 96 ] and dynamic consent [ 20 ] can also address some of the issues raised, by using, re-using, and sharing big data (publicly available or not). Nonetheless, informed consent should not be considered a panacea for all ethical issues in big data research—especially in the case of publicly available social media data [ 97 ]. If the ethical implications of big data studies affect the society and its vulnerable sub-groups, individual consent cannot be relied upon as an effective safeguard. For this reason, ERCs should move towards a more democratic process of review. Possible strategies include engaging research subjects and communities in the decision-making process or promoting a co-governance system. The recent Montreal Declaration for Responsible AI is an example of an ethical oversight process developed out of public involvement [ 98 ]. Furthermore, this inclusive approach could increase the trustworthiness of the ethics review mechanism itself [ 99 ]. In practice, the more that ERCs involve potential data subjects in a transparent conversation about the risks of big data research, the more socially accountable the oversight mechanism will become.

ERCs must also address their lack of big data and general computing expertise. There are several potential ways to bridge this gap. First, ERCs could build capacity with formal training on big data. ERCs are willing to learn from researchers about social media data and computational methodologies used for data mining and analysis [ 85 ]. Second, ERCs could adjust membership to include specific experts from needed fields (e.g., computer scientists, biotechnologists, bioinformaticians, data protection experts). Third, ERCs could engage with external experts for specific consultations. Despite some resistance to accepting help, recent empirical research has shown that ERCs may be inclined to rely upon external experts in case of need [ 86 ].

In the data-driven research context, ERCs must embrace their role as regulatory stewards, and walk researchers through the process of ethics review [ 40 ]. ERCs should establish an open communication channel with researchers to communicate the value of research ethics while clarifying the criteria used to assess research. If ERCs and researchers agree to mutually increase transparency, they create an opportunity to learn from past mistakes and prevent future ones [ 100 ]. Universities might seek to educate researchers on ethical issues that can arise when conducting data-driven research. In general, researchers would benefit from training on identifying issues of ethics or completing ethics self-assessment forms, particularly if they are responsible for submitting projects for review [ 101 ]. As biomedical research is trending away from hospitals and clinical trials, and towards people’s homes and private corporations, researchers should strive towards greater clarity, transparency, and responsibility. Researchers should disclose both envisioned risks and benefits, as well as the anticipated impact at the individual and population level [ 54 ]. ERCs can then more effectively assess the impact of big data research and determine whether the common good is guaranteed. Furthermore, they might examine how research benefits are distributed throughout society. Localized decision making can play a role here [ 55 ]. ERCs may take into account characteristics specific to the social context, to evaluate whether or not the research respects societal values.

Complementary reforms

An additional measure to tackle the novelty of big data research might consist in reforming the current research ethics system through regulatory and procedural tools. However, this strategy may not be sufficient: the current system might require additional support from other forms of oversight to complement its work.

One possibility is the creation of hybrid review mechanisms and norms, merging valuable aspects of the traditional ERC review model with more innovative models, which have been adopted by various partners involved in the research (e.g., corporations, participants, communities) [ 102 ]. This integrated mechanism of oversight would cover all stages of big data research and involve all relevant stakeholders [ 103 ]. Journals and the publishing industry could play a role within this hybrid ecosystem in limiting potential dual use concerns. For instance, in the research publication phase, resources could be assigned to editors so as to assess research integrity standards and promote only those projects which are ethically aligned. However, these implementations can have an impact only when there is a shared understanding of best practice within the oversight ecosystem [ 19 ].

A further option is to include specialized and distinct ethical committees alongside ERCs, whose purpose is to assess big data research and provide sectorial accreditation to researchers. In this model, ERCs would not be overwhelmed by the numbers of study proposals to review and could outsource evaluations requiring specialist knowledge in the field of big data. It is true that specialized committees (data safety monitoring boards, data access committees, and responsible research and innovation panels) already exist and support big data researchers in ensuring data protection (e.g., system security, data storage, data transfer). However, something like a “data review board” could assess research implications both for the individual and society, while reviewing a project’s technical features. Peer review could play a critical role in this model: the research community retains the expertise needed to conduct ethical research and to support each other when the path is unclear [ 101 ].

Despite their promise, these scenarios all suffer from at least one primary limitation. The former might face a backlash when attempting to bring together the priorities and ethical values of various stakeholders, within common research norms. Furthermore, while decentralized oversight approaches might bring creativity over how to tackle hard problems, they may also be very dispersive and inefficient. The latter could suffer from overlapping scope across committees, resulting in confusing procedures, and multiplying efforts while diluting liability. For example, research oversight committees have multiplied within the United States, leading to redundancy and disharmony across committees [ 47 ]. Moreover, specialized big data ethics committees working in parallel with current ERCs could lead to questions over the role of the traditional ERC, when an increasing number of studies will be big data studies.

ERCs face several challenges in the context of big data research. In this article, we sought to bring clarity regarding those which might affect the ERC’s practice, distinguishing between novel and persistent weaknesses which are compounded by big data research. While these flaws are profound and inherent in the current sociotechnical transformation, we argue that the current oversight model is still partially capable of guaranteeing the ethical assessment of research. However, we also advance the notion that introducing reform at several levels of the oversight mechanism could benefit and improve the ERC system itself. Among these reforms, we identify the urgency for new ethical guidelines and new ethical assessment tools to safeguard society from novel risks brought by big data research. Moreover, we recommend that ERCs adapt their membership to include necessary expertise for addressing the research needs of the future. Additionally, ERCs should accept external experts’ consultations and consider training in big data technical features as well as big data ethics. A further reform concerns the need for transparent engagement among stakeholders. Therefore, we recommend that ERCs involve both researchers and data subjects in the assessment of big data research. Finally, we acknowledge the existing space for a coordinated and complementary support action from other forms of oversight. However, the actors involved must share a common understanding of best practice and assessment criteria in order to efficiently complement the existing oversight mechanism. We believe that these adaptive suggestions could render the ERC mechanism sufficiently agile and well-equipped to overcome data-intensive research challenges and benefit research at large.

Availability of data and materials

Not applicable.

There is an unsettled discussion about whether ERCs ought to play a role in evaluating both scientific and ethical aspects of research, or whether these can even come apart—but we will not go into detail here. 25.Dawson AJ, Yentis SM. Contesting the science/ethics distinction in the review of clinical research. Journal of Medical Ethics. 2007;33(3):165–7, 26.Angell EL, Bryman A, Ashcroft RE, Dixon-Woods M. An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examined. BMJ Quality & Safety. 2008;17(2):131–6.

Abbreviations

Ethics Review Committee(s)

Health Insurance Portability and Accountability Act

Institutional Review Board(s)

National Health Service

Research Ethics Committee(s)

United Kingdom

United States

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Acknowledgements

This article reports the ideas and the conclusions emerged during a collaborative and participatory online workshop. All authors participated in the “Big Data Challenges for Ethics Review Committees” workshop, held online the 23-24 April 2020 and organized by the Health Ethics and Policy Lab, ETH Zurich.

This research is supported by the Swiss National Science Foundation under award 407540_167223 (NRP 75 Big Data). MS1 is grateful for funding from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The funding bodies did not take part in designing this research and writing the manuscript.

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AF drafted the manuscript, MI, MS1 and EV contributed substantially to the writing. EV is the senior lead on the project from which this article derives. All the authors (AF, MI, MS1, AB, ESD, BF, PF, JK, WK, PK, SML, CN, GS, MS2, MRV, EV) contributed greatly to the intellectual content of this article, edited it, and approved the final version. All authors read and approved the final manuscript.

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Ferretti, A., Ienca, M., Sheehan, M. et al. Ethics review of big data research: What should stay and what should be reformed?. BMC Med Ethics 22 , 51 (2021). https://doi.org/10.1186/s12910-021-00616-4

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Introduction: What is Research Ethics?

Research Ethics is defined here to be the ethics of the planning, conduct, and reporting of research. This introduction covers what research ethics is, its ethical distinctions, approaches to teaching research ethics, and other resources on this topic.

What is Research Ethics

Why Teach Research Ethics

Animal Subjects

Biosecurity

Collaboration

Conflicts of Interest

Data Management

Human Subjects

Peer Review

Publication

Research Misconduct

Social Responsibility

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Whistleblowing

Descriptions of educational settings , including in the classroom, and in research contexts.

Case Studies

Other Discussion Tools

Information about the history and authors of the Resources for Research Ethics Collection

What is Research Ethics?

Research Ethics is defined here to be the ethics of the planning, conduct, and reporting of research. It is clear that research ethics should include:

• Protections of human and animal subjects

However, not all researchers use human or animal subjects, nor are the ethical dimensions of research confined solely to protections for research subjects. Other ethical challenges are rooted in many dimensions of research, including the:

• Collection, use, and interpretation of research data
• Methods for reporting and reviewing research plans or findings
• Relationships among researchers with one another
• Relationships between researchers and those that will be affected by their research
• Means for responding to misunderstandings, disputes, or misconduct
• Options for promoting ethical conduct in research

The domain of research ethics is intended to include nothing less than the fostering of research that protects the interests of the public, the subjects of research, and the researchers themselves.

Ethical Distinctions

In discussing or teaching research ethics, it is important to keep some basic distinctions in mind.

• It is important not to confuse moral claims about how people ought to behave with descriptive claims about how they in fact do behave. From the fact that gift authorship or signing off on un-reviewed data may be "common practice" in some contexts, it doesn't follow that they are morally or professionally justified. Nor is morality to be confused with the moral beliefs or ethical codes that a given group or society holds (how some group thinks people should live). A belief in segregation is not morally justified simply because it is widely held by a group of people or given society. Philosophers term this distinction between prescriptive and descriptive claims the 'is-ought distinction.'  
• A second important distinction is that between morality and the law. The law may or may not conform to the demands of ethics (Kagan, 1998). To take a contemporary example: many believe that the law prohibiting federally funded stem cell research is objectionable on moral (as well as scientific) grounds, i.e., that such research can save lives and prevent much human misery. History is full of examples of bad laws, that is laws now regarded as morally unjustifiable, e.g., the laws of apartheid, laws prohibiting women from voting or inter-racial couples from marrying.  
• It is also helpful to distinguish between two different levels of discussion (or two different kinds of ethical questions): first-order or "ground-level" questions and second-order questions.  
• First-order moral questions concern what we should do. Such questions may be very general or quite specific. One might ask whether the tradition of 'senior' authorship should be defended and preserved or, more generally, what are the principles that should go into deciding the issue of 'senior' authorship. Such questions and the substantive proposals regarding how to answer them belong to the domain of what moral philosophers call 'normative ethics.'  
• Second-order moral questions concern the nature and purpose of morality itself. When someone claims that falsifying data is wrong, what exactly is the standing of this claim? What exactly does the word 'wrong' mean in the conduct of scientific research? And what are we doing when we make claims about right and wrong, scientific integrity and research misconduct? These second-order questions are quite different from the ground-level questions about how to conduct one's private or professional life raised above. They concern the nature of morality rather than its content, i.e., what acts are required, permitted or prohibited. This is the domain of what moral philosophers call 'metaethics' (Kagan, 1998).

Ethical Approaches

Each of these approaches provides moral principles and ways of thinking about the responsibilities, duties and obligations of moral life. Individually and jointly, they can provide practical guidance in ethical decision-making.

• One of the most influential and familiar approaches to ethics is deontological ethics, associated with Immanuel Kant (1742-1804). Deontological ethics hold certain acts as right or wrong in themselves, e.g., promise breaking or lying. So, for example, in the context of research, fraud, plagiarism and misrepresentation are regarded as morally wrong in themselves, not simply because they (tend to) have bad consequences. The deontological approach is generally grounded in a single fundamental principle: Act as you would wish others to act towards you OR always treat persons as an end, never as a means to an end.  
• From such central principles are derived rules or guidelines for what is permitted, required and prohibited. Objections to principle-based or deontological ethics include the difficulty of applying highly general principles to specific cases, e.g.: Does treating persons as ends rule out physician-assisted suicide, or require it? Deontological ethics is generally contrasted to consequentialist ethics (Honderich, 1995).  
• According to consequentialist approaches, the rightness or wrongness of an action depends solely on its consequences. One should act in such a way as to bring about the best state of affairs, where the best state of affairs may be understood in various ways, e.g., as the greatest happiness for the greatest number of people, maximizing pleasure and minimizing pain or maximizing the satisfaction of preferences. A theory such as Utilitarianism (with its roots in the work of Jeremy Bentham and John Stuart Mill) is generally taken as the paradigm example of consequentialism. Objections to consequentialist ethics tend to focus on its willingness to regard individual rights and values as "negotiable." So, for example, most people would regard murder as wrong independently of the fact that killing one person might allow several others to be saved (the infamous sacrifice of an ailing patient to provide organs for several other needy patients). Similarly, widespread moral opinion holds certain values important (integrity, justice) not only because they generally lead to good outcomes, but in and of themselves.
• Virtue ethics focuses on moral character rather than action and behavior considered in isolation. Central to this approach is the question what ought we (as individuals, as scientists, as physicians) to be rather than simply what we ought to do. The emphasis here is on inner states, that is, moral dispositions and habits such as courage or a developed sense of personal integrity. Virtue ethics can be a useful approach in the context of RCR and professional ethics, emphasizing the importance of moral virtues such as compassion, honesty, and respect. This approach has also a great deal to offer in discussions of bioethical issues where a traditional emphasis on rights and abstract principles frequently results in polarized, stalled discussions (e.g., abortion debates contrasting the rights of the mother against the rights of the fetus).  
• The term 'an ethics of care' grows out of the work of Carol Gilligan, whose empirical work in moral psychology claimed to discover a "different voice," a mode of moral thinking distinct from principle-based moral thinking (e.g., the theories of Kant and Mill). An ethics of care stresses compassion and empathetic understanding, virtues Gilligan associated with traditional care-giving roles, especially those of women.  
• This approach differs from traditional moral theories in two important ways. First, it assumes that it is the connections between persons, e.g., lab teams, colleagues, parents and children, student and mentor, not merely the rights and obligations of discrete individuals that matter. The moral world, on this view, is best seen not as the interaction of discrete individuals, each with his or her own interests and rights, but as an interrelated web of obligations and commitment. We interact, much of the time, not as private individuals, but as members of families, couples, institutions, research groups, a given profession and so on. Second, these human relationships, including relationships of dependency, play a crucial role on this account in determining what our moral obligations and responsibilities are. So, for example, individuals have special responsibilities to care for their children, students, patients, and research subjects.  
• An ethics of care is thus particularly useful in discussing human and animal subjects research, issues of informed consent, and the treatment of vulnerable populations such as children, the infirm or the ill.  
• The case study approach begins from real or hypothetical cases. Its objective is to identify the intuitively plausible principles that should be taken into account in resolving the issues at hand. The case study approach then proceeds to critically evaluate those principles. In discussing whistle-blowing, for example, a good starting point is with recent cases of research misconduct, seeking to identify and evaluate principles such as a commitment to the integrity of science, protecting privacy, or avoiding false or unsubstantiated charges. In the context of RCR instruction, case studies provide one of the most interesting and effective approaches to developing sensitivity to ethical issues and to honing ethical decision-making skills.  
• Strictly speaking, casuistry is more properly understood as a method for doing ethics rather than as itself an ethical theory. However, casuistry is not wholly unconnected to ethical theory. The need for a basis upon which to evaluate competing principles, e.g., the importance of the well-being of an individual patient vs. a concern for just allocation of scarce medical resources, makes ethical theory relevant even with case study approaches.  
• Applied ethics is a branch of normative ethics. It deals with practical questions particularly in relation to the professions. Perhaps the best known area of applied ethics is bioethics, which deals with ethical questions arising in medicine and the biological sciences, e.g., questions concerning the application of new areas of technology (stem cells, cloning, genetic screening, nanotechnology, etc.), end of life issues, organ transplants, and just distribution of healthcare. Training in responsible conduct of research or "research ethics" is merely one among various forms of professional ethics that have come to prominence since the 1960s. Worth noting, however, is that concern with professional ethics is not new, as ancient codes such as the Hippocratic Oath and guild standards attest (Singer, 1986).
• Adams D, Pimple KD (2005): Research Misconduct and Crime: Lessons from Criminal Science on Preventing Misconduct and Promoting Integrity. Accountability in Research 12(3):225-240.
• Anderson MS, Horn AS, Risbey KR, Ronning EA, De Vries R, Martinson BC (2007): What Do Mentoring and Training in the Responsible Conduct of Research Have To Do with Scientists' Misbehavior? Findings from a National Survey of NIH-Funded Scientists . Academic Medicine 82(9):853-860.
• Bulger RE, Heitman E (2007): Expanding Responsible Conduct of Research Instruction across the University. Academic Medicine. 82(9):876-878.
• Kalichman MW (2006): Ethics and Science: A 0.1% solution. Issues in Science and Technology 23:34-36.
• Kalichman MW (2007): Responding to Challenges in Educating for the Responsible Conduct of Research, Academic Medicine. 82(9):870-875.
• Kalichman MW, Plemmons DK (2007): Reported Goals for Responsible Conduct of Research Courses. Academic Medicine. 82(9):846-852.
• Kalichman MW (2009): Evidence-based research ethics. The American Journal of Bioethics 9(6&7): 85-87.
• Pimple KD (2002): Six Domains of Research Ethics: A Heuristic Framework for the Responsible Conduct of Research. Science and Engineering Ethics 8(2):191-205.
• Steneck NH (2006): Fostering Integrity in Research: Definitions, Current Knowledge, and Future Directions. Science and Engineering Ethics 12:53-74.
• Steneck NH, Bulger RE (2007): The History, Purpose, and Future of Instruction in the Responsible Conduct of Research. Academic Medicine. 82(9):829-834.
• Vasgird DR (2007): Prevention over Cure: The Administrative Rationale for Education in the Responsible Conduct of Research. Academic Medicine. 82(9):835-837.
• Aristotle. The Nichomachean Ethics.
• Beauchamp RL, Childress JF (2001): Principles of Biomedical Ethics, 5th edition, NY: Oxford University Press.
• Bentham, J (1781): An Introduction to the Principles of Morals and Legislation.
• Gilligan C (1993): In a Different Voice: Psychological Theory and Women's Development. Cambridge: Harvard University Press.
• Glover, Jonathan (1977): Penguin Books.
• Honderich T, ed. (1995): The Oxford Companion to Philosophy, Oxford and New York: Oxford University Press.
• Kagan S (1998): Normative Ethics. Westview Press.
• Kant I (1785): Groundwork of the Metaphysics of Morals.
• Kant I (1788): Critique of Practical Reason.
• Kant I (1797): The Metaphysics of Morals.
• Kant I (1797): On a Supposed right to Lie from Benevolent Motives.
• Kuhse H, Singer P (1999): Bioethics: An Anthology. Blackwell Publishers.
• Mill JS (1861): Utilitarianism.
• Rachels J (1999): The Elements of Moral Philosophy, 3rd edition, Boston: McGraw-Hill.
• Regan T (1993): Matters of Life and Death: New Introductory Essays in Moral Philosophy, 3rd edition. New York: McGraw-Hill. The history of ethics.
• Singer P (1993): Practical Ethics, 2nd ed. Cambridge University Press.

The Resources for Research Ethics Education site was originally developed and maintained by Dr. Michael Kalichman, Director of the Research Ethics Program at the University of California San Diego. The site was transferred to the Online Ethics Center in 2021 with the permission of the author.

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This material is based upon work supported by the National Science Foundation under Award No. 2055332. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

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Improving the process of research ethics review

• Stacey A. Page   ORCID: orcid.org/0000-0001-6494-3671 1 , 2 &
• Jeffrey Nyeboer 3  

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Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.

Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.

Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.

Peer Review reports

Instances of research misconduct and abuse of research participants have established the need for research ethics oversight to protect the rights and welfare of study participants and the integrity of the research enterprise [ 1 , 2 ]. In response to such egregious events, national and international regulations have emerged that are intended to protect research participants (e.g. [ 3 , 4 , 5 ]).

Research Ethics Boards (REBs) also known as Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are charged with ensuring that research is planned and conducted in accordance with such laws and regulatory standards. In protecting the rights and welfare of participants, REBs must weigh possible harms to individuals against the plausible societal benefits of the research. They must ensure fair participant selection and, where applicable, confirm that appropriate provisions are in place for obtaining participant consent.

REBs often operate under the auspices of post-secondary institutions. Larger universities may support multiple REBs that serve different research areas, such as medical and health research and social science, psychology, and humanities research. Boards are constituted of people from a variety of backgrounds, each of whom contributes specific expertise to review and discussions. Members are appointed to the Board through established institutional practice. Nevertheless, most Board members bring a sincere interest and commitment to their roles. For university Faculty, Board membership may fulfil a service requirement that is part of their academic responsibilities.

The Canadian Tri-Council Policy Statement (TCPS2) advances a voluntary, self-governing model for REBs and institutions. The TCPS2 is a joint policy of Canada’s three federal research agencies (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council), and institutional and researcher adherence to the policy standards is a condition of funding. Recognizing the independence of REBs in their decision-making, institutions are required to support their functioning. Central to the agreement is that institutions conducting research must establish an REB and ensure that it has the “necessary and sufficient ongoing financial and administrative resources” to fulfil its duties (TCPS2 [ 3 ] p. 68). A similar requirement for support of IRB functioning is included in the US Common Rule (45 CFR 46.103 [ 5 ]). The operationalization of “necessary and sufficient” is subjective and likely to vary widely. To the extent that the desired outcomes (i.e. timely reviews and approvals) depend on the allocation of these resources, they too will vary.

Time and research ethics review

From the academic hallways to the literature, characterizations of REBs and the research ethics review process are seldom complimentary. While numerous criticisms have been levelled, it is the time to decision that is most consistently maligned [ 6 , 7 , 8 , 9 , 10 , 11 ].

Factors associated with lengthy review time include incomplete or poorly completed applications [ 7 , 12 , 13 ], lack of administrative support [ 14 ], inadequately trained REB members [ 15 ], REB member competing commitments, expanding oversight requirements, and the sheer volume of applications [ 16 , 17 , 18 ]. Nevertheless, objective data on the inner workings of REBs are lacking [ 6 , 19 , 20 ].

Consequences of slow review times include centres’ withdrawing from multisite trials or limiting their participation in available trials [ 21 , 22 ], loss of needed research resources [ 23 ], and recruitment challenges in studies dependent on seasonal factors [ 24 ]. Lengthy time to study approval may ultimately delay patient access to potentially effective therapies [ 8 ].

Some jurisdictions have moved to regionalize or consolidate ethics review, using a centralized ethics review of protocols conducted on several sites. This enhances review efficiency for multisite research by removing the need for repeating reviews across centres [ 9 , 25 , 26 , 27 , 28 ]. Recommendations for systemic improvement include better standardization of review practices, enhanced training for REB members, and requiring accreditation of review boards [ 9 ].

The research ethics review processes are not well understood, and no gold standard exists against which to evaluate board practices [ 19 , 20 ]. Consequently, there is little information on how REBs may systematically improve their methods and outcomes. This paper presents a model based on stakeholder responsibilities in the process of research ethics review and illustrates how each makes contributions to the time an application spends in this process. This model focusses on REBs operating under the auspices of academic institutions, typical in Canada and the USA.

Modelling the research ethics review process

The research ethics review process may appear to some like the proverbial black box. An application is submitted and considered and a decision is made:

SUBMIT > REVIEW > DECISION

In reality, the first step to understanding and improving the process is recognizing that research ethics review involves more than just the REB. Contributing to the overall efficiency—or inefficiency—of the review are other stakeholders and their roles in the development and submission of the application and the subsequent movement of the application back and forth between PIs, administrative staff, reviewers, the Board, and the Chair, until ideally the application is deemed ready for approval.

Identifying how a research ethics review progresses permits better understanding of the workflow, including the administrative and technological supports, roles, and responsibilities. The goal is to determine where challenges in the system exist so they can be remediated and efficiencies gained.

One way of understanding details of the process is to model it. We have used a modelling approach based in part on a method advanced by Ishikawa and further developed by the second author (JN) [ 29 , 30 ]. Traditionally, the Ishikawa “fishbone” or cause and effect diagram has been used to represent the components of a manufacturing enterprise and its application facilitates understanding how the elements of an operation may cause inefficiencies. This modelling provides a means of analysing process dispersion (e.g. who is accountable for what specific outcomes) and is frequently used when trying to understand time delays in undertakings.

In our model (Fig.  1 ), “Categories” represent key role actions that trigger a subsequent series of work activities. The “Artefacts” are the products resulting from a set of completed activities and reflect staged movement in the process. Implicit in the model is a temporal sequence and the passage of time, represented by the arrows.

Basic business activity model

Applying this strategy to facilitate understanding of time delays in ethics review requires that the problem (i.e. time) be considered in the context of all stakeholders. This includes those involved in the development and submission of the application, those involved in the administrative movement of the application through the system, those involved in the substantive consideration and deliberation of the application, and those involved in the final decision-making.

The model developed (Fig.  2 ) was based primarily on a review of the lead author’s (SP) institution’s REB application process. The model is generally consistent with the process and practices of several other REBs with which she has had experience over the past 20 years.

Research ethics activity model

What this model illustrates is that the research ethics review process is complex. There are numerous stakeholders involved, each of whom bears a portion of the responsibility for an application’s time in the system. The model illustrates a temporal sequence of events where, ideally, the movement of an application is unidirectional, left to right. Time is lost when applications stall or backflow in the process.

Stakeholders, accountabilities, and the research ethics review model

There are four main stakeholder groups in the research ethics review process: researchers/research teams, research ethics unit administrative staff, REB members, and the institution. Each plays a role in the transit of an application through the process and how well they undertake their role responsibilities affects the time that the application takes to move through. Table  1 presents a summary of recommendations for best practices.

Researchers

The researcher initiates the process of research ethics review by developing a proposal involving human participants and submitting an application. Across standards, the principal investigator is accountable for the conduct of the study, including adherence to research ethics requirements. Such standards are readily available both from the source (e.g. Panel on Research Ethics [Canada], National Institutes of Health [USA], Food and Drug Administration [USA]) and, typically, through institutional websites. Researchers have an obligation to be familiar with the rules for human participant research. Developing a sound proposal where ethics requirements are met at the outset places the application in a good position at the time of submission. Researchers are accountable for delays in review when ethical standards are not met and the application must be returned for revision. Tracking the reasons for return permits solutions, such as targeted educational activities, to be developed.

Core issues that investigators can address in the development of their applications include an ethical recruitment strategy, a sound consent process, and application of relevant privacy standards and legislation. Most research ethics units associated with institutions maintain websites where key information and resources may be found, such as consent templates, privacy standards, “frequently asked questions,” and application submission checklists [ 31 , 32 , 33 ]. Moreover, consulting with the REB in advance of submission may help researchers to prevent potentially challenging issues [ 15 ]. Investigators who are diligent in knowing about and applying required standards will experience fewer requests for revision and fewer stalls or backtracking once their applications are submitted. Some have suggested that researchers should be required, rather than merely expected, to have an understanding of legal and ethics standards before they are even permitted to submit an application [ 19 ].

The scholarly integrity of proposed research is an essential element of ethically acceptable human participant research. Researchers must be knowledgeable about the relevant scientific literature and present proposals that are justified based on what is known and where knowledge gaps exist. Research methods must be appropriate to the question and studies adequately powered. Novice or inexperienced researchers whose protocols have not undergone formal peer review (e.g. via supervisory committees, internal peer review committees, or competitive grant reviews) should seek consultation and informal peer review prior to ethics review to ensure the scientific validity of their proposals. While it is within the purview of REBs to question methods and design, it is not their primary mandate. Using REB resources for science review is an opportunity cost that can compromise efficient ethics review.

Finally, researchers are advised to review and proof their applications prior to submission to ensure that all required components have been addressed and the information in the application and supporting documents (e.g. consent forms, protocol) is consistent. Missing or discrepant information is causal to application return and therefore to time lost [ 7 ].

Administrators

Prior to submission, administrators may be the first point of contact for researchers seeking assistance with application requirements. Subsequently, they are often responsible for undertaking a preliminary, screening review of applications to make sure they are complete, with all required supporting documents and approvals in place. Once an application is complete, the administrative staff assign it to a reviewer. The reviewer may be a Board member or a subject-matter expert accountable to the Board.

Initial consultation and screening activities work best when staff have good knowledge of both institutional application requirements and ethics standards. Administrative checklists are useful tools to help ensure consistent application of standards in this preliminary application review. Poorly screened applications that reach reviewers may be delayed if the application must be returned to the administrator or the researcher for repair.

Reviewers typically send their completed reviews back to the administrators. In turn, the administrators either forward the applications to the Chair to consider (i.e. for delegated approval) or to a Board meeting agenda. In addition to ensuring that applications are complete, administrators may be accountable for monitoring how long a file is out for review. When reviews are delayed or incomplete for any reason, administrators may need to reassign the file to a different reviewer.

Administrators are therefore key players in the ethics review process, as they may be both initial resources for researchers and subsequently facilitate communication between researchers and Board members. Moreover, given past experience with both research teams and reviewers, they may be aware of areas where applicants struggle and when applications or reviews are likely to be deficient or delinquent. Actively tracking such patterns in the review process may reveal problems to which solutions can be developed. For example, applications consistently deficient in a specific area may signal the need for educational outreach and reviews that are consistently submitted late may provide impetus to recruit new Board members or reviewers.

REB members

The primary responsibility for evaluating the substantive ethics issues in applications and how they are managed rests with the REB members and the Chair. The Board may approve applications, approve pending modifications, or reject them based on their compliance with standards and regulations.

Like administrators, an REB member’s efficiency and review quality are enhanced by the use of standard tools, in this case standardized review templates, intended to guide reviewers and Board members to address a consistent set of criteria. Where possible, matching members’ expertise to the application to be reviewed also contributes to timely, good quality reviews.

REB functioning is enhanced with ongoing member training and education, yielding consistent, efficient application of ethics principles and regulatory standards [ 15 ]. This may be undertaken in a variety of ways, including Board member retreats, regular circulation of current articles, and attending presentations and conferences. REB Chairs are accountable to ensure consistency in the decisions made by the Board (TCPS 2014, Article 6.8). This demands that Chairs thoroughly understand ethical principles and regulatory standards and that they maintain awareness of previous decisions. Much time can be spent at Board meetings covering old ground. The use of REB decision banks has been recommended as a means of systematizing a record of precedents, thus contributing to overall quality improvement [ 34 ].

Institution

Where research ethics review takes place under the auspices of an academic institution, the institutions must typically take responsibility to adequately support the functioning of their Boards and promote a positive culture of research ethics [ 3 , 5 ]. Supporting the financial and human resource costs of participating in ongoing education (e.g. retreats, speakers, workshops, conferences) is therefore the responsibility of the institution.

Operating an REB is costly [ 35 ]. It is reasonable to assume that there is a relationship between the adequacy of resources allocated to the workload and flow and the time to an REB decision. Studies have demonstrated wide variability in times to determination [ 8 , 9 , 10 , 22 ]. However, comparisons are difficult to make because of confounding factors such as application volume, number of staff, number of REB members, application quality, application type (e.g. paper vs. electronic), and protocol complexity. Despite these variables, it appears that setting a modal target turnaround time of 6 weeks (±2 weeks) is reasonable and in line with the targets set in the European Union and the UK’s National Health Service [ 36 , 37 ]. Tracking the time spent at each step in the model may reveal where applications are typically delayed for long periods and may be indicative of areas where more resources need to be allocated or workflows redesigned.

As institutions grow their volumes of research, workloads correspondingly increase for institutional REBs. To maintain service levels, institutions need to ensure that resources allocated to REBs match the volume and intensity of work. Benchmarking costs (primarily human resources) relative to the number of applications and time to a decision will help to inform the allocation of resources needed to maintain desired service levels.

Finally, most REB members typically volunteer their Board services to the institution. Despite their good-faith intent to serve, Board members occasionally find that researchers view them as obstacles to or adversaries in the research enterprise. Board members may believe that researchers do not value the time and effort they contribute to review, while researchers may believe the REB and its members are unreasonable, obstructive, and a “thorn in their side” [ 15 ]. Clearly, relationships can be improved. Nevertheless, improving the timeliness and efficiency of research ethics review should help to soothe fevered brows on both sides of the issue.

Upshur [ 12 ] has previously noted that the contributions to research ethics such as Board membership and application review need to be accorded the same academic prestige as serving on peer review grant panels and editorial boards and undertaking manuscript reviews. In doing so, institutions will help to facilitate a culture of respect for, and shared commitment to, research ethics review, which may only benefit the process.

The activities, roles, and responsibilities identified in the ethics review model illustrate that it is a complex activity and that “the REB” is not a single entity. Multiple stakeholders each bear a portion of the accountability for how smoothly a research ethics application moves through the process. Time is used most efficiently when forward momentum is maintained and the application advances. Delays occur when the artefact (i.e. either the application or the application review) is not advanced as the accountable stakeholders fail to discharge their responsibilities or when the artefact fails to meet a standard and it is sent back. Ensuring that all stakeholders understand and are able to operationalize their responsibilities is essential. Success depends in part on the institutional context, where standards and expectations should be well communicated, and resources like education and administrative support provided, so that capacity to execute responsibilities is assured.

Applying this model will assist in identifying activities, accountabilities, and baseline performance levels. This information will contribute to improving local practice when deficiencies are identified and solutions implemented, such as training opportunities or reduction in duplicate activities. It will also facilitate monitoring as operational improvements over baseline performance could be measured. Where activities and benchmarks are well defined and consistent, comparisons both within and across REBs can be made.

Finally, this paper focused primarily on administrative efficiency in the context of research ethics review time. However, the identified problems and their suggested solutions would contribute not only to enhanced timeliness of review but also to enhanced quality of review and therefore human participant protection.

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Acknowledgements

The authors would like to thank Dr. Michael C. King for his review of the manuscript draft.

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The listed authors (SP, JN) have each undertaken the following: made substantial contributions to conception and design of the model; been involved in drafting the manuscript; have read and given final approval of the version to be published and participated sufficiently in the work to take public responsibility for appropriate portions of the content; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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SP is the Chair of the Conjoint Health Research Ethics Board at the University of Calgary. She is also a member of the Human Research Ethics Board at Mount Royal University and a member of the Research Ethics Board at the Alberta College of Art and Design. She serves on the Board of Directors for the Canadian Association of Research Ethics Boards.

JN is an Executive Technology Consultant specializing in Enterprise and Business Architecture. He has worked on process improvement initiatives across multiple industries as well as on the delivery of technology-based solutions. He was the project manager for the delivery of the IRISS online system for the Province of Alberta’s Health Research Ethics Harmonization initiative.

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Page, S.A., Nyeboer, J. Improving the process of research ethics review. Res Integr Peer Rev 2 , 14 (2017). https://doi.org/10.1186/s41073-017-0038-7

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Research ethics board approval: What, why, when, how?

At the BC Medical Journal , we often receive submissions from clinicians who want to share their findings, but they aren’t sure how to approach the subject of research ethics. Here is a brief summary for our readers and prospective authors.

What is a research ethics board?

Research ethics boards (REBs) are “autonomous entities whose primary responsibility is to protect the rights and welfare of human participants taking part in research.”[ 1 ] They can also help to ensure that research is of high quality and is clinically important.[ 2 ] The University of British Columbia has several such boards, including Children’s and Women’s, BC Cancer, Providence Health Care, and the UBC Clinical Research Ethics Board. These committees are composed of individuals from varied backgrounds such as physicians, scientists, researchers, ethicists, and community members. There are also private for-profit ethics boards, which adhere to the same principles and are selected by some researchers for expediency or if the researchers are not affiliated with a university.

Why is research ethics approval necessary?

Involuntary studies on human subjects in the past have had horrendous consequences. The Nuremberg trials exposed the “scientific” evils of the Nazi regime and resulted in the creation of the Nuremberg Code in 1947.[ 3 ] Unfortunately, around the world, including in North America, there were many subsequent occurrences of atrocities committed in the name of research. The World Medical Association Declaration of Helsinki (1964, last updated 2013) was created to further address the ethics and safety of human research and its application to special populations.[ 4 ]

Today, the standards for research involving humans adhere to the Tri-Council Policy Statement (TCPS2 2018), which is a product of Canada’s three federal research agencies.[ 5 ] Applications to UBC’s REBs require all team members to have completed a tutorial on the Tri-Council Policy Statement.[ 6 ] The key principle is informed consent, where research participants are fully informed about the potential risks and benefits of the study.

When does a study need research ethics board approval?

In Canada, any research study involving human participants, human tissue, or human data requires research ethics board approval before commencement. If you are undertaking a quality improvement project, it does not require REB oversight. However, it is important to note that REBs cannot review research that has already been done; if there is any doubt about your project constituting research, it is best to consider the intention of the project before beginning. A sorting tool, available on the PHSA website, can be a helpful first step ( https://rc.bcchr.ca/redcap/surveys/?s=HNWAAKFF97 ). If research ethics appear to be required or you are uncertain, contact your local REB.

At the BCMJ , we also receive submissions of quality improvement projects that have been written up for publication. For example, a medical student was supervised by an attending physician to perform a review of treatment times for different diagnoses in the emergency department. This study represents a retrospective chart review, which involved collecting patient data, de-identifying the information, and analyzing the results. Depending on the nature and specifics of the project, the BCMJ may ask the principal investigator to seek confirmation from a local REB that the project was, in fact, quality improvement and, therefore, did not require REB oversight. If the research would have required REB approval, it cannot be granted retrospectively; therefore, the submission would not be accepted for publication.

How can researchers obtain ethics approval?

Research ethics boards have a standardized application process. UBC uses an online platform called Research Information Systems (RISe) to track applications, amendments, and annual renewals. Ethics boards generally allow for two levels of review depending on the type of study: delegated review (subcommittee review of studies deemed minimal risk) and full review (anything beyond minimal risk). The timeline for review and approval can vary due to committee schedules and the number of revisions required, but it may take anywhere from days to months. Researchers affiliated with UBC can get started at www.rise.ubc.ca/guidance-notes-and-tutorials .

Acknowledgments

Dr Dunne would like to thank Ms Jennie Prasad and Dr Marc Levine of the BC Women’s and Children’s Hospital Research Ethics Board for their editorial input on this article. —Caitlin Dunne, MD, FRCSC

1.    UBC Office of Research Ethics. UBC clinical research ethics general guidance notes. Accessed 22 March 2021. https://ethics.research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes#A1 .

2.    Hyer CF. What is an IRB, why do we need it, and what is a private IRB? Foot Ankle Spec 2010;3:91-94.

3.    Shuster E. Fifty years later: The significance of the Nuremberg Code. N Engl J Med 1997;337:1436-1440.

4.    World Medical Association. World Medical Association declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013;310:2191-2194.

5.    Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council. Tri-Council policy statement ethical conduct for research involving humans. 2018. Accessed 21 March 2021. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf .

6.    Panel on Research Ethics. TPS2: CORE – tutorial. Accessed 21 March 2021. http://tcps2core.ca/welcome .

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Ethics reviews - ESRC

Introduction.

All ESRC-funded research should benefit from appropriate ethics review. Such review exists to support the ethical aspects of high-quality research, to help researchers reach high standards, and to support and protect all the parties involved in research. Ethics scrutiny should assess the risks and benefits of a project, consider the balance between, and take a proportionate view of whether risks which cannot be eliminated may or may not be justified.

It is the responsibility of the researcher – guided by standards set by their professional society, disciplinary body and research organisations (ROs) – to determine the type of review that is required. However, the relevant research ethics committee (REC) is expected to ensure that the appropriate ethics review is undertaken, and the RO is expected to ensure that research will not proceed without securing the appropriate level of review.

The review body (for example,  principal REC, secondary REC, or NHS REC) will be determined by the issues raised by the research, the nature of the data to be obtained and the population of participants to be included in the project. This will apply to both single-discipline research and interdisciplinary research, especially where social and biomedical scientists are working together.

Light-touch review

A light-touch review, when fully justified, identifies those projects where the actual or potential risk or harm to participants (and others affected by the proposed research) is minimal.

Light-touch reviews can be delegated by a principal REC, but at a minimum a REC sub-committee will monitor all proposals including those of students. Many student projects may require only a light-touch review, however this cannot be assumed. Projects, including student projects, which involve more than minimal risk should receive a full REC review.

Some RECs have facilitated ethics review by establishing ethics protocols for commonly occurring situations with potentially vulnerable participants – for example, research undertaken with typically developing children in mainstream school settings.

If the researcher can confirm that they are following an established protocol which has had full ethics review, and that this is appropriate for their research, a light-touch review may be justified. The use of these protocols can limit the number of research proposals that need to go to a full ethics review.

Expedited review

Expedited review (full ethics review that is conducted quickly and at short notice) may be appropriate in exceptional circumstances where research projects require a full review but have a short lead time and are commissioned in response to a demand of pressing importance.

Most RECs only permit expedited review in exceptional and clearly justified cases. Such exceptions may include external drivers which are outside the control of the researcher (for example,  access to a sample) where ethics clearance is required within a short timescale, or perhaps when fieldwork is linked to a particular event or period.

An expedited review should meet the criteria required for a full review, and must not be carried out by REC members who are in a position of dependence with the applicant that could be perceived as a conflict of interest.

This framework provides examples of research that would normally require a full ethics review, because it will entail more than minimal risk. It is likely that much research activity will require full ethics review, and methods such as further analysis of data are not necessarily exempt from full review.

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How Do We Protect Trust in Science? Lessons from Inquiry with Integrity

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As instances of plagiarism and academic misconduct have hit the headlines, the academy has to ask: How do we ensure public trust in science? The McCoy Family Center for Ethics in Society and the Stanford Center for Biomedical Ethics “Inquiry with Integrity” panel took place against the backdrop of recent academic scandals to tackle this question. Panelists were clear that science needs a structural shift – but what might this shift look like, and what solutions can we offer?

Research Quality Over Quantity

The first panelist to present, Elisabeth Bik, is an independent science integrity consultant who searches academic papers for errors and manipulation to report them to journals. She got her start when she found a paper that plagiarized her own work, leading her to leave her role as a researcher at Stanford School of Medicine to pursue academic integrity investigation full-time. In searching for errors in papers, Bik works like a detective – carefully comparing images side-by-side to look for repeated patterns indicative of oversight, careless handling of data, or, worse, intentional manipulation. According to her blog, Science Integrity Digest, her work has led to over a thousand retractions as of November 2023 .

Bik discussed common circumstances that lead to misconduct. She believes that there’s a low risk and a high reward for publishing flawed results that disincentivize academics from regarding data integrity. Because publishing requirements can be demanding, many researchers feel high pressure to deliver impactful results on a speedy turnaround. At this pace, researchers may deprioritize careful data handling or even turn to intentional manipulation. Once these erroneous results are published, consequences may be minimal. In Bik’s experience, scientific journals can be slow to print corrections or retractions and, in most cases, do not take action at all. “It definitely seems to be very profitable to cheat in science because the chances of getting caught or having any repercussions are very small, with some exceptions, ” said Bik. She proposed that academia change what it expects of researchers and that we focus on the quality of research and not the quantity. “But it takes the role of everybody involved in science to do that.”

Accountability and Transparency

Taking the stage next was Holden Thorp, editor-in-chief of Science journals and former chancellor of UNC Chapel Hill. The most important piece of integrity, he argued, is how we respond to mistakes. Presiding over the university’s response to its academic-athletic scandal, he learned that prompt accountability and transparency from the institution are absolutely essential, even though they may be an unfortunate rarity. Now, in his role as editor-in-chief of Science journals, he believes that the biggest obstacle to integrity is the stigma of correcting mistakes. Because there is such a high volume of academic work, errors are inevitable. Instead of focusing on punishing scientists who make mistakes, we need to encourage them to fix them. “We need to lower the stigma associated with correcting papers,” said Thorp, “correction is courageous." He believes that correcting papers quickly is key to protecting public trust in science and that getting bogged down in questions of blame only slows us down. “As long as we're talking about who contributed and who didn’t, we’re not solving it.”

Rethinking “Good Science”

Ruth O’Hara, the final panelist, feels that "We need to build a culture that emphasizes rigor and reproducibility." O’Hara is the Senior Associate Dean of Research at Stanford School of Medicine. She, like Thorp, spoke about changing the culture of scientific inquiry. She proposed reorienting academic culture away from prestige and changing how we think about "good science." She argued that science needs to recognize more than just the flashiest work with the biggest impact and agreed with Bik that science ought to focus primarily on producing quality results rather than a large quantity of results. For O’Hara, quality work means work that is thorough and reproducible.

Ultimately, O’Hara believes that everyone in academia has a role in changing the culture. For example, one symptom of high pressure in academia is the tendency for faculty members to spread themselves too thin. Because there is such high pressure to deliver a large quantity of results, faculty members feel the need to take on more Ph.D. students and postdocs than they have time to oversee adequately. She believes that building a culture of rigor may mean scaling back the size of their labs so that they can be sufficiently involved in day-to-day operations. “That’s a thorny problem and one we have to address,” said O’Hara.

The Ethics and Society Review: One Way to Shift the Culture

As our panelists discussed, changing the culture of research is complicated. It requires individuals, institutions, and systems to change. And it requires intentionality and accountability throughout the research process. The McCoy Ethics Center’s Ethics and Society Review (ESR) project, developed in partnership with the Stanford Institute for Human-Centered Artificial Intelligence (HAI), presents a promising model for reorienting the academy to prioritize ethics in research. In order to catch ethical issues at the earliest stage possible, the ESR prompts researchers to stop and consider the societal impacts of their projects from the outset. Evaluation of the ESR is ongoing, but preliminary results are promising – a majority of interviewed researchers said they would submit to the ESR again voluntarily . The ESR offers one way of bringing ethics and integrity to the forefront of the research process.

All told, panelists raised many important questions about how we can meet the ideals of scientific inquiry. Fundamentally, the goal of science is the pursuit of truth, but the practical problems of human error, pressure to deliver results, and aversion to correcting errors can prevent us from reaching that goal. There are still more questions than answers, but transparency, rigor, reproducibility, and open dialogue are solid ways to start working toward solutions.

To learn more about the challenges and potential solutions of research integrity, watch the full Inquiry with Integrity panel recording .

Ellie Jordan Vela is a Master’s student in computer science at Stanford University, studying how technology produces power and inequality. On the rare occasions when they’re not doing coursework or research with the Ethics in Society Review, you can find them spending time with their partner or working on their technique at the drum set.

Multi-jurisdictional research and research ethics review

In January 2023, a new version of the TCPS2 was released resulting in changes to Chapter 8: Multi-Jurisdictional research for researchers in collaborative partnerships . REBs affiliated with an institution eligible to receive and administer Tri-Agency funds are encouraged to adopt a model of single ethics review for multi-jurisdictional research that is deemed to be minimal risk. 

The Research Ethics Boards at the University of Waterloo have adopted the recommendation. Waterloo's multi-jurisdictional single review model for minimal risk research began on March 18, 2024. Although the single REB review model is recommended, it is not required. Other institutional REBs may choose to not participate in the single REB review model. 

Regardless of where the research is conducted, and which REB reviewed the research, researchers must remember the responsibility for the ethical conduct of the study remains with the researchers and their institutions (i.e., reviewer REB's institution and non-reviewing REB's institution). 

Is my research a multi-jurisdictional project? 

Multi-jurisdictional projects must meet one or more of the following criteria: 

• The research team includes investigators (i.e., faculty, staff, students) affiliated with a non-University of Waterloo institution. 
• Members of the research team hold multiple institutional affiliations.
• The research project involves combining data from several projects independently conducted by investigators affiliated with different institutions into one overall project. 
• The research involves collecting data or recruiting participants at different institutions using the institution's resources (e.g., email lists, space). 
• The research requires collaborating with a community, non-Waterloo institution, or organization (e.g., local schools, hospital, public health, Indigenous community). 

Is my research eligible for a single REB review? 

The following criteria must be met for a REB to conduct a single review for multi-jurisdictional research:

• The research is defined as minimal risk research . More than minimal risk studies are not eligible for single REB review, unless an official REB review agreement is in place between those institutions.
• NSERC – list of eligible institutions
• SSHRC – list of eligible institutions
• CIHR – list of eligible institutions

What do I need to do if I am the lead Principal Investigator (PI)? 

• Contact Research Ethics  to discuss your study and things to consider for a single REB review according to Chapter 8 , TCPS2. Research Ethics will confirm the risk level with the other REB(s) and send you further instructions, if needed.
• Name all non-Waterloo collaborators in the external investigator section.
• Name all the locations and institutions in the study sites section and include REB contact information, if known. 
• Single REB review is recommended, not required. The other REB(s) may decline participating in the single REB model. 

What do I need to do if I am NOT the lead Principal Investigator (PI)? 

• Name of lead PI and their institution
• Name of reviewing REB and contact information
• Title of study and REB # from the reviewing REB
• Your role in the study
• Research Ethics will confirm the risk level with the reviewing REB and send you instructions for what you need to do to allow Waterloo to document and accept the reviewing REB's review. 
• Single REB review for multi-jurisdictional minimal risk research is only possible if the reviewing REB is affiliated with an institution eligible to administer Tri-agency funds. 

Frequently asked questions

Question : How do I determine if I am the lead PI on the study?

Response: The lead PI is often named in the grant as the lead Principal Investigator for the research team. Typically, the lead PI's institution will receive funding for the project. If you are not sure if you are the lead PI, please contact Research Ethics .

Question: I am working with investigators in a country outside of Canada who have received ethics clearance from their institutions. Does this qualify for a single REB review? 

Response: The reviewing REB must be affiliated with an institution eligible to receive and administer Tri-Agency funds. If the University of Waterloo is the reviewing REB, a single REB review may be possible. Contact Research Ethics to discuss next steps. 

Question:   I am working with a researcher at another institution on a multi-jurisdictional project. We will receive a sub-grant for students to address particular objectives in the research and for thesis work. Can a multi-jurisdictional review be facilitated?

Response: Discuss with the lead investigator what their ethics application will cover, then contact Research Ethics to discuss. 

March 15, 2024

Mediating Role of Cultural Values in the Impact of Ethical Ideologies on Chinese Consumers’ Ethical Judgments

• Original Paper
• Open access
• Published: 24 March 2024

Cite this article

You have full access to this open access article

• Ricky Y. K. Chan 1 ,
• Piyush Sharma   ORCID: orcid.org/0000-0002-6953-3652 2 ,
• Abdulaziz Alqahtani 2 , 3 ,
• Tak Yan Leung 4 &
• Ashish Malik 5  

This paper develops and tests a new conceptual model incorporating the indirect impact of two ethical ideologies (idealism and relativism) on Chinese consumers’ ethical judgments under four ethically problematic consumption situations (active benefit, passive benefit, deceptive practice, and no/indirect harm) through two cultural values (integration and moral discipline). Data from a large-scale online consumer survey in five major Chinese cities ( N  = 1046) support most hypotheses. The findings are consistent with the postulated global impact of ethical ideology on forming an individual’s beliefs and values and highlight the importance of a thorough understanding of the significant determinants of consumer ethics to promote ethically responsible consumption behaviors. This study also uses an emic approach to conceptualize and measure Chinese cultural values by using cultural constructs and measures that are designed explicitly in the Chinese context.

Avoid common mistakes on your manuscript.

Introduction

The moral principles that guide consumer behaviors in the consumption process have received much attention from academics and practitioners in the last couple of decades, which has resulted in the emergence of consumer ethics as an important research discipline (Chowdhury, 2019 ; Hassan et al., 2021 ; Ozgen & Esiyok, 2020 ; Vitell, 2015 ). Several studies examine consumer ethics from an international business and cross-national perspective (e.g., Lim et al., 2019 ; Summers, 2016 ; Summers & Van Heuvelen, 2017 ), but most of these focus on the developed markets in Europe and North America, with limited attention to the emerging markets from Asia (Arunachalam et al., 2020 ; Lim et al., 2019 ; Sharma et al., 2018 ).

Many studies also explore the impact of factors that may influence consumers’ beliefs of what constitutes right or wrong consumption practices (e.g., individual-level or personal factors) on the consumers’ ethical behaviors. These personal factors may include religiosity (Arli et al., 2021 ; Huang & Lu, 2017 ), attitude toward business (Fukukawa & Ennew, 2010 ; Koay et al., 2020 ; Lu et al., 2015 ), materialism (Chowdhury & Fernando, 2013 ; Ozgen & Esiyok, 2020 ), spirituality (Vitell et al., 2015 ), Machiavellianism (Arli et al., 2019 ), ethical beliefs (Cheung & To, 2021 ), and ethical ideology (Arli & Pekerti, 2016 ; Lu & Lu, 2010 ; Zaikauskaite et al., 2020 ). Overall, these studies have revealed varying degrees of influence of all these factors on different ethically questionable consumption practices based on the perceived ethicality of the practice in question.

Among all the above individual-level factors, ethical ideology appears to be the most logical determinant of consumers’ responses toward ethically questionable consumption practices because it refers to individuals’ most basic moral philosophy that guides their judgment on moral issues of various kinds (Chen & Moosmayer, 2020 ; Chowdhury, 2019 ; Forsyth, 1980 , 1992 ). In other words, it serves as the ultimate arbiter of individual responses toward circumstances having ethical overtones (Culiberg, 2015 ; Forsyth et al., 2008 ). Given its global impact on individual responses across various ethics-laden situations, ethical ideology is thus expected to influence how consumers perceive and respond to potentially unethical consumption situations (Chowdhury, 2019 ).

In addition to ethical ideology, prior research also uses Hofstede’s national cultural values, particularly the individualism/collectivism dimension, to examine how culture affects individuals’ responses to different types of ethically questionable consumer practices (e.g., Culiberg, 2015 ; Swaidan, 2012 ). Most of these studies show that collectivist (vs individualist) consumers are less tolerant of unethical practices (e.g., Huang & Lu, 2017 ). Notwithstanding the popularity of Hofstede’s national cultural values framework, these dimensions were developed based on the Western cultural lens, which has raised concerns about their validity when applied to other socio-cultural settings, such as China (e.g., Chen & Moosmayer, 2020 ; Cheung & To, 2021 ; Huang and Wen 2021 ), India (Gillani et al., 2021 ), and other parts of the world (Bürgin & Wilken, 2021 ). These concerns suggest the need for researchers to adopt an emic approach to harness specifically developed constructs and measures to better represent the unique socio-cultural setting under investigation.

Despite the important roles played by ethical ideology and culture in consumer ethics, it is surprising to note that previous studies seldom include both factors in their analysis at the same time. Of these studies, Culiberg ( 2015 ) and Smith ( 2009 ) appear to be two exceptions. Even so, these two studies only treat ethical ideology and culture as two unrelated immediate antecedents of consumer ethics. Specifically, when studying the determinants of consumers’ responses toward various ethically questionable practices, Culiberg ( 2015 ) has treated both ethical ideology and collectivism as two independent determinants that, respectively, exert a direct impact on these responses. Similarly, Smith ( 2009 ) has focused only on the respective direct effect of ethical ideology and major cultural values on an individual’s ethical intention across different ethically problematic scenarios.

When examined more closely, this direct approach does not seem to be conceptually grounded. According to system justification theory (Jost et al., 2008 ), ideologies reflect an individual’s unconscious motivational processes. They comprise sets of basic beliefs or philosophies attributed to an individual or a group of individuals (Jost & Hunyady, 2003 ). They are some pre-packaged units of interpretation that function because of basic human motives to understand the world, avoid an existential threat, and maintain valued interpersonal relationships. These motives will consequently lead to individuals’ adoption of system-justifying worldviews or ideologies to make sense of the world around them, thus shaping how they interpret and interact with their environment and other people (Jost et al., 2008 ). In short, given the fundamental nature of ideologies, they are likely to be universal or culture-free by nature.

Alongside this theoretical perspective, Clark ( 2002 ), in her manuscript titled In Search of Human Nature , has further conceptualized the worldviews or ideologies as the shared values and assumptions that set the ground rules for culture. Subsequent researchers also echo this conceptualization by maintaining that ideologies inform and shape cultural values and constitute the soil from which these values are nurtured (Feijs et al. 2008 ). Overall, this foregoing literature suggests that ideologies are not only likely to be culture-free, but also likely to affect culture. This analysis furnishes new insights into the relationship between ideologies and cultural values, instead of each exerting a respective impact on individuals’ responses toward a particular issue. It is plausible that ideologies do indeed serve as an ultimate antecedent of these responses via the mediator of cultural values. Within the context of consumer ethics, the above discussion points to the possibility that cultural values may mediate the influence of ethical ideology on individuals’ responses toward ethically questionable consumption practices.

Despite its theoretical plausibility, the posited mechanism of ‘ethical ideology → cultural value → consumer ethical judgment’ is yet to be empirically tested. Hence, to fill this research gap and to advance understanding of the socio-psychological mechanism underlying consumers’ ethical decision-making process, the present study is undertaken to empirically test the mechanism. Given the marked differences between the Chinese and Western cultures (Scarborough, 1998 ; Varnum et al., 2010 ), understanding how unique Chinese (i.e., Confucian) cultural values may relate to individuals’ fundamental ethical ideologies and consequently affect their judgments on ethically questionable consumption practices are deemed to be academically important. This academic importance becomes even more apparent when judged against the prevalence and heavy influence of Confucian cultural values within the entire East Asian region, which accounts for around 20% of the world’s population (Wang et al., 2018 ). A better understanding of the socio-psychological mechanism underlying the ethical responses of this vast group of consumers constitutes a valuable addition to the extant consumer ethics literature, which is still largely dominated by research conducted within a Western cultural context (Hassan et al., 2021 ).

As the software of the mind (Hofstede, 1994 ), culture has long been conceived as an immediate driver for individual conative and behavioral responses. Due to culture’s deep-rootedness, earlier anthropologists such as Hall ( 1966 , p. 188) has also maintained that “people cannot act or interact in any meaningful way except through the medium of culture.” Empirical findings from the present study help verify all these classical premises about culture. To address the aforementioned concerns about employing Hofstede’s cultural dimensions to a unique socio-cultural setting, this study adopts an emic approach by choosing two specific Chinese cultural values, integration and moral discipline for investigation. Of all the major Chinese cultural values, both integration and moral discipline are strongly correlated with collectivism (Chinese Culture Connection, 1987 ). Given that collectivism affects ethical decision-making more than other cultural dimensions (Huang & Lu, 2017 ; Husted & Allen, 2008 ), this choice is thus considered appropriate.

Being the largest emerging economy that has experienced tremendous economic achievements over the past four decades, China is undoubtedly important for both domestic and foreign firms (Chan & Ma, 2016 ). To help cultivate an ethically responsible culture and promote sustainable corporate development by creating a more harmonious and fairer marketplace for businesses and consumers, we need to understand the major determinants of consumer ethics in China (Chen & Moosmayer, 2020 ). Moreover, the Confucian cultural values are quite prevalent and influential in East Asia that comprises highly developed countries/regions, such as Japan, South Korea, Hong Kong, and Macau (Chung et al., 2008 ). This suggests the applicability of the present findings to these countries/regions too. As these countries/regions are among the world’s most prosperous economies that account for up to 30% of the world’s gross domestic product (International Monetary Fund, 2020 ), the heavy influence of Chinese cultural values further points to the practical value of this study. Lastly, because of the foregoing concerns over the validity issue of using Hofstede’s cultural value measures developed from a Western cultural perspective, from a theoretical contribution perspective, this study also makes contributions by employing measures specifically designed for assessing Chinese cultural values to enhance the rigor and relevance of the analysis.

Literature Review

Ethical ideologies.

Ethical ideology refers to individuals’ most basic moral philosophy that guides their judgment on moral issues of various kinds (Chen & Moosmayer, 2020 ; Forsyth, 1980 ). It reflects individual variations in ethical decisions and comprises two dimensions, idealism and relativism (Forsyth, 1992 ). Idealism is the extent to which people believe that desirable outcomes can always be achieved through ethically right actions. It is based on altruism and concern for the welfare of others. Individuals high on idealism believe that inherent rightness or wrongness exists for an ethical issue and that harming others is always avoidable (Forsyth, 1980 ). As regard relativism, it is the extent to which people reject universal ethical rules when making ethical decisions (Forsyth, 1980 ). Individuals high on relativism reject universal moral absolutes and believe that ethical decisions should depend on circumstances or on the trade-off between the potential benefits and harms of the ethical issue at stake (Hunt & Vitell, 1986 ). Overall, idealism and relativism can be conceived as two basic moral philosophies for individuals to make ethical judgments, and, respectively, stem from deontological and teleological schools of thought (Barnett et al., 1996 ; Forsyth, 1992 ). These moral philosophies serve as the ultimate arbiter of individual responses toward ethics-laden situations (Culiberg, 2015 ) and constitute the basis for forming an individual’s attitudes, beliefs, and values (Forsyth, 1980 ). On this basis, these ideologies are thus expected to directly influence Chinese people’s cultural values, such as integration and moral discipline. A more detailed rationale behind the influence of ethical ideology on cultural values will be further discussed in the hypothesis development section below.

Cultural Values

Culture is defined as “the collective programming of the human mind that distinguishes the members of one human group from those of another” and it refers to a system of collectively held values (Hofstede, 1980 , p. 25). These cultural values are important beliefs and norms commonly conceived by members of a society that can affect various aspects of members’ behavior (Hofstede, 1980 ; Rokeach, 1973 ). In the ethics literature, cultural values are regarded as one of the most important variables influencing ethical decision-making (Ralston et al., 1994 ). Given the popularity of Hofstede’s ( 1980 , 1994 ) cultural value dimensions, previous researchers often use these to conduct investigation involving cultural values of Chinese consumers (e.g., Elliott & Tam, 2014 ; Hur et al., 2015 ; Ramasamy & Yeung, 2008 ). Such use is not uncommon in prior investigation specifically on the relationship between Chinese cultural values and consumer ethics too (e.g., Huang & Lu, 2017 ).

Despite the popularity of Hofstede’s cultural value dimensions, the fact that measures of these dimensions were developed from the Western cultural perspective, as mentioned, has raised concerns about if these measures could accurately reflect other distinctive non-Western cultural singularities (Laleman et al., 2015 ). These concerns are particularly heightened among researchers studying cultural values in China (Bond, 1996 ; Wong & Lau, 2001 ) and India (Malik & Pereira, 2015 , 2016 ; Pereira & Malik, 2015 ). Relating specifically to the investigation of Chinese cultural values, a group of researchers known collectively as the Chinese Culture Connection ( 1987 ) has adopted an emic approach to developing measurement items to capture cultural values within the setting of a Chinese social value system that is derived from the Confucian ethos (Ackerman et al., 2009 ; Lu et al., 1999 ; Ramasamy et al., 2010 ).

Based on this emic approach and a large-scale cross-cultural survey, the Chinese Culture Connection ( 1987 ) identifies four Chinese cultural value (CVS) dimensions, namely integration, moral discipline, human-heartedness, and Confucian work dynamism. Integration reflects a cultural value that emphasizes social stability through promoting harmony, solidarity, and inclusion with others, whereas moral discipline refers to moral restraint and how individuals exercise their self-control. Human-heartedness is concerned with the values of how individuals handle things with compassion, whereas Confucian work dynamism is concerned with Confucian work ethics that preserves such virtues as persistence and thrift. (Chinese Culture Connection, 1987 ; Wong & Lau, 2001 ). Subsequently, this CVS instrument has been used in studies examining Chinese cultural values in diverse contexts, such as consumer research (Ackerman et al., 2009 ; Lu et al., 1999 ; Ramasamy et al., 2010 ) and even hospitality and tourism (Tsang, 2011 ; Wong & Lau, 2001 ).

Of the four CVS dimensions, integration and moral discipline are regarded as tapping into a more fundamental Chinese cultural dimension, namely collectivism (Chinese Culture Connection, 1987 ), as evident from their strong correlations with collectivism ( r  = 0.65 and 0.54, respectively). In addition, the limited prior research on the respective influence of ethical ideology and cultural values on consumer ethics has invariably chosen collectivism as a representative cultural value for analysis (Culiberg, 2015 ; Smith, 2009 ). Similarly, ethics researchers also contend that collectivism affects ethical decision-making more than other cultural values (Huang & Lu, 2017 ; Husted & Allen, 2008 ). Therefore, in view of the dominance of collectivism within the Chinese culture and for a parsimonious conceptual model, this study focuses on the two collectivism-related cultural values (i.e., integration and moral discipline) for an investigation to see how they may influence Chinese consumers’ responses to various ethically questionable consumption practices.

Ethically Questionable Consumption Practices

In their seminal study, Muncy and Vitell ( 1992 , p. 298) define consumer ethics as “the moral principles and standards that guide the behavior of individuals or groups as they obtain, use, and dispose of goods or services.” Muncy and Vitell ( 1992 ) further propose four types of ethically questionable consumption practices and develop a consumer ethics scale to operationalize these practices in the same study. These practices are (1) consumers’ actively benefiting from illegal activities (ACTIVE BENEFIT) (e.g., changing the labels of goods in a store); (b) consumers’ passively benefitting from questionable activities (PASSIVE BENEFIT) (e.g., remaining silent when receiving excessive change); (c) consumers’ actively benefiting from deceptive but legal activities (DECEPTION) (e.g., using a coupon for merchandise that consumers do not buy); and (d) engaging in no harm and no foul activities (NO HARM) (e.g., returning goods that consumers do not like after use). When examined more carefully, these practices are based on three criteria, including a) actively or passively seeking benefits, b) legal or illegal practices, and c) perceived harm to the seller (Vitell, 2003 ). Interestingly, this scale has undergone some modifications over time to better reflect the changing social conditions (Vitell & Muncy, 2005 ; Vitell et al., 2007 ) and has been used extensively by researchers worldwide.

Since its inception, the consumer ethics scale has been widely employed in research conducted across different settings, and the findings generally demonstrate its reliability and usefulness (Hassan et al., 2021 ; Lu & Lu, 2010 ). Most of these studies identify the determinants of consumers’ responses toward ethically questionable consumption practices (Hassan et al., 2021 ). For example, researchers have shown particular interest in examining how consumers’ various personal characteristics, such as personality traits (Gentina et al., 2018 ; Ozgen & Esiyok, 2020 ), attitudes (Vitell et al., 2007 ), and demographic attributes (Lu & Lu, 2010 ; Vitell et al., 2007 ) are related to these responses.

According to Hassan et al.’s ( 2021 ) recent review, most of the previous studies on consumer ethics were conducted in Western developed countries, such as those in North America (#34 or 26%) and Europe (#49 or 37%). Among the relatively fewer consumer ethics studies in Asia (#29 or 22%), nine (7%) were conducted in China. While this indicates the popularity of China as a setting for consumer ethics research in Asia, it does not seem to proportionately reflect the size and spending power of Chinese consumers amidst the country’s rapid economic development. Coupled with the fact that consumer ethics varies among cultures (Huang & Lu, 2017 ), a more comprehensive investigation of how unique Chinese cultural values may affect Chinese consumers’ responses toward ethically questionable practices is thus considered necessary to enrich the extant literature further.

Finally, Vitell and Muncy ( 2005 ) caution the use of their modified consumer ethics scale as it was based on small samples for verification (85 students and 96 non-students). Moreover, a systematic review of the original consumer ethics scale confirms its “relatively consistent factor structure….even when used cross-culturally” (Vitell, 2003 , p. 40). Many recent consumer ethics studies still employ the original scale to tap responses toward consumption-related unethical behaviors (e.g., Lu & Lu, 2010 ; Vitell et al., 2018 ). Hence, this study employs the original consumer scale for greater rigor.

Hypotheses Development

Drawing upon system justification theory (Jost et al., 2008 ), this study, as mentioned, takes ideologies as sets of basic beliefs that help individuals understand the world, avoid the existential threat and maintain valued relationships with others (Jost & Hunyady, 2003 ). Consistent with this theory, prior research on worldviews or ideologies further conceptualizes ideologies as some universal shared values and assumptions that lay down the ground rules for culture (Clark, 2002 ) and constitute the soil to nurture cultural values (Feijs et al. 2008). In short, deviating from some previous researchers’ approach to treat both ethical ideology and cultural values as two independent and direct determinants of consumers’ ethically questionable practices (Culiberg, 2015 ; Smith, 2009 ), the foregoing literature on worldviews and ideologies suggests that ethical ideology may indeed serve as an ultimate antecedent of these practices via the mediator of cultural value. The conceptual model proposing this new perspective is depicted in Fig.  1 .

Conceptual model

Ethical Ideologies and Cultural Values

In addition to the literature on worldviews and ideologies, Forsyth ( 1980 ) provides further justifications for the focal role of ethical ideology for culture. According to him, ethical ideology comprises both the idealistic and relativistic dimensions and due to its deontological heritage, idealism focuses on the action rather than its consequences to judge whether it is ethical (Al-Kathib et al. 2016 ; Forsyth, 1980 ). To this end, the action will be benchmarked against rules or principles based on universal laws to determine its ethicality. The universal laws, in turn, refer to some fundamental and unchanging laws of this universe, which reflect how a rational being may like everyone else to act (MacNab et al., 2011 ). The reliance on universal laws to judge the ethicality of actions suggests that idealism is likely to be culture-free (Forsyth, 1980 ).

Given its teleological heritage, relativism, on the other hand, focuses on the consequences of an action to judge if it is ethical or not (Al-Kathib et al. 2016 ; Forsyth, 1980 ). At the most basic level, relativists consider the pursuit of happiness the final and ultimate end of all human acts (Barnett et al., 1994 ; Mudrack & Mason, 2019 ). This pursuit could occur through either individual hedonism or utilitarianism (Sinnott-Armstrong, 2003 ). Briefly, while hedonism advocates the greatest pleasure and least pain for the individual, utilitarianism holds that an action is morally right if it promotes happiness and morally wrong if it promotes the reverse (Sinnott-Armstrong, 2003 ). The reliance on the basic preference of a rational being (i.e., pursuing happiness or avoiding pain) also points to the global nature of relativism.

All in all, the preceding theoretical perspectives point to ideologies’ universality or culture-free nature. Relating specifically to the domain of ethics, ethical ideology as a manifestation of individuals’ worldviews further suggests that it helps determine their most basic moral philosophies (Dubinsky et al., 2005 ) and as a basis for forming other beliefs and values (e.g., cultural values) (Forsyth, 1980 ; Zaikauskaite et al., 2020 ). Following this, it is thus posited here that rather than directly and independently affecting consumers’ ethical judgment, ethical ideology indirectly influences this judgment via cultural values.

Effects of Idealism on Cultural Values

As mentioned, individuals high on idealism emphasize others’ welfare and try to avoid harming others (Forsyth, 1980 ). They believe in the absolute value of ethical standards based on unselfish concern for others (Forsyth et al., 2008 ). This moral philosophy assumes that desirable consequences can always be obtained with the appropriate action (Forsyth, 1992 ). When judging the characteristics of idealism against the Chinese cultural value of integration (e.g., see Chinese Culture Connection, 1987 ; Forsyth, 1992 ), the two constructs seem to echo well in various aspects. For instance, idealism’s unselfish concern for others aligns well with the Chinese cultural value of integration, which promotes harmony and solidarity to achieve social stability. With their strong proclivity to avoid doing things detrimental to others, idealistic individuals are also likely to develop a strong preference to avoid competition with others, one of the key features of integration (Tsang, 2011 ). Hence, given the compatibility between idealism and integration and those mentioned above possible direct impact of ethical ideology on cultural values, the following hypothesis is offered:

Hypothesis 1a

Consumers’ level of idealism is positively related to their level of integration.

At first glance, idealism and the cultural value of moral discipline seem to be compatible with each other. For instance, while idealism is associated with subscribing to some moral absolutes or inherent universal ethical rules to encourage ethical behaviors, moral discipline is also characterized by strong adherence to a system of semi-formal behavior norms to improve individuals’ manner and self-restraint (Cua, 2002 ). However, it should be noted that moral discipline is indeed dominated by the Doctrine of the Mean (Chinese Culture Connection, 1987 ). It is because of this holistic and situation-based doctrine that there may be an inherent incompatibility between idealism and moral discipline. The Doctrine of the Mean is a distinctive and important philosophical thought in Chinese culture (Cheung et al., 2003 ). In a way, it shares considerable similarities with Aristotle’s Nicomachean Ethics, which focuses on striking a balance between two vices, excess and deficiency, to pursue happiness (Intezari & Pauleen, 2014 ). This doctrine is the most influential cognitive concept for Chinese people (Ma et al., 2018 ) and is characterized by holistic information processing, tolerance of apparent contradictions, and avoidance of extremities (Chiu, 2000 ; Yau, 1988 ).

Individuals subscribing to this doctrine can recognize and accept contradictions and integrate various perspectives to develop a ‘mid-way’ approach to cope with differences (Chen, 2002 ). The ultimate goal of this doctrine is to help individuals avoid conflicts and maintain harmony with other concerned parties within the social system (Cheung et al., 2003 ). In sum, the doctrine represents the Confucian ideal of perfecting every relationship and activity in human life (Yau, 1988 ). It guides individuals to resort to appropriate yet flexible courses of action under different circumstances, depending on the specific requirements of situational contexts and intrinsic personal expectations (Wu & Lin, 2005 ). This situational approach contradicts idealism, which strongly subscribes to moral absolutes or universal ethical rules (Forsyth, 1980 ). Because of this inherent incompatibility, the fundamental moral philosophy of idealism may likely serve as an inhibitor rather than a driver for developing the cultural value of moral discipline. Accordingly, we hypothesize:

Hypothesis 1b

Consumers’ level of idealism is negatively related to their level of moral discipline.

Effects of Relativism on Cultural Values

As mentioned earlier, the core feature of the cultural value of integration is to preserve social stability (Chinese Culture Connection, 1987 ). Culturally integrative individuals stress the importance of promoting harmony and solidarity with others to achieve this stability. Moreover, they stress the importance of tolerating different opinions and avoiding competition with others (Tsang, 2011 ). Hence, although this Chinese culture-specific value is not aimed at rejecting moral absolutes in the first place, its focus on promoting interpersonal harmony and, ultimately, social stability inevitably prompts its followers to be more flexible and receptive to others’ different views. From this perspective, integration seems not to conflict with relativism’s fundamental moral philosophy, which rejects universal moral rules and takes a situational approach to arrive at ethical decisions (Forsyth, 1992 ; Hunt & Vitell, 1986 ). Based on this discussion and the direct impact of ethical ideology on cultural values, as hypothesized earlier, the following hypothesis is proposed:

Hypothesis 2a

Consumers’ level of relativism is positively related to their level of integration.

The two constructs appear to relate well with the respective nature and characteristics of relativism and the moral discipline mentioned above. Specifically, while relativism’s emphasis on rejecting moral absolutes and adopting a flexible approach to arrive at ethical judgments based on situational contexts (Forsyth, 1992 ), the heavy influence of the Doctrine of the Mean on moral discipline, as mentioned, prompts individuals to take into account specific situational factors and employ a tempered mind to search for a harmonized ‘mid-way’ course of action to reconcile different perspectives and seek common ground (Yang et al., 2016 ). This suggests a compatible relationship between relativism and moral discipline. On this basis, the following hypothesis is proposed:

Hypothesis 2b

Consumers’ level of relativism is positively related to their level of moral discipline.

Chinese Cultural Values and Ethical Behavior

Effects of integration on ethical behavior.

Integration refers to a relationship-oriented cultural value characterized by a broadly integrative, socially stabilizing emphasis (Chinese Culture Connection, 1987 ). The items constituting this cultural value further highlight that preserving social stability depends much on promoting harmony, solidarity, and inclusion with others (Wong & Lau, 2001 ). Tapping into the more fundamental cultural dimension of collectivism, integration is characterized by emphasizing group instead of individual beliefs (Hofstede et al., 2010 ). In collectivist cultures, individuals often priorities group interests throughout their lives to enable them to be integrated into strong, cohesive in-groups to maintain a loyalty-based society (Hofstede et al., 2010 ). These individuals also tend to follow ethical regulations and standards generally accepted by their society (Vitell et al., 1993 ). Prior research shows that consumers with high levels of collectivism are more inclined to reject questionable activities than those with lower levels of collectivism (Swaidan, 2012 ). Hence, culturally integrative individuals are likely to be more inclined to follow socially acceptable norms to minimize conflicts with others and, finally, achieve social stability. Moreover, they do so even if these norms contradict their beliefs. Thus, consumers high on the cultural value of integration may have more negative judgments about ethically questionable consumption practices that counter prevailing social norms. This leads to the following hypothesis:

Hypothesis 3

Consumers’ level of integration is negatively related to their degrees of approval of ethically questionable consumption practices, namely a) Active Benefit, b) Passive Benefit, c) Deception, and d) No Harm.

Effects of Moral Discipline on Ethical Behavior

Moral discipline refers to moral restraint and how individuals exercise their self-control. According to Chinese Culture Connection ( 1987 ), this cultural value refers to moderation or the middle-way approach representing a firm and disciplined moral stance. In a way, moral discipline is akin to the Chinese cultural value of activity orientation proposed by Yau ( 1988 ). Being influenced by this value, Chinese people are highly disciplined and conform to a system of semi-formal norms of behavior called ‘ Li ’ (propriety). These norms guide Chinese people to live properly, act politely and respectfully when dealing with others, and become socially responsible (Tsang, 2011 ; Yau, 1988 ). The middle-way approach suggests that Chinese people exhibit a high degree of moral self-control or self-regulation, at least publicly (Chou, 1979 ; Yau, 1988 ).

It should be noted that moral discipline is heavily influenced by the philosophical thinking of moderation or the ‘Doctrine of the Mean’ (Cheung et al., 2003 ). This doctrine is rooted in Confucian philosophy and refers to a stance of not being inclined to either side or extreme (Legge, 1960 ). At an interpersonal level, this doctrine maintains that an individual should adopt a holistic perspective and consider the interests of other concerned parties when determining his/her appropriate course of action in a particular circumstance (Chiu, 2000 ). The ultimate purpose is to resolve conflicts among all the relevant stakeholders and maintain social harmony within the interaction system. At a personal level, instead of letting human desires be completely repressed or unrestrictedly gratified, this doctrine teaches individuals to regulate their desires and satisfy them according to socially acceptable ways for fear of troubling others (Cheung et al., 2003 ).

To effectively regulate their desires or keep themselves disinterested from external temptations, these individuals have long been socialized to exercise self-control over their behaviors (Yau, 1988 ). Confucian teaching considers self-control to be highly essential for the maintenance of social harmony (Yao, 2000 ). In Chinese history, various documented prominent role models have exercised extraordinary control over their personal desires to promote society’s interests (Ren et al., 2018 ).

The characteristics mentioned above of moral discipline suggest that individuals influenced by these cultural values are likely to develop a disposition that enables them to view themselves as embedded in a socially interactive system and, thus, see things holistically and in social terms. This disposition also entails that action is not merely according to one’s preference but also to the prevailing social norms. In determining the most appropriate course of action, individuals influenced by moral discipline pay particular attention to interpersonal dynamics, assess the possible consequences of different actions, and strive to maintain harmony within their social circles (Yang et al., 2016 ). The strong emphasis on maintaining social harmony further implies that while these individuals may be more tolerant of others’ different opinions and practices to avoid interpersonal confrontation, they may, at the same time, exercise self-restraint over their acts according to prevailing social norms to avoid troubling others (Cheung et al., 2003 ; Tsang, 2011 ). Consequent upon these harmony-oriented cultural characteristics, these individuals are likely to judge unethical practices per se unfavorably while still tend not to disapprove of others engaging in these practices openly. Accordingly, we hypothesize as follows:

Hypothesis 4

Mediating role of cultural values.

As mentioned earlier, this study aims at rectifying the direct approach commonly adopted in previous studies, which treated ethical ideology and cultural value as two immediate independent antecedents of individual ethical judgment. Specifically, drawing upon system justification theory that takes ideologies as individuals’ world views or basic shared values and assumptions that set the ground rules for culture (Clark 2003; Jost et al., 2008 ), we posit that ethical ideology may influence this ethical judgment via cultural values, as follows:

Hypothesis 5

Consumers’ levels of a) integration and b) moral discipline mediate the impact of idealism and relativism on their degrees of approval for ethically questionable consumption practices.

Methodology

Sampling and data collection.

All the hypotheses were tested with data collected from a comprehensive online survey of adult consumers in five major cities of China, including the capital (Beijing), two cities from the economically most advanced regions (Shanghai and Guangzhou) and two from relatively less developed regions (Qingdao and Chengdu). Besides the significant differences in their economic development and income levels, these cities also provide wide geographical coverage of our survey (Beijing in North, Guangzhou in South, Shanghai and Qingdao in East, and Chengdu in West), thus further enhancing the representativeness of our sample. Three hundred fifty ethnic Chinese consumers aged 18 or above in each of the five cities were randomly selected from the sampling frame of a Chinese consumer research agency. They were then requested to complete a questionnaire on the agency’s online survey platform, and a token of appreciation was offered to encourage their participation. This process resulted in 1,370 completed questionnaires, representing an overall response rate of about 78%. Appendix 1 shows demographic characteristics of our sample.

Measures employed in the survey were first generated through a thorough literature review. They were then fine-tuned based on three expert researchers’ knowledge about the topic under investigation and a pre-test with 50 adult Chinese consumers. The questionnaire was then translated into Chinese to facilitate native Chinese respondents’ comprehension. Its linguistic equivalence was ensured by back-translation (Bhalla & Lin, 1987 ). Specifically, items were adapted from Muncy and Vitell ( 1992 ) to measure the four ethically questionable consumption practices, ACTIVE, PASSIVE, DECEPTIVE, and NO HARM. The items were coded on a five-point scale anchored with 1 = ‘very wrong’ and 5 = ‘not very wrong.’

Regarding the Chinese cultural value of integration and moral discipline, relevant items were adapted from the Chinese Culture Connection ( 1987 ) and coded on a nine-point scale anchored with 1 = ‘totally unimportant’ and 9 = ‘totally important.’ Finally, the two ethical ideology dimensions, idealism and relativism, were measured using items adapted from Forsyth ( 1980 ). The items were coded on a nine-point scale anchored with 1 = ‘totally disagree’ and 9 = ‘totally agree.’ The empirical findings of the survey are discussed.

Data Analysis and Results

Measurement model.

We used the well-established two-stage method with structural equation modeling to analyze the data by testing a measurement model with all the constructs in the conceptual model followed by a path model including all the hypothesized relationships. First, confirmatory factor analysis with AMOS 26.0 shows a close fit for the measurement model with the full sample ( χ 2  = 2330.68; df  = 1181; χ 2 / df  = 1.97; NFI = 0.95; CFI = 0.96; RMSEA = 0.028; SRMR = 0.038) and a city-wise model with each city as a separate group ( χ 2  = 23,274.96; df  = 12,615; χ 2 / df  = 1.84; NFI = 0.96; CFI = 0.97; RMSEA = 0.026; SRMR = 0.036), with all the fit indices better than their recommended cut-off values (Hu & Bentler, 1999 ). All the scales also show good psychometric properties with high factor loadings (0.66–0.88), composite reliabilities (0.80–0.90), and average variance extracted (0.51–0.61), which indicate high convergent validity (Fornell & Larcker, 1981 ). Average variance extracted for each factor is greater than its squared correlations with other factors, confirming discriminant validity (Fornell & Larcker, 1981 ). Appendix 2 shows all the scale items and their descriptive properties. Appendix 3 shows all the bivariate correlations and the average variances extracted for all the constructs for the city-wise samples and the full sample. Table 1 shows the correlations of all the hypothesized direct relationships for the overall sample. All the correlations are above the threshold of 0.10 for ‘small’ effect-sizes in psychological research, about half of them pass the threshold of 0.20 for ‘medium’ effect, and one even exceeds the threshold of 0.30 for ‘large’ effect (Funder and Ozer 2019).

Direct effects (H1-H4) A path model with all the hypothesized direct effects using AMOS 26.0 also shows a close fit for the full sample ( χ 2  = 62.58; df  = 32; χ 2 / df  = 1.96; NFI = 0.98; CFI = 0.99; RMSEA = 0.030; SRMR = 0.032) and a city-wise model with each city as a separate group ( χ 2  = 190.57; df  = 135; χ 2 / df  = 1.41; NFI = 0.94; CFI = 0.98; RMSEA = 0.020; SRMR = 0.047), with all the fit indices better than their cut-off values (Hu & Bentler, 1999 ). Table 2 shows all the results. First, the ethical ideology of idealism has significant positive effects on integration and negative effects on moral discipline. Hence, H1a and H1b are supported. Next, the ethical ideology of relativism has significant positive effects on both integration and moral discipline. Thus, H2a and H2b are also supported. Chinese cultural value of integration has significant negative effects on the four consumer ethical judgments, including active benefit, passive benefit, deceptive practices, and no/indirect harm, for the full sample and all city samples except Chengdu. Thus, H3a-d are supported. Next, the Chinese cultural value of moral discipline has significant negative effects only on three consumer ethical judgments and no significant effect on deceptive practices for the full sample and all the city samples except Qingdao. Thus, H4a, H4b, and H4d are supported but not H4c. None of the control variables (age, gender, education, occupation, and income) significantly affect the variables included in the model and their relationships with each other.

Mediating effects (H5) Next, we tested our hypotheses about the mediating roles of cultural values of integration and moral discipline in the impact of the two ethical ideologies (idealism and relativism) on the four ethically questionable consumption practices, using Hayes’ PROCESS technique ( 2017 ). As shown in Table  3 , the mediating effects of integration are significant for idealism on all four ethically questionable consumption practices and on two out of four for relativism. Thus, H5a finds partial support. Finally, the mediating effects of moral discipline are not significant for both idealism and relativism on most of the four ethically questionable consumption practices. Thus, H5b is not supported. We repeated this analysis using SEM with AMOS and found similar results.

We also calculated the squared multiple correlations (R-squared) for all the constructs in our conceptual model to assess the variance in each construct explained by its antecedents. The overall sample shows moderate R -square values (0.03–0.13), which indicates that the two ethical ideologies (idealism and relativism) and cultural values (integration and moral discipline) may have a significant (albeit limited) impact on the Chinese consumers’ ethical judgments under the four ethically problematic consumption situations in our study. Finally, we found no meaningful pattern in our results among the samples from the five cities. Moreover, studying the differences across the five cities is not the primary focus of our paper; hence, we do not discuss these differences in detail, but we highlight this as a potential avenue for future research in our limitations and future research section.

Common Method Bias

We controlled for potential common method bias (Podsakoff et al., 2003 ) with two approaches. First, we used the marker variable technique, using items conceptually unrelated to all the other variables in our model, and found no significant differences in our results after controlling for the marker variables. Second, we included a method factor whose indicators included all the constructs’ indicators to assess if each indicator’s variances may be explained by the focal construct and the method, as suggested by Liang et al. ( 2007 ). The ratio of substantive variance to method variance is more than 100:1, with most method loadings as non-significant. Thus, common method bias is unlikely to be a concern for this study.

Theoretical Contributions

This study proposes and empirically tests a model delineating how ethical ideologies (idealism and relativism) may influence ethically questionable consumption practices (ACTIVE, PASSIVE, DECEPTIVE, and NO HARM) through the unique Chinese cultural values of integration and moral discipline. To this end, the study involves a large-scale survey of Chinese consumers from five major cities in China. Except for H2c concerning the proposed negative impact of moral discipline on DECEPTIVE and H5b about the mediating role of moral discipline, all the hypotheses are supported. These findings make theoretical contributions to the extant literature on consumer ethics, especially in emerging markets.

First, unlike prior research that focuses on the direct impact of ethical ideology on ethically questionable consumption practices (e.g., Arli & Pekerti, 2016 ; Culiberg, 2015 ), this study takes this ideological construct as individuals’ fundamental moral principle that at first influences the formation of their specific cultural values, and consequently their ethical judgment on these practices. Based on this approach, the present study furnishes empirical evidence to advance understanding of the relationship among the global moral construct of ethical ideology, unique Chinese cultural values and consumer ethics, thus enriching the extant literature on the socio-psychological mechanism underlying ethical consumption. While this paper focuses only on the cultural values of Chinese consumers, it does pave a new way for undertaking academic inquiry in other nations regarding how their unique cultural values may mediate the impact of ethical ideology on consumer ethics.

Second, the Chinese cultural value of integration is found to negatively affect the four ethically questionable consumption practices under investigation. Third, except for its non-significant influence on DECEPTIVE, the Chinese cultural value of moral discipline, as mentioned, is also found to negatively influence the other three consumption practices. The findings highlight that Chinese consumers’ strong proclivity to maintain social stability (integration) and exercise self-control, particularly on public occasions (moral discipline), effectively refrains them from engaging in various ethically questionable consumption behaviors. As both integration and moral discipline tap into Chinese people’s more fundamental cultural orientation of collectivism (Chinese Culture Connection, 1987 ), the present study disentangles the documented blanket negative influence of collectivism on such behavioral engagement (e.g., Huang & Lu, 2017 ). In short, by empirically delineating the respective influences of integration and moral integration on each of the four ethically questionable consumption practices, this study helps researchers better appreciate the complexity and dynamics involved in the ethical judgment process of collectivist Chinese consumers. These results would also inspire researchers to employ the two emic cultural values (integration and moral discipline) to examine the influence of collectivism in their future studies with Chinese consumers, to advance our understanding of the intricate relationships between Chinese consumers’ collectivist characteristic and their psychological responses across various behavioral categories.

Third, it is somewhat surprising to see a non-significant (negative) influence of moral integration on DECEPTIVE (H2c) and its mediating role in the impact of ethical ideologies on ethically questionable practices (H5b). Given the dominance of the Doctrine of the Mean in moral discipline, Chinese consumers may tend to take a more compromising approach when dealing with apparent contradictions (Chiu, 2000 ). For instance, although DECEPTIVE consists of consumption practices that involve dishonesty and thus unethicality, they are generally perceived as legally permissible (Muncy & Vitell, 1992 ). This perceived legality may somehow cloud Chinese consumers’ ethical judgment and prompt them to unconsciously exhibit higher tolerance to these deceptive practices. In addition, there is growing evidence that modern Chinese consumers may not adhere to traditional Confucian cultural values, such as moral discipline, due to the rise in the popularity of capitalism in the last few decades (Jackson, 2018 ). Despite the plausibility of these explanations, further empirical verification will help establish their tenability.

Fourth, by employing measures specifically designed for assessing Chinese cultural values, this study also helps address the concerns over the validity of applying Hofstede’s cultural value measures to study individuals from a non-Western cultural setting (Wong & Lau, 2001 ). This emic approach furnishes empirical results to supplement previous studies based on Hofstede’s instruments and enhances the rigor and relevance of the analysis involving ethnic Chinese subjects. As mentioned, this approach helps disentangle the complex dynamics associated with the influence of collectivism on Chinese people’s psychological responses. In sum, the approach helps generate findings that complement the extant literature based on a Western perspective to operationalize Chinese collectivism.

Fifth, the respective influences of idealism and relativism on integration and moral discipline warrant some further discussion. In short, while idealism positively influences integration, its influence on moral discipline is negative. This contrasts the positive influences of relativism on both integration and discipline. The above findings lead to an interesting conclusion: relativism could represent a more effective moral philosophy to discourage various ethically questionable consumption practices compared to idealism. In short, while previous studies propose that idealism and relativism lead to direct disapproval and tolerance of ethically questionable consumption practices, respectively (Swaidan et al., 2004 ; Zaikauskaite et al., 2020 ), this study extends the extant literature by highlighting a more complex set of relationships among the two moral philosophies and ethically questionable consumption practices mediated by Chinese cultural values.

Finally, this study empirically demonstrates the global impact of ethical ideology on unethical consumption practices via two unique Chinese cultural values for Chinese consumers. The model proposed and verified here contributes to future research for business ethics, and in particular, within the domain of consumer ethics, by highlighting the ultimate determining role of ethical ideology for subsequent ethical practices as well as the potential to adopt an emic approach to study the relationship between cultural values and these practices. All these would serve as valuable references to guide business ethics researchers to pursue their research endeavors in this domain.

Practical Implications

Apart from its theoretical contributions, this study offers valuable practical insights into promoting ethical consumption practices among Chinese consumers. First, the present findings demonstrate that Chinese consumers high on integration and moral discipline (albeit to a lesser extent) are likely to disapprove of ethically questionable consumption practices of various kinds. With the gradual dilution of traditional Chinese cultural values through China’s rapid economic development over the past couple of decades (Lin, 2013 ), consumers there have become more materialistic and focused more on self-gratification in their consumption (Wang et al., 2013 ). This egoistic consumption style may divert their attention from ethical considerations in the purchase and eventually undermine the country’s morality. The significant negative influences of integration and moral discipline on various unethical consumption practices derived from the present study provide the Chinese government with useful insights into how to crack down on unethical consumption practices in the country.

Specifically, if the government could further refine its civic education to make its citizens subscribe more to the traditional cultural values of integration and moral discipline, they may even refrain from engaging in such practices. Such refinement in civic education may be done by better embedding these important cultural values into the curricula of the country’s formal educational system and through well-crafted communications messages to appeal to its citizens at large. Relating specifically to the latter, messages may include featuring how social harmony between sellers and buyers could be achieved if both parties could deal with each other fairly and honestly. These messages should also emphasize how this dealing would eventually lead to the continued healthy economic development of the country and an enhanced national image in the international community.

Second, retail firms may also crack down on various ethically questionable consumption practices through tactually designed communication campaigns. Given the debilitating effect of integration and moral discipline on unethical consumption practices, and the focus of these two cultural values on preserving social harmony, retailers may consider featuring their communications with real-life stories about how unethical consumption practices will jeopardize such preservation. For instance, the communications may convey that, once discovered, unethical consumption practices would lead to conflicts between store employees and wrongdoing consumers, undermining social harmony. By highlighting the undesirable social consequences that contravene the inherent cultural virtues of integration and moral discipline, Chinese customers may be more restrained from engaging in these practices.

Similarly, as the Doctrine of the Mean prompts Chinese people to avoid doing things that are not endorsed by the public, communication messages and materials (e.g., posters, advertisements) may feature on a public occasion on which others show disrespect to a consumer who has been caught red-handed for unethical practices. Finally, the present results reveal the non-significant influence of moral discipline on DECEPTION. As moral discipline is highly concerned with adherence to socially acceptable norms, it is plausible that the non-significance is attributed to Chinese customers’ lack of adequate awareness of the anti-social nature or even illegality involved in deception-laden unethical consumption practices. On this premise, it is thus considered necessary for the government to strengthen its civic education to help Chinese customers better recognize the anti-social nature of these practices. To this end, it may even highlight the severe legal consequences of those gravely wrong, deceptive practices. In short, as Chinese customers become conscious of the social unacceptability and/or illegality of engaging in these deceptive practices, their espoused cultural value of moral discipline would likely exert a more substantial deterrence effect on such engagement.

Limitations and Future Research

This paper has a few limitations that future research may address. First, this study is confined to consumers in China. Although this confinement is considered practically significant due to the country’s vast and lucrative domestic consumer market, future research may still apply similar frameworks to study other countries worldwide further to establish the external validity of the present findings. Second, although the extant literature mentioned above provides theoretical justifications for the culture-free nature of ideologies, such justifications are yet to be empirically tested. It is thus desirable to conduct research in the future to empirically verify them. Third, while it is considered theoretically and empirically justified to focus on the two collectivism-laden Chinese cultural values, integration and moral discipline, in the present investigation, excluding the remaining two cultural values (i.e., Confucian work dynamism and human-heartedness) from the proposed model would still undermine the completeness of the analysis. Future research that takes all the four Chinese cultural values into account would thus help further verify the present proposed model.

Fourth, the ethically questionable consumption practices under investigation here are based on Muncy and Vitell ( 1992 ). Given that ethically questionable consumption practices are likely to evolve over time, future research may incorporate the violations of more recently evolved practices (e.g., recycling, saving energy, buying from socially responsible firms, etc.) into the analysis to further confirm the generalizability of the proposed model. Fifth, although the explanation for the non-significant influence of moral discipline on DECEPTION appears plausible, a more thorough examination is still necessary to further assess its tenability. Finally, scholars can further advance the field’s knowledge by employing an experimental design to help unbundle the issue of causality.

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The Bioethics-CSR Divide A Proposal for Bridging the Chasm

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Bioethics and Corporate Social Responsibility (CSR) were born out of similar concerns, such as the reaction to scandal and the restraint of irresponsible actions by individuals and organizations. However, these fields of knowledge are seldom explored together. This article attempts to explain the motives behind the gap between bioethics and CSR, while arguing that their shared agenda – combined with their contrasting principles and goals – suggests there is potential for fruitful dialogue that enables the actualization of bioethical agendas and provides a direction for CSR in health-related organizations.

INTRODUCTION

Bioethics and Corporate Social Responsibility (CSR) seem to be cut from the same cloth: the concern for human rights and the response to scandal. Both are tools for the governance of organizations, shaping how power flows and decisions are made. They have taken the shape of specialized committees, means of stakeholder inclusion at deliberative forums, compliance programs, and internal processes. It should be surprising, then, that these two fields of study and practice have developed separately, only recently re-approaching one another.

There have been displays of this reconnection both in academic and corporate spaces, with bioethics surfacing as part of the discourse of CSR and compliance initiatives. However, this is still a relatively timid effort. Even though the bioethics-CSR divide presents mostly reasonable explanations for this difficult relationship between the disciplines, current proposals suggest there is much to be gained from a stronger relationship between them.

This article explores the common history of bioethics and corporate social responsibility and identifies their common features and differences. It then explores the dispute of jurisdictions due to professional and academic “pedigree” and incompatibilities in the ideological and teleological spheres as possible causes for the divide. The discussion turns to paths for improving the reflexivity of both disciplines and, therefore, their openness to mutual contributions.

I.     Cut Out of the Same Cloth

The earliest record of the word “bioethics” dates back to 1927 as a term that designates one’s ethical responsibility toward not only human beings but other lifeforms as well, such as animals and plants. [1] Based on Kantian ethics, the term was coined as a response to the great prestige science held at its time. It remained largely forgotten until the 1970s, when it resurfaced in the United States [2] as the body of knowledge that can be employed to ensure the responsible pursuit and application of science. The resurgence was prompted by a response to widespread irresponsible attitudes toward science and grounded in a pluralistic perspective of morality. [3] In the second half of the twentieth century, states and the international community assumed the duty to protect human rights, and bioethics became a venue for discussing rights. [4] There is both a semantic gap and a contextual gap between these two iterations, with some of them already being established.

Corporate social responsibility is often attributed to the Berle-Dodd debate. The discussion was characterized by diverging views on the extent of the responsibility of managers. [5] It was later settled as positioning the company, especially the large firm, as an entity whose existence is fomented by the law due to its service to the community. The concept has evolved with time, departing from a largely philanthropic meaning to being ingrained in nearly every aspect of a company’s operations. This includes investments, entrepreneurship models, and its relationship to stakeholders, leading to an increasing operationalization and globalization of the concept. [6]

At first sight, these two movements seem to stem from different contexts. Despite the difference, it is also possible to tell a joint history of bioethics and CSR, with their point of contact being a generalized concern with technological and social changes that surfaced in the sixties. The publishing of Silent Spring in 1962 by Rachel Carson exemplifies this growing concern over the sustainability of the ruling economic growth model of its time by commenting on the effects of large-scale agriculture and the use of pesticides in the population of bees, one of the most relevant pollinators of crops consumed by humans. The book influenced both the author responsible for the coining bioethics in the 1971 [7] and early CSR literature. [8] By initiating a debate over the sustainability of economic models, the environmentalist discourse became a precursor to vigorous social movements for civil rights. Bioethics was part of the trend as it would be carried forward by movements such as feminism and the patients’ rights movement. [9]

Bioethics would gradually move from a public discourse centered around the responsible use of science and technology to academic and government spaces. [10]   This evolution led to an increasing emphasis on intellectual rigor and governance. The transformation would unravel the effort to take effective action against scandal and turn bioethical discourse into governance practices, [11] such as bioethics and research ethics committees. The publication of the Belmont Report [12] in the aftermath of the Tuskegee Syphilis Experiment, as well as the creation of committees such as the “God Committee,” [13] which aimed to develop and enforce criteria for allocating scarce dialysis machines, exemplify this shift. On the side of CSR, this period represents, at first, a stronger pact between businesses and society due to more stringent environmental and consumer regulations. But afterward, a joint trend emerged: on one side, the deregulation within the context of neoliberalism, and on the other, the operationalization of corporate social responsibility as a response to societal concerns. [14]

The 1990s saw both opportunities and crises that derived from globalization. In the political arena, the end of the Cold War led to an impasse in the discourse concerning human rights, [15] which previously had been split between the defense of civil and political rights on one side and social rights on the other. But at the same time, agendas that were previously restricted territorially became institutionalized on a global scale. [16] Events such as the European Environment Agency (1990), ECO92 in Rio de Janeiro (1992), and the UN Global Compact (2000) are some examples of the globalization of CSR. This process of institutionalization would also mirror a crisis in CSR, given that its voluntarist core would be deemed lackluster due to the lack of corporate accountability. The business and human rights movement sought to produce new binding instruments – usually state-based – that could ensure that businesses would comply with their duties to respect human rights. [17] This rule-creation process has been called legalization: a shift from business standards to norms of varying degrees of obligation, precision, and delegation. [18]

Bioethics has also experienced its own renewed identity in the developed world, perhaps because of its reconnection to public and global health. Global health has been the object of study for centuries under other labels (e.g., the use of tropical medicine to assist colonial expeditions) but it resurfaced in the political agenda recently after the pandemics of AIDS and respiratory diseases. [19] Bioethics has been accused from the inside of ignoring matters beyond the patient-provider relationship, [20] including those related to public health and/or governance. Meanwhile, scholars claimed the need to expand the discourse to global health. [21] In some countries, bioethics developed a tight relationship with public health, such as Brazil, [22] due to its connections to the sanitary reform movement. The United Kingdom has also followed a different path, prioritizing governance practices and the use of pre-established institutions in a more community-oriented approach. [23] The Universal Declaration on Bioethics and Rights followed this shift toward a social dimension of bioethics despite being subject to criticism due to its human rights-based approach in a field characterized by ethical pluralism. [24]

This scenario suggests bioethics and CSR have developed out of similar concerns: the protection of human rights and concerns over responsible development – be it economic, scientific, or technological. However, the interaction between these two fields (as well as business and human rights) is fairly recent both in academic and business settings. There might be a divide between these fields and their practitioners.

II.     A Tale of Jurisdictions

It can be argued that CSR and business and human rights did not face jurisdictional disputes. These fields owe much of their longevity to their roots in institutional economics, whose debates, such as the Berle-Dodd debate, were based on interdisciplinary dialogue and the abandonment of sectorial divisions and public-private dichotomies. [25] There was opposition to this approach to the role of companies in society that could have implications for CSR’s interdisciplinarity, such as the understanding that corporate activities should be restricted to profit maximization. [26] Yet, those were often oppositions to CSR or business and human rights themselves.

The birth of bioethics in the USA can be traced back to jurisdictional disputes over the realm of medicine and life sciences. [27] The dispute unfolded between representatives of science and those of “society’s conscience,” whether through bioethics as a form of applied ethics or other areas of knowledge such as theology. [28] Amid the civil rights movements, outsiders would gain access to the social sphere of medicine, simultaneously bringing it to the public debate and emphasizing the decision-making process as the center of the medical practice. [29] This led to the emergence of the bioethicist as a professional whose background in philosophy, theology, or social sciences deemed the bioethicist qualified to speak on behalf of the social consciousness. In other locations this interaction would play out differently: whether as an investigation of philosophically implied issues, a communal effort with professional institutions to enhance decision-making capability, or a concern with access to healthcare. [30] In these situations, the emergence and regulation of bioethics would be way less rooted in disputes over jurisdictions.

This contentious birth of bioethics would have several implications, most related to where the bioethicist belongs. After the civil rights movements subsided, bioethics moved from the public sphere into an ivory tower: intellectual, secular, and isolated. The scope of the bioethicist would be increasingly limited to the spaces of academia and hospitals, where it would be narrowed to the clinical environment. [31] This would become the comfort zone of professionals, much to the detriment of social concerns. This scenario was convenient to social groups that sought to affirm their protagonism in the public arena, with conservative and progressive movements alike questioning the legitimacy of bioethics in the political discourse. [32]

Even within the walls of hospitals and clinics, bioethics would not be excused from criticism. Afterall, the work of bioethicists is often unregulated and lacks the same kind of accountability that doctors and lawyers have. Then, is there a role to be played by the bioethicist?

This trend of isolation leads to a plausible explanation for why bioethics did not develop an extensive collaboration with corporate social responsibility nor with business and human rights. Despite stemming from similar agendas, bioethics’ orientation towards the private sphere resulted in a limited perspective on the broader implications of its decisions.

This existential crisis of the discipline led to a re-evaluation of its nature and purpose. Its relevance has been reaffirmed due to the epistemic advantage of philosophy when engaging normative issues. Proper training enables the bioethicist to avoid falling into traps of subjectivism or moralism, which are unable to address the complexity of decision-making. It also prevents the naïve seduction of “scientifying” ethics. [33] This is the starting point of a multitude of roles that can be attributed to the bioethicists.

There are three main responsibilities that fall under bioethics: (i) activism in biopolicy, through the engagement in the creation of laws, jurisprudence, and public policies; (ii) the exercise of bioethics expertise, be it through the specialized knowledge in philosophical thought, its ability to juggle multiple languages related to various disciplines related to bioethics, or its capacity to combat and avoid misinformation and epistemic distortion; (iii) and, intellectual exchange, by exercising awareness that it is necessary to work with specialists from different backgrounds to achieve its goals. [34]

All of those suggest the need for bioethics to improve its dialogue with CSR and business and human rights. Both CSR and business and human rights have been the arena of political disputes over the role of regulations and corporations themselves, and the absence of strong stances by bioethicists risks deepening their exclusion from the public arena. Furthermore, CSR and business and human rights are at the forefront of contemporary issues, such as the limits to sustainable development and appropriate governance structures, which may lead to the acceptance of values and accomplishment of goals cherished by bioethics. However, a gap in identifying the role and nature of bioethics and CSR may also be an obstacle for bridging the chasm between bioethics and CSR.

III.     From Substance to Form: Philosophical Groundings of CSR and Bioethics

As mentioned earlier, CSR is, to some extent, a byproduct of institutionalism. Institutional economics has a philosophical footprint in the pragmatic tradition [35] , which has implications for the purpose of the movement and the typical course of the debate. The effectiveness of regulatory measures is often at the center of CSR and business and human rights debates: whatever the regulatory proposal may be, compliance, feasibility, and effectiveness are the kernel of the discussion. The axiological foundation is often the protection of human rights. But discussions over the prioritization of some human rights over others or the specific characteristics of the community to be protected are often neglected. [36] It is worth reinforcing that adopting human rights as an ethical standard presents problems to bioethics, given its grounding in the recognition of ethical pluralism.

Pragmatism adopts an anti-essentialist view, arguing that concepts derive from their practical consequences instead of aprioristic elements. [37] Therefore, truth is transitory and context dependent. Pragmatism embraces a form of moral relativism and may find itself in an impasse in the context of political economy and policymaking due to its tendency to be stuck between the preservation of the status quo and the defense of a technocratic perspective, which sees technical and scientific progress as the solution to many of society’s issues. [38]

These characteristics mean that bioethics has a complicated relationship with pragmatism. Indeed, there are connections between pragmatism and the bioethics discourse. Both can be traced back to American naturalism. [39] The early effort in bioethics to make it ecumenical, thus building on a common but transitory morality, [40] sounds pragmatic. Therefore, scholars suggest that bioethics should rely on pragmatism's perks and characteristics to develop solutions to new ethical challenges that emerge from scientific and technological progress.

Nonetheless, ethical relativism is a problem for bioethics when it bleeds from a metaethical level into the subject matters themselves. After all, the whole point of bioethics is either descriptive, where it seeks to understand social values and conditions that pertain to its scope, or normative, where it investigates what should be done in matters related to medicine, life sciences, and social and technological change. It is a “knowledge of how to use knowledge.”

Therefore, bioethics is a product of disillusionment regarding science and technology's capacity to produce exclusively good consequences. It was built around an opposition to ethical relativism—even though the field is aware of the particularity of its answers. This is true not only for the scholarly arena, where the objective is to produce ethically sound answers but also for bioethics governance, where relativism may induce decision paralysis or open the way to points of view disconnected from facts. [41]

But there might be a point for more pragmatic bioethics. Bioethics has become an increasingly public enterprise which seeks political persuasion and impact in the regulatory sphere. When bioethics is seen as an enterprise, achieving social transformation is its main goal. In this sense, pragmatism can provide critical tools to identify idiosyncrasies in regulation that prove change is needed. An example of how this may play out is the abortion rights movement in the global south. [42] Despite barriers to accessing safe abortion, this movement came up with creative solutions and a public discourse focused on the consequences of its criminalization rather than its moral aspects.

IV.     Bridging the Divide: Connections Between Bioethics and CSR

There have been attempts to bring bioethics and CSR closer to each other. Corporate responsibility can be a supplementary strategy for achieving the goals of bioethics. The International Bioethics Committee (IBC), an institution of the United Nations Educational, Scientific and Cultural Organization (UNESCO), highlights the concept that social responsibility regarding health falls under the provisions of the Universal Declaration on Bioethics and Human Rights (UDBHR). It is a means of achieving good health (complete physical, mental, and social well-being) through social development. [43] Thus, it plays out as a condition for actualizing the goals dear to bioethics and general ethical standards, [44] such as autonomy and awareness of the social consequences of an organization’s governance. On this same note, CSR is a complementary resource for healthcare organizations that already have embedded bioethics into their operations [45] as a way of looking at the social impact of their practices.

And bioethics is also an asset of CSR. Bioethics can inform the necessary conditions for healthcare institutions achieving a positive social impact. When taken at face value, bioethics may offer guidelines for ethical and socially responsible behavior in the industry, instructing how these should play out in a particular context such as in research, and access to health. [46] When considering the relevance of rewarding mechanisms, [47] bioethics can guide the establishment of certification measures to restore lost trust in the pharmaceutical sector. [48] Furthermore, recognizing that the choice is a more complex matter than the maximization of utility can offer a nuanced perspective on how organizations dealing with existentially relevant choices understand their stakeholders. [49] However, all of those proposals might come with the challenge of proving that something can be gained from its addition to self-regulatory practices [50] within the scope of a dominant rights-based approach to CSR and global and corporate law.

It is evident that there is room for further collaboration between bioethics and CSR. Embedding either into the corporate governance practices of an organization tends to be connected to promoting the other. [51] While there are some incompatibilities, organizations should try to overcome them and take advantage of the synergies and similarities.

Despite their common interests and shared history, bioethics and corporate social responsibility have not produced a mature exchange. Jurisdictional issues and foundational incompatibilities have prevented a joint effort to establish a model of social responsibility that addresses issues particular to the healthcare sector.

Both bioethics and CSR should acknowledge that they hold two different pieces of a cognitive competence necessary for that task: CSR offers experience on how to turn corporate ethical obligations operational, while bioethics provides access to the prevailing practical and philosophical problem-solving tools in healthcare that were born out of social movements. Reconciling bioethics and CSR calls for greater efforts to comprehend and incorporate the social knowledge developed by each field reflexively [52] while understanding their insights are relevant to achieving some common goals.

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[2] . Van Rensselaer Potter, “Bioethics, the Science of Survival,” Perspectives in Biology and Medicine 14, no. 1 (1970): 127–53, https://doi.org/10.1353/pbm.1970.0015.

[3] . Maximilian Schochow and Jonas Grygier, eds., “Tagungsbericht: 1927 – Die Geburt der Bioethik in Halle (Saale) durch den protestantischen Theologen Fritz Jahr (1895-1953),” Jahrbuch für Recht und Ethik / Annual Review of Law and Ethics 21 (June 11, 2014): 325–29, https://doi.org/10.3726/978-3-653-02807-2.

[4] George J. Annas, American Bioethics: Crossing Human Rights and Health Law Boundaries (Oxford ; New York: Oxford University Press, 2005).

[5] Philip L. Cochran, “The Evolution of Corporate Social Responsibility,” Business Horizons 50, no. 6 (November 2007): 449–54, https://doi.org/10.1016/j.bushor.2007.06.004. p. 449.

[6] Mauricio Andrés Latapí Agudelo, Lára Jóhannsdóttir, and Brynhildur Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility,” International Journal of Corporate Social Responsibility 4, no. 1 (December 2019): 23, https://doi.org/10.1186/s40991-018-0039-y.

[7] Potter, “Bioethics, the Science of Survival.” p. 129.

[8] Latapí Agudelo, Jóhannsdóttir, and Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility.” p. 4.

[9] Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 2003). p. 368-371.

[10] Jonsen. p. 372.

[11] Jonathan Montgomery, “Bioethics as a Governance Practice,” Health Care Analysis 24, no. 1 (March 2016): 3–23, https://doi.org/10.1007/s10728-015-0310-2.

[12] . The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research” (Washington: Department of Health, Education, and Welfare, April 18, 1979), https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf.

[13] Shana Alexander, “They Decide Who Lives, Who Dies,” in LIFE , by Time Inc, 19th ed., vol. 53 (Nova Iorque: Time Inc, 1962), 102–25.

[14] . Latapí Agudelo, Jóhannsdóttir, and Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility.”

[15] . Boaventura de Sousa Santos, “Por Uma Concepção Multicultural Dos Direitos Humanos,” Revista Crítica de Ciências Sociais , no. 48 (June 1997): 11–32.

[16] Latapí Agudelo, Jóhannsdóttir, and Davídsdóttir, “A Literature Review of the History and Evolution of Corporate Social Responsibility.”

[17] . Anita Ramasastry, “Corporate Social Responsibility Versus Business and Human Rights: Bridging the Gap Between Responsibility and Accountability,” Journal of Human Rights 14, no. 2 (April 3, 2015): 237–59, https://doi.org/10.1080/14754835.2015.1037953.

[18] . Kenneth W Abbott et al., “The Concept of Legalization,” International Organization , Legalization and World Politics, 54, no. 3 (2000): 401–4019.

[19] . Jens Holst, “Global Health – Emergence, Hegemonic Trends and Biomedical Reductionism,” Globalization and Health 16, no. 1 (December 2020): 42–52, https://doi.org/10.1186/s12992-020-00573-4.

[20] . Albert R. Jonsen, “Social Responsibilities of Bioethics,” Journal of Urban Health: Bulletin of the New York Academy of Medicine 78, no. 1 (March 1, 2001): 21–28, https://doi.org/10.1093/jurban/78.1.21.

[21] . Solomon R Benatar, Abdallah S Daar, and Peter A Singer, “Global Health Challenges: The Need for an Expanded Discourse on Bioethics,” PLoS Medicine 2, no. 7 (July 26, 2005): e143, https://doi.org/10.1371/journal.pmed.0020143.

[22] . Márcio Fabri dos Anjos and José Eduardo de Siqueira, eds., Bioética No Brasil: Tendências e Perspectivas , 1st ed., Bio & Ética (São Paulo: Sociedade Brasileira de Bioética, 2007).

[23] . Montgomery, “Bioethics as a Governance Practice.” p. 8-9.

[24] . Aline Albuquerque S. de Oliveira, “A Declaração Universal Sobre Bioética e Direitos Humanos e a Análise de Sua Repercussão Teórica Na Comunidade Bioética,” Revista Redbioética/UNESCO 1, no. 1 (2010): 124–39.

[25] John R. Commons, “Law and Economics,” The Yale Law Journal 34, no. 4 (February 1925): 371, https://doi.org/10.2307/788562; Robert L. Hale, “Bargaining, Duress, and Economic Liberty,” Columbia Law Review 43, no. 5 (July 1943): 603–28, https://doi.org/10.2307/1117229; Karl N. Llewellyn, “The Effect of Legal Institutions Upon Economics,” The American Economic Review 15, no. 4 (1925): 665–83; Carlos Portugal Gouvêa, Análise Dos Custos Da Desigualdade: Efeitos Institucionais Do Círculo Vicioso de Desigualdade e Corrupção , 1st ed. (São Paulo: Quartier Latin, 2021). p. 84-94.

[26] Milton Friedman, “A Friedman Doctrine‐- The Social Responsibility of Business Is to Increase Its Profits,” The New York Times , September 13, 1970, sec. Archives, https://www.nytimes.com/1970/09/13/archives/a-friedman-doctrine-the-social-responsibility-of-business-is-to.html.

[27] Montgomery, “Bioethics as a Governance Practice.” p. 8.

[28] John Hyde Evans, The History and Future of Bioethics: A Sociological View , 1st ed. (New York: Oxford University Press, 2012).

[29] David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making , 2nd pbk. ed, Social Institutions and Social Change (New York: Aldine de Gruyter, 2003). p. 3.

[30] Volnei Garrafa, Thiago Rocha Da Cunha, and Camilo Manchola, “Access to Healthcare: A Central Question within Brazilian Bioethics,” Cambridge Quarterly of Healthcare Ethics 27, no. 3 (July 2018): 431–39, https://doi.org/10.1017/S0963180117000810.

[31] Jonsen, “Social Responsibilities of Bioethics.”

[32] Evans, The History and Future of Bioethics . p. 75-79, 94-96.

[33] Julian Savulescu, “Bioethics: Why Philosophy Is Essential for Progress,” Journal of Medical Ethics 41, no. 1 (January 2015): 28–33, https://doi.org/10.1136/medethics-2014-102284.

[34] Silvia Camporesi and Giulia Cavaliere, “Can Bioethics Be an Honest Way of Making a Living? A Reflection on Normativity, Governance and Expertise,” Journal of Medical Ethics 47, no. 3 (March 2021): 159–63, https://doi.org/10.1136/medethics-2019-105954; Jackie Leach Scully, “The Responsibilities of the Engaged Bioethicist: Scholar, Advocate, Activist,” Bioethics 33, no. 8 (October 2019): 872–80, https://doi.org/10.1111/bioe.12659.

[35] Philip Mirowski, “The Philosophical Bases of Institutionalist Economics,” Journal of Economic Issues , Evolutionary Economics I: Foundations of Institutional Thought, 21, no. 3 (September 1987): 1001–38.

[36] David Kennedy, “The International Human Rights Movement: Part of the Problem?,” Harvard Human Rights Journal 15 (2002): 101–25.

[37] Richard Rorty, “Pragmatism, Relativism, and Irrationalism,” Proceedings and Addresses of the American Philosophical Association 53, no. 6 (August 1980): 717+719-738.

[38] . Mirowski, “The Philosophical Bases of Institutionalist Economics.”

[39] . Glenn McGee, ed., Pragmatic Bioethics , 2nd ed, Basic Bioethics (Cambridge, Mass: MIT Press, 2003).

[40] . Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics , 7th ed (New York: Oxford University Press, 2013).

[41] . Montgomery, “Bioethics as a Governance Practice.”

[42] . Debora Diniz and Giselle Carino, “What Can Be Learned from the Global South on Abortion and How We Can Learn?,” Developing World Bioethics 23, no. 1 (March 2023): 3–4, https://doi.org/10.1111/dewb.12385.

[43] . International Bioethics Committee, On Social Responsibility and Health Report (Paris: Unesco, 2010).

[44] . Cristina Brandão et al., “Social Responsibility: A New Paradigm of Hospital Governance?,” Health Care Analysis 21, no. 4 (December 2013): 390–402, https://doi.org/10.1007/s10728-012-0206-3.

[45] Intissar Haddiya, Taha Janfi, and Mohamed Guedira, “Application of the Concepts of Social Responsibility, Sustainability, and Ethics to Healthcare Organizations,” Risk Management and Healthcare Policy Volume 13 (August 2020): 1029–33, https://doi.org/10.2147/RMHP.S258984.

[46] The Biopharmaceutical Bioethics Working Group et al., “Considerations for Applying Bioethics Norms to a Biopharmaceutical Industry Setting,” BMC Medical Ethics 22, no. 1 (December 2021): 31–41, https://doi.org/10.1186/s12910-021-00600-y.

[47] Anne Van Aaken and Betül Simsek, “Rewarding in International Law,” American Journal of International Law 115, no. 2 (April 2021): 195–241, https://doi.org/10.1017/ajil.2021.2.

[48] Jennifer E. Miller, “Bioethical Accreditation or Rating Needed to Restore Trust in Pharma,” Nature Medicine 19, no. 3 (March 2013): 261–261, https://doi.org/10.1038/nm0313-261.

[49] John Hardwig, “The Stockholder – A Lesson for Business Ethics from Bioethics?,” Journal of Business Ethics 91, no. 3 (February 2010): 329–41, https://doi.org/10.1007/s10551-009-0086-0.

[50] Stefan van Uden, “Taking up Bioethical Responsibility?: The Role of Global Bioethics in the Social Responsibility of Pharmaceutical Corporations Operating in Developing Countries” (Mestrado, Coimbra, Coimbra University, 2012).

[51] María Peana Chivite and Sara Gallardo, “La bioética en la empresa: el caso particular de la Responsabilidad Social Corporativa,” Revista Internacional de Organizaciones , no. 13 (January 12, 2015): 55–81, https://doi.org/10.17345/rio13.55-81.

[52] Teubner argues that social spheres tend to develop solutions autonomously, but one sphere interfering in the way other spheres govern themselves tends to result in ineffective regulation and demobilization of their autonomous rule-making capabilities. These spheres should develop “reflexion mechanisms” that enable the exchange of their social knowledge and provide effective, non-damaging solutions to social issues. See Gunther Teubner, “Substantive and Reflexive Elements in Modern Law,” Law & Society Review 17, no. 2 (1983): 239–85, https://doi.org/10.2307/3053348.

Caio Caesar Dib

PhD candidate at the Faculty of Law of the University of São Paulo

Article Details

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• Research Ethics At Queen's University
• Ethics Standard Operating Procedures (SOPs)

SOP 302 - REB Submission Requirements and Administrative Review

Research ethics at queen's university standard operating procedure.

Title:  REB Meeting Administration

SOP Code:  302.004

Effective Date:  05/15/2023

Site Approvals:

1.0 PURPOSE

This standard operating procedure (SOP) describes the required activities for preparing, managing and documenting Full Board meetings of the Research Ethics Board (REB).

This SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

4.0 DEFINITIONS

See Glossary of Terms .

5.0 PROCEDURE

Except when a delegated review procedure is used, the REB must review proposed research at Full Board meetings at which a quorum is present.   The REB meeting agenda provides the meeting content and establishes a review sequence. It also provides an overview of all items previously (i.e., during the preceding time between REB meetings) reviewed and approved by delegated review procedures, a list of items pending review by the Full Board and assigned reviewer(s) for each. T h e i n f o r m a t i o n documented in the REB meeting agenda provides the foundation for the meeting minutes.

The REB meeting minutes document the actions that occur during an REB meeting. The minutes should enable a person who was absent from the REB meeting to determine how and with what justification the REB arrived at its decisions. They should also provide the REB itself with sufficient detail to help it reconstruct its discussions later, if necessary.

5.1    Agenda Preparation

5.1.1    Following an administrative review of the submission (e.g., new studies, amendments, continuing review applications, reportable events) by the REB Office Personnel and the determination of the review type by the REB Chair or designee, the responsible REB Office Personnel will add any submissions requiring Full Board review to the next appropriate Full Board meeting agenda.

5.1.2    For submissions that were reviewed and approved via delegated review procedures, the REB will be made aware of these approvals promptly.

5.1.3    The REB Office Personnel will attach to the agenda any previous REB meeting minutes for Full Board review and approval and adds any other items for information or discussion at the REB meeting (e.g., SOPs, educational articles, presentations, reports, etc.);

5.1.4    The REB Office Personnel, in consultation with the REB Chair or designee as necessary, will review the agenda, confirm REB meeting attendance, and assign the reviewers.

5.1.5    The REB Chair or designee will invite the appropriate alternate REB member to the meeting when a regular REB member cannot attend.

5.1.6    The reviewer assignment and the agenda will be issued in a timely manner before the REB meeting date. HSREB and GREB will give a minimum of 1.5 weeks to review documents before the full board meeting date. The REB members attending the REB meeting will receive a copy of the REB meeting agenda before the meeting date.

5.1.7    Ad hoc advisors will receive copies of relevant submissions.

5.1.8    Any changes to the agenda are communicated to all REB members and REB Office Personnel. The REB Office Personnel or designee may also issue an updated agenda notice depending on the nature of the changes.

5.2    Primary and Secondary Reviewers

5.2.1    Before the meeting, the REB Office Personnel, in consultation with the REB Chair or designee as necessary, will assign a primary and may assign one or more secondary reviewers for each new research ethics application project and at least one reviewer for each amendment.

5.2.2    No REB member will be assigned as a reviewer on a submission in which they are a Researcher or co-Researcher or in which there is a declared conflict of interest.

5.2.3    The REB Office Personnel will issue the reviewer assignment. The assigned reviewers will receive a notification with a copy of the meeting agenda.

5.2.4    If any assigned reviewers declare a conflict, the submission is reassigned to another reviewer.

5.3    Prior to the REB Meeting

5.3.1    The primary and secondary reviewers (if applicable) will conduct in-depth reviews of their assigned submissions and must submit reviewer comments prior to the REB meeting. The primary reviewer should be prepared to lead the discussion at the Full Board meeting.

5.3.2    All REB members are expected to conduct a review of each agenda item prior to the Full Board meeting, including previous REB meeting minutes on the agenda and any attachments to the agenda for review or discussion.

5.3.3    REB members who are not assigned as primary or secondary reviewers are asked to submit their individual comments for each submission research ethics application prior to the meeting. Each member will have an opportunity to provide or add to, or reshape comments during the meeting.   5.3.4    All REB members should be prepared to present their comments and participate in the discussion at the Full Board meeting.

5.4    During the REB Meeting

5.4.1    A quorum must be present to proceed with a Full Board meeting.

5.4.2    Should quorum fail during a Full Board meeting (e.g., through recusal of REB members with conflicts of interest or early departures), the REB may not make further decisions unless quorum can be restored.

5.4.3    An alternate REB member may attend in the place of a regular REB member to meet quorum requirements. When a REB member and his/her alternate both attend the REB meeting, only one is allowed to participate in the deliberations and final decisions regarding approval.

5.4.4    Should a REB member not be physically present during a Full Board meeting, he/she may participate via videoconference or teleconference. REB members participating by videoconference or teleconference count towards quorum.

5.4.5    Ad hoc advisors/affiliate members and/or research ethics coordinators/manager will not be used to establish a quorum.

5.4.6    REB members recusing themselves due to a conflict of interest are not counted toward quorum.

5.4.7    Under unusual circumstances (e.g., public health alerts and quarantines) the REB Chair or designee may, at his/her discretion, conduct an REB meeting with all REB members attending via simultaneous videoconference or teleconference, provided everyone has access to the review materials and quorum is met.

5.4.8    Only those REB members present (i.e., in person or via videoconference or teleconference) at the Full Board meeting may participate in the deliberation and final decision regarding approval.

5.4.9    Observers may be invited or permitted to attend REB meetings by the Chair of their designate, subject to the agreement of the REB and execution of a Confidentiality Agreement. Observers must disclose any vested interest in, or scientific or management responsibility for, any applications considered at the REB meeting.   5.4.10    If requested, Researchers may (in person or via teleconference) attend the REB meeting to present their research and respond directly to any comments or questions raised by the REB, subject to the agreement of the REB.

5.4.11    Any individual not listed on the official REB membership roster may not participate in the decisions of the REB.

5.5    Meeting Minute Preparation

5.5.1    The REB Office Personnel will draft meeting minutes, including key discussions, decisions and votes.

5.5.2    The key REB discussions and decisions for submissions are recorded.

5.5.3    As discussed at the REB meeting, the REB’s concerns, clarifications, and recommendations to the Researcher are included in the REB review letter sent to the Researcher. These letters are accessible to all REB members through an online system. The information documented in the letter will be reflective of the comments submitted before the REB meeting, as well as a reflection of the discussion at the meeting itself.

5.5.4    The meeting may be audio tape recorded (on an encrypted device) for reference purposes and to provide additional reference information to generate the final draft of the minutes. Records will be deleted within 10 business days or when the initial response to applicant has been sent following a full board meeting.

5.5.5    The minutes are intended to reflect what the REB decided, how it resolved controversial issues, and any determinations required by the regulations.

5.5.6    The draft minutes should be completed before the next REB meeting.

5.6    Meeting Minutes

5.6.1    The minutes will be available at the next appropriate REB meeting, and members are requested to review the minutes and note any errors for correction.

5.7    Documentation

5.7.1    The REB meeting minutes include the following items:

• Date, place, and time the REB meeting commenced and adjourned,
• Names of REB members in attendance (present, teleconference, videoconference),
• Names of REB Office Personnel present at the meeting,
• Presence of observers,
• Use of ad hoc advisors and their specialty,
• List of declared conflicts of interest, a summary of any discussions, and the decision taken by the REB to address them (as applicable) or a note that none were declared,
• A summary of key discussions and controverted issues and their resolution for each submission, as applicable,
• The decisions taken by the REB regarding approval for each submission, as applicable,
• The basis for requiring changes or for disapproving submissions,
• Number of REB members in attendance for the review of each submission requiring a decision,
• REB member(s) recused related to conflicts of interest for each submission requiring a decision,
• Number(s) voting for, against and abstaining in the event of a vote for each submission requiring a decision,
• Reference to any attachments to the agenda.

5.7.2    All REB meeting agendas and minutes are retained in the REB records.

5.7.3    The agendas, REB meeting minutes and review documents are confidential and will not be released or made available unless required for inspection or auditing purposes.

6.0 REFERENCES

See References .

7.0 REVISION HISTORY

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Ethics Committees: Structure, Roles, and Issues

Pankti mehta.

1 Department of Clinical Immunology and Rheumatology, King George’s Medical University, Lucknow, India.

Olena Zimba

2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.

3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.

4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.

Armen Yuri Gasparyan

5 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.

Birzhan Seiil

6 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Marlen Yessirkepov

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Graphical Abstract

INTRODUCTION

The journey of the role of ethics in biomedical research began with “The Doctor’s Trial” post-World War II in which 23 doctors and administrators were tried for war crimes, crimes against humanity, and conducting research without informed consent. This judgment, known as the “Nuremberg Code” was one of the first international ethical standards which gave a ten-point rule with respect to the protection of human research participants. The core principle was the requirement of voluntary consent of human subjects and respecting human autonomy. 1 , 2

However, some researchers continued to ignore the code and violations like the Willow Brook Hepatitis Study (1956), Jewish Chronic Disease Study (1963), and 22 others were highlighted by Beecher in 1966. 3 , 4 This led to the composition of the Declaration of Helsinki by the World Medical Association in Finland in 1964 with revisions at regular intervals. 5 This affirmed the principles highlighted in the Nuremberg Code stating that research should be conducted upholding the interests and rights of the human subjects. It proposed for the first time, the submission of a research protocol to an ethics committee (EC) before the initiation of the study ( Fig. 1 ). 6

EC refers to “Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices.” Committees that consider the ethical dimensions of patient care are Clinical ECs whereas committees established to protect the welfare of research subjects are Research ECs. 7 In this review, we will be using the terms ECs and Research ECs interchangeably.

It was in the 1960s that most nations developed guidelines regarding the formation of ECs with the main task of protection of human subjects. 8 EC is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects. ECs can be of two types—Institutional Review Boards (IRBs) or Institutional ECs (IECs) (referred to IRB or IEC by different countries) that are formally constituted by an institution to review research projects for that institute. An independent EC is an autonomous EC that is not part of any institute and performs the same functions independently. It is helpful for institutes that don’t have an IRB.

Despite these regulations, the unethical standards of the Tuskegee Syphilis study emerged in 1972 in which treatment was denied to the participants in order to study the natural course of the disease. This was followed by the conversion of the National Research Act in the USA into law (1974) and the setting up of the national commission of ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ that submitted the Belmont report in 1979. The Belmont report described the role of assessment of risk-benefit of research involving human subjects, appropriate guidelines for selection of human subjects, and definition of informed consent. It was based on the three pillars of ethics- respect, beneficence, and justice. 9 , 10 It stressed the need for the approval of studies by an EC in accordance with the 1975 revision of the World Medical Association in Tokyo. Subsequently, countries like China, India, and South Korea adopted and legalized the need for submission of protocols to ECs from the 1980s onwards. 11 , 12 , 13 , 14

ECs function on six basic principles 15 :

• 1. Autonomy: respect the patient’s right to act on his/her own value and choice.
• 2. Justice: fair treatment of the research subjects.
• 3. Beneficence: work for the benefit of the patient.
• 4. Nonmaleficence: primum non-nocere or first do no harm to the patient.
• 5. Confidentiality: privacy protection.
• 6. Honesty: truthfulness in terms of the study.

Ethics approval is required for most research studies to uphold the above-mentioned principles, and protect the participants as well as the researcher. 16

In this narrative review, we aim to study the structure and function of ECs or IRBs with a focus on the composition, role, violations, and development perspectives of ECs.

Searches through MEDLINE (PubMed) and Scopus were performed in line with previously published recommendations. 17

Articles published till March 15, 2023 were reviewed using the following keywords: ("Ethics Committees, Clinical/classification"[Mesh] OR "Ethics Committees, Clinical/economics"[Mesh] OR "Ethics Committees, Clinical/ethics"[Mesh] OR "Ethics Committees, Clinical/history"[Mesh] OR "Ethics Committees, Clinical/legislation and jurisprudence"[Mesh] OR "Ethics Committees, Clinical/organization AND administration"[Mesh] OR "Ethics Committees, Clinical/standards"[Mesh] OR "Ethics Committees, Clinical/statistics and numerical data"[Mesh] OR "Ethics Committees, Clinical/trends"[Mesh]). Additional searches about subtopics were also carried out (“Data Safety Monitoring Boards” OR “Independent Data Review Committees”, “Institutional Review Boards” OR “Ethics Committees” and “Problems” OR “Issues”).

Articles in languages other than English, and reviews, conference proceedings, and editorials were excluded. Relevant articles searchable at the Directory of Open Access Journals and references of included articles were also processed for eligibility and inclusion for this narrative review. 18 , 19 , 20 , 21

RESEARCH, SUBMISSION PROCESS, AND EXEMPTIONS

IRB approval is required for most research to protect human rights and assess the scientific soundness of the research. For this, we first need to understand what research is. Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” ( Table 1 ). 8

IRB = Institutional Review Board.

An EC approval is required for studies with more than minimal risk to the subjects where the intention is to publish findings or contribute to the scientific knowledge, studies involving the compilation or analysis of data containing patient identifying information, studies with any risk of physical or mental discomfort to participants or their families, and studies on vulnerable groups. 22 Minimal risk refers to the probability of discomfort posed by the research is not greater than that ordinarily encountered in routine daily life activities of an average healthy individual. 5 , 8 , 22

Thus, even surveys and archived data that contain patient identifying information (name, age, address) and sensitive information (illicit drug use, comorbidities, communicable diseases, e.g., HIV AIDS) need ethical approval to uphold the privacy and anonymity of the participants as well as protection the possibility of psychological discomfort to them. 10 , 23 , 24 , 25

Some studies may be exempted from ethical approval including most educational research, case reports on one to three patients (without any hypothesis testing), those that pose no risk to the participants, involve information freely available in the open domain for the community, analysis of open-source datasets or anonymized datasets obtained from other researchers with due informed consent taken at the time of primary data collection, research evaluating the public health programs or government public schemes. 26 , 27 However, a formal exemption is to be decided by the IRB and not the investigator. 8 , 28

For projects requiring an EC approval, the type of reviews includes expedited and a full board review. Expedited review is for research involving no more than minimal risk to the subjects, minor revisions of an already approved study, and is usually conducted by an experienced person or the chair of the IRB. A full board review on the other hand is for research with greater than minimal risk to the subjects or those involving vulnerable populations. This is reviewed extensively by a full IRB meeting.

The documents usually required for a full ethics review include the name of the applicant with designation, approval of the head of the department, research/trial protocol, ethical issues if any, and plans to address them, written informed consent form (and assent forms) in the language the participant understands, data collection tools, patient information sheet, regulatory clearances (e.g., Drug Controller General of India in India for drug trials), finance and funding details, Insurance, statement of conflicts of interest, information about payment or compensation to the subjects, scientific or departmental review board permission, Curriculum Vitae of the investigators, declaration of interests and any other relevant information. 29 , 30 Waivers of consent may be provided for no more than minimal risk to the subjects when the waiver will not endanger the rights and welfare of the subjects like retrospective studies, secondary analysis of data wherein consent had been taken previously, use of open access databases with anonymized data, and emergency research as seen fit by the EC. 31 , 32 In emergencies like the coronavirus disease 2019 pandemic, waivers may be provided if the patient is incapacitated or in life-threatening situations where there is no time for informed consent. Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent. 33 , 34

EC PERSONNEL, THEIR EXPERIENCE, AND DUTIES

ECs have the primary responsibility of reviewing research and its alignment with the Good Clinical Practice (GCP) guidelines. 35 The research design must be scientifically sound and conducted in an ethical way to include human subjects with voluntary informed consent.

The composition of ECs varies depending on the country, center, volume, and nature of the research reviewed. However, there are some basic recommendations laid down by national authorities and GCP. 30

• a) Most countries in Europe, the USA, and South Korea have a requirement of at least five members whereas recommendations in China and India need a minimum of seven members and a maximum of 12–15 members. 14 , 36 , 37 , 38 , 39
• b) At least one member who is autonomous, independent of the institution or trial site. It is mandatory that the chairperson of the EC is not part of the institution where the research is to be conducted.

Others include a member secretary from within the institution and members from the scientific field. The composition should have an adequate gender and age representation with a blend of basic scientists, clinician scientists, one legal expert, one social scientist, one philosopher, and one layperson. Review of research involving vulnerable populations like children, pregnant women, handicapped, prisoners, etc., must involve one member with expertise in dealing with that population. 40 , 41 It is also desirable to have a member or expert advisor for special areas of research who has proficiency in that field.

Responsibilities

The chairperson has the primary responsibility of independent and smooth functioning of the EC, ensuring the participation of all members, seeking Conflict of Interests from all members, and handling complaints against the researchers and EC members. 39 It’s the responsibility of the member secretary to schedule EC meetings, handle documentation, organize an effective review of proposals, define and maintain adherence to standard operating procedures (SOPs), train EC members, and assess the need for expedited reviews/exemption from review. 39 The members of the scientific community have the primary responsibility of reviewing the research protocols and their scientific soundness. The non-scientist member is crucial to safeguard the human subjects and practical issues of the research. 40 , 41 However, studies have shown lesser participation by laypersons as compared to scientific members. A study conducted across 10 academic centers across the USA with 20 IRB meetings recorded noted that 29 community members were present in 17 of those meetings. They were primary reviewers in only two of the 93 submitted protocols due to refusal on grounds of lack of knowledge regarding medical research. Even as secondary and tertiary reviewers, they were less active and were more likely to focus on issues related to confidentiality. However, they played a greater role when they were not designated reviewers. 42

The EC or IRBs function to review and approve research protocols, monitor ongoing research involving human subjects with the aims of continual protection of human volunteers, advancement of research, and protecting the institute from litigation. Its main role is the protection of the human rights, autonomy, confidentiality, and welfare of the research subjects especially vulnerable populations. The GCP recommends the following for duties of the IRB ( Table 2 , Fig. 3 ) 35 :

e.g., An immunosuppressive drug “X” being evaluated for patients with Lupus Nephritis.

IRB = Institutional Review Board, SOC = standard of care, GCP = Good Clinical Practice, MMF = mycophenolate mofetil, CYC = cyclophosphamide, ICU = intensive care unit, SOP = standard operating procedure, RCT = randomized controlled trial.

• • The IRB should obtain and review all the necessary documents for the research/trial within a reasonable time and document its views following standardized operating procedures with clear identification of the dates for approval, modifications, disapproval, or termination of an ongoing trial that was initially approved in writing.
• • Qualification of the investigators should be considered for the proposed research.
• • Reviewing of ongoing research as appropriate to the risks involved (at least once a year).
• • Protocols indicating exemption of prior consent of the subject or their legally acceptable representative (e.g., emergency situations) should be assessed in detail for all the regulatory needs.
• • Review the sum and method of compensatory payment to subjects if required.
• • Functions should be performed as per written SOPs which should comply with the GCP guideline.

Most IRBs conduct meetings regularly (one–two per month depending on the number of protocols) and SOPs are followed as per the national governing authority.

An EC review is a continuous process and is needed before the initiation of research, before the extension of the approval period, prior to modifications to an already approved study, for monitoring of any adverse events, and until all the data collection and analysis is complete. 8 An oversight to the monitoring of trials (usually single center, early phase, less risky) is provided by the IRBs through annual reviews, adverse event monitoring, and reporting of undue events by the principal investigator (PI). However, complex clinical trials and/or multicenter, randomized controlled trials, interventional studies with pre-existing concerns about safety, or study participants who might need additional protection through an additional committee referred to as the Data Safety Monitoring Board (DSMB). 43 , 44

RISKS, BENEFITS, CONFIDENTIALITY, AND PRIVACY ISSUES IN RESEARCH PROTOCOLS

The role of the EC is not only to provide direct protection to human subjects from physical or mental harm but also to weigh the risks and benefits involved in the research. It must be assessed if the study is designed to add to the current scientific knowledge base and help society. 8

The research protocol is the document that includes the research question, aims and objectives, a critical literature review, methodology, and statistical plan. It is pertinent that the IRB reviews the protocol with respect to the clarity and focus of the research question; and whether the study design is suitable to answer the same. This is decided by the chair or a special departmental committee ( Table 2 , Fig. 3 ).

Privacy and confidentiality are a part and parcel of every physician-patient relationship. Needless to say, this must be maintained in a researcher-human subject relationship as well. It helps build trust, curbs participant anxiety, maintains their dignity, and above all their autonomy. 10 The International Committee of Medical Journal Editors recommends that authors must ensure that nonessential information like names, initials hospital record numbers, etc., are omitted during data collection, storage, and publication whenever possible. 45 However, there’s an extent to which this confidentiality can be maintained. Information required for scientific purposes (e.g., clinical photographs) or those with mandated legal reporting may breach participant privacy. This needs to be explained to the participant and recorded in written informed consent ( Table 2 ).

The role of the IRB with respect to privacy and confidentiality is to:

• • Review the consent document and assess the sensitivity of the information, the duration for which it will be held, the usefulness of the information, and the ability to protect it.
• • For multicenter projects, review the measures taken by the research team to maintain the privacy of the research subjects including the number of personnel with access to the information, data storage, and transfer.
• • An ongoing review of the research must include monitoring of confidentiality issues to check for maintenance of the same and the need for a revised privacy protection plan.
• • Educate researchers and IRB members regarding the data privacy and protection process. 46

Review of informed consent by IRBs is especially important in low-middle-income countries. There are various issues related to the lack of understanding of the information provided, maintaining privacy due to interference by family members, and the inability to assess risk and benefit by the research participant. IRBs have an additional responsibility to ensure that studies have minimal/no risk to the participant, the consent forms are clear and simple to understand and ensure the proper process of obtaining informed consent is being followed without undue pressure or coercion to participate in the study. 47

VIOLATIONS OF ETHICS APPROVAL RULES AND REGULATIONS

Violations of IRB approval rules like lack of approval, lack of approval of modifications to the protocol, and lack of informed consent can result in dire aftermaths for the authors. It can result in the withdrawal of the article if it’s still in press, retraction if it’s already published, and even removal if it has legal consequences. The number of papers retracted as searched on the retraction database 48 is steadily increasing by the decade from 474 in the 1990s to 6120 in the 2010s. The most common reason for retraction is plagiarism whereas violation of IRB rules accounts for 4–5% of all retractions. 49 , 50 When consultations for ethical inquiries to the Korean Association of Medical Journal Editor were analyzed, the most common reason was duplicate publications (12 of 80) with issues with IRB approval (5 of 80) and informed consent (6 of 80). 51 Some of the examples of types of studies and their reasons for retractions have been summarized in Table 3 .

Violations can be assessed before the studies are published for those with IRB approval. It is the responsibility of the IRBs to monitor whether ongoing studies are abiding by the ethical regulations and whether the approved protocol is being followed. A study conducted in India by an IRB at a tertiary care hospital in Mumbai monitored 12 clinical trials from 2011–2017. The most common violations were related to informed consent, followed by a lack of understanding of protocol and protocol deviations. This was corrected by re-taking of the informed consent and retraining in GCP by the IRB. 52 A similar study in Uganda done from 2007–2010 with monitoring of 40 research projects also found a similar frequency and reasons for violations. 53

Journal editors routinely check if a statement mentioning whether ethics approval was sought has been mentioned in the manuscript. Depending on the journal and type of article, further details of the EC approval can be sought by the journal editorial board. 54

ISSUES AND ONGOING DEVELOPMENTS

ECs were developed to provide ethical oversight to clinical research. But here are various issues associated with the functioning of IRBs.

• • Composition: Most studies indicate a skewed gender representation in the structure IRBs. Further, the participation of laypersons on the board is minimal. 14 , 42 , 55 , 56 , 57
• • Overburdened IRBs, delays, and operational costs: The IRB reviews have been associated with delays from over 4 to 7 months on average from surveys conducted across the USA. 58 , 59 A delay in biomedical research can translate into more than monetary loss as biomedical research saves lives and a delay in the approvals can result in greater loss of life. 60 An older survey conducted across 63 institutions (with 20 being low volume, 24 intermediate volume, and 19 being high volume centers) in the USA in 2005 reported the median amount spent by academic medical centers on IRB was $750,000/year with an average of $559 per review. The main costs are divided across staff salary, board salary, space, outsourcing of the reviews, travel, supplies, and equipment. 61 Over the years, there is a definite increase in the number of ongoing research projects thus increasing these costs further. Furthermore, documentation of Food and Drug Administration (FDA) warning letters to IRBs was predominantly related to paperwork stressing on documentation of reviews and meetings rather than ethical issues. 62 Increasing paperwork further results in delays and added costs. These deficiencies are more marked in developing nations like India and China dealing with issues like lack of regulation, informal ethics reviews, lack of supervision, and insufficient ethics review capacity. 63 , 64
• • Multi-site projects: With multicenter projects on the rise, a single protocol is often reviewed by multiple IRBs. In a review of 17 articles reported from UK, USA and Europe, which underwent multiple IRB reviews of the same protocol there were discrepancies in the judgment. Five of 26 reported rejection at some and acceptance by some IRBs. However, there were great differences in the protocol revisions, consent, patient information sheets, risk-benefit assessment, and compensation arrangements. 65 Keeping these issues in mind, the Common Rule in the USA was revised in 2017 with IRB approval required only from one center for multisite projects. 66 This may be extrapolated to other nations or consideration of an expedited review at other sites when fully reviewed at one IRB can be considered.
• • Independent EC and IEC: Independent ECs have inherent tissues of limitation of knowledge about the local community and use of these may promote IRB shopping. Whereas, local IRBs can have conflicts of interest as colleagues of investigators may be on the review board. Thus, a central IRB can alleviate some of these concerns by avoiding repetitive reviews, minimizing conflicts, and establishing a centralized adverse event reporting system. 67 , 68 , 69 A central IRB can be formed by experts on a particular subject or by a group of institutes like the National Cancer Institute’s Central IRB and the Biomedical Research Alliance of New York respectively. 70 , 71
• • Scientific expertise of the IRB reviewers: The IRB reviewers may lack the scientific expertise to review sophisticated research projects that may affect the quality of the research. 11 , 14 , 57 , 72 Regular training in research ethics and GCP along with adequate consultations with external experts is needed. This can be done at a national, regional, and international level. First, by identifying core issues and then solutions for them by focused training. 73 Training of EC members is conducted across Central Asia and Eastern Europe under the framework of Forum for Ethics Committees in the Confederation of Independent States and Strategic Initiative for Developing Capacity in Ethical Review program that train members regarding GCP, bioethics, the establishment of an EC, review processes and SOPs, choosing independent consultants, and confidentiality agreements. 74
• • Review of studies involving complementary and integrative medicine (CIM) is a challenge due to the lack of quality evidence to support the basis for their use. Moreover, most international regulatory bodies and research regulations do not address CIM, thus leaving the review process and decision-making to the IRBs. However, it is to be emphasized here studies irrespective of the type (modern or CIM) must be reviewed using the same principles of respect, beneficence, and justice. Well-designed studies on CIM are essential to ascertain the health and safety of patients. 75

DSMB is defined by the FDA, USA as “a group of individuals with pertinent scientific expertise that review research data of an ongoing trial on a regular basis, advises the sponsor/or researcher regarding the continuing safety of research subjects and those yet to be recruited into the research trial, and advises as to the continuing validity and scientific merit of the trial.” 76 It’s an autonomous entity independent of the researchers, sponsors, and the IRB so as to control data sharing and protect the authenticity of the clinical trial from unfavorable impact. 35 It was first developed in the USA in the 1960s as the NIH began sponsoring multicenter trials, the first trial was the Coronary Drug Project which used a DSMB for monitoring. 77 Over time, it became a common practice for the sponsors to have experienced scientific personnel serving on these committees. Although the FDA does not mandate DSMB for all trials, DSMBs are generally recommended for large, multi-site studies evaluating treatments that intend to reduce mortality and morbidity.

DSMBs are usually constituted for:

• • The study outcome is such that a highly encouraging or detrimental result is a possibility in an interim analysis that may require an early termination of the study on ethical grounds.
• • When the safety concerns are high, e.g., invasive therapy is administered.
• • Previous data suggesting serious toxicity with the study treatment.
• • Studies involving vulnerable populations.
• • Studies including subjects at an increased risk of death or serious outcomes.
• • Large, multisite, long-duration studies.

In India, it is recommended by the Indian GCP guidelines that the sponsor may establish a DSMB to assess the progress of the trial, and in 2006 Indian Council of Medical Research (ICMR) mandated a DSMB to review data emerging from research on interventions in the emergency setting. 39 These were updated in 2012 by the ICMR to include all stem cell research involving human subjects. The SOPs for the constitution and responsibilities of the DSMB are laid down by the World Health Organization and are similar across USA, Europe, and South Korea. 78 , 79

DSMBs are constituted by scientific members and are appointed by the funding agency, before the recruitment of the first subject in the trial. It can consist of as few as three members and is typically constituted of clinicians and at least one biostatistician. Others that may be included are medical ethicists, other scientists, etc. The most important requisite is that the members should be independent of the sponsors, investigators IRBs, regulatory authorities, and site or study staff. They should have no conflicts of interest with the sponsors, researchers, or study staff.

The functions of the DSMB are:

• • To uphold participant safety.
• • Ensure credibility and integrity of the trial for future subjects.
• • Ensure the timely conclusion of the study so that the results can be disseminated.
• • Identify protocol violations if any.
• • Identify unexpectedly high dropouts and evaluate for the same.
• • Ensure the validity of the results.

The above functions are carried out by an initial organizational meeting to understand the protocol and safety monitoring plan followed by an early safety review meeting to review early safety information. Continuing periodic reviews to assess safety, efficacy, and the progress of the trial are then carried out with reporting of serious adverse events. 44 A final meeting is to be held at the termination of a study. DSMBs function independently of the IRBS but the PIs must submit DSMB reports or minutes to the IRB.

Dramatic instances in which trials have been stopped prematurely on the recommendation of the DSMB include the withdrawal of rofecoxib and celecoxib in two trials on the prevention of colonic polyps due to increased cardiovascular events. 80 , 81

We have come a long way from the horrific ethical compromises in clinical studies in history to establishing adequate safety for the human subjects participating in clinical research today. The establishment of the IRB or EC has ensured safe study designs and the safety of human subjects right from before the study initiation until its completion. This is further supplanted by additional boards like DSMBs. However, we still need studies assessing the outcomes of the ECs on a global basis and addressing various issues that are still pertinent to the working of the ECs. 82

Disclosures: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.
• Data curation: Mehta P.
• Writing - original draft: Mehta P.
• Writing - review & editing: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.