research about legal medicine

AMERICAN COLLEGE OF LEGAL MEDICINE

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The American College of Legal Medicine (ACLM) is the most prominent professional society in the United States concerned with addressing issues that arise at the interface of law and medicine. ACLM represents the specialty of Legal Medicine in the American Medical Association House of Delegates.  

Most Fellows-of-the-College have dual degrees in medicine or dentistry and law and are designated by “FCLM” after their names. ACLM members include physicians, dentists, podiatrists, and other health professionals as well as attorneys, scientists, and students in certain graduate programs. 

ACLM Mission Statement

The Mission of the American College of Legal Medicine is to “promote the continued professional advancement of its members, as well as non-member physicians, and other interested professionals, through education, research, publications, and interdisciplinary and collaborative exchanges of information. The educational meetings are designed to improve the professional performance of the participants and focus primarily on research, methodologies, techniques, and issues and advances in the field of legal medicine. The education activities encourage interdisciplinary exchanges of ideas and information, and thereby facilitate enhanced service to society in the healing arts and legal professions.” 

Officers & Board of Governors

The officers of the College consist of the President, the President-Elect, the Immediate Past President, the Treasurer, and the Secretary. They are ex officio members of the Board of Governors with the authority in the management of the business and affairs of the College. The Board of Governors itself consists of nine individuals. Information about the Board of Governors is available in the ACLM Bylaws. In addition, the Editor of the Journal of Legal Medicine, the Chair of the Education Fund Committee, and the Chair of the American Board of Legal Medicine are ex officio members of the Board of Governors.

ACLM Committees

ACLM entrusts many of its functions and activities on various committees. Click here for the list of ACLM committees and committee members. For information about committee functions, please see the ACLM Bylaws .

Past Presidents

The American College of Legal Medicine honors its Past Presidents for their exceptional meritorious service while serving as the Chief Executive Officer of ACLM during their terms. Their service and dedication to their duty as President of the College greatly contributed to the continued success of ACLM’s mission.  

ACLM History

The American College of Legal Medicine (ACLM) was incorporated in 1960, with organizational roots dating back to 1955. It is the most prominent professional society in the United States concerned with addressing issues that arise at the interface of law and medicine. Fellows of the American College of Legal Medicine, which comprise over 50% of its membership, have degrees in law and one or another health science. Most Fellows have both MD/DO or DMD/DDS and JD degrees. College members include physicians, dentists, podiatrists, other health professionals, scientists, and attorneys. 

Through its medical legal resources, the ACLM educates and assists health care and legal professionals, advances the administration of justice, influences health policy, improves health care, promotes research and scholarship, and facilitates peer group interaction.

In addition, the American College of Legal Medicine represents the specialty of legal medicine in the American Medical Association’s Specialty and Service Society. 

PUBLICATIONS

ACLM’s mission is achieved through a diverse array of scholarly and professional endeavors that are nationally and internationally recognized. The Journal of Legal Medicine is one of the leading internationally circulated journals in its field. The Journal includes articles and commentaries on topics of interest in legal medicine, health law and policy, professional liability, hospital law, food and drug law, medical legal research and education, the history of legal medicine, and a broad range of other related topics. Indexed in national and international databases, the Journal is circulated throughout the world. Articles contained in the Journal have been cited by state and federal courts (including the United States Supreme Court).

Complementing the scholarly work contained in the Journal of Legal Medicine is the further body of medical legal knowledge that appears in the ACLM’s published monograph, entitled Legal Medicine . The Seventh Edition of this treatise was released in February of 2007 and has sold over 1,000 copies nationally and internationally. Published by Mosby/Elsevier, Legal Medicine Seventh Edition is one of the leading textbooks in the field of legal medicine. It incorporates the intellectual contributions of more than 80 nationally and internationally recognized authors. Moreover, the publication features 75 chapters that focus on the most important topics in the field, including professional medical liability, confidentiality and privacy, the business aspects of medical practice, patents and intellectual property, access to health care, ethical and legal issues in life-care planning, pain relief and pain management, legal aspects of bioterrorism, public health law, and forensic science.

The ACLM’s monograph, Medical Malpractice Survival Handbook , released in 2007 by Mosby/Elsevier, contains 43 chapters authored by a renowned field of experts. The four sections focus, respectively, on physicians and malpractice, the etiology of malpractice, malpractice lawsuit resolution, and liability of specialists and subspecialists in medical malpractice cases.

The American College of Legal Medicine produces another publication, Legal Medicine Perspectives , which offers analyses of recent developments in federal and state courts, as well as recent statutory enactments by Congress and throughout the states. ACLM also previously published Legal Medicine Questions & Answers , a case-based bimonthly publication offering answers to complex medical legal and medical ethical issues arising in clinical situations that form part of everyday medical practice. Both of these publications, along with the Journal of Legal Medicine, can be readily accessed and reviewed online by ACLM members.

The medical legal advocacy and scholarship of the ACLM is reflected in other important activities. At the national level, the work of the ACLM Amicus Curiae Committee has continued to showcase the College’s efforts to participate in the administration of justice at the state and federal level. Amicus briefs have been filed in cases that were pending before various state supreme courts, United States Courts of Appeal, and the United States Supreme Court.

ACADEMIC PROGRAMS

Additionally, at the national level, the ACLM is a co-sponsor, since 1995, of the National Health Law Moot Court Competition—the nation’s highly regarded law student competition addressing issues at the interface of medicine and law. This competition, which began in 1992, is held each year in November on the Carbondale, IL campus of Southern Illinois University School of Law.

Consistent with these efforts of the American College of Legal Medicine is to recognize and reward oral advocacy in the area of legal medicine, the ACLM is also committed to recognizing written advocacy and written scholarship on the part of law students, medical students, and allied health professions students. The ACLM annually sponsors a student writing competition open to students in multi areas of legal medicine including bioethics. Medical students, law students and allied health professions students are all encouraged to participate. Authors of winning papers not only receive a generous honorarium but their award-winning manuscripts may be published in the Journal of Legal Medicine, following peer review. Through this writing contest, efforts of the ACLM to promote research and scholarship are highly visible at law schools, medical schools, and health professions education programs.

ANNUAL CONFERENCES

Perhaps of greatest significance, is the excellent record of achievement held by the American College of Legal Medicine in sponsoring successful scientific meetings and conferences in multiple venues throughout the United States. Since its inception, the ACLM has sponsored annual meetings, each lasting approximately three days and focusing on the most current and critical issues confronting the field of legal medicine. Each annual program showcases an internationally recognized panel of expert faculty who address a diverse and compelling array of medical legal issues that challenge health care professionals in virtually every arena of medical practice and research. At the annual meeting in 2010, the ACLM celebrated its 50th anniversary since incorporation. A history book celebrating the 50th anniversary of the ACLM is available on this website.

Download 50th Anniversary Complete History

Honorary fellows.

The American College of Legal Medicine confers Honorary Fellowships to individuals who demonstrate an outstanding reputation in the field of Legal Medicine. Honorary Fellows are individuals who had exceptional and lasting contributions to the field of Legal Medicine. They are entitled to all privileges of ACLM membership except that of voting and holding office. Honorary Fellowships are awarded during ACLM’s annual banquet. 

Gold Medal Award

The Gold Medal Award of the American College of Legal Medicine is awarded to members who have provided outstanding and distinguished service to ACLM. It is the highest award given by ACLM to its members. Gold Medal awardees receive this honor during ACLM’s annual banquet. 

The Bylaws of the American College of Legal Medicine, Inc. provide the framework and rules for the management and operation of the College. 

The American Board of Legal Medicine administers examinations to individuals with both legal and medical degrees. Learn more about the ABLM here .

The American College of Legal Medicine is a proud partner of the Australasian College of Legal Medicine . Learn more about their College here .

The American College of Legal Medicine is a member of the AMA House of Delegates representing the specialty of Legal Medicine. Learn more about the AMA here.

The American College of Legal Medicine partners with the American Bar Association in promoting Legal Medicine in the legal profession. Learn more about the ABA here .

Health Law Research

Secondary sources, primary sources, practice materials, organizations, interdisciplinary materials, getting help.

This guide provides an overview of health law research strategies. It will highlight some of the key secondary and primary resources in these areas. It will also provide current awareness sources. To learn more about performing legal research generally, please visit:

• Legal Research Strategy by AJ Blechner Last Updated Sep 21, 2023 4639 views this year

Health law has become a distinct field in its own right. However, researchers may also wish to explore:  Bioethics, Health Care Policy & Reform, Medical Device Law & Industry, Medical Malpractice, Medicare/Medicaid, Pharmaceutical Law & Industry, and Public Health. For a brief summary of health law please visit:

• Health Law: An Overview Cornell Legal Information Institute

Using Secondary Sources

Secondary sources are a great place to begin your research.  To learn more about secondary sources and how to use them, visit the following guide:

• Secondary Sources: ALRs, Encyclopedias, Law Reviews, Restatements, & Treatises by Catherine Biondo Last Updated Sep 12, 2023 2910 views this year

Encyclopedias & American Law Reports

Legal encyclopedias contain brief, broad summaries of legal topics. They provide introductions to legal topics and explain relevant terms of art. State encyclopedias can also be found on Westlaw and Lexis.

• American Jurisprudence 2d - Health - Westlaw
• American Jurisprudence 2d - Health - Lexis
• Corpus Juris Secundum - Health and Environment - Westlaw
• Lawyers' Medical Cyclopedia of Personal Injuries and Allied Specialties

The American Law Reports contains in-depth articles on narrow topics of the law.  Use the following Indices to access the ALR.  Note: Lexis also has some ALR materials but Westlaw's are more complete.

• Health Index Topic - ALR - Westlaw
• Medical Care Index Topic - ALR - Westlaw

Health Law Treatises

There are many health law treatises within our collection.  Users can search in Hollis  for the most up-to-date legal treatises.

• Hollis, the Harvard Library Catalog

Explore books by topic: Select Option Below Show All General Administration Bioethics & Biotechnology Mental Health Pandemic Response Policy Public Health

Books - General

Books - Administration

Books - Bioethics & Biotechnology

Books - Mental Health

Books - Pandemic Response

Books - Policy

Books - Public Health

Legal and Medical Journals

In addition to Hollis, mentioned above, many databases can be used for secondary source research:

• HeinOnline Health and Medicine
• Lexis Healthcare Law Journals
• Westlaw Health Law Journals

In addition to traditional law reviews and journals many advocacy organizations also publish:

• American Health Law Association Seminar Papers For papers prior to 2009 visit the American Health Law Association Seminar Papers - Archive
• American Journal of Law & Medicine by the American Society of Law and Medicine
• Food and Drug Law Journal by the Food and Drug Law Institute
• Internet Journal of Law, Healthcare and Ethics by Internet Scientific Publications
• Issues in Law & Medicine by the National Legal Center for the Medically Dependent & Disabled
• Journal of Law, Medicine, and Ethics by the American Society of Law, Medicine & Ethics
• Journal of Legal Medicine by the American College of Legal Medicine

Using Primary Sources

Primary authority is  "authority that issues directly from a law-making body." Authority , Black's Law Dictionary (11th ed. 2019).  To learn more about primary sources and how to use them visit:

• Primary Sources - Legal Research Strategy Guide
• Health Law Statutes - Westlaw
• Healthcare Law Statutes - Lexis
• State Health Statutes - LII Table of state codes on health law, for general use only, not citation.

Statutes & Legislation

50 State Surveys are tools used to compare the law across multiple states.  To learn more about using and accessing 50 State Surveys see our guide on:

• Comparing State Law - Prepare to Practice Guide

Comparing State Law

For 50 State Surveys on Health Law visit:

• 50 State Surveys - Health - Westlaw
• 50 State Surveys - COVID19 - Westlaw
• 50 State Surveys Healthcare, Public Health, & Welfare Law - Lexis
• State by State Guide to Managed Care Law

Legislative History

• Federal & State Legislative History by Mindy Kent Last Updated Sep 12, 2023 253 views this year

This may help when considering the impact of Federal and State statutes related to health. Consider searching for earlier versions of the law, supporting testimony, and additional documentation. If available, consider consulting published legislative history.

• A Legislative history of the Federal Food, Drug, and Cosmetic Act and its Amendments.
• Legislative History of the Health Insurance Portability and Accountability Act of 1996
• Legislative History of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
• Legislative History of the Social Security Amendments of 1965
• Legislative History of the Patient Protection and Affordable Care Act
• ProQuest Regulatory Insight Find regulations that have been promulgated as a result of the ACA.

If there is no existing legislative history, researchers may need to consult congressional materials directly.

Regulatory & Administrative Law

Regulations comprise a substantial portion of primary sources in health law research. Statutes may enable change in health policy (such as the Affordable Care Act) and create specific health programs (such as Medicare and Medicaid). Yet, the way those policies and programs are administered relies primarily on regulation.

If you are unfamiliar with how to conduct regulatory research, please visit:

• Administrative Law Research by AJ Blechner Last Updated Sep 12, 2023 351 views this year

The regulatory process can be complex, especially in the field of health care. Multiple agencies can be involved in promulgating regulations, further complicating the process. This visual overview can be helpful:

It may be easiest to start with a regulation by number or agency by name. Secondary sources such as books, scholarly articles, or advocacy communications can help you get started.

Government agencies websites provide information about proposed regulations and track them through the regulatory process.

• Federalregister.gov Contains federal agency documents, including proposed rules, final rules, public notices, and Presidential actions. This unofficial format provides the same material printed in the official Federal Register. It also contains related material from the Code of Federal Regulations and the US Code.
• Regulations.gov Allows users to search regulatory materials, submit comments, and sign up for email alerts. Some agencies require that comments be submitted through their own individual platforms. However, regulations.gov serves as a clearinghouse for the majority of publicly available public comment material.
• Reginfo.gov Produced by the Office of Management and Budget (OMB) and the General Services Administration (GSA). OMB's Office of Information and Regulatory Affairs (OIRA) reviews Federal regulations and information collections. The site provides information about regulations under development to enable public participation.

Administrative Materials are also accessible on both Westlaw and Lexis:

• Health Law Regulations - Westlaw
• Health Law Administrative Decisions & Guidance - Westlaw
• Healthcare Law Administrative Codes & Regulations - Lexis
• Healthcare Law Administrative Materials - Lexis

Agency websites also contain regulations and resources that can aid in conducting research:

• Health and Human Services Regulations
• Food & Drug Administration Regulations
• Centers for Medicare & Medicaid Services Regulations
• Federal & State Health Law Cases - Westlaw
• Federal & State Health Law Cases - Lexis

Some agencies can also decide cases related to particular regulations. These agency decisions may not be included in general case law databases. Decisions can often be accessed through agency websites:

• HHS Compliance - Advisory Opinions
• CMS Medicare Advantage/Prescription Drug Plan Decisions
• HHS Departmental Appeals Board Decisions
• HHS Enforcement Actions
• FDA Enforcement Reports
• FDA Warning Letters

Using Practice Materials

Practitioners often write the most helpful resources in the field of health law. Although they have similarities to treatises, they are directed at lawyers in practice. They may contain checklists and forms not available in a traditional treatise.

Practice Centers

• Healthcare Practice Center - Vitallaw
• Health Practice Center - Bloomberg Law
• Health Law Practice Center - Westlaw
• Medical Litigation Practice Center - Westlaw
• Healthcare Law Practice Center - Lexis

Practitioner Materials

Handbooks and guides are helpful when working on health law issues as a new practitioner.

• Health Law Handbook
• Health Care Compliance Guide - Bloomberg
• Health Law Practice Guide
• Health Care Law: A Practical Guide

Current Awareness Sources

Advocacy resources.

• POLITICO Pro PoliticoPro provides subject-based issue and policy tracking tools in multiple areas including Health Care. It prepares issue pages for major policy areas. Features include: news, calendar function, whiteboard, charts, graphs, and glossaries, all in well-organized practice centers. PoliticoPro content relies on policy experts in the field, writing in real time. The site also stores all primary source documents in a "document drawer" for easy access.
• Legistorm The In the News section curates news from Capitol Hill. StormFeed provides updates from press releases, twitter accounts from legislators, and relevant trending hashtags. For regular alerts request a personal account, contact [email protected].
• Vitallaw The Health Care library includes several Daily Documents and Newsletters. Researchers can also find CMS manuals and guidance, and State Health Care information.

News Sources

Keeping up-to-date with new developments in the field of health law will enhance research projects. Recent headlines in the field may also inspire researchers still looking for a paper topic. Use these links to find news sources related to health law:

• Kaiser Health News A nonprofit news service committed to in-depth coverage of health care policy and politics (not affiliated with Kaiser Permanente).
• Health Affairs A leading peer-reviewed journal of health policy thought and research. Aims to offer a nonpartisan forum to promote analysis and discussion.
• Medpac An independent congressional agency advising the U.S. Congress on issues affecting the Medicare program.
• Health Law & Business News - Bloomberg
• Health Law Daily - Westlaw Daily updates on current health law developments including the areas of food safety and Medicaid.

Legal Blogs have become an increasingly rich source of information and legal news.  Below are two indices to health law blogs:

• ABA Journal Health Law Blogs Index
• Justia Healthcare Law Blogs

Non Profits and NGOs

• National Agencies and Organizations from Pace Health Law Research Guide

The following organizations may be particularly useful to researchers:

• Center for Medicare Advocacy Nonprofit, nonpartisan law organization providing education, advocacy, and legal assistance to help people obtain Medicare. In addition to the newsroom, you can sign up for alerts via email.
• Families USA A consumer advocacy group that focuses on Health Care, with a robust newsroom. You can access insights, reports, raw data, and more under their resources tab.

Kaiser Family Foundation

• Kaiser Family Foundation A non-profit organization focusing on national health issues. They provide policy analysis, journalism, and communication for the general public.

Kaiser Health News includes a morning briefing and updates via email or RSS feed:

Community Catalyst

• Community Catalyst Non-profit dedicated to consumer health advocacy, working in 40 states across the country.
• Dual Agenda Newsletter Includes state highlights on health care reform. Their  ACA Implementation Fund  partners with state-based advocacy groups on issues related to the implementation of health care reform. They focus on the state level, and explore the impact of potential repeal.
• Health Policy Hub Blog Allows for email subscription.

The latest posts from their feed are included below:

Health & Medical Field Resources

Health law is an interdisciplinary area. You may benefit from accessing health and biomedical resources.  

For unfamiliar terms and acronyms consult the following:

There are several health and medical databases that may be helpful in your research:

• Harvard Medicine & Public Health Databases
• PubMed For how to use please visit the Pubmed Research Guide
• Web of Science

Additional Resources

Health law also touches on many different research areas.  These additional research guides contain important content related to health law:

• Disability Law by AJ Blechner Last Updated Sep 12, 2023 91 views this year
• Elder Law by AJ Blechner Last Updated Sep 12, 2023 101 views this year
• Health Policy by James Adams Last Updated May 25, 2023 76 views this year
• Law and Public Policy by Mindy Kent Last Updated Sep 12, 2023 251 views this year
• Research Guide on International Health Law GlobaLex Guide from Professor Chenglin Liu, St. Mary's University School of Law

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• Last Updated: Sep 12, 2023 10:46 AM
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• v.21(1); Spring 2021

A Modern History of Informed Consent and the Role of Key Information

Lydia a. bazzano.

1 Department of Internal Medicine, Ochsner Clinic Foundation, New Orleans, LA

2 The University of Queensland Faculty of Medicine, Ochsner Clinical School, New Orleans, LA

3 Institutional Review Board, Division of Academics, Ochsner Clinic Foundation, New Orleans, LA

Jaquail Durant

Paula rhode brantley.

4 Institutional Review Board, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA

Background: The concept of informed consent has evolved significantly with regard to both the practice of medicine and research conducted with human volunteers. Yet the process of informed consent used in clinical research and the lengthy consent documents that are difficult to comprehend have been criticized.

Methods: We review the history of informed consent as a legal and regulatory concept and the intended impact of the new key information section, a requirement that was introduced in the 2017 revisions to the Common Rule.

Results: The key information section is intended to be a concise and focused presentation at the beginning of the informed consent document that facilitates potential participants’ comprehension of the research. However, the lack of regulatory guidance regarding content and length has been problematic. To avoid the risk of noncompliance, many institutions have sought safe harbor by following the limited format guidelines included in the preamble to the revisions to the Common Rule.

Conclusion: Research examining formats for the key information section and aids to increasing potential participants’ understanding of a research project should be conducted to ensure that the new regulations achieve the original intent rather than simply lengthening an already lengthy paper document. In addition, the human research protections community should evaluate whether the key information section increases research participants’ understanding of what they will be undertaking in a particular study.

INTRODUCTION

Informed consent is one of the primary principles on which the framework of protections for human subjects in research is built. In the United States, informed consent was codified in law via the statutes at 45 CFR 46 and 21 CFR 50 of the Code of Federal Regulations, yet the intellectual scaffolding on which it has been built over time has shifted, just as the landscape of human subjects research itself has changed. The most comprehensive modifications to the Common Rule—the Federal Policy for the Protection of Human Subjects—since its adoption in 1991 were enacted in 2018.

The need for improving the process of informed consent has been documented by a wide variety of studies. 1 - 6 Empirical research has demonstrated that the informed consent process often fails to provide information in an understandable format to individuals with low health literacy and that the expectation of detailed information recall from a document that is often more than 20 pages is not realistic. 7 , 8 To explain how the process of informed consent has evolved over time, how the limitations 9 of the process developed, and how well these limitations may be addressed by new regulations, we review the intellectual and legal scaffolding of informed consent as it currently exists.

HISTORY OF INFORMED CONSENT

The concept of informed consent has a relatively short history, beginning with a series of 4 judicial decisions in the early 20th century that laid the foundation for the principle of patient autonomy. 10 - 12 These legal decisions began in 1905, with the cases of Mohr v Williams and Pratt v Davis . 13 , 14 Subsequently, 2 additional cases, 15 , 16 Rolater v Strain and Schloendorff v Society of New York Hospital , established and solidified the principle of patient autonomy that ultimately formed the basis of the requirement for informed consent in medicine and research.

In the case of Mohr v Williams , the plaintiff, Mrs Anna Mohr, consented to an operation on her right ear; however, once she had been anesthetized, the defendant physician changed the plan of surgery from the right ear to the left after determining that the right ear was not as severely affected by disease as had been expected. 14 Mrs Mohr's hearing was further impaired by the operation, and she sued the surgeon for assault and battery in changing the laterality of the operation without consent. The Supreme Court of Minnesota agreed that the surgeon should have obtained consent before performing surgery on the opposite ear. Similarly, in the case of Pratt v Davis , a 1905 Illinois appellate decision, the plaintiff, Mrs Parmelia J. Davis, had filed suit against her surgeon for battery after he performed a hysterectomy without her consent. 13 The physician had obtained consent for an earlier operation but admitted to failing to obtain consent for the second procedure and not disclosing the fact that he intended to perform a hysterectomy to treat Mrs Davis's epileptic seizures. The surgeon, Dr Edwin H. Pratt, acknowledged intentionally misleading the plaintiff as to the purpose of the operation, claiming that because Mrs Davis suffered from epilepsy, she was not competent to give her consent or to deliberate intelligently about her situation. 13 In its decision in favor of Mrs Davis, the appellate court stated,

…under a free government at least, the citizen's first and greatest right, which underlies all others—the fight to the inviolability of his person, in other words, his right to himself is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent, who has been asked to examine, diagnose, advise and prescribe (which are at least the necessary first steps in treatment and care) to violate without permission the bodily integrity of his patient. 13

The third case of this early period, Rolater v Strain , extended the findings of the legal decisions in the Mohr and Pratt cases to similar situations in which surgeons performed procedures that the patient had explicitly controverted. 16 In Rolater , the plaintiff sued her surgeon for removing a bone from her foot during an operation that was ostensibly to incise and drain an infection. While the surgeon had obtained consent to perform the procedure to drain an infection, the patient had expressly stated the wish that the surgeon not remove the bones of the foot during surgery, so that the removal constituted a trespass to her person and resulted in the charges of assault and battery. In contrast to the ruling in the cases of Mohr and Pratt , in the Rolater case, the surgeon had obtained the patient's consent before the surgical procedure and performed the surgery on the proper foot. Nevertheless, the Supreme Court of Oklahoma held that the principles of the earlier cases were applicable because the surgeon had not performed the procedure in the manner agreed upon between the physician and patient.

The 1914 case of Schloendorff v Society of New York Hospital was the final landmark case that legally established the principle of patient autonomy. The plaintiff, Mary Schloendorff, explicitly stated her wish not to undergo surgery yet was subjected to hysterectomy to remove a fibroid tumor without her consent. 15 In the ruling, Judge Benjamin Cardozo wrote, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages.” 15

Notably, these landmark cases that established the legal precedent of patient autonomy all had female plaintiffs at a time when women did not have the right to vote in the United States, indelibly intertwining the right of patient autonomy with the right of a woman to consent to procedures on her own body.

Nevertheless, the principle of “informed consent” remained nameless and not legally binding until the term was first publicly recorded in the court documents for the 1957 case Salgo v Leland Stanford Jr University Board of Trustees . 17 The plaintiff in the case, Mr Martin Salgo, had arteriosclerosis of the aorta and underwent a translumbar procedure to evaluate its extent. During the procedure, a contrast agent was injected into his aorta to identify blockages, and the procedure resulted in permanent paralysis of his lower limbs. Mr Salgo sued the university medical center and its chief surgeon for lack of disclosure of this potential risk. In a California appellate court decision, the court directed that each physician must exercise practical insight in completely divulging potential procedural hazards and that physicians are liable for failing to disclose information that a patient would need to make an informed decision regarding medical procedures. 17 This legal ruling was the first to identify and focus attention on the need to provide the patient with information about the potential benefits and the risks of any medical procedure.

While these cases established the legal framework for and the principle of informed consent, as well as the duty of physicians to obtain informed consent for diagnostic and/or therapeutic medical procedures, the concept of informed consent in human subjects research began to emerge in parallel as a consequence of the investigation of Nazi war crimes at the end of World War II. On August 20, 1947, the trial of 23 physicians and bureaucrats charged with crimes against humanity and war crimes for medical experiments conducted on concentration camp inmates concluded in Nuremberg, Germany. 18 The verdict of the International Military Tribunal, a trio of American judges empowered under international law adopted by the Allied powers, set forth a series of 10 basic rules for the conduct of human experiments that has become known as the Nuremberg Code. 19 The Nuremberg Code represents the first explicit attempt to regulate the ethical conduct of research experiments with human subjects and is notable for the emphasis it places on voluntary consent. A section of the ruling entitled “Permissible Medical Experiments” states, “…certain basic principles must be observed in order to satisfy moral, ethical and legal concepts” in human subjects research. 18 The first of these concepts is the voluntary consent of the human subject. In further statements, the court defined the specific context and meaning for this concept:

This means that the person…should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment. 18

This 2-sentence statement distills the major issues in the process of informed consent. First, it highlights that a consenting individual must have sufficient knowledge and comprehension to understand what he or she is agreeing to as part of the research. The word comprehension is particularly noteworthy. Second, these statements identify several specific items of information that must be made known to the potential subject of the research.

Subsequent events helped to lay the groundwork for the US regulatory definition of informed consent in human subjects research, a definition that was articulated in federal law with the publication in 1981 of coordinated US Department of Health and Human Services and US Food and Drug Administration (FDA) policies for human subjects research protections as 45 CFR 46, 20 and the 1991 adoption of Title 45, Public Welfare, Part 46, 21 Protection of Human Subjects, subpart A, also known as the Common Rule. The historical events that preceded the regulatory definition included the Declaration of Helsinki adopted by the World Medical Association in 1964, 22 the work of medical ethicist Henry Beecher, 23 and the public outcry against the 1972 revelation of the Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male 24 that was critical to the creation of the National Research Service Award Act on July 12, 1974. 25 A provision of the Act was the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Informed by regular deliberations for more than 4 years and several days of intense discussion in 1976, the Commission's final publication of the Belmont Report in 1979 identified basic ethical principles and guidelines regarding the conduct of research with human subjects. 26

The Belmont Report identified 3 specific concepts critical to the process of informed consent in research: information, comprehension, and voluntariness. The concept of information includes specific elements: “research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.” 26

The report noted that a number of additional items had “been proposed, including how subjects are selected, the person responsible for the research, etc.,” 26 and also stated,

…the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation. 26

This statement speaks to another critical contribution of the Belmont Report, the standard of the “reasonable volunteer” in research who may desire information beyond what a reasonable person undergoing medical therapy would desire. In proposing the reasonable volunteer standard, the Belmont Report concept of information appears to explicitly extend beyond the accepted extent of disclosures to patients about diagnostic or therapeutic medical procedures.

The second principle articulated in the Belmont Report, Part C: Applications, Informed Consent, was comprehension . 26 Comprehension became one of the significant issues in contemporary thought regarding informed consent and ultimately led to the idea and implementation of a key information section as one of the changes to the Common Rule announced in final form in 2017 27 and enacted in subsequent years. The first sentence in the Belmont Report section on comprehension states, “The manner and context in which information is conveyed is as important as the information itself.” 26 Extensive literature, punctuated in 2015 by the Institute of Medicine workshop on informed consent and health literacy, 6 recognized the need to close this gap in communicating information in a meaningful manner. 5

KEY INFORMATION

For a number of reasons, obtaining informed consent for research from human subjects has become a lengthy and complex process, even for relatively simple studies that pose little or no risk to participants. The modern process of obtaining informed consent from individuals interested in participating in research focuses in large part on a written text that documents investigators’ attempts to provide the critical elements of information that have been outlined in 45 CFR 46.116 from its inception. This focus on a lengthy legal document has been roundly criticized because of poor comprehension by potential research participants. For example, a 1983 article in the Journal of the American Medical Association concluded, “…little progress has been made in ensuring that the information is comprehensible, understood, and used.” 2 Such criticisms have continued and strengthened, with evidence demonstrating that consent forms have increased in length and complexity 28 over time and are typically written at a much higher educational level than appropriate. 29 Although changes in federal regulations for human subjects research present the hope of improvement in this status quo of a suboptimal informed consent processes, the wording of the regulation permits the investigator to exercise a large amount of flexibility at his/her discretion, pending acceptability to a member or members of the review board.

In the 2017 revisions to the Common Rule, text at §__.116(a)(5)(i) states,

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 27

Thus, the purpose of presenting “key information” in a “concise and focused” format is to facilitate comprehension. The regulations do not provide a specific definition of key information, although the preamble to the revised rule includes the following list of topics that likely should be included to meet the regulatory intent of the key information requirement: (1) the fact that consent is being sought for research and that participation is voluntary; (2) the purposes of the research, the expected duration of the prospective subject's participation, and the procedures to be followed in the research; (3) the reasonably foreseeable risks or discomforts to the prospective subject; (4) the benefits to the prospective subject or to others that may reasonably be expected from the research; and (5) appropriate alternative procedures or courses of treatments, if any, that might be advantageous to the prospective subject. 27 The authors state that the lack of specific instructions about the types of information and the length of the concise presentation in the final rule will allow institutions to design informed consents that are tailored to particular research studies and highlight specific fundamental aspects of that research for prospective participants. 27

While some flexibility is important given the range of human subjects research, extensive flexibility may result in such variation that in practice, the new key information section of the informed consent document may not fulfill the original purpose of facilitating comprehension. On the other hand, many versions of the key information section implemented at various institutions and by researchers include a near-verbatim list of the 5 items listed in the preamble and instruct subjects to read the entire informed consent document for more details. Although this form of the key information section may not be optimally helpful to participants, it may prevail as the most common version because of the limited guidance provided by official sources regarding content.

The Secretary's Advisory Committee on Human Research Protections (SACHRP) provided commentary and response to several queries posed jointly by the Office for Human Research Protections (OHRP) and the FDA regarding key information in attachment C of their letter of November 13, 2018, to the Secretary of Health and Human Services. 30 In their recommendations, SACHRP advised flexibility to include other elements of consent, or even additional information that is not a required element of consent, if it would assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. Regarding providing information about risks, SACHRP recommended not including the full list of risks and benefits because a lengthy list would not aid in a subject's understanding of which risks may be reasonably foreseeable and concerning. In addition, discomforts and inconveniences associated with participation may be important key information for some studies. However, SACHRP specifically noted that from a compliance perspective, the 5 elements listed in the preamble make them a safe harbor of sorts, but that simply following this format may not be in keeping with the intent of the regulatory change. 30 In the same letter, SACHRP notably recommends that

…OHRP specifically state that diverging from the preamble suggestions of key information would not incur a compliance risk as long as the full consent document meets the requirements of the regulations. This is critical to encourage the development of creative and potentially better approaches to presenting key information and to improvement of the consent form and process as a whole. 30

A statement from OHRP permitting divergence from the preamble suggestions would reassure the research community as a whole and potentially allow for creative and effective key information sections.

Letters and commentaries from the research ethics community have expressed both enthusiasm and concern regarding the addition of the key information section. 31 In a 2019 article, Nancy King wrote that the requirement for the key information section has potentially shifted the process of informed consent into a more genuinely patient-centered exchange of information, but she also pointed out the conundrum of “compliance-vs.-flexibility” and the fact that uncertainty is particularly uncomfortable in the regulated research community. 31 In a different commentary, Mark Yarborough also recognized the key information requirement as a critical opportunity to improve the process of informed consent but more specifically through its potential to create new standards for disclosure. 32 In cataloging the proposed changes to informed consent under the revised rule, Jeremy Sugarman noted that the revised rule retains the focus on a traditional written document. 33 In contrast, Kraft and colleagues called for improving the consent process by offering reasons why some enroll in research and other choose not to enroll. 34

The OHRP and other federal agencies issued little guidance other than what is provided in the preamble and no examples of key information sections that would comply with the new regulations prior to the implementation of the 2018 revisions to the Common Rule on January 19, 2019. Flexibility in the presentation of the key information is appropriate if sufficient information is presented in a manner that facilitates comprehension. However, the current state of uncertainty—lack of assurance that flexibility or creativity in designing the key information section is not associated with a risk of noncompliance—leaves many institutions in the position of seeking safe harbor by following the format presented in the preamble. Empirical research examining formats and aids to increasing understanding should be conducted to ensure that the new regulations achieve the original intent rather than lengthening an already lengthy paper document. In addition, the human research protections community should collect and examine evidence to determine if the key information requirement increases research participants’ understanding of what they will be undertaking in a particular study.

ACKNOWLEDGMENTS

The authors have no financial or proprietary interest in the subject matter of this article.

This article meets the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties Maintenance of Certification competencies for Medical Knowledge and Professionalism.

Search committee co-chairs named for vice president for research

University of Iowa President Barbara Wilson has named Denise Jamieson, vice president for medical affairs and dean of the Carver College of Medicine, and Jamie Jorgensen, vice president for legal affairs and general counsel, as co-chairs of a committee tasked with selecting the next vice president for research.

“I am very pleased to name Denise and Jamie as co-chairs of this search,” says Wilson. “They understand the importance of advancing our research enterprise at Iowa and they have a multi-leveled appreciation of the unique skills needed to provide campuswide leadership in this area.”

Jamieson became vice president for medical affairs and dean of the Carver College of Medicine on Aug. 1. In her short time on campus, Jamieson helped lead the university through the purchase of Mercy Iowa City and the transition of its employees to the new UI Health Care Medical Center Downtown campus. Before coming to Iowa, Jamieson was the James Robert McCord Professor and Chair of the Department of Gynecology and Obstetrics at Emory University School of Medicine in Atlanta.

Jorgensen returned to the university in September 2022 to serve as vice president for legal affairs and general counsel, having previously served as associate and deputy general counsel at Iowa from 2006—2018. Before returning to Iowa, Jorgensen served as chief of staff and chief legal counsel at Pitzer College and senior counsel at Husch Blackwell LLP in Denver, Colorado, where he advised colleges and universities on numerous issues, including workplace and academic accommodations, accreditation, student conduct and faculty discipline, real estate negotiations, and academic programming partnerships.

The search firm Spencer Stuart has been selected to assist with the process.

The next vice president for research will succeed Marty Scholtz,  who announced in February that he will step down at the end of his five-year term. He will stay in the role until his successor is hired.

UI Vice President for Research Marty Scholtz to step down

• In the News

Penn panel on "Legal Models for Psychedelics: Ethical, Clinical, and Practical Implications"

March 19, 2024.

As psychedelics become increasingly mainstream, a variety of legal models are developing in tandem, including decriminalization, legalization, and more medicalized approaches, ranging from psychedelic services and therapy provided by specific state-licensed outlets and providers to traditional FDA drug approval. What are the ethical, clinical, and practical implications of these legal models for emerging psychedelic businesses and those interested in using psychedelics? Which models should be preferred – and which should be avoided? In this panel, experts will describe the current legal landscape for psychedelics, how it is playing out in practice, and what shape it should take in the future.

Ismail Ali Director, Policy & Advocacy Multidisciplinary Association for Psychedelic Studies

I. Glenn Cohen James A. Attwood and Leslie Williams Professor of Law and Deputy Dean, Harvard Law School Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics

Natalie Gukasyan Assistant Professor of Psychiatry Columbia University Irving Medical Center

Steven Levine SVP Patient Access and Medical Affairs COMPASS Pathways

Moderator Holly Fernandez Lynch L’06 Assistant Professor of Medical Ethics, University of Pennsylvania Perelman School of Medicine CTIC Affiliated Faculty

You can view the recording here:

• https://www.youtube.com/watch?v=MmXiStd_36c&list=PLR5Q3wC5nyVly6zQBygRg7bkk1ZYIs8PC&index=2

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Good manufacturing practice

This content applies to human and veterinary medicines.

Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.

GMP requires that medicines:

• are of consistent high quality;
• are appropriate for their intended use;
• meet the requirements of the marketing authorisation or clinical trial authorisation.

Also on this topic

• EudraGMDP database
• Guidance on good manufacturing practice and good distribution practice: Questions and answers

GMP/GDP Inspectors Working Group

• Mutual recognition agreements (MRA)
• International collaboration on GMP inspections
• Joint Audit Programme

Regulatory expectations and GMP certificates following the-COVID-19 public health emergency

EMA, the European Commission and Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic .

This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.

On-site GMP and GDP inspections have restarted after being postponed or carried out remotely during the pandemic.

However, a considerable number of postponed inspections still need to be carried out.

The validity of GMP and GDP certificates was extended until the end of 2023. The GMP/GDP Inspectors Working Group has decided to continue the extension of the validity date until 2024 or the conclusion of the next on-site inspection, whichever comes first, except where clarifying remarks in the document state otherwise. 

Meanwhile, competent authorities will perform risk-based supervision of sites, either by on-site inspections or distant assessments , and based on the outcome may continue to issue, withdraw or restrict GMP and GDP certificates, as appropriate.

The inspections will be prioritised based on risk, so that the highest priority manufacturers, such as manufacturers of sterile product and biological products , and wholesale distributors are inspected first. In addition, inspections will be prioritised depending on the date of the last inspection.

Questions about the validity date of a GMP or GDP certificate should be addressed to the competent authority that issued the certificate. 

It is incumbent upon manufacturers , importers and distributors to continue complying with GMP and GDP as appropriate. 

Supervisory authorities will remain vigilant to ensure the quality of medicines that are made available to patients in the EEA.

Inspections (including distant assessments) may be carried out at any time. In case of serious non-compliance , appropriate regulatory actions will be triggered.

The guidance was agreed by the GMP/GDP Inspectors Working Group  coordinated by EMA. It will be updated when there is additional information available.

The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorisation in the EU is submitted through the centralised procedure or as part of a referral procedure.

The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level. It is involved in:

• coordinating the preparation of new and revised guidance on GMP;
• ensuring common interpretation of EU GMP requirements and related technical issues;
• developing EU-wide procedures on GMP inspections and related activities;
• facilitating cooperation between Member States for inspections of manufacturers in third countries.

Marketing authorisation holders and applicants need to use EMA's IRIS system  to communicate with EMA on  GMP inspections  requested by the Agency’s scientific committees.

Using IRIS for GMP inspections improves efficiency by harmonising and automating processes and re-using master data held by EMA. It also simplifies retrieving and reporting data.

More information on the use of EMA's IRIS system:

• IRIS system

Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Legal framework and guidance

These legal instruments lay down the principles and guidelines of GMP in the EU:

• Regulation No. 1252/2014  applying to active substances for human use;
• Directive 2001/83/EC  and Directive (EU) 2017/1572 , applying to medicines for human use;
• Directive 91/412/EEC  and Regulation (EU) 2019/6 applying to medicines for veterinary use.
• Directive 2001/20/EC and Regulation (EU) 536/2014 applying to Investigational medicinal products.

The EU GMP guidelines provide interpretation of these principles and guidelines, supplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.

The GMP / Good Distribution Practice (GDP) Inspectors Working Group provides additional interpretation of the EU GMP guidelines in the form of questions and answers (Q&As) .

Annex 1: Manufacture of Sterile Medicinal Products was revised in August 2022. It comes into operation on 25 August 2023 except for point 8.123 which is postponed until 25 August 2024.

Manufacturing authorisation

Manufacturers and importers located in the European Economic Area (EEA) must hold an authorisation issued by the national competent authority of the Member State where they carry out these activities.

They must comply with EU GMP to obtain a manufacturing or import authorisation. They can ensure that they meet all their legal obligations by following the EU GMP guidelines.

Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.

Marketing authorisation applicants are responsible to ensure that the proposed manufacturing sites included in the marketing authorisation application comply with GMP. For more information, see section 5.2 Inspections of the Pre-authorisation guidance .

Registration of manufacturers of active substances

Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where they are located.

Active substance manufacturers must comply with GMP. In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.

Importers of active substances intended for the EU market are also required to register. In addition, each consignment needs to be accompanied by a confirmation by the competent authority of the country where it is produced that it conforms to GMP standards equivalent to those in the EU, unless a waiver applies.

Responsibility for inspections

In the EU, national competent authorities are responsible for inspecting manufacturing sites located within their own territories.

Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned. If an MRA applies, the authorities mutually rely on each other's inspections.

If products are imported directly into more than one Member State from a manufacturing site outside the EU, there may be more than one national competent authority responsible for inspecting it. EMA facilitates cooperation between the authorities concerned in supervising the site.

EU competent authorities plan routine inspections following a risk-based approach, or if there is suspicion of non-compliance.

EudraGMDP is a publicly accessible EU database which contains manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates and non-compliance statements.

After inspecting a manufacturing site, EU competent authorities issue a GMP certificate or a non-compliance statement, which is entered in the EudraGMDP database.

EMA chairs and provides the secretariat for the GMP/GDP Inspectors Working Group of senior inspectors appointed by all the EEA competent authorities. It meets at EMA four times a year.

The European Commission and observers from EU accession countries, mutual recognition partner authorities, the European Directorate for the Quality of Medicines and HealthCare and the World Health Organization also attend the working group's meetings.

The group provides a forum for harmonisation and discussion of common issues, such as:

• updates or amendments to the EU GMP guidelines;
• the compilation of Union procedures;
• harmonised interpretation of GMP and related requirements.

Compilation of Union procedures

EMA maintains a compilation of GMP and good distribution practice (GDP) inspection-related procedures and forms agreed by all Member States. This facilitates cooperation between EU Member States and supports harmonisation and exchange of inspection-related information.

It covers the basis for national procedures that form part of the national inspectorates' quality systems:

Compilation of Union procedures on inspections and exchange of information

EMA published the Word and PDF versions of some of the templates for the convenience of inspectorates

The forms and templates should be downloaded and saved first before being completed, using for example “Save target as” function. To report any technical issues with the form, please use the  EMA Service Desk  portal.

• Rapid alert notification of a quality defect / recall
• Follow-up and non-urgent information for quality defects
• Good-manufacturing-practice inspection report - Community format

Revision of template for serious GMP non-compliance

EMA's GMP/GDP Inspectors Working Group is discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, specifically where this can lead to a shortage of critical medicines . EMA has held a public consultation on an updated template for GMP non-compliance statement in 2018:

• Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement

Inspections for pharmaceutical starting materials

Plasma master file (pmf) inspections.

For products derived from blood or blood plasma, EMA is responsible for coordinating inspections of the blood establishments in which collection, testing, processing, storage and distribution is carried out under the PMF certification procedure.

For more information on the PMF certification procedure, see Plasma master files .

Vaccine antigen master file (VAMF) inspections

EMA is responsible for coordinating inspections of vaccine antigen manufacturing sites under the VAMF certification procedure.

For more information on the VAMF certification procedure, see Vaccine antigens .

• Mutual recognition agreements

The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU. This allows EU authorities and their counterparts to:

• rely on each other's GMP inspections;
• waive batch testing of products on entry into their territories;
• share information on inspections and quality defects.
• The scope of each agreement differs.

More information

• GMP/GDP inspectors working group
• Questions and answers: Good manufacturing practice
• International collaboration

Related content

• Good distribution practice
• Medicine shortages

Related EU legislation

• Regulation No. 1252/2014
• Directive 2003/94/EC
• Directive 91/412/EEC

Publications

• PDA Journal: GMP oversight of medicines manufacturers in the EU

Contact point

• Regulatory and procedural guidance

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Aims and scope

It is the aim of the International Journal of Legal Medicine to improve the scientific armamentarium necessary for the elucidation of crime and for related forensic applications at a high level of evidential proof. The subject will be dealt with in:

   Review articles tracing development in specific areas and providing up-to-date analysis of them

   Original articles discussing recent research results of a high standard

   Case reports describing interesting and exceptional cases

    Short Communications discussing research results on a maximum of 4 pages

   Letters to the Editors , in which the readers have the opportunity of expressing their comments on new results reported or indeed on other matters, and 

   Technical notes , which appear in a section originally created for rapid publication of data in the dynamic field of DNA analysis. Other fields have already made valuable contributions, however, and of course these are also welcome. This section is designed to provide a forum for discussion of innovative protocols and methodologies: papers submitted for publication have should provide clear and concise information on the advantages over existing methods and/or new data. DNA manuscripts can also deal with short validation studies, population data, quality control studies, etc. Manuscripts should not exceed 6 typescript pages in length; much shorter contributions are also very welcome.

   Forensic imaging related papers will be considered if directly related to forensic medicine issues. Either forensic clinical or postmortem imaging papers using X-ray, computed tomography, magnetic resonance tomography, sonography, 3D-surface scanning, angiography techniques or other technology may be submitted whereas papers related digital image forgery issues will not be considered within the International Journal of Legal Medicine . 

The International Journal of Legal Medicine will continue to be a regular source of essential information in the areas of: - Forensic pathology, including sudden death, thanatology, and demonstration of vital reactions - Clinical forensic pathology, including such topics as non-accidental injury and rape - Forensic haemogenetics, with special emphasis on the recent advances in DNA technology and PCR - Forensic toxicology, as it relates for example to alcohol and drug addiction, and recent technology - Traffic medicine, with special reference to reconstruction, causal connections, and medical complications

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Artificial Intelligence in Medicine

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Legal Considerations

Research tools, research organizations, research datasets, search pubmed for ai articles.

• AI Publishing

MAIC–10 brief quality checklist for publications using artificial intelligence and medical images.

MAIC–10 brief quality checklist for publications using artificial intelligence and medical images . Insights Imaging, published online January 6, 2023.

Cerdá-Alberich, L., Solana, J., Mallol, P. et al. Insights Imaging 14, 11 (2023).

When Gathering Data for AI Analysis, Proceed with Caution

Always check a publisher's AI restrictions before reusing their content. This is in addition to any potential copyright and publishing restrictions. Publishers often impose restrictions on analyzing their published materials using AI for research purposes due to concerns about copyright infringement and protecting their intellectual property. Access to content for AI analysis may be limited by subscription or licensing agreements, requiring researchers to obtain explicit permission or negotiate terms for data access. These restrictions aim to balance the rights of publishers with the advancement of research while ensuring compliance with legal and ethical standards.

This article offers a useful summary of the complexity of these challenges and how "content owners have been resoundingly successful in copyright claims against companies and individuals who distribute their content on the internet."

Information Policy and A.I. Tracy Mitrano . Inside Higher Ed. Published online March 18, 2024

"In the aughts, as the director of IT Policy at Cornell, I sat in meetings with Google representatives who asked to scan the university’s library holdings. Never mind the original accumulated expense Cornell bore of eight million volumes. To engage in the transformational effort to “organize the world’s information and make it universally accessible and useful” proved compelling enough that the university agreed to it (along with “free” mail services, but that is another story told in this  document ).  Never mind that Google monetized that repository.  And now OpenAI is asking us to never mind that they scraped it."

• Elsevier's Terms and Conditions " You may not use Content from the Services in combination with an artificial intelligence tool, (including to train an algorithm, test, process, analyse, generate output and/or develop any form of artificial intelligence tool)."

" AlphaFold Protein Structure Database , developed by Google DeepMind , is able to computationally predict protein structures with accuracy and speed. Working in partnership with EMBL’s European Bioinformatics Institute (EMBL-EBI) , they've released over 200 million protein structure predictions by AlphaFold that are freely and openly available to the global scientific community. Included are nearly all catalogued proteins known to science." More >

AI Health Lab Led by Prof. Ying Ding from School of information, and Prof. Justin Rousseau from Dell Medical School at the University of Texas at Austin. AI Health Lab  is made up of scholars and students from different fields and disciplines. They focus on cutting-edge research on AI in health and data-driven science of science.

American College of Radiology (ACR) Data Science Institute Working with stakeholders to develop and implement radiology-related artificial intelligence applications. Host of the Informatics Learning Hub and "ACR Data Science Institute® AI Central database, the most complete and up-to-date online, searchable directory of commercially available Imaging AI products in the United States. Browse through more than 200 FDA-cleared products created by more than 100 manufacturers to find algorithms that best support your patients and workflows."

Alliance for Artificial Intelligence in Healthcare The AAIH, consisting of technology developers, pharmaceutical companies, and research organizations, utilizes AI in healthcare to improve the quality of care..

Cedars-Sinai Cedars-Sinai Medical Center's Department of Medicine houses the Artificial Intelligence in Medicine (AIM) research program. The AIM program aims to create software that can analyze three-dimensional images of the heart, like how a trained human operator would. The program measures critical parameters for understanding the state and behavior of the human heart using artificial intelligence techniques.

Center on AI Research for Health At University of Southern "aims to nurture collaborations between researchers in AI and those in the health sciences." In 2023, they released projects on radiation oncology, neurodegenerative diseases and mental health.

Gates Foundation . Focused on the ethics of AI access and use, including the development of new technologies and their application in resource-poor settings. Research grants available. "The projects we selected focus on a wide array of critical health and development issues, including primary health care, education, agricultural development, women’s health, and nutrition. We are optimistic and excited about the diversity of problems being addressed because they often intersect."  

There is a multitude of databases and datasets in medicine related to AI and healthcare. These databases provide valuable resources for researchers and developers working on AI and machine learning applications in healthcare and medicine. They enable tasks such as imaging analysis, clinical decision support, predictive modeling, and drug discovery. Many are freely available for research. Always check the organization's policy on data re-use.

Alzheimer’s Disease Neuroimaging Initiative The dataset for a longitudinal study includes neuroimaging, clinical, and genetic data from individuals with Alzheimer's disease, mild cognitive impairment, and healthy controls.

Genomic Data Commons A dataset containing comprehensive cancer genomics, clinical data, and imaging data for various types of cancer enables research on the diagnosis, prognosis, and treatment of cancers.

Medical Segmentation Decathlon This benchmark dataset features ten different segmentation tasks across various anatomical structures and imaging modalities, making it ideal for evaluating and comparing medical image segmentation algorithms.

MIMIC-III  A large, freely-available database of deidentified health-related data associated with over forty thousand patients who stayed in critical care units of the Beth Israel Deaconess Medical Center between 2001 and 2012. The database contains demographics, vital sign measurements taken at the bedside (~1 data point per hour), laboratory test results, procedures, medications, caregiver notes, imaging reports, and mortality (including post-hospital discharge).

NIH Chest X-ray dataset A dataset comprising over 100,000 chest X-ray images released by the National Institutes of Health (NIH), annotated for the presence of common thoracic pathologies.

To search for articles related to artificial intelligence in medicine on PubMed using the National Library of Medicine (NLM) Medical Subject Headings (MeSH) terms in Boolean format, copy and paste the following search string into the search box on PubMed .

• PubMed PubMed comprises more than 26 million citations for biomedical literature from MEDLINE, life science journals, and online books dating back to the 1950s with PCOM Full Text Finder to full text.

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Police arrest former soccer player Robinho in Brazil - local media

Police arrested former soccer player Robinho in the Brazilian city of Santos on Thursday to serve out a nine-year prison sentence for rape, local news website G1 reported.

New England Journal of Medicine Series: Wearable Digital Health Technologies

Courtesy of the researchers

by Rosalind W. Picard

March 18, 2024

• #wearable computing
• #technology
• #cognitive science
• #mental health
• #public health
• Rosalind W. Picard Professor of Media Arts and Sciences
• Media Lab Research Theme: Life with AI
• Media Lab Research Theme: Connected Mind + Body

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Researchers in the Affective Computing group at the MIT Media Lab have been invited to edit a series of articles on the topic of Wearable Digital Health Technologies in the New England Journal Medicine ; the series includes articles related to epilepsy, depression, diabetes, and cardiovascular disease, among other areas. 

Peruse the articles in this series below! 

Wearable Digital Health Technology for Epilepsy

Elizabeth Donner, Orrin Devinsky, and Daniel Friedman; guest editors Stephen H. Friend, Geoffrey S. Ginsburg, Rosalind W. Picard, Jeffrey M. Drazen. "Wearable Digital Health Technology for Epilepsy." New England Journal of Medicine 2024; 390:736-745. DOI: 10.1056/NEJMra2301913

Wearable Digital Health Technologies for Monitoring in Cardiovascular Medicine

Erica S. Spatz, Geoffrey S. Ginsburg, John S. Rumsfeld, and Mintu P. Turakhia; guest editors Stephen H. Friend, Geoffrey S. Ginsburg, Rosalind W. Picard, Jeffrey M. Drazen. "Wearable Digital Health Technologies for Monitoring in Cardiovascular Medicine." New England Journal of Medicine 2024; 390:346-356. DOI: 10.1056/NEJMra2301903

Wearable technology in clinical practice for depressive disorder

Fedor, S., Lewis, R., Pedrelli, P., Mischoulon, D., Curtiss, J., & Picard, R. W. (2023). Wearable technology in clinical practice for depressive disorder. New England Journal of Medicine, 389(26), 2457-2466.

Digital Technology for Diabetes

Michael S. Hughes, Ananta Addala, and Bruce Buckingham; guest editors Stephen H. Friend, Geoffrey S. Ginsburg, Rosalind W. Picard, Jeffrey M. Drazen. "Digital Technology for Diabetes." New England Journal of Medicine 2023; 389:2076-2086. DOI: 10.1056/NEJMra2215899

Wearable Digital Health Technology

Friend, Stephen H., Geoffrey S. Ginsburg, and Rosalind W. Picard. "Wearable Digital Health Technology." New England Journal of Medicine 389.22 (2023): 2100-2101.

AI and Accountability: Who is responsible for managing AI?

On the Technically Optimistic podcast, Prof. Rosalind Picard and others discuss the challenges of accountability and responsibility in AI.

Scientist and Engineer Rosalind Picard Is Transforming Digital Health with Wearable AI

Rosalind Picard’s unique technology is revolutionizing digital health.

Research Group Overview: Affective Computing

Advancing human wellbeing by developing new ways to communicate, understand, and respond to emotion