is my study research hra

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HRA Approval

On 16 April 2018, HRA Approval became HRA and Health and Care Research Wales (HCRW) Approval and now applies to all project-based research taking place in the NHS in England and Wales. We are in the process of updating our online guidance to reflect this change. For information on how to prepare and submit an application for HRA and HCRW Approval please refer to the IRAS website . For information relating to site setup and local processes for the NHS in Wales please refer to the HCRW website .

HRA Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent ethical opinion by a Research Ethics Committee (REC) so that you only need to submit one application.  It applies where the NHS organisation has a duty of care to participants, either as patients/service users or NHS staff/volunteers. References to participants include people whose data or tissue is involved in a research project. 

This page provides an overview of the HRA Approval process. For detailed guidance, go to the Integrated Research Application System (IRAS) .

To support you with writing and submitting your application for HRA Approval, we have also created a series of top tips,  which can be found in the IRAS  help section . We also recommend you visit our research planning section for help before you begin your IRAS application

HRA and HCRW Approval applies only to the NHS in England and Wales

If your project is led from Northern Ireland or Scotland and involves NHS/HSC sites then you will not apply to the HRA. You should apply through the appropriate NHS/HSC permission process for that lead nation . Studies with sites in Northern Ireland or Scotland are supported through existing UK-wide compatibility systems where each country accepts relevant centralised assurances from national coordinating functions to avoid duplication. Guidance is available on IRAS.

Planning your application for HRA Approval

If your project  is eligible for HRA Approval  there are four main steps that should be completed in the following order:

• Complete a research application form on the  Integrated Research Application System (IRAS)
• Prepare your study documents
• Book your application in through the Online Booking Service
• E-submit your applications in IRAS.

Once you have completed the steps above, the diagram below shows you the main steps in gaining HRA Approval.

You may receive separate correspondence about your REC opinion. More detailed information on the ethical review part of HRA Approval  is available.

Validation 

We are currently piloting a single HRA Approval validation which incorporates both assessment and ethical review validation. Currently however you may still receive separate validation letters for the assessment and ethical review aspects of your approval.

• The ethical review validation letter will confirm that your application is valid and contain details of the ethical review that will take place.
• The initial assessment letter will confirm that your application is valid and some assessment checks have already been carried out.

To ensure your application is 'valid first time' then you are encouraged to read the information contained in our  research planning section .

HRA Assessment

The UK Study-wide governance criteria is intended for reference and use by research sponsors and by other key parties who support researchers seeking HRA Approval.

It outlines the criteria against which research studies submitted for HRA Approval will be assessed and the standards that these studies will be expected to meet.

It is critical that sponsors understand the content of this document in order to provide appropriate advice and support to their researchers in applying for HRA Approval.

Questions or comments relating to this document and its contents should be emailed to [email protected].

Before applying for HRA Approval, a sponsor is expected to have identified potential participating sites that will be listed in the IRAS application and in most cases have discussed the project with local researchers and the research management staff supporting them. You can find contact details for Research and Development (R&D) staff at NHS organisations on the  NHS R&D Forum website .

NIHR CRN Portfolio

A Portfolio Application Form (PAF) is no longer required to apply for NIHR Clinical Research Network (CRN) support. To apply for NIHR CRN support you should select ‘yes’ to question 5b of the IRAS Project Filter. Key information from your IRAS submissions will then be shared with the NIHR CRN and used to assess eligibility. If HRA or HCRW Approval is not required you should contact your Local Clinical Research Network for advice on how to apply. More information is available on the NIHR website .

Non-commercial studies

For non-commercial studies, you must prepare the   Organisation Information Document  for each type of research site in your study. 

Commercial studies

For commercial studies, you must prepare the draft template agreement you propose to use with sites and the costing template . For studies which are part of the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Portfolio you must ask the lead CRN to validate the costing template, at least one week before application for HRA Approval.

Providing feedback

We continually review and improve the approval process to ensure that it meets user needs. If you have any comments or suggestions for improvements, please feedback via the online feedback survey.

We publish regular updates on HRA Approval performance

Latest performance data .

Related links

• NHS site set up in England
• Amending an approval
• Customer charter
• Privacy notice
• Terms & conditions
• Accessibility statement
• Feedback or concerns

Is my study research?

Hra decision tool.

Is my study research? – The aim of this decision tool is to help you decide whether or not your study is research. It is based on the Defining Research leaflet produced by the National Research Ethics Service (NRES) of the Health Research Authority (HRA).

Do I need NHS REC approval? – Not all research conducted within the UK requires approval from an NHS Research Ethics Committee (REC). This decision tool will help you to determine if your study requires this type of approval.

The following resources provide guidance on defining research and audit evaluation.

REC leaflet defining research/audit evaluation

Research Ethics Service guidance aims to help you decide if your project requires review by a Research Ethics Committee. The purpose of the leaflet is to help you decide if a project is research, which normally requires review by a Research Ethics Committee (REC), or whether it is some other activity such as audit, service evaluation or public health surveillance. The leaflet can be found here .

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Is my study research?

How to determine if your project is research, audit, quality improvement or service evaluation.

Classifying your study correctly is an important place to start, as not all investigative projects undertaken within the NHS are classified as research, and the different categories are subject to different approval processes.

To help you decide whether your project is classified as research you should use the interactive HRA Decision Tool .

If your study is research

If your project is classified as research then you will need to inform us via:   [email protected] . If you are not sure if your project would be classified as research please contact us for advice as soon as possible. We will advise you on how to apply for Health Research Authority (HRA) Approval. Every research project involving people and their data must also have a sponsor. For further guidance please read S tudy sponsorship

We have a dedicated team of research support staff to facilitate your study set up, recruitment and ongoing management and also provide support to local research investigators.  If you would like more information or are interested in setting up a clinical research study at UHSussex please see information on supporting researchers .

If your project is clinical audit or service evaluation

If you determine that the project is clinical audit, quality improvement or service evaluation, it will not be managed as research within the NHS. Such projects do not require HRA Approval, ethical review by an NHS Research Ethics Committee, or management permission through the NHS R&D office.

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Research, service evaluation or audit?

Is my project research.

Not all projects are classed as research and they can also fall under “service evaluation” or “clinical audit”.

A well-used distinction is the following:

Research is designed and conducted to generate new knowledge.

Service evaluations are designed to answer the question “What standard does this service achieve?”.

Audits are designed to find out whether the quality of a service meets a defined standard.

The HRA has devised a decision tool to help you assess whether your project is considered research: Is my study research? .

It can sometimes be difficult to decide whether a project is research, service evaluation or audit and you can find further guidance to help you decide in the Defining Research Table .

NHS Research Ethics Committee and HRA/HCRW Approval are only required for research projects , however local Trust / Organisations will need to agree to participate in any audit or service evaluation and may have separate processes for this. Please note that even if your project is not classed as research you still need to carefully consider any ethical issues that could arise.

If you remain unsure and you are running your project within primary or community care in Norfolk and Suffolk please submit a draft proposal to the research office at [email protected] . We will review your proposal and can provide you with advice.

Service evaluation

The Research Office runs training on how to design and conduct service evaluations . We can also advise on the design of your local evaluation. Please contact [email protected] for more information.