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Researcher’s toolkit

Is my project research.

Early in the study planning process, you need to first assess if the project being developed is research, service evaluation or audit. The Health Research Authority (HRA)  decision tool  can help you decide if your study is research.

Please see below a summary about these project categories. You can find a more exhaustive description in this link:

Research projects attempt to derive generalisable or transferable new knowledge to answer questions with scientifically sound methods. This includes studies that aim to generate hypotheses as well as those that aim to test them, in addition to simply descriptive studies.

Please note that our  Research Management Team  will only review and assess those projects classified as Research by the HRA decision tool.

These projects include: clinical trials, basic science, studies administering questionnaires, qualitative studies, research tissue banks and databases etc.

Clinical research studies

The National Institute for Health Research (NIHR)  Clinical Trials Guide  provides an excellent information resource about Clinical Research.

If your project is Clinical Research, then it is important to consider whether it will be classified as a  Clinical Trial of an Investigational Medicinal Product  (CTIMP) or a  Medical Device Trial , as different processes and regulations will be applied.

The Medicines and Healthcare products Regulatory Agency (MHRA) have produced an algorithm to help you decide whether your study is a CTIMP or not. Please see:  Is it a Clinical Trial of a Medicinal Product?

For further support please contact  [email protected]

Research Database

A research database is a structured collection of individual-level personal information, which is stored for potential research purposes beyond the life of a specific research project with defined endpoints. Research purposes in this context refers to analysis of data to answer research questions in multiple projects.

HRA Approval is not required for the establishment of research databases . Organisations responsible for the management of research databases anywhere in the UK may apply on a voluntary basis for ethical review of their arrangements for collection, storage, use and distribution of data, including arrangements for release of non-identifiable data for analysis by external researchers.

Where the activities of a research database would include accessing or otherwise processing the identifiable data of patients or services users in England and Wales outside the normal care team without consent, a favourable ethical opinion from a Research Ethics Committee (REC)  is required by law, and an application to the  Confidentiality Advisory Group  under Section 251 of the NHS Act 2006 should be made to set aside the common law duty of confidentiality owed by care professionals to their patients or clients.

Service evaluation and clinical audit

Service evaluation.

A Service Evaluation is designed and conducted solely to define or judge current care. It evaluates the effectiveness or efficiency of an existing or new service/practice that is evidence-based, with the intention of generating information to inform local decision-making.

This type of activity is sometimes referred to as a clinical effectiveness study, baseline audit, activity analysis, organisational audit and bench-marking.

Service development

A Service Development is a special category that introduces a change in service delivery or practice for which there is evidence derived from research or from other health/social care settings that have already introduced and evaluated the change.

Clinical audit

A Clinical Audit is a way to find out if healthcare is being provided in line with standards and lets care providers and patients know where their service is doing well, and where there could be improvements.

The aim is to allow quality improvement to take place where it will be most helpful and will improve outcomes for patients. Clinical audits can look at care nationwide (national clinical audits) and local clinical audits can also be performed locally in trusts, hospitals or GP practices anywhere healthcare is provided.

For more information see:  The Healthcare Quality Improvement Partnership (HQIP) .

To register and conduct a Service Evaluation or a Clinical Audit at the Trust, please contact  [email protected]

Page last reviewed: 20 March, 2024

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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.

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Health Research Authority (HRA) Approval or NHS Permission

Health Research Authority Approval is the process for research in the NHS in England.

It comprises a review by an NHS Research Ethics Committee (REC) (where required) as well as an assessment of regulatory compliance, and study-wide research governance checks undertaken by dedicated HRA staff.

It replaces the need for research governance review by the Clinical Research Network, or each participating NHS organisation. This allows the participating NHS organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

HRA Approval applies only to the NHS in England . The HRA has compatibility arrangements in place with the national NHS permissions coordinating functions in Northern Ireland, Scotland and Wales that mean that the HRA will share information with those national coordinating functions to benefit study set-up in participating NHS/HSC organisations across the UK where applicable.

If your study involves recruitment of NHS patients, staff, premises, resources (pharmacy, radiology or laboratories) or data/tissue you will need to have HRA Approval in place.

Additionally you will need to work with the OUH R&D Team to confirm local capacity and capability to carry out your project at Oxford University Hospitals NHS Foundation Trust.

In this section

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Approvals for  NHS-Related Research

Approvals for NHS-Related Research

This page provides information regarding obtaining ethics and governance approvals for projects conducted in the NHS. All health and social care research undertaken in the NHS is regulated by the Health Research Authority (HRA) UK Policy Framework for Health and Social Care Research. The policy framework applies to clinical health and social care research projects undertaken in the UK which involve:

• NHS patients or service users (including NHS patients treated under contracts with private sector institutions)
• Potential participants identified because of their status as relatives and/or carers of patients or service users of the NHS
• Identifiable NHS patient biomaterial; organs or other bodily material of past and present NHS patients. Foetal material and IVF involving NHS patients
• Identifiable NHS patient data (related to past or present patient medical records)
• Use of or access to NHS premises or facilities

Quick links

HRA approval > What is the process for university sponsorship of applications to the HRA? > What documents do the university and HRA require? > Is my study research? Do i need to apply for NHS ethics approval? >

HRA approval

Such studies (described above) require ‘HRA Approval’ from the Health Research Authority (HRA), the review process required for research conducted in the NHS in England. HRA Approval comprises an independent ethics review opinion from an NHS Research Ethics Committee (REC) (where required) in addition to the assessment of regulatory compliance, and study-wide research governance checks undertaken by HRA staff. Applications for HRA Approval are made through the Integrated Research Application System (IRAS):

View the website here > 

Additionally, specialist NHS RECs operate for specific activities:

• HRA Confidentiality Advisory Group (CAG) reviews research requiring access to confidential patient information without patient consent.
• HRA Social Care Research Ethics Committee reviews research involving individuals under the care of social or community care professionals, their families, or NHS Staff. 

Studies involving the NHS that require HRA approval but fall outside the scope of NHS REC review include:

• Research involving NHS staff recruited due to their professional role: NHS REC review is not normally required for research recruiting NHS or social care staff as participants by virtue of their professional role. These studies require submission to the Health Research Authority solely for the NHS governance review assessment portion of HRA Approval (and not NHS Ethics review). Please note studies that involve a cohort of NHS staff in addition to healthy volunteers must be submitted for HRA Approval. See the approval pathway for BSMS research studies (led by staff or students) recruiting NHS staff as participants for further guidance. 

View the approval pathway guidance here >

*No research activity, including any data collection or recruitment activities, can commence until HRA Approval (NHS ethics and/or NHS governance and legal assessment approval) has first been secured from the HRA* 

What is the process for University Sponsorship of applications to the HRA?

All research conducted in the NHS requires a research Sponsor. If you are a member of BSMS Staff or a PGR student, before you can apply for HRA Approval University of Sussex Sponsorship must be obtained. Applicants will need to: 

• Apply for University of Sussex Sponsorship, before proceeding to the HRA’s review processes. 
• Submit your application to the Pre-Sponsorship Review Panel (PSRP) prior to onward submission to the University of Sussex Sponsorship Sub-Committee. The order of application is: PSRP, University Sponsorship Sub-Committee, HRA.
• A schedule Pre-Sponsorship Review Panel of meeting dates can be found via the website below.

View the website here >

• Information on University Sponsorship can be found on the website below. 

View the website here >  

What documents do the University and HRA require?

• Applications for University Sponsorship and for HRA Approval (including solely for the assessment of regulatory and study-wide research governance compliance) are made using IRAS. View the website here . If you are using IRAS for the first time, you will need to register your details, and start completing the IRAS project filter form for your project. Projects require completion of an IRAS Form and supporting study documents for both University Sponsorship approval and HRA Approval. The application will need to be sufficiently robust (and cannot be rushed due to limited time constraints).
• All applications to the HRA must enclose: Signed IRAS application; Research protocol; Summary CV for the Chief Investigator; Participant information sheets and consent forms; Evidence of insurance or indemnity (for non-NHS sponsors only). Other documents may also be necessary and will be outlined in the IRAS checklist. The IRAS application and checklist are downloaded from IRAS.
• Guidance on completing the IRAS application form and supporting documentation is available on the IRAS website – when completing IRAS forms online green ‘i’ symbols appear next to some sections providing extra information about how to answer a question.

It can take time to obtain NHS ethics approval. Your application may be returned with a request for further amendments. The average time for approval is between 2-3 months but can be longer. Please note: the HRA introduced new eligibility criteria for standalone student research projects conducted in the NHS. The policy came into force on 1 September 2021. Please refer to The Health Research Authority's (HRA) New Eligibility Criteria for Standalone Student Research for further guidance on the implications for taught student research. 

View the eligibility criteria here >

Is my study research? Do I need to apply for NHS Ethics approval?

Is NHS ethics approval required? Please ensure that you use the HRA’s decision tool to establish this: 

• The HRA provides an online decision tool to assist researchers in determining whether a project is deemed research. View the HRA website here . Results may be saved and printed/emailed by way of confirmation of the outcome. Following confirmation, an HRA decision tool can be used to determine whether your study requires NHS Ethics approval. View the decision tool here .

However, some activities are exempt from requiring approval from an NHS REC or NHS governance review assessment. HRA Approval is not normally required from the HRA, for example, if: 

• Your project falls under the category of Clinical Audit, Service Evaluation, or Quality Improvement. While Service Evaluations and Clinical Audits involving NHS patients do not usually need HRA Approval, they require registration at the NHS Trust at which they are conducted. The Trust will usually require confirmation of the data required and likely sources and information governance solutions on how data will be transferred and stored and who will have access to it. *Clinical projects run in NHS settings require registration and approval via the respective NHS Trust* Refer to the guidance on clinical audit versus research below.

View the guidance on clinical audit versus research here >

Please Note: If work is not classed as ‘research’ or falls under specific exemption criteria such as that defined by the Health Research Authority (HRA), be aware that in the vast majority of cases research with human participants requires appropriate consent. Formal ethics review may still be required through the Universities of Brighton and Sussex research governance procedures. Please note, if your study qualifies for ethics exemption but you intend to publish the results of your research, you may still be asked for proof of institutional ethics review by a journal or funder. Please ensure that you find out if this will be a requirement by speaking with the journal/funder and contacting the BSMS Research Governance and Ethics Committee ahead of time. *Ethics approval cannot be granted retrospectively*

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For lead site/single site studies at UH Bristol

Applications for regulatory approvals to conduct research in the NHS are made in the  Integrated Research Application System  (IRAS). This is a single application system which streamlines the process for gaining approvals (e.g from Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA), Research Ethics Committee (REC) etc).

The system allows researchers to enter information about their study into a single data set and is designed to prevent duplication of information in separate applications for each type of approval.

Further instructions on how to complete the application form can be found on IRAS. However please note the following handy tips:

• When you create a new study in IRAS you will be asked to complete a set of filter questions. It is important to answer these correctly as these are used to  generate the correct set of forms for your research.
• If you would like your study to be considered for the NIHR Portfolio please ensure that filter question 5b is ticked "yes". This will create the Portfolio Adoption Form.  If in doubt, please click "yes".
• Once you have completed the filter questions and these have been saved, if you click on the "navigate" box this will take you to a screen where you can see a list of forms that has been created for your project (on the left-hand side).
• When any of the individual forms are selected a number of tabs appear on the screen. One of these is called  "checklist". This will tell you which project specific documents you must submit with that form to create a valid application pack for each relevant agency. There is a second tab called "submission", which details the submission process to each of the agencies.

If UH Bristol is only a participating site you do not need to create the project on IRAS as this will be completed by the lead site/Sponsor.

What regulatory approvals will I need?

This depends on your proposed research.  Please liaise with your sponsor for advice on what approvals are required. As a general guide please note the following (not an exhaustive list):

• All research conducted in the NHS in England requires HRA approval 
• For research conducted in sites outside England, national processes apply.
• Most research in the NHS requires an NHS Ethics (REC) review. However some research is exempt from this under the Governance Arrangements for Research Ethics Committees (GAFREC), e.g. research only involving NHS staff as participants. Please use the HRA decision tool to determine whether your study requires REC review: http://www.hra-decisiontools.org.uk/ethics/
• Research involving an Investigational Medicinal Product or an Investigational Device requires MHRA approval
• Confirmation of Capacity and Capability is required at participating sites (as described in the HRA approval letter)
• Other approvals may be required (e.g. for gene therapy trials etc)

What is Health Research Authority (HRA) Approval?

HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK research ethics service. It replaces the need for local checks of legal compliance and related matters by each participating NHS R and D office in England (previously called R and D approval).

Please refer to the HRA website for further information

If after reading the guidance on the HRA website you still have queries please contact one of the Research Management Facilitators in R&I on 0117 342 0233.

What are Statement of Activities and Schedule of Events?

These are documents that must be completed per site type and submitted to the HRA through IRAS as part of the HRA approval process. When setting up participating sites these will form part of the local document pack.

Please note that for single site studies a Statement of Activities and Schedule of Events for UH Bristol site need to be submitted if the study is co-ordinated and managed by a dedicated trials unit/team who is separate from delivery staff.

The latest versions of these forms can be downloaded from the HRA website .  Please contact R&I as early as possible if you are unsure what documentation to complete on 0117 342 0233.

What is Capacity and Capability review?

An assessment of Capacity and Capability to undertake the proposed research at a participating site is required in accordance with the HRA approval letter for that study. Please refer to SOP_017 Confirmation of Capacity and Capability to deliver research at UH Bristol for further details on the process. The HRA website also contains further information.

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Accessing study support and advice services

There is a range of support to help you as you develop your research, whatever the type of study and wherever it’s taking place in the UK. This page covers services in England, along with UK-wide guidance and links to the services available in Scotland, Wales and Northern Ireland.

Before you start

Is it research? Use this tool to check whether your project is categorised as research. If it is a research project, see our sections below for the study support available to you.

Commercially sponsored studies involving the NHS/HSC

In England, commercial sponsors can request support from the National Institute for Health and Care Research (NIHR) Study Support Service for the life sciences industry . Visit this webpage to check if your study is eligible for support and to contact the NIHR’s industry team. The NIHR works with colleagues in Northern Ireland, Wales and Scotland to enable a smooth and quick research delivery experience across the UK.

Non-commercially sponsored studies involving the NHS/HSC

For non-commercial studies, support is led within each nation and the process may be different depending on which nation is leading and which are participating. Visit the NIHR CRN Portfolio webpage for more information.

Nation Specific Guidance

The NIHR Clinical Research Network (CRN) offers a range of services designed to help you plan, place and perform your research.

For studies eligible for inclusion on the NIHR CRN Portfolio, the NIHR will work with you, Research and Development (R&D) offices, funders and other stakeholders to deliver your study to time and target.

For more information and to check if your non-commercial study is eligible for CRN support, visit the NIHR Run your study webpage .

Applying for NIHR CRN support

If you would like to run your study through the NIHR CRN , you should contact the relevant local network as early as possible. They can tell you more about the support available and give up to date advice on how to run your project efficiently.

For Clinical Trials of Investigational Medical Products (CTIMPs) and combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials), applicants must apply for NIHR CRN support and inclusion on the NIHR CRN Portfolio through the Non-commercial Portfolio Application service in CPMS .

For all other study types, applications for inclusion on the NIHR CRN Portfolio can be made by completing the relevant questions on the IRAS Project Filter page. Once submitted, information from your IRAS Form is automatically shared with the NIHR CRN for review.

Northern Ireland

Guidance on conducting research in Northern Ireland is available on the HSC R&D Division Northern Ireland website .

NHS Research Scotland provides advice and support on conducting research in Scotland.

Health Care Research Wales provides advice and support on conducting research in Wales.

We always recommend you contact the lead NHS research and development office for advice on setting up your study.

Toolkits and Decision Tools for UK based research

When you’re ready to complete your application in IRAS, there is guidance to help you alongside the IRAS questions and in our Help sections.

Toolkits and Decision Tools

• Clinical Trials Toolkit . For advice on designing and conducting publicly funded clinical trials in the UK.
• Regulatory Advice Service for Regenerative Medicine . Offers a single point of access to free, clear and expert responses to queries about the regulation of regenerative medicines.
• Consent and Participant Information Guidance . Advice on preparing your Participant Information Sheet (PIS) and consent form
• Student Research Toolkit . Students and their supervisors should use this toolkit before proceeding with their application.
• Do I need NHS REC approval? This tool will help you work out whether your study needs approval from an NHS REC. You can print the answer as evidence.
• Proportionate Review toolkit - this tool will help you to decide whether a Full or Proportionate NHS/Social Care REC review is needed, depending on the type of research you are carrying out
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