Streamlining research applications where NHS staff are participants

This page explains how to make an application for HRA and HCRW Approval (England and Wales) and/or NHS R&D Permissions (Scotland and Northern Ireland) if your study is using NHS/HSC Staff as participants only.

The Health Research Authority (HRA) and the devolved administrations of Wales, Scotland and Northern Ireland are committed to removing barriers to research. Following a successful pilot in 2024-2025, we have been working together to develop this proportionate approach to staff studies.

The approach consists of:

• a reduced IRAS question set
• study specific guidance on a proportionate approach to Confirmation of Capacity and Capability (in England, Wales and Northern Ireland) and NHS Permission (in Scotland).

This should make applications quicker, and site set up more efficient, helping researchers to recruit participants more quickly and accelerate their research.

This proportionate route is only open to research applications in the following category which you should select at Project Filter question 4b:

• Research limited to involvement of staff as participants (no involvement of patients/service users as participants).

The guidance on this page is split into the following sections:

• How do I apply?
• How do I prepare my application?
• What happens once I have submitted?
• Will you expect anything else of me?

How do I apply?

By completing an IRAS application using the guidance set out on this page.

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How do I prepare my application?

You will be required to fully complete the following questions only in IRAS:

• Project filter questions
• A1 (full title)
• A3 (CI details)
• A4 (sponsor contact details)
• A5-1 (reference numbers - as applicable)
• A6-1 (summary of the study)
• A14-1 (public involvement)
• A50 (will the research be registered on a public database)
• A64-1 (sponsor details)
• A68-1 (lead NHS R&D contact details)
• A65 (funding arrangements)
• A69-2 (study duration)
• A71-2 (nations participating)
• A65 (funding arrangements)
• A76 (insurance)
• A77 (insurance)
• Section D (CI and sponsor declarations)

For studies taking place in Scotland and Northern Ireland, you will also be required to complete Section C (participating sites).

You should answer question A54 (peer review) with the following: “Not applicable - this application is testing proportionate approaches with the HRA and the Devolved Administrations of Wales, Scotland and Northern Ireland.

This will allow you to pass the verification step in IRAS. If this is not done, you will not be able to submit your application.

You should submit your completed IRAS form along with the following project documentation:

• research protocol (which should include Recruitment and Data Confidentiality sections)
• participant information sheet/informed consent form
• letters of invitation (if applicable)
• evidence of sponsor insurance or indemnity (non-NHS sponsors only)
• interview schedules/topic guides/questionnaires
• Organisation Information Document (if applicable)

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What happens once I have submitted?

Once you have submitted, we will allocate your application to a member of operational staff in your study’s lead nation. They will then conduct a study wide review. The operational team will contact you with any questions or change requests.

Once the review is complete:

• if you have sites in England or Wales, you will receive HRA and HCRW Approval
• if you have sites in Scotland or Northern Ireland, those sites will be notified of the completion of the Study Wide Review

Your approval/notification will provide guidance to the site on a proportionate approach to the confirmation of capacity and capability (in England, Wales and Northern Ireland) and NHS Permission (in Scotland).

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Will you expect anything else of me?

We ask that all NHS/HSC organisations you approach for your study complete a short survey after you have begun recruitment to your study. A link to the survey will be provided in your Letter of HRA and HCRW Approval/the outcome of your Study Wide Review in Scotland and Northern Ireland.

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HS/HSC Staff Studies

Guidance for Study Wide Review and for Staff Study Locations

The term ‘NHS/HSC Staff Studies’ refers to non-interventional research limited to involvement of NHS/HSC staff as participants (no involvement of NHS/HSC patients, service users or their relatives and/or carers as participants). These are studies that are exempt from National Research Ethics Committee (REC) review, but which still require Study Wide Review (SWR – undertaken as part of HRA and HCRW Approval/NRS Approval/HSC RD Approval), ensuring that the research meets the necessary governance and legal compliance standards. SWR is needed for all project-based research in the NHS, including studies involving NHS/HSC staff and/or their data.

Whilst this guidance is for NHS and HSC organisations, the principles contained within can be applied to non-NHS organisations.

This guidance is divided into three areas:

• defining a Staff Study
• setting up an NHS/HSC Staff Study
• examples of NHS/HSC Staff Study Activities and what is required to set them up

Defining a Staff Study

A project is considered an NHS/HSC Staff Study taking place in the NHS/HSC when it meets all the following criteria:

• A non-interventional research project
• it identifies potential research participants from pools of NHS/HSC staff only; no patients, carers or family members will be recruited to the study;

and:

• it identifies and recruits NHS/HSC staff, in their capacity as NHS/HSC employees – they are recruited because of their employment status as part of the NHS/HSC workforce (as opposed to, for instance, medical or clinical staff working in private healthcare, or approached simply because they have a particular professional registration) and/or the research activities take place on NHS/HSC premises.

Note: Clinical Audit and Service Evaluation examine how standard care is delivered in an existing NHS/HSC Service. Projects undertaking Clinical Audit and/or Service Evaluation activities are typically not considered research and therefore do not need SWR (HRA and HCRW Approval/NRS Approval/ HSC RD Approval). 

Note: Studies that involve only Social Care staff as participants would not usually require an IRAS submission, SWR or Approvals for England, Wales or Scotland, but do for Northern Ireland (NI) given the integration of health and social care. For other nations there may be examples of social care studies that do require IRAS submission, SWR and Approvals if deemed to be within the NHS (for example, if undertaken by NHS staff) or funded by DHSC/NIHR (for example, on the NIHR RDN Portfolio (4.1.1)).

Setting up an NHS/HSC Staff Study

Research sponsors should:

1. Consider the use of NHS/HSC organisations at the project design/feasibility stage.
2. Where possible, as early as possible, approach relevant NHS/HSC organisations to discuss their support to act as Staff Study Locations in principle.
3. Detail all activities and resource requirements proposed for organisations within the IRAS Application.
4. IRAS Filter Question 3 asks: In which countries of the UK will the research sites be located? (Tick all that apply). Please ensure to select ALL NATIONS of the UK that will have staff take part in the study. This is essential in ensuring the appropriate assessment checks are carried out for research to take place in each nation.
5. Complete the IRAS Reduced Dataset for Staff Studies in line with the relevant guidance detailed in IRAS Help. Note that this includes the requirement that recruitment activities and information governance considerations be fully detailed in the research protocol.
6. Include the Outline Organisation Information Document in the IRAS submission if required. An OID is usually only required for this study type if the study involves:
   
   a. Data Processing (any processing of Personal Data by the participating NHS/HSC organisation for the purpose of the study and on behalf of the sponsor); 
   
   and/or
   
   b. Data Sharing (the transfer of Personal Data and/or Confidential Patient Information from the participating NHS/HSC organisation to the sponsor or its agents)
   
   and/or
   
   
   c. Finance Provisions (if funds/resources/equipment are being provided to the participating NHS/HSC organisation by the sponsor) 
   
   
7. Ensure the UK Local Information Pack is received by the NHS/HSC organisation as part of their set-up process, along with the HRA and HCRW Approval Letter (for sites in England or Wales)/HSC RD Approval. For Scotland, there is no requirement to send the documents to the participating R&D teams, the NRS Permissions Coordinating Centre is able to share these on behalf of the Sponsor. The Sponsor remains responsible for sharing with any local research teams. For this study type, the UK Local Information Pack should only contain documents which are relevant to the activities being undertaken in the research (please refer to Examples of NHS/HSC Staff Study Activities and what is required to set them up for further guidance). This may include, as relevant to the activities being undertaken in the individual project:
   
   a. Organisation information Document (if required)
   
   b. Invitation letters/Participant Information Sheets (where the NHS/HSC organisation is expected to disseminate these to potential participants)
   
   c. Posters
   
   d. Any other documents to support recruitment activity
   
   
8. Study oversight at Staff Study Locations:
   
   - Chief Investigator (CI): The overall lead researcher for a research project, responsible for its conduct and overall management.
   
   - Principal Investigator (PI): The individual responsible for the conduct of the research at a specific research site. Where PIs are needed, there should be one PI for each research site, and the CI and PI may be the same person in a single-site study.
   
   - Local Collaborator: A named collaborator at a specific site, whose role may be specified in the research approval letter. 
   
   The right type of oversight/local support is essential for ensuring the effective management and conduct of research projects.
   
   
   Usually, the Chief Investigator may be responsible for oversight of all research activities at Staff Studies Locations, with no requirement for a local PI. An LC may be required at the Staff Study Location to make the appropriate arrangements for the researcher to gain access to the organisation.
   
   Basic administrative support (including putting up posters, adding information to newsletters etc) may be required, but this alone does not require the appointment of a local PI or Local Collaborator. The CI, or a member of their research team, will liaise with organisations to determine who will provide local support.
   
   Staff Studies involving researchers from external organisations undertaking research activity in NHS/HSC organisations should refer to the Algorithm of Research Activity and Pre-Engagement Checks. For clarity, the term ‘if in NHS facilities’, used in the Algorithm of Research Activity and Pre-Engagement Checks for the purposes of specifying when a Letter of Access is expected for research involving staff or their data, should be taken as referring to areas within NHS premises where care is provided. Offices and other non-care areas should be regarded as business premises and letters of access will therefore not be expected for access to such locations for staff research. External researchers working under such arrangements are expected to comply with the off-site working policies and procedures of their employing organisation.
   

When can Staff Studies activity begin?

• NHS organisations in England or Wales – activity may only begin once HRA and HCRW Approval has been issued, capacity and capability has been confirmed by the NHS/HSC research site if required, and there is an appropriate agreement in place with the NHS/HSC organisation if required. If your letter of HRA and HCRW Approval  indicates it, you can begin recruiting immediately.
  
  
•  HSC organisations in Northern Ireland – Activity may only begin once HSC RD Approval has been issued by the HSC RD Approval Service, capacity and capability has been confirmed by the research site if required, and there is an appropriate agreement in place with the NHS/HSC organisation if required.
  
  
•  NHS organisations in Scotland – Activity may only begin once NRS Approval is granted by the research site, if required, and there is an appropriate agreement in place with the NHS organisation if required.
  

Note: Formal confirmation of capacity and capability (or NHS Permission, in Scotland) is not always required for this study type, which is deemed to be of low risk to the day-to-day operations of NHS/HSC organisations. Where study activities require the use of an OID and formal confirmation of capacity and capability, that confirmation (or R&D Permission, in Scotland) consists of the research site returning the Organisation Information Document to the sponsor, explicitly executing it as the study agreement.  

 

Examples of NHS/HSC Staff Study Activities and what is required to set them up

The following table gives examples of the types of activities commonly carried out in NHS/HSC Staff Studies, and indicates the requirements related to SWR, PI/LC, Local Information Pack, and local confirmation of capacity and capability (or NHS Permission, in Scotland) for each. 

No.	Activity	UK Study-wide Review (including nation-specific checks)	Local PI or Local Collaborator	Required documentation by NHS/HSC Organisations (not exhaustive)	Local Confirmation (NHS Permission in Scotland)
1	Questionnaire sent directly to NHS/HSC staff as participants (direct from researcher to NHS/HSC contact)	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	No
2	Questionnaire sent directly to NHS/HSC staff as participants via social media / professional bodies	No	No	No	No
3	Questionnaire sent to NHS/HSC staff as participants via their employer	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI) OID Non-validated Questionnaire SoE/SoECAT (if applicable) 47	Yes
4	Telephone interview with NHS/HSC staff with invites sent directly to staff as participants (direct contact from researcher to NHS/HSC contact)	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	No
5	Telephone/online interview with invites sent directly to NHS/HSC staff as participants via social media / professional bodies	No	No	No	No
6	Telephone/online interview with NHS/HSC staff with invites sent via their employer	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI) OID SoE/SoECAT (if applicable Invite Letter	Yes
7	Interview/focus group on NHS/HSC premises with invites sent directly to NHS/HSC staff (direct NHS/HSC contact)	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	No
8	Interview/focus group on NHS/HSC premises with invites sent to NHS/HSC staff via their employer	Yes	LC	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI) OID SoE/SoECAT (if applicable) 113	Yes
9	Snowballing – questionnaire sent to contacts who identify further potential participants (direct NHS/HSC contact)	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	No
10	Snowballing – questionnaire via social media / professional bodies where participants share with further potential participants	No	No	No	No
11	Snowballing – telephone/online interviews with contacts who identify further potential participants (direct NHS/HSC contact)	Yes	No	No	No
12	Snowballing – telephone/online interview via social media / professional bodies where participants share with further potential participants	No	No	No	No
13	Snowballing – interview/focus group on NHS/HSC premises where initial participants identify further potential participants	Yes	LC	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	Yes – only those organisations where the focus groups are taking place need to issue C&C; not organisations whose staff participate elsewhere.
14	Poster/advert to be displayed in areas	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	No
15	Poster/advert to be added to organisational circulars (e.g. newsletters)	Yes	No	HRA and HCRW Approval Letter (England & Wales) NRS Approval (Scotland) HSC RD Approval (NI)	No

Note – For Single Centre, Same Site studies (a study sponsored by the same organisation that the research is taking place in) no model agreements (no OID) or confirmation of capacity & capability is required.  This is similar to studies where the site shares a Joint Research Office with the site and the site has confirmed to the HRA or devolved nation equivalent that it does not require a Local Information Pack for studies sponsored by its partner academic institution.  However, in this case if the site is processing personal data on behalf of the sponsor, GDPR Article 28(3) requires a contract or equivalent to be in place as a data processing agreement. The data only OID serves this function.

Note - Snowballing involves identifying additional sites/participants through initial sites/participants.  This might be a participant suggesting a colleague at another organisation to be interviewed, or the use of a questionnaire or similar study activity/documentation, where participants identified for the study may find and share the documentation with further potential participants once recruitment has begun. In some examples, participants may choose to share the documentation with further potential participants at another NHS/HSC organisation within the same country. No further SWR or Approvals are required at this stage, as the study has already been approved, and one condition of the approval is that evidence of approval is shared with each participant. It is the sponsor’s responsibility to ensure that this is done. Should snowballing occur between nations (for example,. a study approved in England & Wales but snowballing has identified participants in Scotland or Northern Ireland), national checks will be required as this would mean the study is taking place in that nation. If you indicated in your IRAS form that you do have participating organisations in either of these devolved administrations, the final document set and the study wide governance report (including this letter) have been sent to the coordinating centre of each participating nation. The relevant national coordinating function/s will contact you as appropriate. If you have not indicated as such, a modification to the study will be required, to identify which nations will have participating NHS/HSC organisations after the modification.