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Health and social care research

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OU researchers wishing to carry out health and social care research in the UK may need to submit an application for ethics review to the appropriate NHS Research Ethics Committee (NHS REC) within the UK Health Departments’ Research Ethics Service. Applications are co-ordinated via the Integrated Research Application System (IRAS). Visit the Health Research Authority (HRA) website to find out what approvals are needed.

Approvals for research carried out in England and Wales will be processed via the Health Research Authority (HRA) and Health and Care Research Wales (HCRW). Projects that are led from Northern Ireland or Scotland involving NHS and Health and Social Care will need appropriate permission for that lead nation. Studies that include 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. Contact information and meeting dates for NHS RECs within the UK Health Departments’ Research Ethics Service are listed on the HRA website.

You can assess whether your research will need approval from an NHS REC using the decision tool provided on the HRA website. Scenarios where staff participate by virtue of their professional roles (i.e. “involving voluntary NHS and health and social care staff participation by virtue of their professional role”) and involving ‘interaction’ with patients etc. is likely to need ethical review. Examples of studies NOT requiring NHS REC review, for example audit or service evaluations, are provided on page 19 in the HRA ‘decision tools’ document. However, such activities would still require OU HREC review if they involve collecting data from or about people.

Engaging with the HRA Integrated Research Applications System

Research ethics applications across the UK are submitted to the HRA using the Integrated Research Application System. The IRAS online guide provides guidance about the application process, as does the step by step guide to using IRAS to apply to conduct research in or through the NHS/HSC, which offers a useful flowchart and helps provide an overview of how the OU HREC and HRA IRAS processes work.

Previous researchers, such as Sam Gould, doctoral researcher in the OU's Faculty of Wellbeing, Education and Language Studies, emphasise that: 

“It is useful to know that the IRAS form is read by multiple people - all of whom who read different sections, which is why it might feel as if you are repeating yourself a lot.

“Both the IRAS and REC teams are approachable and happy to be contacted.”

You are welcome to submit a draft of your IRAS application form using the Research Ethics Application system. A member of the HREC chairing team will review your application and respond with suggested revisions.

Checking your insurance cover

Please review the insurance cover for your study. You can download a certificate for Employer and Public Liability cover from the Finance and Business Services webpage (internal link only).

The OU indemnity insurance covers the research design and management of the project; these are two of the questions asked on the IRAS form.

Please note that this University policy does not cover personal liability for research with patients or for clinical trials. It is the researcher’s responsibility to check whether they are covered as this will usually be the case if the researcher is a clinician or works within the NHS. In this case NHS-employed researchers must check that their employer knows about and has agreed to support the research, hence covering them with NHS insurance.

The research can be covered by both the OU and NHS Indemnity Insurance e.g if researchers are recruiting patients and also carers - the patients would be covered by the NHS and the carers covered by the OU insurance. It is important to clearly say in the free text box which organisation is responsible for which group of participants.

In cases where researchers are not employed by the NHS, the researcher will need to obtain their own indemnity. Please see advice below about ‘conducting research in the NHS’.

The need for a research sponsor

The IRAS application must be reviewed by HREC prior to submission for review by the HRA REC. Once a favourable opinion has been agreed, HREC will organise for this to be signed off electronically by the OU research sponsor, as outlined below. Professor Kevin Shakesheff, Pro-Vice-Chancellor, Research and Innovation, is the current named OU sponsor for IRAS applications. 

Research ethics permissions across the four nations

England and Wales

Applications for multi- and single-centre research led from England or Wales should be submitted via IRAS (see above). Researchers wishing to conduct research in the NHS led from England or Wales should refer to the HRA and HCRW approval guidance.

Northern Ireland

Applications for multi- and single-centre research led from Northern Ireland should be submitted via IRAS. Researchers wishing to conduct research in Northern Ireland should refer to the Research approvals service for HSC in Northern Ireland. The R&D Application Gateway acts as the national co-ordinating function for Northern Ireland, that co-ordinates the study-documentation, and subsequent amendments. The Gateway’s role is to facilitate and support the application process by working in partnership with the HSC Trust R&D Offices and Sponsors/applicants. Contact details, a set of FAQs and further guidance on HSC Trust Research Applications specifically related to Northern Ireland can be found on the HSC Trust Research Application Guidance (v7.0). Further advice and guidance for applicants is also available from the Office for Research Ethics Committees in Northern Ireland.

Scotland

Applications for multi- and single-centre research led from Scotland should be submitted via IRAS. Researchers wishing to conduct research in Scotland should refer to the NHS Research Scotland Permission Co-ordinating Centre website or contact the relevant regional scientific officer according to the information provided on the associated research ethics page. Contact details are given for the four ‘nodal’ regions at the bottom of the webpage.

Process for gaining HREC authorisation

  1. Register on the IRAS system and download an IRAS application form. You will need to submit your ethics project application in the Research Ethics Application.
  2. It is recommended that you also download and refer to the protocol. It is best to use this protocol to help guide your completion of the HREC application and, unlike other HREC applications, to use the HRA participant information and consent guidance and templates, rather than the templates provided more generally by the OU.
  3. You will be prompted to attach a PDF copy of your draft IRAS application form to the HREC application. This needs to be one document. This should include your supporting documents e.g. consent forms, participant information sheets and questionnaires), be signed by your supervisor and the name of the research sponsor – see above.
  4. Your application will be reviewed by HREC and you may need to enter into dialogue with HREC and the Data Protection Team to offer clarifications and resolve any mitigations of ethical issues. 
  5. When the HREC are ready to offer a favourable opinion for your application you will be notified in the same way as other applications. This favourable opinion letter will include support for your draft IRAS application and will act as the University's sponsorship letter for your study. You will need to attach this to your submission to the HRA.

The process for gaining HRA approval through the IRAS

  1. Once you have received notification that your IRAS application has been supported by the OU sponsor, which will happen electronically, you will get an email from HREC saying you have your OU favourable opinion.
  2. You now need to use the HRA online booking service to book your review. It is important to note that you have to book your REC review and submit your IRAS form on the same day.
  3. Please note that you will go through several processes before you can book the review, including requesting authorisations from the sponsor and supervisors. These do not happen automatically. It is useful to email all who are being asked to authorise as they may need to log into IRAS to see the request. You will receive an email confirming when each person has authorised. Please note: Any changes to the form after this will invalidate the approvals and the process will need to be completed again.  
  4. As a result of the HRA review you may be asked to make revisions or offer clarifications. This all needs to be responded to within the HRA paperwork and you will be supported by an allocated member of HREC, who will also be informed by the HRA as to the nature of the requests.
  5. You may receive two sets of amendments - those requested by the REC and those requested by the HRA admin/approvals team. The information will include a date by which the amends need to be submitted. This is flexible. The REC just ask that they are informed if there is going to be a delay. It may not be necessary to make changes to the IRAS form. The feedback will say if you need to do this. The REC will ask you to upload any revisions/ additions to the checklist section of the IRAS form paying attention to dates and version numbers and upload a table of changes. The REC would like changes to be highlighted so that they are easily seen.
  6. When the HREC have approved your responses to any revisions required by the HRA, if you do need to amend the IRAS form you should submit your responses (and any revised documents) through IRAS. You will be issued with a new HREC favourable opinion to submit to IRAS for them to complete their review.
  7. The e-submission box needs to be opened by the REC prior to submitting the amends so it is useful to inform the REC when you are planning to submit. 
  8. When HRA approval has been obtained, you will be informed through IRAS. HREC will be copied into this decision.

The process for making an amendment to an HRA project

Please first read the detailed IRAS amendment guidance about how to make an amendment to a HRA project. Below summarises the main steps involved.

  1. Complete sections 1 and 2 of the HRA amendment tool, which is an excel file. Section 2 will only appear once section 1 is completed. Top tip: You will need to download and save the file to your computer to allow ‘macros’ to be enabled. Add the project information and lay summary of the main changes in section 1. Leave the Sponsor Reference Number blank as this will be completed by HREC. In section 2, add the details of each change separately. Ensure you select the correct ‘area of change’ and ‘specific change’ as this determines the amendment type, which is automatically shown in section 4. This is important because some amendments can be implemented immediately, whereas others require NHS REC approval and will take longer to implement. A list of the types of changes are provided in the tool under the tab labelled ‘Glossary of Amendment Options’.
  2. Send the completed HRA amendment tool, along with any changes to the study documents using track changes (e.g., protocol, participant information sheet) to the OU HREC. HREC will check the documents and provide Sponsor approval by completing section 3 and returning the completed amendment tool back to you as a locked pdf file.
  3. HRA amendments are submitted online. This is a different login system to IRAS and requires a separate account. Follow the online instructions to create and submit the amendment. Ensure the details entered in the online submission are exactly the same as the details on the locked amendment tool otherwise the submission may not work or may be delayed. Note: the amendment category type is listed in section 4 of the amendment tool.
  4. Follow this detailed IRAS amendment guidance on what to do after submitting an amendment. This includes how you should share the amendment with participating NHS sites, which differs depending on the category type of your amendment. Information at this link provides the template email that should be used when informing sites of a pending amendment and when HRA approval of the amendment has been given.
  5. Once the amendment has been approved, please email OU HREC  with the approval e-mail/letter (the timeline for approval by HRA will vary depending on whether the amendment can be approved straight away of if it needs NHS REC review). Top tips: Keep a record of amendments and current and superseded study documents in a tracking log.

Conducting research in the NHS

If a researcher is not an NHS employee covered by their NHS employer’s insurance cover then other forms of personal liability insurance need to be taken out. This could be through following advice from professional associations, such as the British Psychological Society, if you were a Clinical Psychologist. If you are not an NHS employee you should check with the Research and Development (R&D) Department of the NHS Trust to see if you are covered by their insurance.

Non-NHS staff who intend to carry out research on an NHS site are advised to obtain a Research Passport and an honorary NHS contract. The OU contact for guidance on applying sits within the Operational Enablement team. Please contact this team for help in initiating a DBS check which is required for research passports and honorary contracts. The Research and Development (R&D) Department of the NHS site will be the most appropriate first point of contact for research queries.

Even if a researcher is an NHS employee and they are involving participants beyond their own organisation, that employer’s insurance would not cover the researcher in these other settings, unless a formal MOU/collaborative agreement had been set up for this project/or this project was covered across both organisations.

It is usual practice in the NHS for staff and those on honorary contracts to complete the following:

  • confidentiality agreement,
  • DBS declaration,
  • a contract that includes agreeing to NHS policies on Information Governance for Third Parties in line with The Data Protection Act 2018/General Data Protection Legislation (GDPR) and ISO27001,
  • Complete an NIHR course on Good Clinical Practice (GCP).

ISO27001 describes the minimum standards for information security management systems. GCP Certificates can be obtained once the NIHR course is completed.

Additional resources

The INVOLVE online resource provides researchers with useful guidance on how to involve members of the public in NHS public health and social care research.

Notes

Additional websites: