Seeking Approvals: R&D management permissions

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Introduction

In order for research involving the NHS to begin, the relevant NHS organisation(s) need to either issue NHS R&D permission or confirm that they have the capacity and capability to participate in the study (this is in addition to ethical approval).

If your study is led from England and involves the NHS then you will need to apply for HRA Approval (see 1st resource below).  For more guidance on when you should apply for HRA Approval, NHS/HSC permission and/or Site-Specific Assessment, please see the Regulatory Support Centre's tool:  HRA Approval - what you need to know

For multi-site studies coordinated systems are available to conduct the necessary legal and governance checks (for more information see resources 2-4 below).

Without agreement from the relevant NHS organisation(s) (i.e. either HRA approval and confirmation from each NHS organisation that they will participate or NHS R&D permission(s)), NHS indemnity cannot be assumed to be in place to cover the proposed research activity.

NIHR CRN support for those working in the NHS in England

Be aware that researchers working in England whose study is potentially eligible for NIHR Clinical Research Network (NIHR CRN) support, will need to submit a Portfolio Adoption Form (PAF) at the time of applying for funding.  A PAF can be generated on IRAS and should be submitted to NIHR CRN.  They will inform you if your study is to be adopted onto the NIHR portfolio, and if so how you should proceed with obtaining HRA Approval, when you are ready to do so.


Studies that do not involve the NHS

Where studies do not involve the NHS then neither HRA Approval or NHS R&D permission are required. Where NHS REC approval is required for research at non-NHS sites (e.g. for some tissue studies) then non-NHS SSI form(s) may be required. Further information is available from IRAS (5th resource).


The Research Passport and Honorary Research Contracts

If your research is likely to have a direct impact on the quality of care of NHS patients and you do not already hold an NHS contract, then you are likely to need an Honorary Research Contract. If you will only access patient identifiable data, and your research will not have a direct impact on quality of care, then only a Letter of Access will be required. To facilitate the process of obtaining Honorary Research Contracts or Letters of Access the Research Passport scheme has been developed.

The Research Passport is a mechanism for sharing information about pre-engagement checks undertaken on behalf of one organisation, with other NHS organisations. The aim of the Research Passport being to streamline the process of obtaining an Honorary Research Contract (HRC) or Letter of Access at each of the research site(s).

An HRC or proof of acceptance of the terms of an existing HRC, is issued as part of the NHS R&D permission process where the individual researcher’s activity could have a foreseeable and direct impact on the quality of care. HRCs ensure that the researcher is accountable to the NHS organisation(s) for their activities that impact on patient care. In addition, HRCs ensure that the substantive employer understands the research activities, the risks involved, and has undertaken all necessary checks. Those who already hold an Honorary Clinical Contract or a Substantive Employment Contract with the NHS organisation, will not require an HRC.

Researchers who think that a Research Passport will be relevant to them should visit the NIHR Interactive Route map (available from the 6th resource below) and contact the NHS R&D Office at their lead site at the earliest opportunity, prior to seeking R&D permission.

For more information on when an HRC or Letter of Access is required please visit the ‘Research Passport: Algorithm of Research Activity and Pre-Engagement Checks’ (7th resource below).


University/research unit management permission or notification

All relevant university or research unit R&D offices (a.k.a. research governance office/clinical research office), will require notification that the study involves their staff or premises, to ensure that appropriate indemnity/insurance is in place.

Where the organisation is the sponsor or taking on a role in sponsorship, these offices will need to give their permission. More information on sponsorship is available from Discuss sponsorship and agreements and Confirm sponsor(s).

Resources

  • 1. HRA Approval

    Advice on applying for HRA Approval and when NHS/HSC permission is required.

    Standard process for specific research projects Date added: 22 November 2017
  • 2. NHS Research Scotland (NRS)

    NRS streamlines the process of obtaining R&D permission for commercial and non-commercial multicentre studies in Scotland.

    Standard process for all research Date added: 9 December 2009
  • 3. Health and Care Research Wales

    Health and Care Research Wales is funded and overseen by the Welsh Government’s Division for Social Care and Health Research. It provides an infrastructure to support and increase capacity in research and development (R&D), runs a range of funding schemes and manages the NHS R&D funding allocation.

    Standard process for all research Date added: 26 May 2011
  • 4. HSC R&D - HSC Trust Research Governance Permission (Northern Ireland)

    Information regarding research governance approval in Northern Ireland.

    Standard process for all research Date added: 17 March 2011
  • 5. IRAS: Integrated Research Application System

    Link to the new Integrated Research Application System for research in the Health Service.

    Standard process for all research Date added: 14 December 2007
  • 6. NIHR guidance on the Research Passport

    NIHR guidance on the research passport.

    Standard process for all research Date added: 17 March 2011
  • 7. NIHR Research Passport - Algorithm of Research Activity and Pre-Engagement Checks

    Guidance on the pre-engagement check requirements for researchers undertaking research activities in the NHS.

    Standard process for all research Date added: 17 March 2011