NHS Health Research Authority (HRA) and NHS Research Ethics Committees (REC)
Ensuring that you have the correct approvals and oversight for your study is vital in assuring your participants that you are conducting the study in line with regulations and standards. Explore the topic of sponsorship and external approval requirements below.
Under the UK Policy Framework for Health and Social Care Research, when a student or a member of staff is undertaking their own research within the NHS, then the organisation at which they study or work, should ideally take on the role of the research Sponsor. The Sponsor is defined as an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research. The study will likewise need a Chief Investigator who should sign the declaration form, in applying for BU sponsorship. Please see the Standard Operating Procedure for further details.
The Sponsor (email details below) should be your first point of contact with any queries.
Under new guidance, undergraduate students are no longer permitted to make an application to conduct research in the NHS. In certain cases, Master’s students are also not permitted, but should check their eligibility via the Health Research Authority’s student research toolkit.
NHS Ethics Review Process
Research involving the NHS, including patients, carers or data may require ethics approval from an NHS Research Ethics Committee (REC). Application for NHS REC is via the Integrated Research Application System (IRAS) and is coordinated by the Health Research Authority (HRA), so you only need to submit one application.
If you are unsure as to whether your research requires NHS REC approval, the HRA have provided a useful decision tool which determines whether or not NHS REC approval is required. If you are unsure whether your project is deemed as 'research', you can check using this HRA decision tool.
Please note the decision tool only confirms whether NHS REC is required or NOT; you may need other approvals such as HRA and HCRW Approval (see below) or CAG Approval (access to identifiable data without patient consent).
HRA and HCRW
HRA and Health and Care Research Wales (HCRW) Approval is for all project-based research that involves NHS organisations and/or their facilities in England and Wales where the NHS organisation has a duty of care to participants, either as patients/service users or NHS staff*/volunteers.
If you are unsure as to whether your project is classed as research and therefore requires HRA and HCRW approval, they have provided this useful decision tool, or alternatively you can contact Clinical Research, or the HRA for advice via email – [email protected]
Please note that research tissue banks; research databases, and project-based research not involving the NHS only require NHS REC review and not HRA and HCRW approval. More guidance on non-NHS research projects requiring REC only, can be found here.
*Please note that HRA approval is not required where you are approaching and recruiting participants through your own professional or personal networks, where the NHS organisation is not involved and does not owe a duty of care to the participants as their employer. For example, recruiting through social media or LinkedIn.
Policies and IRAS
The UK Policy Framework for Health and Social Care Research (Nov 2017) sets out the principles of good practice in the management and conduct of health and social care research in the UK. Research which falls within the scope of the Framework requires a research Sponsor. Formal confirmation of sponsorship must be obtained prior to an IRAS application. If the BU Researcher has an associated NHS contract, the NHS Trust or third party should be approached to take the role of Sponsor. In all other cases (including BU students/Postgraduate Researchers [PGRs]), BU will act as Sponsor. To apply please refer to the Standard Operating Procedure (SOP) for obtaining approval for BU Sponsorship and email Clinical Research.
If applying for HRA/NHS REC, there is an online guide available which provides instructions on the use of Integrated Research Application System (IRAS). This online tool guides you through the process of making an application and was developed by the Medical Research Council (MRC) Regulatory Support Centre and the Health Research Authority on behalf of the IRAS Partners.
NHS – RECORDS MANAGEMENT CODE OF PRACTICE FOR HEALTH AND SOCIAL CARE 2021: This Code of Practice sets out what people working with or in NHS organisations in England need to do to manage records correctly.
You can also look up retention schedules.here.
BU Ethics Review Process
Don’t forget in all cases you will need to complete an online ethics checklist for BU ethics approval. The new checklist has options from which you will need to select the route your study will go through, once submitted via the IRAS system.
If you have any questions regarding research ethics at BU, please email Research Ethics.
Projects that do not require NHS Research Ethics committee favourable opinion are required to obtain BU Ethics favourable opinion before the research can be undertaken.