NHS ETHICAL APPROVAL
Research involving the NHS, including patients, carers or data may require ethical 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.
Please note the decision tool only confirms whether NHS REC is required or NOT; you may need other approvals such as HRA Approval (see below) or CAG Approval (access to identifiable data without patient consent).
HRA Approval is for all project-based research that involves NHS organisations in England 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 approval, they have provided this useful decision tool, or alternatively you can contact the HRA for advice via email – HRA.Queries@nhs.net.
Please note that research tissue banks; research databases and project-based research not involving the NHS only require NHS REC review and not HRA. More guidance on non-NHS research projects requiring REC only, can be found here.
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 Procedures (SOP) for obtaining approval for BU Sponsorship and email firstname.lastname@example.org.
Please note that the ‘PI declaration’ found as an appendix to the SOP, is now the ‘Chief Investigator (CI) declaration’, to reflect NHS research terminology. The new form can be found here, and will be incorporated into the SOP once the new version has been ratified. Please use this document in applying for BU Sponsorship.
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 2016 – This Code of Practice sets out what people working with or in NHS organisations in England need to do to manage records correctly.
Appendix 3 of the CoP contains the detailed retention schedules.
BU ETHICAL APPROVAL
Don’t forget in all cases you will need to complete an online ethics checklist for BU ethical 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 email@example.com.
Projects that do not require NHS Research Ethics committee approval are required to obtain BU Ethics approval before the research can be undertaken.