Ethical Review Processes

NHS RECs in the UK operate in accordance with the Department of Health’s ‘Research Governance Framework for Health and Social Care’ (second edition 2005). The National Research Ethics Service (NRES) oversees operation of NHS RECs, with the dual mission:

  • to protect the rights, safety, dignity and well-being of research participants; and
  • to facilitate and promote ethical research that is of potential benefit to participants, science and society.

The NRES website at http://www.nres.npsa.nhs.uk/ is the primary source of guidance on ethical issues that need to be addressed and application procedures.

Any research work requiring access to patients, confidential information, staff or NHS facilities will require permission from an NHS REC. Where NHS REC permission is required, the ESRC does not require duplication of ethical review in the academic institution. However, it is essential to be aware of specific requirements in one’s own institution and how procedures will interact.

NOTE: Although the UK law relating to clinical trials of medicinal products (the Medicines for Human Use (Clinical Trials) Regulations 2004 SI 2004/1031 technically relates only to clinical trials of medicinal products, NRES and the REC standard operating procedures apply the same rules and standards to all research reviewed by NHS RECs.

NHS RECS: remit, constitution and membership

Specific information on the role, remit constitution and membership of NHS RECs is set out in the Department of Health’s ‘Governance Arrangements for RECs’ (GafREC, 2001). For Scotland the relevant GafREC document is available here.

NHS RECs are also guided by the ‘Standard Operational Procedures (SOPs) for Research Ethics Committees’ (version 4). The Department of Health’s ‘Research Governance Framework for Health and Social Care’ is the primary context of operation, together with applicable laws, including:

  • Data Protection Act 1998
  • Human Rights Act 1998
  • Freedom of Information Act 2000
  • EC Clinical Trials Directive 2001/20/EC
  • Human Tissue Act 2004
  • EC Tissues and Cells Directive 2004/23/EC
  • Mental Capacity Act 2005
  • Human Fertilization and Embryo Act 2008
  • Health and Social Care Act 2008 s158

Individual NHS RECs:

  • are constituted by Strategic Health Authorities and gain their authority as subcommittees of the SHA
  • are not accountable to NHS Trusts (in particular, they are separate in function from R&D Departments)
  • are made up of Lay members and Expert members up to a maximum of eighteen members
  • must include at least one third Lay members. While “Lay members” can include “non-medical clinical staff who have not practised their profession for a period of at least five years”, committees must also include members who are unconnected with research and are not health or social care professionals.

Amongst others, an NHS REC might include, for example:

  • General Practitioner
  • Nurse/Midwife
  • Professional Allied to Medicine/Clinical Psychologist
  • Clinical Pharmacologist/Pharmacist
  • Social scientist
  • Hospital Consultant
  • Statistician
  • Public Health Physician/Epidemiologist
  • Lay person

What research requires NHS REC approval?

Section 3.1 of GafREC lists 8 criteria for which application to a REC is necessary. For social science work not involving clinical trials criteria a, b, f and g are relevant.

Ethical advice from the appropriate NHS REC is required for any research proposal involving:

  • patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user's past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions
  • individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above
  • access to data, organs or other bodily material of past and present NHS patients
  • foetal material and IVF involving NHS patients
  • the recently dead in NHS premises
  • the use of, or potential access to, NHS premises or facilities
  • NHS staff - recruited as research participants by virtue of their professional role.’
  • All clinical trials of investigational medicinal products (CTIMPs). CTIMPs including Healthy Volunteer Studies (Phase One)

NHS REC applications

The following points should be borne in mind when developing your application:

  • The ethical considerations in your protocol design should drive your research
  • From the beginning look at the research from the view of a potential participant
  • Review the literature & discuss it with colleagues – look at what other researchers have done to address similar ethical dilemmas
  • Draft the question you wish to answer and be prepared to modify it
  • Ask, will your protocol design help you to answer the research question?

In regard to the applications three basic points to note are:

  • There is a standard UK wide online application procedure which you should use to apply to a research ethics committee. The Integrated Research Application System (IRAS) is at: https://www.myresearchproject.org.uk/Signin.aspx.
  • Application must be made by Chief Investigator (who must be professionally based in the UK)
  • Only one application for full ethical review needs to be made in the UK. For proposed research which will take place at more than one site the Principle Investigator at each site should complete a ‘Part C’ for a Site Specific Application for that site.

The National Research Ethics Service (NRES) website sets out comprehensive advice on all aspects of application:

http://www.nres.npsa.nhs.uk/ NRES homepage
http://www.nres.npsa.nhs.uk/applications/guidance/ NRES – Guidance on application and ethical issues
http://www.nres.npsa.nhs.uk/applications/ NRES – How to apply
http://www.nres.npsa.nhs.uk/contacts/find-your-local-rec/ NRES – find RECs and information about types of REC

 

 

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