Seeking Approvals: Ethical approval

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Introduction

It is good practice for studies involving people as participants to be ethically reviewed. In some cases this is a legal requirement to safeguard the rights, dignity and welfare of people participating in research. Research Ethics Committees (RECs) are responsible for undertaking these ethical reviews and should be independent in membership of the researcher and the organisations funding and hosting the research.

NHS Research Ethics Committees

The remit and types of studies that NHS RECs review is harmonised across the UK Health Departments and defined in GafREC - the Governance arrangements for research ethics committees (see 1st resource).

Where there is a legal requirement, NHS RECs will review projects that propose to use tissues from non-NHS patients, or imported material. e.g. where ethical approval is being used to apply an exemption to HTA licensing. For other projects that are not within the remit of NHS RECs, a University Research Ethics Committee may review the project (see University Research Ethics Committees below).

Before making an application you should check whether your project falls within the remit of an NHS REC. The MRC Regulatory Support Centre (RSC) has developed a decision tool on behalf of the Health Research Authority (HRA) to determine if your research requires NHS REC approval (see 2nd resource below).

If a project is audit, service evaluation or public health surveillance then it would NOT be classified as research nor require review by an NHS REC. The MRC Regulatory Support Centre (RSC) has developed a decision tool on behalf of the HRA to help determine if your study is research (see 3rd resource below).

Where a study involves the use of tissue, the HTA Definition of Research is provided in their research code of practice (available from the 4th resource below).

Projects not classified as research do not require NHS REC approval but may require other NHS management arrangements via NHS R&D Offices. A consensus of opinion between RECs and NHS R&D departments is therefore desirable so that projects are handled in the same way by different organisations.

HRA Approval
For research conducted in the NHS in England ethical review is carried out as part of HRA Approval. HRA Approval combines ethical review with the legal and governance checks that NHS organisations used to perform. Please see HRA Approval – What you need to know for more information.

Applications for ethical approval from an NHS REC should be made using the Integrated Research Application System (IRAS) (5th resource below).

IRAS makes provision, in the project filter, for Research Tissue Banks to voluntarily apply for ethical review of their bank. This focuses on the consent process for the collection of tissues for banked purposes. The application includes the option to apply for overarching review of all projects that will use the banked tissues, in line with specific conditions. The bank through its access policy will be best placed to make management decisions on the optimal and most appropriate use of these valuable resources.

A similar approach has been developed for the ethical review of research databases, also referred to as data banks.

University Research Ethics Committees

Some Universities have Research Ethics Committees to review research projects that cannot be reviewed by NHS RECs. The Economic and Social Research Council has produced a framework for these committees (6th resource below). The application process and form will differ for each committee and the relevant University school or department should be contacted for further information. It should be noted that ethical approval from a University REC does not meet the licensing exemption of the Human Tissue Act 2004 (see HTA Licence for further guidance).

Stem Cell and Gene Therapy Clinical Trials (Gene Therapy Advisory Committee)

Under the Medicines for Human Use (Clinical Trials) Regulations 2004 (7th resource), applications for ethical review of clinical trials with gene therapy medicinal products in the UK must legally be submitted to the Gene Therapy Advisory Committee (GTAC).   The legal definition of a gene therapy medicinal product can be found in the HRA Standard Operating Procedures for Research Ethics Committees (Annex J in the 8th resource below).  GTAC moved to the HRA in July 2011. Applications for ethical review should be made through the NHS REC Central Booking Service, and the application submitted to an appropriate REC. Please see the 9th resource below for more information.

In addition to trials of gene therapy medicinal products, the HRA also provide ethical review for the following types of research: 

  • Trials of other Advanced Therapy Medicinal Products (ATMPs), i.e. somatic cell therapy and tissue engineered products 
  • Trials of stem cell therapy involving cells derived from stem cell lines 
  • Trials of vaccines involving recombinant vectors or vectors with potentially immuno-regulatory mediator molecules First in human trials of vaccine vectors (or variants of vectors in use) or of engineered antigen molecules 
  • Other non-CTIMP gene therapy research (e.g. non-interventional trials).

International studies

Research studies that involve the collection of data or tissues from other countries will require Research Ethics Committee review in the source country or local equivalent as well as UK review depending on funder / sponsor policy (see 10th resource below for developing countries, and Collection and storage of tissues for tissue import requirements).

Resources

  • 1. GafREC: Governance arrangements for research ethics committees

    UK Health Departments' policy on what is expected from research ethics committees as well as the principles and standards by which they abide.

    Good practice for all research Date added: 23 May 2011
  • 2. HRA / MRC Decision Tool: Do I need NHS REC approval?

    This decision tree, developed by the Medical Research Council (MRC) Regulatory Support Centre on behalf of the Health Research Authority (HRA) will help you determine if your study requires NHS REC approval.

    Legal requirement for specific research projects Date added: 28 May 2013
  • 3. HRA / MRC Decision Tool: Is my study research?

    The aim of this decision tree, developed by the Medical Research Council (MRC) Regulatory Support Centre on behalf of the Health Research Authority (HRA), is to help you decide whether or not your study is research.

    Legal requirement for specific research projects Date added: 28 May 2013
  • 4. HTA Codes of Practice and Standards (April 2017)

    Provide practical guidance for those carrying out activities within the scope of the HTA’s remit. The Consent code, Research code and Research Standards and guidance are most relevant for researchers.

    Legal requirement for tissues Date added: 5 September 2007
  • 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. ESRC Ethics framework

    Framework outlining structure and function for University Research Ethics Committees.

    Good practice for specific research projects Date added: 6 September 2007
  • 7. Medicines for Human Use (Clinical Trials) Regulations 2004

    Medicines for Human Use (Clinical Trials) Regulations 2004.

    Legal requirement for specific research projects Date added: 17 March 2011
  • 8. HRA Standard Operating Procedures for Research Ethics Committees

    HRA Standard Operating Procedures for NHS RECs

    Standard process for all research Date added: 17 March 2011
  • 9. HRA Gene Therapy Advisory Committee

    The Gene Therapy Advisory Committee (GTAC) is the UK national Research Ethics Committee (REC) for gene therapy clinical research according to regulation 14(5) of the Medicines for Human Use (Clinical Trials) Regulations 2004. Since 2012, the Health Research Authority has taken responsibility for reviewing these applications via NHS RECs flagged as 'Gene Therapy or Stem Cell Clinical Trials'.

    Legal requirement for specific research projects Date added: 16 October 2013
  • 10. Nuffield Council on Bioethics publication

    The Ethics of Research Related to Healthcare in Developing Countries.

    Good practice for specific research projects Date added: 6 September 2007