Governance arrangements for NHS research ethics committees, July 2001

Preface

1. For many years the NHS has had the benefit of a generally high standard of advice from its Research Ethics Committees (RECs), which were formally established in England under cover of HSG(91)5 for Local Research Ethics Committees (LRECs) and HSG(97)23 for Multicentre Research Ethics Committees (MRECs).

2. The Department of Health (DH) has also established additional committees that offer an ethical opinion on research proposals within certain very specialist areas. These include the Gene Therapy Advisory Committee (GTAC), and the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA).

3. The recently published DH Research Governance Framework for Health and Social Care (RGF) indicated a need for a review of LRECs and MRECs. There are also new developments in the national and international legal and regulatory framework in which research must in future be conducted. In particular, significant changes are required in order to respond to the rigorous standards set by European Directive 2001/20/EC.

4. The accountability for the various aspects of research was clarified in the RGF. The current document describes the role and remit of RECs as part of this overall governance framework.

5. Whilst the research environment itself is changing, the need for a prior favourable ethics opinion before the categories of research defined later in this document may be started is central to Research Governance. The provision of this opinion will remain the prerogative of Research Ethics Committees.

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