NHS research ethics committees

National Health Service research ethics committees exist to ensure that research performed within the NHS complies with recognised ethical standards and to protect the rights, safety, and dignity of all actual or potential participants. In the past decade the operation of research ethics committees has come under, and continues to come under, close scrutiny. Researchers now consider the process of acquiring ethical approval to be so onerous that it is compromising clinical research.1 2 3 Medical educators also think that the process is too unwieldy to allow undergraduate students to acquire research experience,4 an essential learning outcome required by the General Medical Council.5

To understand why such dissatisfaction has arisen we need to go back to the early 2000s, when the Central Office for Research Ethics Committees (COREC) was established and the Department of Health issued the Research Governance Framework for Health and Social Care.6 The implementation in 2001 of the European Union Directive 2001/20/EC (the clinical trials directive) forced changes in the system, leading …