Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the effectiveness of the current regulatory framework for Research Ethics Committees (RECs), including the Governance Arrangements for Research Ethics Committees, in providing adequate guidance for RECs considering research proposals pertaining to gender and sex.

No specific assessment has been made by the Department. The Health Research Authority (HRA) and the devolved administrations provide a Research Ethics Service so that research proposals relating to their areas of responsibility can be reviewed by a Research Ethics Committee (REC) for all kinds of health and social care research proposals within the scope of the UK Policy Framework for Health and Social Care research, including those pertaining to gender and sex.

A REC is a group of people appointed to review research proposals to assess formally if the research is ethical. This means the research must conform to recognised ethical standards. RECs protect the rights, safety, dignity and wellbeing of research participants and the Governance Arrangements for Research Ethics Committees, a United Kingdom wide policy, describes what is expected from RECs when reviewing research proposals.

Each REC is required to adopt the UK Standard Operating Procedures approved by, or on behalf of, its appointing authority, and each REC is audited against these standards on a rolling basis. RECs reviewing Clinical Trials of Investigational Medicinal Products must be accredited by the UK Ethics Committee Authority before they can review applications to ensure committees comply with legislation and uphold standards.

The HRA has a duty to provide an efficient and robust research ethics review service to protect participants.