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National Patient Safety Agency - National Research Ethics Service - facilitating and promoting ethical research
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Protecting participant safety

In the UK, review by an ethics committee is one of a series of safeguards intended to protect the people taking part in the research. These are set out in a series of documents and guidance:

  • Declaration of Helsinki
    (World Medical Association, as amended 2008)

    Sets out ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration of Helsinki is regarded as the most important document in the history of research ethics. It is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.


  • Research Governance Framework for Health and Social Care (2nd edition)
    (Department of Health, published 24 April 2005)

    Establishes a framework for the governance of research in health and social care. It applies to all research that relates to the responsibilities of the Secretary of State for Health (that is, research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-departmental public bodies and the NHS), and research undertaken by or within social care agencies.

    It includes clinical and non-clinical research; research undertaken by NHS or social care staff using the resources of health and social care organisations; and any research undertaken by industry, charities, research councils and universities within the health and universities within the health and social care systems that might have an impact on the quality of those services.


  • Governance Arrangements for NHS Research Ethics Committees (GAfREC)
    (Department of Health, published July 2001)

    Provides a standards framework for the ethical review of all NHS and social care research proposals which is efficient, effective and timely, and which will command public confidence. It sets out general standards and principles for an accountable system of Research Ethics Committees (RECs) working together to shared high standards of review and operating process throughout the NHS. It should be read in conjunction with the Research Governance Framework for Health and Social Care, above.

    Superseded in May 2011 by Governance arrangements for research ethics committees: a harmonised: edition