Relevant and appropriate research always aims to answer a new question and contribute to the current body of medical and scientific knowledge. For this reason, there is a certain amount of risk for research participants. Independent ethical review is vital to ensure that participant safety is at the centre of the research.
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 2013) 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.
UK Policy Framework for Health and Social Care Research (HRA and the UK Health Departments, published October 2017) This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK. These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.
It is for organisations and individuals that have responsibilities for health and social care research. This includes funders, sponsors, researchers and their employers, research sites and care providers..
Governance Arrangements for NHS Research Ethics Committees: a harmonised edition (GAfREC) (Department of Health, published May 2011) 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. An updated version was published on 20 July 2021.