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Research Ethics Committees
19/7/02. By Deirdre Janson-Smith
Research Ethics Committees are responsible for reviewing all research proposals that involve the use of NHS patients, their organs, tissues or data, to ensure that the studies comply with recognised national and international ethical standards.
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Research Ethics Committees are independent committees, established and governed by local Health Authorities or the Department of Health. They review all research falling within certain categories and involving the NHS, to ensure it meets the required ethical standards. Research cannot be started until the Research Ethics Committees has given its approval.
At least one third of the Research Ethics Committee membership must be 'lay' members, who are independent of the NHS and who do not work or have a specific professional interest in a research area.
The Department of Health Research Governance Framework states that the research goals must always be secondary to the participants' dignity, rights, safety and wellbeing. This covers not only patients and the communities they represent, but also researchers and other NHS workers.
Researchers must also apply for review if their work involves fetal material, in vitro fertilisation, the recently dead on NHS premises and/or the use or potential use of NHS premises, facilities and staff. Using prisoners requires special guidance, and in Scotland special applications must also be made for patients unable to give consent.
Research Ethics Committees may also be called upon to comment on the ethics of other proposed research to be carried out by the private sector, charities, the research councils or universities. These organisations are actively encouraged to submit their proposals.
Research Ethics Committees operate at different levels. Generally, local Research Ethics Committees vet proposals. Where five or more different research sites are involved, a multi-centre research ethics committee (MREC) is used. A further central office (COREC) was set up by the Department of Health in 2000 to coordinate the work of the committees and act as a training resource
for Research Ethics Committees members and administrators. COREC also provides training and advice to anyone involved in research – from patients and carers, to funders, employers, care organisations and professionals. It publishes frameworks for review, and guidance on making an application.
Special research categories
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Certain types of research specified under the Human Fertilisation and Embryology Act, 1990, need a licence from the Human Fertilisation and Embryology Authority as well as REC approval
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Research involving gene therapy must be vetted by the Gene Therapy Advisory Committee (GTAC)
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Clinical research that involves xenotransplantation (the use of animal organs or tissues) is vetted by the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA).
Research Ethics Committees review all research proposals that involve the use of NHS patients, their organs, tissues or data.