Research governance: panacea or problem?
Clinical research must meet contemporary professional, legal and ethical standards. Research governance aims to improve quality whilst safeguarding the interests of the public. Research on humans is covered by several internationally recognised ethical codes designed to protect persons from the hazards of experimental treatment. However, to date there is no overarching statutory framework that regulates health and social care research, which is governed by common law principles. The recent European Union Clinical Trials Directive aims to harmonise regulation of clinical trials and protect the interest of study participants. Approval by the new Central Office for Research Ethics Committees (COREC) is now a mandatory requirement for research projects in the UK to ensure stringent ethical standards. Research that involves NHS patients, staff, resources or premises is subject to a framework for research governance that monitors performance and adverse incidents and delineates lines of responsibility and accountability. Researchers at all levels must be fully aware of these new initiatives and of their responsibilities. NHS organisations should acknowledge and commit to clinical research as an intrinsic component of high quality health service delivery.
Samanta
Ash
A
Department of Rheumatology, University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary. ash.samanta@uhl-tr.nhs.uk
Samanta
Jo
J
D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000592:standards*; D028744:Ethics Committees, Research; D033161:Government Regulation; D006801:Humans; D011785:Quality Assurance, Health Care / Q000592:standards; D012955:Societies, Medical; D006113:United Kingdom