Authors: Samanta, Ash; Samanta, Jo

Source: Clinical Medicine, Journal of the Royal College of Physicians, Volume 5, Number 3, May/June 2005 , pp. 235-239(5)

Publisher: Royal College of Physicians

Abstract:

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.

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Keywords: CENTRAL OFFICE FOR RESEARCH ETHICS COMMITTEES (COR; EUROPEAN UNION CLINICAL TRIALS DIRECTIVE; IMPLICATIONS FOR NHS RESEARCH; MEDICAL RESEARCH; NHS RESEARCH; RESEARCH; RESEARCH GOVERNANCE

Document Type: Research article

Publication date: 2005-05-01

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• Clinical Medicine is published six times a year and circulated to 20,000 Fellows and Members of the Royal College of Physicians. The journal is read by physicians both established and in training in hospitals across the world. It features a wide range of articles including original papers, professional issues, clinical guidance, medical humanities, ethics and clinical governance. The journal publishes the key features from the College lectures and conferences. Each issue has a CME section which reviews the latest advances in a chosen specialty.
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