Free accessResearch articleFirst published online 2011-9
Passing the Buck: How the Academy of Medical Sciences's ‘New Pathway for the Regulation and Governance of Health Research’ Shifts the Regulatory Burden but Fails to Improve the Quality of Research Governance
In this paper the author argues that the Academy of Medical Sciences's ‘Review of the regulation and governance of medical research’ has produced a set of muddled recommendations that could increase complexity and uncertainty in research governance rather than reduce it. Issues discussed in the paper include the additional legal burden placed upon the newly proposed Health Research Agency by the plan for a National Research Governance Service and its system of centralized permissions, the consequences that this may have for the research ethics committees in the discharge of their legal duty, and the unanswered questions surrounding the TGN1412 incident.
New pathway for the regulation and governance of health research (Report) paragraph 9.3. http://www.acmedsci.ac.uk/p99.html. Accessed: 7th July 2011.
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Report paragraph 9.3.
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Report paragraph 4.5.1.
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Report paragraph 4.5.1.
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Report paragraph 4.5.1.
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Report paragraph 4.5.2.
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Report paragraph 5.5.4.
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Report paragraph 9.5.2.
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Report Sub-Heading 4.4 and content.
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Report paragraph 4.5.3.
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Governance Arrangements for research ethics committees Final Edition (2011) at paragraph 5.4.2 (a).
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Professor Adam Hedgecoe (Cardiff University). The TGN1412 clinical trial: a “normal” accident. A lecture delivered in London on 12th November 2009 as part of the conference RECs: Help or Hindrance? The conference was hosted by University College London.
(Medicines for Human Use (Clinical Trials) Regulations 2004) Memorandum of understanding between MHRA, COREC and GTAC Final version 1 (dated 23 October 2006); First time in man (FTIM) and other clinical trials subject to assessment by the Expert Advisory Group and Commission on Human Medicine. A Letter from the Director of NRES to Chairs of RECs dated 14th August 2007.
