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Illegality in the Research Protocol: The Duty of Research Ethics Committees under the 2001 Clinical Trials Directive
Research Ethics 4 (3):111-116 (2008)
Abstract
In this paper, the author shows how research ethics committees must deal with illegality in the research protocol. He defines their legal duty by reference to the 2001 Clinical Trials Directive, and especially in the key areas of insurance, indemnity and no-fault compensation. The author is critical of the current GAfREC and recent guidelines issued by the Royal College of Physicians. He concludes that new rules are needed to replace the 2001 edition of GAfREC.My notes
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Citations of this work
The Legal Research Committee: A Response to Roy-Toole.Colin Parker - 2009 - Research Ethics 5 (1):30-32.
The ‘New Governance Arrangements for Research Ethics Committees’: Policy-Shift and Equivocation on Matters of Illegal Research.Christopher Roy-Toole - 2009 - Research Ethics 5 (4):160-161.
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.Christopher Roy-Toole - 2011 - Research Ethics 7 (3):82-90.
Research Ethics Committees and the Legality of the Protocol: A Rejoinder and a Challenge to the Department of Health.Christopher Roy-Toole - 2009 - Research Ethics 5 (1):33-36.
References found in this work
Research Ethics Committees and the Law: Indemnity and Independence.Desmond R. Laurence - 2006 - Research Ethics 2 (4):140-143.
Meeting the Needs of the Investigator and the REC Member.John Saunders - 2007 - Research Ethics 3 (4):111-112.
Guide, Guide Thyself: Law and Order in Clinical Research.Desmond R. Laurence - 2008 - Research Ethics 4 (2):69-72.
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