Illegality in the Research Protocol: The Duty of Research Ethics Committees under the 2001 Clinical Trials Directive

The role of the REC is to aim for a fair and effective trial protocol and to provide to potential trial subjects sufficient information to allow them to make a rational decision on whether to participate in it or not. The members are medical specialists and members of the public together fitted to these tasks. In his paper ‘Illegality in the research protocol: the duty of research ethics committees under the 2001 Clinical Trials Directive’ Roy-Toole has made a number of suggestions on how to improve the function of the RECs, but he has not given persuasive evidence to show that the RECs themselves are the most effective bodies to implement possible legal requirements to improve medical research.

Section: Introductionmentioning

confidence: 99%

The Legal Research Committee: A Response to Roy-Toole

Parker

2009

“…This response is intended to serve as a manifesto for future reform and a challenge for future action. Reference should also be made to my earlier article on this topic [3]. For ease of reference I set out my position in summary form.…”

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confidence: 99%

Research Ethics Committees and the Legality of the Protocol: A Rejoinder and a Challenge to the Department of Health

Roy-Toole¹

2009

Self Cite

“…Failure to do this is likely to yield nothing of benefit to REC recruitment or to the confidence of the members in the organisation that they are meant to represent. This point has resonance when we come to examine the matters detailed below.In the time preceding the publication of the consultation on the new GAfREC, there was an exchange of views in the pages of this journal on the matter of how RECs should deal with illegal research [3][4][5]. The Department of Health issued guidance on this matter [6].…”

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confidence: 99%

“…In the time preceding the publication of the consultation on the new GAfREC, there was an exchange of views in the pages of this journal on the matter of how RECs should deal with illegal research [3][4][5]. The Department of Health issued guidance on this matter [6].…”

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confidence: 99%

The ‘New Governance Arrangements for Research Ethics Committees’: Policy-Shift and Equivocation on Matters of Illegal Research

Roy-Toole¹

2009

Self Cite

The consultation for the new Governance Arrangements for Research Ethics Committees [1] [GAfREC] has now closed. As the Editor of the Research Ethics Review has recently commented [2], there is a question as to whether the method of consultation was as comprehensive as it should have been and whether all REC members were made aware of its existence. This observation is more than fanciful. REC recruitment has always relied upon the goodwill and unpaid time of members from a wide range of backgrounds, of whom some are skilled professionals accustomed to exercising a high degree of accountability for their own decision making. In order to retain these members it is necessary to engage in proper and inclusive dialogue with them. Failure to do this is likely to yield nothing of benefit to REC recruitment or to the confidence of the members in the organisation that they are meant to represent. This point has resonance when we come to examine the matters detailed below. In the time preceding the publication of the consultation on the new GAfREC, there was an exchange of views in the pages of this journal on the matter of how RECs should deal with illegal research [3-5]. The Department of Health issued guidance on this matter [6]. Some members of the Royal College of Physicians supported that guidance. REC members should understand that the terms of the new GAfREC now appear to reverse this earlier guidance from the Department. The following paragraphs show why this is so and also raise further questions about the intellectual consistency of the approach that the Department has chosen to adopt on the matter of protocol illegality. The origin of the dispute lies in paragraph 9.11 of the 2001 edition of GAfREC. This provision is to be replaced by paragraph 3.2.10 of the new version. The Department of Health seized upon the statement in paragraph 9.11 that it was not the role of the REC to provide a legal opinion and that it was open to a REC merely to recommend to the researcher that further legal advice be obtained where needed. The Department published an open letter on the NRES website and which was sent on behalf of the NRES Directorate to each REC member. It stated that a REC