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.

This article is a response to the letter from the Department of Health that was published in the previous edition of the Research Ethics Review upon the matter of the legal duty of the research ethics committees. It also deals briefly with the article published in the current edition of Research Ethics Review by Colin Parker on what appears to be the same topic.

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

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.

In this article, the author contends that the current indemnity provided to REC members is unfair and is so badly drafted that it cannot be described as an indemnity at all. He contends that the Appointing Authorities should give guidance to clarify the scope of the indemnity or replace it. The author discusses potential legal claims by REC members against their Appointing Authority if this is not provided. The legal liability of REC members for negligence and other claims is also discussed. The author provides a solution in a simpler form of indemnity framed by reference to actual claims that can be made against a REC member.