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 public consultation on the draft Code of Practice issued by the Human Tissue Authority on the import and export of human bodies, body parts and tissue. The question is whether the Draft Code and the Human Tissue Act go far enough to prevent the unethical acquisition and movement of human tissue. I conclude that the answer to this question is ‘no’ and go on to demonstrate how the identified deficiencies can be remedied.

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. (shrink)

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.

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. (shrink)