Kaur, S.; (2011) The adequacy of the ethics review process in Malaysia: protection of the interests of mentally incapacitated adults who enrol in clinical trials. Doctoral thesis , UCL (University College London).

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Abstract

The objective of this thesis is to answer the question, “does the ethics committee review process in Malaysia provide meaningful protection to mentally incapacitated adults who enrol in clinical research trials?” This question is answered by examining three important aspects of the ethics review process. First, the quality of the deliberations of ethics committees is examined by looking at the underlying principles that are meant to guide ethics decision-making. Second, the thesis looks at the current regulatory framework under which ethics committees operate and considers the adequacy of these guidelines in protecting human subjects. Finally, this thesis considers the notion of conflicts of interests in the clinical trials arena and calls into question the independence of the ethics review process and how this impacts on the interests of human subjects in general and mentally incapacitated adults in particular. The conclusion reached at the end of this thesis is that the ethics review process in Malaysia fails adequately to provide meaningful protection to mentally incapacitated adults. While the reasons for this are many, several factors are particularly significant, namely, the creation of a globalised clinical trials market, the lack of formal and systematic training of ethics committee members and the institutional structures of ethics committees. Although the main focus of this thesis is the Malaysian ethics review process, many of the comments and discussions put forward in this thesis are highly relevant to the ethics review processes in other jurisdictions given the international regulatory scheme that currently governs the conduct of clinical trials in many parts of the world.

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