The adequacy of the ethics review process in Malaysia : protection of the interests of mentally incapacitated adults who enrol in clinical trials

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