Ethical issues in research ethics governance and their application to the Malaysian context

Evidence available shows that the ethics review process in Malaysia suffers from a range of problems (Kaur, 2011). These problems may be the result of a lack of training given for REC members and relatedly, it may stem from a lack of understanding of the role of RECs. Since Malaysia is striving to promote the country as a research hub for international collaboration, it is important that the ethics review system that is in place is well set up to ensure only ethical research are being approved. The aim of this thesis is to develop three important key elements of a framework that can be used to provide practical guidance for RECs and their governance in Malaysia. These three important elements of the ethics review process are: - the role of RECs, the criteria of REC membership and the acceptability of variation in decisions made between different RECs. These analysis is then applied to the Malaysian context. My initial recommendation is for RECs to adopt the Daniels and Sabin (1997) accountability for reasonableness model to assist with the decision-making process. The adoption of the model helps to clarify the role of RECs and can be used as a basis to develop the criteria for REC membership as well as to provide a better understanding of the acceptability of variation in decisions between different RECs.This thesis is not currently available in OR