Abstract

This is the final paper in a four-part series which addresses the methodology of research studies under ethical review. The focus is on study conduct, governance and peer review. The nature and adequacy of peer review as a mechanism for assessing the study design and analysis are discussed. The paper argues that a properly constituted and functioning research team is crucial to the ethical conduct of a study and that an ethical review of methodology should extend beyond study design and analysis to a concern with data collection, storage and availability, and publication. While ethical review committees cannot monitor study conduct, they can ensure that the protocol pays sufficient attention to appropriate monitoring structures and personnel.