Division of Medical Ethics and Law
Postgraduate Diploma in Health Research Ethics: Module 2
MODULE 2: DUAL REVIEW OF RESEARCH AS AN ETHICAL IMPERATIVE
Module director(s): Prof. K. Moodley, Prof. S. Naidoo Faculty: Prof. A. Hesseling, Dr N. Siegfried, Dr T. Rossouw, Prof. H. Nell, Prof. L. Burgess, Prof. L. Myer, Prof. G. Ogunbanjo
Scientific review of research protocols remains a challenge in most research ethics committees in Southern Africa. Module 2 will examine the dual responsibility of research ethics committees to conduct both scientific and ethical review. Trainees will be introduced to a broad range of research methodologies and designs that can give rise to significant ethical problems. Trainees will be introduced to the basics of scientific review and will be expected to provide a critical overview of major research designs and methods. Both early phase research (animal studies and phase 1 and 2 research) and late phase research will be included. Important concepts that will be addressed include clinical equipoise, use of placebos, standards of care in control groups and equivalence studies. Trainees will explore the fundamental question of responsiveness of research to health needs and how the relevance of research questions is to be determined. Issues regarding scientific writing, scientific integrity and publication ethics will also be addressed.
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