Ethical Challenges and Evolving Practices in Research on Ethics in Health Research

Introduction 'Research ethics' are "the moral principles guiding research, from its inception through to completion and publication of results and beyond." (1) Ethical review offers guidelines concerning the rights, dignity and safety of human subjects, and plays a critical role in governance, the formalized system set in place to maintain and monitor the integrity of the research enterprise. (2) Although ethical issues in health research are well documented, empirical evidence based on the experiences of those involved in research, is limited. Such knowledge could enhance understanding of the research process and research ethics and underpin an evidence-based system of human subject protection. (3) The current oversight system "does not systemically assess performance and outcomes" in health research. (4) As noted by the Institute of Medicine a "systems-based approach to protecting research participants" is needed, but "the absence of sufficient data regarding human research activities significantly impedes the examination of system performance." (5)