Monitoring approved research protocols--a question of balance. National Health and Medical Research Council

Med Law. 1997;16(4):655-77.


This paper seeks to explore the various problems associated with monitoring research protocols that have received ethical approval by an Institutional Ethics Committee (IEC). It begins with an outline of the current Australian Guidelines on the Monitoring of Research; noting the primary importance of an effective monitoring mechanism being to ensure that the conduct of research involving human beings does not jeopardise the rights and interests of research subjects. The paper provides an outline of the current practice adopted by institutional ethics committees in Australia in fulfilling their obligations to monitor approved research protocols. The paper gives further consideration to some of the problems associated with monitoring, as well as noting the problem concerning the lack of sufficient resources for IECs, impacting not only on their ability to fulfill their monitoring obligations but equally on their capacity to perform their general tasks. Finally, a number of options are proposed, and some attention is given to the resource implication for IECs, with a range of options being canvassed to ensure that IECs are better resourced and in a position to efficiently manage their workload.

Publication types

  • Guideline
  • Practice Guideline

MeSH terms

  • Australia
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Ethics Committees*
  • Human Experimentation
  • Humans
  • Research Design / legislation & jurisprudence