ABSTRACT

The common themes in what follows are the frequent lack of due process, the need to distinguish technical from ethical issues and lack of agreement among institutional ethics committees (IEC) on the interpretation of the National Health and Medical Research Council supplementary notes on epidemiological research. The research committee of Hospital Z recommending to its ethics committee that the project be rejected on ethical grounds; the ethics committee deciding that these 'ethical concerns' were not ethical issues but research issues and referring it back to the research committee for review. As the case studies make clear, many of the problems researchers encounter have very little to do with the ethics of epidemiological research. The Victorian Department of Health and Community Services has an IEC one of whose roles is to facilitate permission for research at multiple hospitals. A major epidemiological project involving several institutions will take at least six to nine months to achieve IEC approval.