ObjectivesTo investigate the views of Human Research Ethics Committee (HREC) members and of researchers concerning the human research ethics review process in Australia.To examine whether there are differences between views of researchers and HREC members.Design and settingRegistrants at the NHMRC Ethics in Human Research Conference held in Canberra in May 2005 were surveyed by anonymous questionnaire comprising 14 questionnaire items and background demographic questions.ResultsOf the 407 registrants, 252 completed the questionnaire (62% response rate). Respondents comprised 219 (87%) HREC members or (...) administrators, and 33 (13%) researchers who were not HREC members. Researchers generally had a less positive attitude to the HREC process than did HREC members. Researchers were less likely to believe that HRECs: make clear and reasonable decisions in an acceptable timeframe; provide informal guidance to researchers; and have the necessary expertise to make appropriate decisions. The largest difference related to relations between researchers and HRECs: 82.5% of HREC members thought relations were good, but only 59.3% of researchers held this view. Despite these differences, both HREC members and researchers held the view that the ethics review process in Australia is working well.ConclusionAlthough our study suggests that both HREC members and researchers are satisfied with the process of human research ethics review in Australia, there are areas of concern that merit further investigation. These include the timeliness and clarity of HREC decisions, the methodological expertise available to HRECs and the basis for HREC decisions. (shrink)

Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand which resulted in the suffering and death (...) of many women diagnosed with carcinoma in situ. (shrink)