“The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back”: a survey of researchers’ and ethics committee members’ views on research ethics reviews in Australia

Abstract

AbstractObjectivesTo identify what types of health and medical research could be exempted from a requirement to undergo research ethics reviews in Australia.DesignA web-based survey.SettingAustralian-based participants completed the survey online between 10 September and 1 November 2019.ParticipantsActive human health and medical researchers and members of Human Research Ethics Committees (HREC).Main outcome measuresParticipants were asked whether they self-identify as a researcher, a member of an Australian human research ethics committee, or both. They were asked whether they had previously changed or abandoned a research project in anticipation of difficulty in obtaining ethics approval; and were presented with 4 hypothetical research scenarios, asking whether they should or should not be exempt from ethics review in Australia. All but the demographic question allowed the respondent to provide a comment clarifying their response. Qualitative data were analysed thematically; quantitative data were analysed in R.ResultsWe received 514 survey responses: 153 from researchers, 196 from HREC members, and 163 from individuals who identified as both. 27% of researchers reported they had changed their projects because they anticipated obstacles resulting from the ethics review process, and 16% abandoned projects for this reason. The most commonly exempted research scenarios involved professional staff providing their views on their area of expertise (84%, 85%); scenarios involving surplus samples and N-of-1 studies in clinical practice were most commonly required to undergo ethics review (82%, 76% respectively). Probability of answering that ethics review was required was the highest for HREC members and nearly identical for respondents who were both HREC members and researchers; it was the lowest for researchers. HREC members were overall 26% more likely to answer that ethics review was required than researchers.ConclusionsOur survey shows considerable differences between the researchers and members of ethics committees, about how best to serve the interests of patients and the public. Those interests are best served by evaluative research to reduce or resolve the uncertainties in the clinical context – the same general principle should be applied to ethics review.