Ethics committee reviews and mutual acceptance: a pilot study.

AIMS: To develop a human research ethics committee (HREC) mutual acceptance (MA) model, based on the National Health and Medical Research Council's guidelines. The MA model aims to facilitate aspects of multicentre research and decrease the time taken to finalise the HREC review process. METHODS: Four HREC (The Alfred Hospital, Austin Health, Peter MacCallum Cancer Centre and Melbourne Health) agreed to participate in a 13-month pilot project to evaluate the MA model. Evaluation included times from submission to approval and stakeholder surveys. RESULTS: Seventeen consecutive studies were submitted to the MA pilot project. Stakeholders agreed that the MA model was efficient and effective and that submission and review processes had improved, with a demonstrable reduction in the levels of duplication. There was a 27% improvement in approval times for multicentre studies. CONCLUSIONS: Our (MA) model resulted in clear improvements in HREC processes and timelines. Stakeholder acceptance was high. This model provides a framework for a broader program of MA.

Trust and confidence: towards mutual acceptance of ethics committee approval of multicentre studies.

AIMS: To compare issues raised by Human Research Ethics Committees (HREC) during the ethics review process and to determine the length of time taken to gain HREC approval for multicentre research studies. METHODS: Review and analysis of HREC documentation and correspondence for all multicentre research studies were conducted through three HREC under the auspices of Cancer Trials Australia, Melbourne, Victoria, Australia, between November 1997 and March 2001 to determine the variance of documentation, correspondence and recommendations across the three HREC and the time taken for study approval. RESULTS: Thirty-one projects were submitted to any two of the HREC (16 studies) or all three HREC (15 studies). The median time for study approval at an individual HREC was 75 days, but it was 111 days for approval at all participating sites. There were 554 clarifications or comments made by the reviewing HREC, the majority of which had no significant bearing on the ethical or scientific calibre of the study. There was only one study in which a significant protocol change was requested by a HREC. CONCLUSIONS: Multicentre study approvals are delayed when submitted to multiple HREC. The three HREC raised similar issues without substantive differences in their recommendations. A process for the mutual acceptance of HREC recommendations could facilitate multicentre research.