Australian HRECs are criticised for inconsistent decision-making, particularly by trials applying to multiple HRECs. While HRECs may reasonably disagree, a degree of predictability is important, especially for decisions made under statute, such as waivers of consent for secondary data use. We undertook a benchmarking exercise to understand how HRECs make decisions about secondary use of data to inform the development of resources.
Using Trace and Kolstoe's Shared Ethical Debate approach, participating HRECs were sent mock ethics applications requesting participant-level data from a 2018 clinical trial. HRECs received one of two versions: one where the original study included broad consent for future use, and one where the original study was silent as to future use. HRECs returned records of deliberation (e.g. minutes, transcripts and feedback summaries), which were iteratively analysed using deductive and inductive qualitative codes.
Of 188 HRECs invited to participate, 34 agreed and 18 returned their records of deliberation. Deliberation outcomes varied strikingly: in the broad consent group, 2 HRECs approved the application, 2 required revisions and 2 rejected it; and in the silent group, 0 HRECs approved the application, 10 required revisions and 2 rejected it. Substantial diversity was also evident in the themes raised by HRECs, with many not expressly linking their decisions to the National Statement or legislation.
This exercise provides a rich evidence base to inform the development of resources for both researchers and HREC members. Engaging in benchmarking exercises represents a potential mechanism for professional development and the promotion of high-quality, consistent ethical review.