Reversing the 'quasi-tribunal' role of human research ethics committees: a waiver of consent case study

This article traces the history of Human Research Ethics Committees ('HRECs') in Australia, noting their development from peer review bodies to a model more akin to quasi-tribunals. We illustrate this shift through the role of HRECs in authorising waivers of consent for health and medical research: a responsibility that is codified under federal and state privacy laws and national research ethics guidelines. Despite the increasingly rule-based nature of HREC decisions, the manner in which HRECs operate has barely changed from their peer review roots. In particular, very limited substantive oversight or appeals mechanisms apply to HREC decisions. Given the stakes involved in authorising - or refusing to authorise - waivers of consent, this may lead to a loss of trust in, and trustworthiness of, the Australian research enterprise. We suggest looking to the model in the United Kingdom and the Republic of Ireland, which delineates the ethical acceptability of a waiver of consent from its legal compliance.