25 - Conceptualizing Human Research Ethics Committees as Regulatory Actors: Implications for Expectations and Practices

Background:  Human Research Ethics Committees (HRECs) and their international counterparts such as Institutional Review Boards (IRBs) act as regulatory partners for the delivery of research ethics services. However, principles of regulatory theory have rarely been applied to their operations. Regulatory frameworks can improve our understandings of HREC roles and responsibilities.

Methods:  This analysis draws on the framework of ‘regulatory scaffolding’, which was developed in the context of non-communicable diseases. The framework proposes that where a regulatory partner—such as an HREC—delivers a public service, governments can and should ‘scaffold’ its operations to ensure that all providers are meeting expectations. Regulatory scaffolding responds to the nature of the service provided by HRECs and their international counterparts rather than individual provider classifications of commercial, not-for-profit, or public.

Conclusion:  Conceptualizing HRECs as a regulatory partner delivering an outsourced public service clarifies and expands the scope of currently accepted HREC responsibilities. These include:
1. Establishing clear roles and responsibilities, along with targets for measuring success or failure. While Australia and other countries have well-developed research ethics guidelines, quality assessment has been more challenging. Understanding HRECs as regulatory actors highlights the importance of establishing and enforcing procedural and substantive metrics of success. These may include through regular audits of membership, training, turnaround time, and complaints.

2. Holding HRECs to account for their decision making. Regulatory actors, including HRECs, should be required to justify their decisions, and there should be an expectation of behavior change should they make decisions that fall outside their governing code. A starting point could be establishing processes for HREC self-reflection on the consistency of their decisions with their governing codes, for example through peer-peer or dummy reviews of applications. A related responsibility is ensuring a level of transparency as to how an HREC reached a decision, including by providing researchers with clear reasons for their decisions.

3. Credible expectation of escalation and review: If a regulatory actor fails to meet expectations, there should be a credible expectation of their role being reviewed. Quality assurance processes through a self-auditing mechanism can provide a first step in this regard. The reasonableness of HREC decisions also could be subject to judicial review through a court or tribunal.

Limitations: This approach and its associated recommendations have been developed in the Australian HREC context. HRECs have a more expansive review role than IRBs and some other international counterparts. However, the broad similarities in history and operationalization of these bodies suggests that the conceptual framework will apply across jurisdictional boundaries with minor variations.

Discussion:  Conceptualizing HRECs as a regulatory actor sheds light on their functions and the performance expectations that should attach to service delivery by all providers. Some of the resulting proposals are already under exploration as standalone measures, including recommendations for greater transparency and accountability. However, these have generally been discussed as isolated measures for performance improvement rather than as connected features of a delegated public service provider. Regulatory scaffolding provides an overarching framework for understanding how HRECs must perform their role and the potential consequences of noncompliance.