35 - HRPPs as Policymakers - The Policy Process Perspective

Background: Human Research Protection Programs (HRPPs) – meaning Institutional Review Boards (IRBs) and other personnel that support research compliance – are an important lever for change in research oversight policy (both internal and federal). Despite HRPPs’ preeminent role in research oversight, their role as policymakers is underappreciated.

Methods: Punctuated equilibrium theory (PET) has gained traction in policy process scholarship as a conceptual framework for understanding why policy change is mostly stagnant (equilibrium) but occasionally undergoes punctuations (large-scale change) [1]. PET focuses on information processing and provides insight on how changes to research oversight policies occur [2, 3]. This poster extends the PET framework to include HRPPs as a policy venue and discuss the implications for HRPP policy development.

Conclusion: The single IRB (sIRB) mandate shows that HRPPs are policy venues: “locations where policies originate, obtain support, and are adopted as binding decisions” [4]. HRPPs recognized that duplicative ethics reviews were a barrier to research and developed master reliance agreements as a solution. Those efforts grew and were eventually adopted by federal agencies through sIRB mandates [5].

The PET framework provides insight to help HRPPs serve as effective policymakers. The core finding of PET is that policymaking organizations are limited by their ability to process information – to attend to shifting public values and adjust policy in response. Public values, as they relate to HRPPs, will come mostly from the local research community and participants, but will also include national considerations like public health. These values naturally change over time – sometimes rapidly, like when a scandal is followed by moral panic [3]. The information processing capabilities of HRPPs are essential for monitoring those changes and producing proportional policy response.

HRPPs can embrace and improve their policymaking in two ways. The first is through communication, which is a critical determinant of information processing capacity. The second is through discretion, in terms of exercising their power to make policy change and discerning when policy change is necessary. Through the lens of PET, a combination of poor communication and discretion lead to inconsistent local punctuations that can be seen as one of the main causes of the widespread variance in research ethics reviews [6].

Limitations: PET offers insight for understanding the role of HRPPs, but it has limitations. The first is that it takes a long-term view. It is difficult to determine whether a policy system is in a state of stability or change at a given moment. Another is that HRPPs are limited as policy venues because they must abide by federal and state policies and because they must work with other departments to develop institutional policies.

Discussion: The application of PET to HRPPs has two key takeaways for practitioners. The first is that HRPPs should invest in communication. They should seek input from researchers and participants to understand public values, ensure there are internal communication channels that support vertical flow of information to decision-makers, and collaborate with each other. The second is that HRPPs should exercise discretion. Improved communication provides HRPPs with the information they need to create policy change, should they choose to embrace their policymaking role. On the opposite end, reactive response to scandal can lead to policy bubbles that create variance between HRPPs.