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ResourcesHuman Research EthicsOf Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight (Papers: Holly Fernandez Lynch, et al | December 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight (Papers: Holly Fernandez Lynch, et al | December 2018)

 


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Abstract

Is your research ethics committee effective? Even deciding what effective means in this context isn’t easy. If effectiveness means research being conducted more ethically, how do judge that? This great paper should be seen as a springboard into an important discussion.

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs “work” requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs.

Keywords
Institutional Review Board, research ethics oversight, effectiveness, quality, empirical evaluation

Lynch, H. F., Nicholls, S., Meyer, M. N., & Taylor, H. A. (2018). Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264618812625
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264618812625#articleCitationDownloadContainer



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