TY - JOUR
T1 - Of Parachutes and Participant Protection
T2 - Moving Beyond Quality to Advance Effective Research Ethics Oversight
AU - For the Consortium to Advance Effective Research Ethics Oversight (AEREO)
AU - Lynch, Holly Fernandez
AU - Nicholls, Stuart
AU - Meyer, Michelle N.
AU - Taylor, Holly A.
N1 - Funding Information:
The author(s) received no financial support for authorship and/or publication of this article. The meeting to launch the AEREO Consortium in May 2018 was supported by the Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, and the Leonard Davis Institute of Health Economics, University of Pennsylvania.
Publisher Copyright:
© The Author(s) 2018.
PY - 2019/7/1
Y1 - 2019/7/1
N2 - 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.
AB - 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.
KW - Institutional Review Board
KW - effectiveness
KW - empirical evaluation
KW - quality
KW - research ethics oversight
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U2 - 10.1177/1556264618812625
DO - 10.1177/1556264618812625
M3 - Article
C2 - 30541368
AN - SCOPUS:85058510609
SN - 1556-2646
VL - 14
SP - 190
EP - 196
JO - Journal of Empirical Research on Human Research Ethics
JF - Journal of Empirical Research on Human Research Ethics
IS - 3
ER -