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Of Straws, Camels, Research Regulation, and IRBs

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Abstract

Institutional review boards (IRBs) have become beleaguered by a growth in responsibilities related to research oversight in the past several decades. A number of regulatory bodies have appeared in response to these novel and complex responsibilities, seeking to respond to among other issues, conflicts of interest, new technologies, and the potential misuse of research findings. Here, we examine several examples of these novel regulatory bodies as well as a number of concerns related to them that have been largely unacknowledged. Evidence suggests that there can be disharmony and conflicts between these regulatory bodies and IRBs, a lack of clarity with regard to their roles and responsibilities, as well as shortcomings within these entities that, at times, look a lot like the worries that have long been raised in relation to IRBs. We offer a brief discussion of how some of these concerns might be ameliorated, either through a significant restructuring of the system of research oversight, or perhaps through smaller changes to these regulatory bodies.

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Authors and Affiliations

  1. NYU Medical Center, Division of Medical Ethics, New York, NY, USA

    Phoebe Friesen PhD, Barbara Redman PhD & Arthur Caplan PhD

  2. Ethox Centre, Big Data Institute, University of Oxford, Old Road Campus, Oxford, OX3 7FZ, UK

    Phoebe Friesen PhD

Authors
  1. Phoebe Friesen PhD
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  2. Barbara Redman PhD
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  3. Arthur Caplan PhD
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Correspondence to Phoebe Friesen PhD.

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Friesen, P., Redman, B. & Caplan, A. Of Straws, Camels, Research Regulation, and IRBs. Ther Innov Regul Sci 53, 526–534 (2019). https://doi.org/10.1177/2168479018783740

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