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From Moving Beyond Compliance to Quality to Moving Beyond Quality to Effectiveness

Realities and Challenges

Bibliographic Data

ID12807191
AuthorsMin‐Fu Tsan (0000-0002-0142-1873, McGuireWoods, corresponding author)
Year2019
Volume14
Issue3
Pages204-208
Publication date2019-05-25
Open AccessYes
TypeARTICLE
VenueJournal of Empirical Research on Human Research Ethics (JOURNAL)
Journal identifiersISSN: 1556-2646 • E-ISSN: 1556-2654
PublisherSAGE Publishing (PUBLISHER • US)
DOI10.1177/1556264619850710
PMID31131677
OpenAlexW2945189456
LanguageEN
Citations received2
References cited16

In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They further claimed that any attempts to measure the quality and performance of IRBs without using such measures, to be developed by them in the unforeseeable future, were not helpful. The realities are that nearly 50 years after its establishment, there has been no systematic assessment of the quality and performance of IRBs, and that nearly two decades after the deaths of Jesse Gelsinger and Ellen Roche and the implementation of reform processes to improve our system of protecting human subjects, there is still plenty of room for improvement. The challenges today are for Taylor to come up with a tool to measure the ethical quality of IRB reviews, for Lynch et al. to develop measures for assessing the effectiveness of IRBs in protecting human subjects, and for the IRB community to decide whether to continue to wait for Taylor and Lynch et al. to develop their promised tools or to start taking advantage of performance measurements to improve the quality and performance of IRBs by using existing IRB performance metrics or to improve those existing performance metrics

Business · Compliance (psychology · Quality (philosophy · Quality management · Set (abstract data type · Biomedical Ethics and Regulation · Computer Science · Ethics in Clinical Research · Health Systems, Economic Evaluations, Quality of Life · Psychology · Social Psychology · Marketing

  • We measure what we can measure”

    Open Access•Holly Fernandez Lynch, Willy Eriksen et al.•Social Science & Medicine•2021

  • How Should Organizations Respond to Repeated Noncompliance by Prominent Researchers

    Open Access•Min‐Fu Tsan, Grace L Tsan•The AMA Journal of Ethic•2020

  • A Systematic Review of the Empirical Literature Evaluating IRBs

    Open Access•Lura Abbott, Christine Grady•Journal of Empirical Research on…•2011

  • Research Ethics Committees’ Oversight of Biomedical Research in South Africa

    Open Access•Blessing Silaigwana, Douglas Wassenaar•Journal of Empirical Research on…•2019

  • The Contribution of Ethics Review to Protection of Human Participants

    Open Access•Caitlin Grady•Journal of Empirical Research on…•2019

  • Effectiveness of Human Research Protection Program Performance Measurements

    Open Access•Min‐Fu Tsan, Hai-Yen Nguyen-Thi•Journal of Empirical Research on…•2017

  • Measuring the Quality and Performance of Institutional Review Boards

    Open Access•Min‐Fu Tsan•Journal of Empirical Research on…•2018

  • Of Parachutes and Participant Protection

    Open Access•Holly Fernandez Lynch, Stuart G Nicholl et al.•Journal of Empirical Research on…•2018

Citations per year0.33
Citation span2020 - 2021 (2)
Highly citedNo

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