Confidence of IRB/REC Members in Their Assessments of Human Research Risk: A Study of IRB/REC Decision Making in Action

Frederick Grinnell, John Z. Sadler, Victoria McNamara, Kristen Senetar, Joan Reisch

Research output: Contribution to journalArticle

Abstract

Understanding how institutional review boards/research ethics committees (IRBs/RECs) perform risk/benefit assessment is important to help improve their function. In environmental ethics, uncertainty about potential outcomes and the precautionary principle play important roles in regulatory oversight but have received little attention in the context of human research ethics. We carried out an empirical study to gain insight into uncertainty by asking IRB/REC members about confidence in their risk assessments immediately after discussion of new protocols under review. Based on 12 meetings carried out by four IRBs/RECs over a 6-month period, we found a robust, inverse relationship between risk and confidence. As risk increased, confidence decreased. We detected different patterns of consensus between different IRBs/RECs and their members. Our study introduces a novel and relatively easy to implement approach to begin to understand IRB/REC decision making in real time that can be used within or across institutions.

Original languageEnglish (US)
Pages (from-to)140-149
Number of pages10
JournalJournal of Empirical Research on Human Research Ethics
Volume12
Issue number3
DOIs
StatePublished - Jul 1 2017

Fingerprint

risk research
Committee Membership
research ethics
Research Ethics Committees
Decision Making
confidence
Decision making
decision making
Research
uncertainty
environmental ethics
Uncertainty
role play
Risk assessment
risk assessment
Research Ethics
Ethics
Consensus

Keywords

  • IRB performance/quality/assessment/evaluation
  • postnormal science
  • precautionary principle
  • research ethics
  • research ethics committee/IRB review
  • risk
  • uncertainty

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication
  • Law

Cite this

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abstract = "Understanding how institutional review boards/research ethics committees (IRBs/RECs) perform risk/benefit assessment is important to help improve their function. In environmental ethics, uncertainty about potential outcomes and the precautionary principle play important roles in regulatory oversight but have received little attention in the context of human research ethics. We carried out an empirical study to gain insight into uncertainty by asking IRB/REC members about confidence in their risk assessments immediately after discussion of new protocols under review. Based on 12 meetings carried out by four IRBs/RECs over a 6-month period, we found a robust, inverse relationship between risk and confidence. As risk increased, confidence decreased. We detected different patterns of consensus between different IRBs/RECs and their members. Our study introduces a novel and relatively easy to implement approach to begin to understand IRB/REC decision making in real time that can be used within or across institutions.",
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