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Related Experiment Video

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Assessment of Social Interaction Behaviors
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Published on: February 25, 2011

How IRBs view and make decisions about social risks.

Robert L Klitzman1

  • 1Department of Psychiatry, Columbia University, New York, NY 10032, USA. rlk2@columbia.edu

Journal of Empirical Research on Human Research Ethics : JERHRE
|August 13, 2013
PubMed
Summary

Institutional Review Boards (IRBs) face challenges in assessing social risks, impacting research ethics. Findings reveal significant variation in how IRBs handle these complex ethical considerations.

Area of Science:

  • Bioethics
  • Public Health Research Ethics

Background:

  • Assessing social risks by Institutional Review Boards (IRBs) is not well understood, with limited empirical data.
  • Social risks, which can affect individuals within groups, present unique ethical challenges in research.
  • The extent of researcher and IRB responsibility for addressing health inequities remains ambiguous.

Purpose of the Study:

  • To investigate how Institutional Review Boards (IRBs) assess and manage social risks in research.
  • To explore the variability in IRB practices regarding the evaluation of social risks versus benefits.
  • To identify the challenges and dilemmas IRBs encounter when balancing individual and group risks.

Main Methods:

  • Survey and interviews with leaders, members, and administrators from 34 Institutional Review Boards (IRBs).

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  • Data collection involved leaders from 60 IRBs, with a 55% response rate.
  • Qualitative analysis of interview data to understand decision-making processes regarding social risks.
  • Main Results:

    • IRBs exhibit significant struggles in assessing and balancing social risks and benefits.
    • There is considerable variation in whether, how, and to what extent IRBs address social risks.
    • IRBs face dilemmas concerning indirect individual risks stemming from group risks and responsibility for health inequities.

    Conclusions:

    • IRBs face critical challenges, dilemmas, and ambiguities in their assessment of social risks.
    • Empirical data highlight the need for clearer guidelines and consistent approaches to managing social risks in research.
    • Understanding IRB decision-making is crucial for enhancing research ethics and protecting participants from social harms.