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Some reflections on evaluating institutional review board effectiveness.

David B Resnik1

  • 1National Institute of Environmental Health Sciences, National Institutes of Health, 111 Alexander Drive, Research Triangle Park, Box 12233, NC, 27709, United States.

Contemporary Clinical Trials
|September 27, 2015
PubMed
Summary
This summary is machine-generated.

Empirical research is crucial for assessing institutional review board (IRB) effectiveness. Future studies must directly measure IRB impact on human subject welfare and rights for improved oversight.

Keywords:
EffectivenessEmpirical researchEthicsInstitutional review boardsOversightProspective cohort studiesRandomized controlled trials

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Area of Science:

  • Biomedical Ethics
  • Clinical Research Oversight
  • Human Subject Protection

Background:

  • Commentators emphasize the need for empirical research on institutional review board (IRB) effectiveness.
  • Current studies often lack direct measures of IRB impact on human subject welfare and rights.
  • Focusing solely on IRB processes (e.g., composition, review times) does not equate to measuring effectiveness.

Purpose of the Study:

  • To highlight the critical need for empirical studies that directly assess the effectiveness of institutional review board (IRB) review and oversight.
  • To advocate for research designs that measure the actual impact of IRBs on human subject welfare and rights.
  • To guide future research methodologies for evaluating IRB performance.

Main Methods:

  • Critique of existing literature on IRB effectiveness.
  • Proposal for developing new study designs, such as randomized controlled trials (RCTs) and prospective cohort studies.
  • Emphasis on collecting data directly related to human research subject welfare and rights.

Main Results:

  • Existing research does not adequately measure IRB effectiveness because it fails to quantify impact on human subjects.
  • Studies focusing on IRB operational aspects (staffing, review times) are insufficient without subject welfare data.
  • There is a significant gap in evidence regarding the direct impact of IRBs.

Conclusions:

  • Direct measurement of IRB impact on human subject welfare and rights is essential for assessing effectiveness.
  • Future research should employ rigorous designs like RCTs to provide this crucial data.
  • Improved IRB oversight and human subject protection can be achieved through evidence-based evaluation.