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Related Experiment Videos

Research involving human subjects.

B H Gray, R A Cooke, A S Tannenbaum

    Science (New York, N.Y.)
    |September 22, 1978
    PubMed
    Summary
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    Institutional Review Boards (IRBs) generally support human subject protection but face criticisms regarding effectiveness, particularly for informed consent. Their actions impact research proposals, yet data suggest varied outcomes in protecting participants.

    Area of Science:

    • Medical Ethics
    • Human Subject Protection
    • Research Oversight

    Background:

    • Institutional Review Boards (IRBs) are critical for safeguarding human research participants.
    • Understanding IRB activities and performance is essential for ethical research conduct.
    • Previous assessments of IRB effectiveness have highlighted both support and areas for improvement.

    Purpose of the Study:

    • To evaluate the activities and performance of Institutional Review Boards (IRBs).
    • To assess the impact of IRBs on research proposals and human subject protection.
    • To identify criticisms and policy implications related to IRB operations.

    Main Methods:

    • Study involved surveying researchers and IRB members.
    • Analysis of IRB activities and their direct impact on research proposals.
    Keywords:
    Empirical Approach

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  • Qualitative and quantitative assessment of IRB performance metrics.

    • Main Results:

    • General support for the IRB system was found among researchers and IRB members.
    • Substantial criticisms regarding IRB processes and effectiveness were also reported.
    • IRBs directly influenced approximately half of reviewed proposals, requiring modifications or additional information.

    Conclusions:

    • While generally supported, IRB effectiveness, especially concerning informed consent, warrants further investigation.
    • The study highlights a need to address criticisms to enhance the human subject protection system.
    • Findings offer policy implications for improving IRB oversight and performance.