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Regulating research with human subjects--is the system broken?

Alan R Fleischman1

  • 1The New York Academy of Medicine, 1216 Fifth Avenue, New York, New York 10029, USA. afleischman@nyam.org

Transactions of the American Clinical and Climatological Association
|March 25, 2006
PubMed
Summary

The research oversight system faces challenges due to outdated regulations and inconsistent Institutional Review Board (IRB) practices. While not broken, it requires updated strategies and performance measures to effectively protect participants and adapt to modern research.

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Area of Science:

  • Biomedical research ethics
  • Regulatory science
  • Public health policy

Background:

  • The current system for regulating research and protecting participants has faced significant criticism.
  • Existing structural and procedural problems stem from an outdated regulatory framework and variations in local Institutional Review Board (IRB) operations.

Observation:

  • Local IRBs exhibit considerable variability in their practices, resource allocation, quality of review, and overall experience.
  • A critical issue is the lack of standardized outcome and performance measures for evaluating the entire system or individual IRBs.

Findings:

  • The research oversight system is strained by the evolving research landscape and insufficient resources, rather than being fundamentally broken.
  • The system demonstrates a capacity to address concerns from both the research community and the public.

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Implications:

  • Thoughtful application of existing regulations is necessary.
  • Developing robust performance assessment strategies is crucial for system improvement and adaptation.
  • Enhancing IRB consistency and resource allocation can strengthen participant protection.