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When experiments go wrong: the U.S. perspective.

Alexander M Capron1

  • 1World Health Organization, Geneva.

The Journal of Clinical Ethics
|June 19, 2004
PubMed
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Recent research injuries highlight flaws in U.S. oversight systems. Improvements are needed for subject compensation and preventing future harm, focusing on better reporting of adverse events.

Area of Science:

  • Biomedical ethics
  • Research integrity
  • Regulatory affairs

Background:

  • The U.S. research oversight system faces challenges following serious participant injuries.
  • Past assumptions about research safety are no longer valid.
  • Existing review mechanisms, including Institutional Review Boards (IRBs), are not consistently effective.

Purpose of the Study:

  • To analyze the shortcomings of the current U.S. system for managing research-related injuries.
  • To explore necessary improvements in subject compensation and harm prevention.
  • To evaluate the effectiveness of local oversight and continuing review processes.

Main Methods:

  • Analysis of recent research-related injuries and their impact.
  • Review of existing regulatory frameworks and oversight mechanisms (IRBs, OHRP).
Keywords:
Biomedical and Behavioral ResearchOffice for Human Research Protection

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  • Examination of the challenges in establishing causality for injuries and implementing compensation systems.

    • Main Results:

    • The current U.S. system is more effective at preventing future problems than compensating for past injuries.
    • The "continuing review" process for approved research is a significant weakness.
    • There is a renewed interest in developing a formal, non-fault compensation system for research injuries.

    Conclusions:

    • The U.S. system for responding to research gone wrong requires significant improvement, particularly in subject compensation.
    • Stricter adherence to reporting adverse events and refining oversight triggers are crucial.
    • An accreditation process for IRBs could enhance system effectiveness and prevent future research-related harms.