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Related Experiment Videos

Clinical trials and physicians as double agents.

R J Levine1

  • 1Yale University School of Medicine, New Haven, Connecticut.

The Yale Journal of Biology and Medicine
|March 1, 1992
PubMed
Summary

Physician-researchers face conflicts of interest beyond informed consent. Institutional Review Boards (IRBs) should assess risks to patient-subjects, considering consent capacity, injury thresholds, and study design when implementing protections.

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Area of Science:

  • Medical Ethics
  • Clinical Research Oversight

Background:

  • Physician-researchers experience inherent conflicts between clinical care and research objectives.
  • Existing policies primarily address informed consent issues, potentially overlooking other critical conflicts.

Purpose of the Study:

  • To highlight that conflicts of interest for physician-researchers extend beyond informed consent.
  • To propose a framework for Institutional Review Boards (IRBs) to determine necessary procedural safeguards for patient-subjects.

Main Methods:

  • The abstract presents a conceptual argument, not empirical data.
  • It suggests a discretionary approach for IRBs in implementing protections.

Main Results:

  • The necessity for special procedural protections should be determined by the Institutional Review Board (IRB).
Keywords:
Analytical ApproachBiomedical and Behavioral ResearchDeclaration of HelsinkiNational Commission for the Protection of Human SubjectsNuremberg Code

Related Experiment Videos

  • IRBs should consider three key factors when evaluating the need for protections.

    • Conclusions:

    • The three factors for IRB consideration are: impaired subject consent capacity, research risks exceeding minimal risk, and protocols involving therapeutic/diagnostic maneuver evaluations.
    • A combination of these factors increases the importance of recommending special procedural protections.