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Related Experiment Videos

Randomized, controlled trials as minimal risk: an ethical analysis.

Marilyn C Morris1, Robert M Nelson

  • 1Department of Pediatrics, Division of Pediatric Critical Care, The Children's Hospital of New York-Presbyterian, Columbia University, New York, NY, USA.

Critical Care Medicine
|January 27, 2007
PubMed
Summary

This study defines minimal risk for randomized controlled trials, guiding when waivers of informed consent are ethically permissible. Key factors include clinical equipoise and standard-of-care treatments to protect participants.

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Area of Science:

  • Medical Ethics
  • Clinical Research Methodology
  • Regulatory Science

Background:

  • Institutional Review Boards (IRBs) face challenges in classifying randomized controlled trials (RCTs) as minimal risk.
  • Waivers of informed consent are sometimes necessary when obtaining consent is not feasible, particularly in emergency settings.

Purpose of the Study:

  • To clarify the criteria for designating RCTs as minimal risk.
  • To guide IRBs in approving RCTs with a waiver of informed consent when feasible.

Main Methods:

  • Ethical analysis of the minimal risk standard applied to RCTs.
  • Evaluation of potential risks associated with research participation versus nonparticipation.

Main Results:

Related Experiment Videos

  • Minimal risk designation requires assessing physical risks, loss of individualized care, non-therapeutic components, and psychological impact.
  • RCTs may pose minimal risk if clinical equipoise exists, treatments are standard of care, and no better alternatives are available.

    • Conclusions:

    • Risk assessment must compare research risks to non-participation risks and consider the psychological impact.
    • Informed consent waivers should be minimal, maximizing opportunities for participant or surrogate decision-making.