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Related Experiment Videos

When "minimal risk" research yields clinically-significant data, maybe the risks aren't so minimal.

Helen M Sharp1, Robert D Orr

  • 1The University of Iowa, USA.

The American Journal of Bioethics : AJOB
|June 10, 2004
PubMed
Summary

Clinical research tools, even those deemed minimal risk, can uncover clinically relevant findings. Investigators and IRBs must plan for monitoring, disclosure, and follow-up to ensure participant safety and avoid therapeutic misconception.

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Area of Science:

  • Clinical research ethics
  • Human subject protection
  • Medical research methodology

Background:

  • Research protocols involving surveys and routine clinical procedures are often classified as minimal risk.
  • The minimal risk designation may lead to overlooking clinically relevant findings from research tools.
  • Minimal risk research can inadvertently increase therapeutic misconception due to its similarity to clinical care.

Purpose of the Study:

  • To highlight the potential for clinically relevant findings from minimal risk research procedures.
  • To emphasize the need for proactive risk assessment and management in clinical research.
  • To address the challenge of therapeutic misconception in minimal risk research settings.

Main Methods:

  • Review of existing research on risk assessment in clinical trials.
Keywords:
Biomedical and Behavioral Research

Related Experiment Videos

  • Analysis of the implications of using clinical tools in minimal risk research.
  • Discussion of regulatory considerations for Institutional Review Boards (IRBs).

    • Main Results:

    • Minimal risk research procedures can yield unexpected clinically relevant results.
    • The therapeutic misconception is a significant risk when research mimics clinical care.
    • Current risk assessment may not adequately address the potential for clinically significant incidental findings.

    Conclusions:

    • Investigators must anticipate clinically important findings from all research measures, regardless of risk classification.
    • Explicit plans for data monitoring, disclosure, and follow-up are crucial for participant welfare.
    • Institutional Review Boards (IRBs) should conduct more detailed risk assessments for protocols involving reliable clinical measures, even if categorized as minimal risk.