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The "Risks of Routine Tests" and Analogical Reasoning in Assessments of Minimal Risk.
1Core Learning, College of Interdisciplinary and Experiential Learning, Singapore University of Social Sciences, Singapore.
The Journal of Medicine and Philosophy
|October 7, 2023
Summary
Determining "minimal risk" in research is crucial for expedited ethics review. This study finds that "risks of routine tests" best aligns with the analogical reasoning used in assessing research risks.
Area of Science:
- Bioethics
- Research Ethics
- Regulatory Science
Background:
- Minimal risk is a key threshold for expedited ethics review, exemption, or consent waivers in research.
- The Common Rule defines minimal risk by comparing research risks to risks of daily life or routine tests.
- Existing comparators for minimal risk assessment have faced criticism, prompting proposals for alternatives.
Purpose of the Study:
- To explore workable comparators for assessing minimal risk in research ethics.
- To analyze the analogical reasoning inherent in ethical assessments of minimal risk.
- To establish criteria for an adequate conception of minimal risk.
Main Methods:
- The study frames the search for comparators within the context of analogical reasoning.
- Two necessary conditions for an adequate minimal risk conception were developed.
- Three distinct comparators were assessed using these developed conditions.
Main Results:
- The assessment revealed that "risks of routine tests" is the most suitable comparator.
- This comparator best supports the analogical reasoning process in minimal risk evaluations.
- The developed conditions provided a framework for evaluating the adequacy of risk comparators.
Conclusions:
- The "risks of routine tests" comparator is recommended for assessing minimal risk in research.
- This finding supports more consistent and ethically sound minimal risk determinations.
- The study contributes to refining ethical frameworks for research oversight and participant protection.
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