CommentaryHow Best to Define the Concept of Minimal Risk
Section snippets
Problems Posed by the US Definition
The US definition of minimal risk poses 3 main problems. The first and second problems could, as we will show, satisfactorily be solved. For the third problem, however, no fully satisfactory solution has yet been proposed.
Another Type of Definition Could Solve the Remaining Issues
We propose to distinguish between the risks of discomfort and the risks of harm and to define for each of these two concepts what can be regarded as “minimal” by “incorporating” the comparisons at stake (Figure and Table).
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Cited by (24)
Ethical Issues in Neonatal and Pediatric Clinical Trials
2012, Pediatric Clinics of North AmericaCitation Excerpt :Children are at risk of injury when they ride a bike, play competitive sports, take ballet lessons, or climb trees, but these risks are different from those to which a child is exposed in a research study. This vagueness creates variable interpretations by investigators and institutional review boards (IRBs).10 In a survey study of IRB chairmen, Shah and colleagues11 identified marked variation in assessment of the level of risk associated with different procedures; for example, allergy skin testing was found by 23% of those surveyed to be minimal risk, by 43% to convey a minor increase compared with minimal risk, and by 27% to impose more than a minor increase compared with minimal risk; similar variation was observed in assessment of potential for direct benefit.
When is it impractical to ask informed consent? A systematic review
2022, Clinical TrialsThe Principle of the Primacy of the Human Subject and Minimal Risk in Non-Beneficial Paediatric Research
2022, Journal of Bioethical InquiryCurrent Situations of Ethical Review of Clinical Research based on Risk - Benefit Ratio at Home and Abroad
2021, Chinese Medical EthicsConsent for Acute Care Research and the Regulatory “Gray Zone”
2020, American Journal of Bioethics
Funded by The Netherlands Organization for Health Research and Development (grant 92003475). The authors declare no conflicts of interest.