Elsevier

The Journal of Pediatrics

Volume 159, Issue 3, September 2011, Pages 496-500
The Journal of Pediatrics

Commentary
How Best to Define the Concept of Minimal Risk

https://doi.org/10.1016/j.jpeds.2011.05.034Get rights and content

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).

First page preview

First page preview
Click to open first page preview

References (29)

  • J. Janofsky et al.

    Assessment of risk in research on children

    J Pediatr

    (1981)
  • D. Wendler et al.

    A standard for assessing the risks of pediatric research: pro and con

    J Pediatr

    (2007)
  • R.M. Nelson et al.

    In defense of a single standard of research risk for all children

    J Pediatr

    (2005)
  • Department of Health and Human Services. US Code of Federal Regulations, 45 CFR 46, Subpart D: Additional Protections...
  • Department of Health and Human Services. US Code of Federal Regulations, 45 CFR 46....
  • S. Shah et al.

    How do institutional review boards apply the federal risk and benefit standards for pediatric research?

    JAMA

    (2004)
  • Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

    Eur J Health Law

    (2008)
  • L.M. Kopelman

    Minimal risk as an international ethical standard in research

    J Med Philos

    (2004)
  • Report and recommendations: Research involving children

    (1977)
  • C.B. Fisher et al.

    Determining risk in pediatric research with no prospect of direct benefit: time for a national consensus on the interpretation of federal regulations

    Am J Bioeth

    (2007)
  • Ethical conduct of clinical research involving children

    (2004)
  • L.F. Ross et al.

    Pediatric research and the federal minimal risk standard

    JAMA

    (2006)
  • E.J. Emanuel et al.

    What makes clinical research ethical?

    JAMA

    (2000)
  • D. Wendler et al.

    Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit

    JAMA

    (2005)
  • Cited by (24)

    View all citing articles on Scopus

    Funded by The Netherlands Organization for Health Research and Development (grant 92003475). The authors declare no conflicts of interest.

    View full text