The Journal of Pediatrics
Volume 150, Issue 6 , Pages 570-572 , June 2007

Minimal Risk, Yet Again

  • Robert M. Nelson, MD, PhD

      Affiliations

    • Corresponding Author InformationReprint requests: Dr. Robert M. Nelson, The Children’s Hospital of Philadelphia, Room 1513, CHOP North, 34th Street and Civic Center Boulevard, Philadelphia, PA 19104.

References 

  1. Department of Health and Human Services. 45 CFR Part 46: Additional Protections for Children Involved as Subjects in Research. Federal Register. 1983;48:9814
  2. Food and Drug Administration. 21 CFR Parts 50 and 56: Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products. Federal Register. 2001;66:20589–20600
  3. Kopelman LM. Minimal risk as an international ethical standard in research. J Med Philosophy. 2004;29:351–378
  4. Kopelman LM, Murphy TF. Ethical concerns about federal approval of risky pediatric studies. Pediatrics. 2004;113:1783–1789
  5. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research?. JAMA. 2004;291:476–482
  6. Nelson RM, Ross LF. In defense of a single standard of research risk for all children. J Pediatr. 2005;147:565–566
  7. Wendler D, Belsky L, Thompson KM, Emanuel EJ. Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. JAMA. 2005;294:826–832
  8. Wendler D, Emanuel EJ. What is a ‘minor’ increase over minimal risk?. J Pediatr. 2005;147:575–578
  9. Ross LF, Nelson RM. Pediatric research and the federal minimal risk standard. JAMA. 2006;295:759
  10. Wendler D, Varma S. Minimal risk in pediatric research. J Pediatr. 2006;149:855–861
  11. Department of Health and Human Services. 45 CFR Part 46: Federal Policy for the Protection of Human Services. Federal Register. 1991;56:28003–28023
  12. Food and Drug Administration. 21 CFR Parts 50 and 56. Federal Register. 1991;56:28025–28029
  13. Wendler D, Glantz L. A Standard for assessing the risks of pediatric research: pro and con. J Pediatr. 2007;150:579–582
  14. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Research Involving Children: Report and Recommendations. Washington, DC: US Government Printing Office; 1977;
  15. Ross LF. Do healthy children deserve greater protection in medical research?. J Pediatr. 2003;142:108–112
  16. In:  Field MJ,  Behrman RE editor. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press; 2004;
  17. SACHRP Chair Letter to HHS Secretary Regarding Recommendations. 2005;Dated July 21. Accessed March 4, 2007. Available from: http://www.hhs.gov/ohrp/sachrp/sachrpltrtohhssec.html

PII: S0022-3476(07)00264-8

doi: 10.1016/j.jpeds.2007.03.040

The Journal of Pediatrics
Volume 150, Issue 6 , Pages 570-572 , June 2007

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