Minimal Risk, Yet Again

Journal of Pediatrics

Volumn 150, Issue 6, 2007, Pages 570-572

  Nelson, Robert M ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DECISION MAKING; EDITORIAL; HEALTH SERVICE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT;

CHILD; ETHICS, RESEARCH; HUMANS; PEDIATRICS; RESEARCH; RISK ASSESSMENT;

EID: 34248593174     PISSN: 00223476     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpeds.2007.03.040     Document Type: Editorial

References (17)

1. Department of Health and Human Services. 45 CFR Part 46: Additional Protections for Children Involved as Subjects in Research. Federal Register 48 (1983) 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 66 (2001) 20589-20600
3. Kopelman L.M. Minimal risk as an international ethical standard in research. J Med Philosophy 29 (2004) 351-378
4. Kopelman L.M., and Murphy T.F. Ethical concerns about federal approval of risky pediatric studies. Pediatrics 113 (2004) 1783-1789
5. Shah S., Whittle A., Wilfond B., Gensler G., and Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research?. JAMA 291 (2004) 476-482
6. Nelson R.M., and Ross L.F. In defense of a single standard of research risk for all children. J Pediatr 147 (2005) 565-566
7. Wendler D., Belsky L., Thompson K.M., and Emanuel E.J. Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. JAMA 294 (2005) 826-832
8. Wendler D., and Emanuel E.J. What is a 'minor' increase over minimal risk?. J Pediatr 147 (2005) 575-578
9. Ross L.F., and Nelson R.M. Pediatric research and the federal minimal risk standard. JAMA 295 (2006) 759
10. Wendler D., and Varma S. Minimal risk in pediatric research. J Pediatr 149 (2006) 855-861
11. Department of Health and Human Services. 45 CFR Part 46: Federal Policy for the Protection of Human Services. Federal Register 56 (1991) 28003-28023
12. Food and Drug Administration. 21 CFR Parts 50 and 56. Federal Register 56 (1991) 28025-28029
13. Wendler D., and Glantz L. A Standard for assessing the risks of pediatric research: pro and con. J Pediatr 150 (2007) 579-582
14. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Research Involving Children: Report and Recommendations (1977), US Government Printing Office, Washington, DC
15. Ross L.F. Do healthy children deserve greater protection in medical research?. J Pediatr 142 (2003) 108-112
16. In: Field M.J., and Behrman R.E. (Eds). Ethical Conduct of Clinical Research Involving Children (2004), The National Academies Press, Washington, DC
17. SACHRP Chair Letter to HHS Secretary Regarding Recommendations (2005). http://www.hhs.gov/ohrp/sachrp/sachrpltrtohhssec.html Dated July 21. Accessed March 4, 2007. Available from: http://www.hhs.gov/ohrp/sachrp/sachrpltrtohhssec.html