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The American Journal of Bioethics Volume 14, 2014 - Issue 9
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Open Peer Commentaries

Using the Lives of Children Who Are Thriving as a Baseline for Minimal Risk Is not Useful for IRB Determinations

Judith NavratilUniversity of Pittsburgh Institutional Review BoardCorrespondence[email protected]
&
Melissa MiklosUniversity of Pittsburgh Institutional Review Board
Pages 21-22 | Published online: 15 Aug 2014

REFERENCES

  • Binik, A. 2014. On the minimal risk threshold in research with children. American Journal of Bioethics 14(9): 3–12.
  • Fisher, C., S. Kornetsky, and E. Prentice. 2007. Determining risk in pediatric research with no prospect of direct benefit: Time for a national consensus on the interpretation of federal regulations. American Journal of Bioethics 7(3): 5–10.
  • Janofsky, J., and B. Starfield. 1981. Assessment of risk and research on children. Journal of Pediatrics 98:842–846.
  • Kopelman, L. 2000. Moral problems in assessing research risk. IRB: Ethics and Human Research 22(5): 3–6.
  • Shah, S., A. Whittle, B. Wilfond, G. Gensler, and D. Wendler. 2004. How do Institutional Review Boards apply the federal risk and benefit standards for pediatric research? Journal of the American Medical Association 291(4): 476–482.
  • Snyder, J., C. Miller, and G. Gray. 2011. Relative versus absolute standards for everyday risk in adolescent HIV prevention trials: Expanding the debate. American Journal of Bioethics 11(6): 5–13.
  • Wada, K. 2011. The concept of minimal risk: The need for better guidance on the ethics review process. American Journal of Bioethics 11(6): 27–29.
  • Wendler, D. 2004. Risk standards for pediatric research. Kennedy Institute of Ethics Journal 14: 187–198.

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