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Editorial

Making Sense of the Undue Burden Interpretation of Minimal Risk

REFERENCES

  • Binik, A. 2014. On the minimal risk threshold in research with children. American Journal of Bioethics 14(9): 3–12.
  • Institute of Medicine. 2004. Ethical conduct of clinical research involving children, ed. M. J. Field and R. E. Berman. Washington, DC: National Academies Press.
  • Kopelman, L. M. 1981. Estimating risk in human research. Clinical Research 29(1): 1–8.
  • Kopelman, L. M. 2004. Minimal risk as an international ethical standard in research. Journal of Medicine and Philosophy 29(3): 351–378.
  • Resnik, D. B. 2005. Eliminating the daily life risks standard from the definition of minimal risk. Journal of Medical Ethics 31(1): 35–38.
  • Shah, S. 2011. The dangers of using a relative risk standard for minimal risk. American Journal of Bioethics 11(6): 22–23.
  • 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.
  • Wendler, D., L. Belsky, K. M. Thompson, and E. J. Emanuel. 2005. Quantifying the federal minimal risk standard: Implications for pediatric research without a prospect of direct benefit. Journal of the American Medical Association 294(7): 826–832.

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