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Open Peer Commentaries

Using the Minimal Risk Threshold for All “No-Benefit” Pediatric Studies

REFERENCES

  • Binik, A. 2014. On the minimal risk threshold in research with children. American Journal of Bioethics 14(9): 3–12.
  • Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. 2002 revision. Geneva, Switzerland: CIOMS. Available at: http://www.cioms.ch
  • Institute of Medicine of the National Academies. 2004. Ethical conduct of clinical research involving children, ed. M. J. Fields and R. E. Behrman. Washington, DC: National Academy Press.
  • Kopelman, L. M. 1989. When is the risk minimal enough for children to be research subjects? In Children and health care: Moral and social issues, ed. L. M. Kopelman and J. C. Moskop, 89–99. Dordrecht, The Netherlands: Kluwer Academic.
  • Kopelman, L. M. 2002. Pediatric research regulations under legal scrutiny: Grimes narrows their interpretation. Journal of Law, Medicine & Ethics 30(1): 38–49
  • Kopelman, L. M. 2004a. Minimal risk as an international ethical standard in research. Journal of Medicine and Philosophy 29(3): 351–378
  • Kopelman, L. M. 2004b. What conditions justify risky nontherapeutic or ‘no benefit’ pediatric studies: A sliding scale analysis. Journal of Law, Medicine and Ethics 32(4): 749–758.
  • U.S. Code of Federal Regulations. 1983. U.S. 45 Code of Federal Regulations 46: 401–409. Additional policy for children involved as subjects in research. (Subpart D.) Federal Register 58: 9816–9820. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

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