Walking the moral tightrope: Respecting and protecting children in health-related research

Cambridge Quarterly of Healthcare Ethics

Volumn 11, Issue 3, 2002, Pages 217-229

  Miller, Paul B ^a,b   Kenny, Nuala P ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b DALHOUSIE UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ACCIDENT PREVENTION; ACNE; CANADA; CAREGIVER; CHILD CARE; CHILD WELFARE; CHILDHOOD CANCER; DEMOGRAPHY; DOCUMENT EXAMINATION; GOVERNMENT; GROWTH CURVE; HEALTH PROMOTION; HEALTH STATUS; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; MORALITY; POLICY; PRACTICE GUIDELINE; PROPHYLAXIS; RESPONSIBILITY; REVIEW; RISK ASSESSMENT; ROLE PLAYING; SOCIAL ASPECT; UNITED STATES;

EID: 0036627224     PISSN: 09631801     EISSN: None     Source Type: Journal    
DOI: 10.1017/S096318010211303X     Document Type: Review

References (40)

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8. See, for example, the work of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its: Research Involving Children: Report and Recommendations. Washington, D.C.: Department of Health, Education, and Welfare (DHEW), 1977. See also: Wilson A. Development of the U.S. federal role in children's health care. In: Kopelman LM, Moskop J, eds. Children and Health Care: Moral and Social Issues. Dordrecht: Kluwer, 1989:27-66; and Grodin M, Glantz L, eds. Children as Research Subjects: Science, Ethics, and Law. London/New York: Oxford University Press, 1994.
9. See, for example, the work of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its: Research Involving Children: Report and Recommendations. Washington, D.C.: Department of Health, Education, and Welfare (DHEW), 1977. See also: Wilson A. Development of the U.S. federal role in children's health care. In: Kopelman LM, Moskop J, eds. Children and Health Care: Moral and Social Issues. Dordrecht: Kluwer, 1989:27-66; and Grodin M, Glantz L, eds. Children as Research Subjects: Science, Ethics, and Law. London/New York: Oxford University Press, 1994.
10. See, for example, the work of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its: Research Involving Children: Report and Recommendations. Washington, D.C.: Department of Health, Education, and Welfare (DHEW), 1977. See also: Wilson A. Development of the U.S. federal role in children's health care. In: Kopelman LM, Moskop J, eds. Children and Health Care: Moral and Social Issues. Dordrecht: Kluwer, 1989:27-66; and Grodin M, Glantz L, eds. Children as Research Subjects: Science, Ethics, and Law. London/New York: Oxford University Press, 1994.
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12. See Robinson W. Ethical issues in pediatric research. Journal of Clinical Ethics 2000;11(2):145-50; and Kenny NP, Miller PB. Research involving children: clarifying roles and authority. Journal of Clinical Ethics 2000;11(2):151-6.
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16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus: Report and Recommendations. Washington, D.C.: DHEW, 1975; Research Involving Prisoners: Report and Recommendations. Washington, D.C.: DHEW, 1976; Research Involving Children: Report and Recommendations. Washington, D.C.: DHEW, 1977; Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations. Washington, D.C.: DHEW, 1978
17. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus: Report and Recommendations. Washington, D.C.: DHEW, 1975; Research Involving Prisoners: Report and Recommendations. Washington, D.C.: DHEW, 1976; Research Involving Children: Report and Recommendations. Washington, D.C.: DHEW, 1977; Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations. Washington, D.C.: DHEW, 1978
18. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus: Report and Recommendations. Washington, D.C.: DHEW, 1975; Research Involving Prisoners: Report and Recommendations. Washington, D.C.: DHEW, 1976; Research Involving Children: Report and Recommendations. Washington, D.C.: DHEW, 1977; Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations. Washington, D.C.: DHEW, 1978
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20. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Title 45, Code of Federal Regulations, Part 46 - Protection of Human Subjects (45 CFR 46). Washington, D.C.: DHHS, 18 Jun 1991. Weijer C. The ethical analysis of risks and potential benefits in human subjects research: history, theory, and implications for U.S. regulation. A background paper prepared for the U.S. National Bioethics Commission (NBAC), 2000.
21. Choudhry S. Review of legal instruments and codes on medical experimentation with children. Cambridge Quarterly of Healthcare Ethics 1994;3:560-73.
22. See: Moreno J. IRBs under the microscope. Kennedy Institute of Ethics Journal 1998;8(3):329-37; Edgar H, Rothman D. The Institutional Review Board and beyond: future challenges to the ethics of human experimentation. Milbank Quarterly 1995;73(4):489, 491-2.
23. See: Moreno J. IRBs under the microscope. Kennedy Institute of Ethics Journal 1998;8(3):329-37; Edgar H, Rothman D. The Institutional Review Board and beyond: future challenges to the ethics of human experimentation. Milbank Quarterly 1995;73(4):489, 491-2.
24. Office of the Inspector General. Institutional Review Boards: A Time for Reform. Washington, D.C.: DHHS, 1998.
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29. Freedman B. Equipoise and the ethics of clinical research. New England Journal of Medicine 1987;317:141-5. Recently re-dubbed "research equipoise" by the U.S. National Bioethics Advisory Commission in their Ethical and Policy Issues in Research Involving Human Subjects - Draft Report. Bethesda, Md.: NBAC, 2000.
30. Freedman B, Fuks A, Weijer C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Center Report 1993;23(2):13-9.
31. Weijer C. Thinking clearly about research risk: implications of the work of Benjamin Freedman. IRB: A Review of Human Subjects Research 1999;21(6):1-5.
32. See note 9, Robinson 2000.
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34. See, for example: Bartholome W. Hearing children's voices. Bioethics Forum 1995;11(4):3-6; Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995;95(2):286-94.
35. See, for example: Bartholome W. Hearing children's voices. Bioethics Forum 1995;11(4):3-6; Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995;95(2):286-94.
36. World Medical Association Declaration of Helsinki as amended by the forty-eighth General Assembly, Somerset West, Republic of South Africa, October 1996.
37. Buchanan A, Brock D. Deciding for Others: The Ethics of Surrogate Decision Making. New York: Cambridge University Press, 1990.
38. See note 24, Baylis, Downie, Kenny 1999.
39. Kenny N. Whose choice? deciding about therapeutic interventions in children. In: Lynch A, ed. The Good Pediatrician: An Ethics Curriculum for Use in Canadian Pediatric Residency Programs. Toronto: The Pediatric Ethics Network Project, Hospital for Sick Children, 1996:133-54.
40. See note 29, Kenny 1996.