Comment: Research involving children: Clarifying roles and authority

Journal of Clinical Ethics

Volumn 11, Issue 2, 2000, Pages 151-156

  Kenny, Nuala ^a   Miller, Paul ^a  

^a DALHOUSIE UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CANADA; CHILD; CHILD HEALTH CARE; DECISION MAKING; GOVERNMENT REGULATION; HIGH RISK BEHAVIOR; HUMAN; HUMAN EXPERIMENT; HUMAN RELATION; INFANT; INFORMED CONSENT; LEGAL ASPECT; PARENTAL CONSENT; PATIENT PARTICIPATION; PEDIATRICS; PRESCHOOL CHILD; PROFESSIONAL STANDARD; RESEARCH ETHICS; STANDARD;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ADOLESCENT; CANADA; CHILD; CHILD HEALTH SERVICES; CHILD, PRESCHOOL; DECISION MAKING; ETHICS COMMITTEES; ETHICS, RESEARCH; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; INFANT; INFORMED CONSENT; PARENTAL CONSENT; PATIENT PARTICIPATION; PEDIATRICS; PROFESSIONAL-FAMILY RELATIONS; RISK-TAKING;

EID: 0034208561     PISSN: 10467890     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

1. C. Weijer, "The Ethical Analysis of Risks and Benefits in Research," NCEHR (National Council on Ethics in Human Research) Communique (Summer/Fall 1999): 9.2-10.1.
2. U.S. 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, Washington, D.C., 18 June 1991 ("The Common Rule").
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research," OPRR Reports (18 April 1979): 1-8.
4. See note 2 above, subpart D.
5. B. Freedman, A. Fuks, and C. Weijer, "Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research," Clinical Research 40, no. 4 (1992): 653-60; B. Freedman and C. Weijer, "Demarcating Research and Treatment Interventions: A Case Illustration," IRB: A Review of Human Subjects Research 14, no. 4 (1992): 5-8.
6. B. Freedman, A. Fuks, and C. Weijer, "Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research," Clinical Research 40, no. 4 (1992): 653-60; B. Freedman and C. Weijer, "Demarcating Research and Treatment Interventions: A Case Illustration," IRB: A Review of Human Subjects Research 14, no. 4 (1992): 5-8.
7. B. Freedman, "Equipoise and the Ethics of Clinical Research," New England Journal of Medicine 317 (1987): 141-5.
8. C. Weijer, "Thinking Clearly about Research Risk: Implications of the Work of Benjamin Freedman," IRB: A Review of Human Subjects Research 21, no. 6 (1999): 1-5, p. 2.
9. Ibid.
10. The adequacy of the minimal risk threshold has been the subject of debate. See L. Kopelman, "Estimating Risk in Human Research," Clinical Research 29 (1981): 1-8; B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children," Hastings Center Report 23, no. 2 (1993): 13-9; Weijer, "Thinking Clearly," see note 8 above, pp. 1-5; L. Kopelman, "Moral Problems Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000); P. Miller and C. Weijer, "Moral Solutions in Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000).
11. The adequacy of the minimal risk threshold has been the subject of debate. See L. Kopelman, "Estimating Risk in Human Research," Clinical Research 29 (1981): 1-8; B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children," Hastings Center Report 23, no. 2 (1993): 13-9; Weijer, "Thinking Clearly," see note 8 above, pp. 1-5; L. Kopelman, "Moral Problems Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000); P. Miller and C. Weijer, "Moral Solutions in Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000).
12. The adequacy of the minimal risk threshold has been the subject of debate. See L. Kopelman, "Estimating Risk in Human Research," Clinical Research 29 (1981): 1-8; B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children," Hastings Center Report 23, no. 2 (1993): 13-9; Weijer, "Thinking Clearly," see note 8 above, pp. 1-5; L. Kopelman, "Moral Problems Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000); P. Miller and C. Weijer, "Moral Solutions in Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000).
13. The adequacy of the minimal risk threshold has been the subject of debate. See L. Kopelman, "Estimating Risk in Human Research," Clinical Research 29 (1981): 1-8; B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children," Hastings Center Report 23, no. 2 (1993): 13-9; Weijer, "Thinking Clearly," see note 8 above, pp. 1-5; L. Kopelman, "Moral Problems Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000); P. Miller and C. Weijer, "Moral Solutions in Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000).
14. The adequacy of the minimal risk threshold has been the subject of debate. See L. Kopelman, "Estimating Risk in Human Research," Clinical Research 29 (1981): 1-8; B. Freedman, A. Fuks, and C. Weijer, "In Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children," Hastings Center Report 23, no. 2 (1993): 13-9; Weijer, "Thinking Clearly," see note 8 above, pp. 1-5; L. Kopelman, "Moral Problems Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000); P. Miller and C. Weijer, "Moral Solutions in Assessing Research Risk," IRB: A Review of Human Subjects Research (in press, 2000).
15. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendation (Washington, D.C.: U.S. Department of Health, Education, and Welfare, 1977). See also J. McCartney, "Research on Children: National Commission Says 'Yes, if...'," Hastings Center Report (October 1978): 26-31; A. Wilson, "Development of the U.S. Federal Role in Children's Health Care," in Children and Health Care: Moral and Social Issues, ed. L. Kopelman and J. Moskop (Dordrecht, The Netherlands: Kluwer Academic, 1989), 27-66; M. Grodin and L. Glantz, ed., Children as Research Subjects: Science, Ethics and Law (New York: Oxford University Press, 1994).
16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendation (Washington, D.C.: U.S. Department of Health, Education, and Welfare, 1977). See also J. McCartney, "Research on Children: National Commission Says 'Yes, if...'," Hastings Center Report (October 1978): 26-31; A. Wilson, "Development of the U.S. Federal Role in Children's Health Care," in Children and Health Care: Moral and Social Issues, ed. L. Kopelman and J. Moskop (Dordrecht, The Netherlands: Kluwer Academic, 1989), 27-66; M. Grodin and L. Glantz, ed., Children as Research Subjects: Science, Ethics and Law (New York: Oxford University Press, 1994).
17. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendation (Washington, D.C.: U.S. Department of Health, Education, and Welfare, 1977). See also J. McCartney, "Research on Children: National Commission Says 'Yes, if...'," Hastings Center Report (October 1978): 26-31; A. Wilson, "Development of the U.S. Federal Role in Children's Health Care," in Children and Health Care: Moral and Social Issues, ed. L. Kopelman and J. Moskop (Dordrecht, The Netherlands: Kluwer Academic, 1989), 27-66; M. Grodin and L. Glantz, ed., Children as Research Subjects: Science, Ethics and Law (New York: Oxford University Press, 1994).
18. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendation (Washington, D.C.: U.S. Department of Health, Education, and Welfare, 1977). See also J. McCartney, "Research on Children: National Commission Says 'Yes, if...'," Hastings Center Report (October 1978): 26-31; A. Wilson, "Development of the U.S. Federal Role in Children's Health Care," in Children and Health Care: Moral and Social Issues, ed. L. Kopelman and J. Moskop (Dordrecht, The Netherlands: Kluwer Academic, 1989), 27-66; M. Grodin and L. Glantz, ed., Children as Research Subjects: Science, Ethics and Law (New York: Oxford University Press, 1994).
19. Robinson's reasons for favoring the clinical perspective in assessing benefit are unclear. The study by Janofsky and Starfield cited by Robinson suggests that the opinions of expert pediatricians vary widely with respect to assigning levels of risk to common procedures. There is no reason to presume that similar variation wouldn't occur in their assessment of direct benefit. See J. Janofsky and B. Starfield, "Assessment of Risk in Research on Children," Journal of Pediatrics 98, no. 5 (1981): 842-6.