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On the Limits of Parental Proxy Consent: Children's Right to Non-Participation in Non-Therapeutic Research

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Abstract

This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect of beneficial outcome to the individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation.

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REFERENCES

  • ACHRE (Advisory Committee on Human Radiation Experiments) (1994). The context for nontherapeutic research with children. Children as a mere means. Retrieved from the world wide web March 1, 2003 at http://tis.eh.doe.gov/ohre/roadmap/ achre/chap7_3.html

  • Alderson, P. (1993). European Charter of Children's Rights, Bulletin of Medical Ethics, October, 13–15. Retrieved March 1, 2003 from the world wide web at http://www.cirp.org/ library/ethics/alderson

  • Alderson, P. (1999). Did children change or just the guidelines? Bulletin of Medical Ethics 150, 38–44.

    Google Scholar 

  • Alliance for Human Research Protection (AHRP) (2001). Linguistic tinkering with regulatory terminology increases the risk of harm for children: "Minimal Risk" "minor increment of minimal risk" and "disorder or condition." Retrieved March 1, 2003 from the world wide web at http://www.researchprotection.org

  • B.(R.) v. Canadian Aid Society of Metropolitan Toronto (1995). 1 S.C.R. 315.

  • Bartholome, W. (1976). Parents, children and the moral benefits of research, Hastings Center Report 6, 44.

    Google Scholar 

  • Bastion, H. (2001). Gains and losses for rights of consumer and research participants. Retrieved March 1, 2003 from the world wide web at http://www.bmj.com

  • Bauchner, H. and Sharfstein, J. (2001). Failure to report ethical approval in child health research: Review of published papers, British Medical Journal 323, 318–319.

    Google Scholar 

  • British Medical Association (2000). Consent, rights and choices in health care for children and young people. Chapter 11: Summary of good practice. Retrieved March 1, 2003 from the world wide web at http://www.bmjpg.com/consent/chapter11.pdf

  • British Medical Association (Committee on Medical Ethics) (2000). The impact of the Human Rights Act 1998 on medical decision making. Retrieved March 1, 2003 from the world wide web at http://www.cirp.org/library/legal/BMA-human-rights

  • British Royal College of Pediatrics, Child Health (Ethics Advisory Committee) (2000). Guidelines for the ethical conduct of medical research involving children, Archives of Diseases of Childhood 82, 177–182.

    Article  Google Scholar 

  • Burchell, J. (1978). Non-therapeutic medical research on children, South African Law Journal 95 (Part 2), 193–216.

    Google Scholar 

  • Burritt, M.F. (1990). Pediatric reference intervals for 19 biologic variables in healthy children, Mayo Clinic Proceedings 65, 329–336.

    Google Scholar 

  • Carpenter, S. (2001). Experts weigh ethical issues in research with ethnic-minority youth, Monitor on Psychology 32(9). Retrieved March 1, 2003 from the world wide web at http://www.apa.org/monitor/oc01/weighissues.html

  • Cheyette, C. (2000). Organ harvests from the legally incompetent: An argument against compelled altruism, Boston College Law Review 41(2), 465–515.

    Google Scholar 

  • Department of Health (2001). Consent: A guide for children and young people. Retrieved March 1, 2003 from the world wide web at http://www.doh.gov.uk

  • Derish, M.T. and Vanden Heuvel, K. (2000). Mature minors should have the right to refuse life-sustaining medical treatment, Journal of Law, Medicine and Ethics 28(2), 109–124.

    Google Scholar 

  • E.(Mrs) versus (1986) 2 S.C.R. (majority opinion per La Forest J.).

  • FDA Ethics Working Group (2000). Consensus statement on the Pediatric Advisory Subcommittee November 15, 1999 meeting. Retrieved March 1, 2003 from the world wide web at http://www.fda/gov/cder/pediatric/ethics-statement.htm

  • Ferguson, L.R. (1978). The competence and freedom of children to make choices regarding participation in research: A statement, Journal of Social Issues 34(2), 114–121.

    Article  Google Scholar 

  • Frankel, M.S. (1978). Social, legal, and political responses to ethical issues in the use of children as experimental subjects, Journal of Social Issues 34(2), 101–113.

    Article  Google Scholar 

  • Freedman, B., Fuks, A. and Weijer, C. (1993). In loco parentis: Minimal risk as an ethical threshold for research upon children, Hastings Center Report March-April, 13–19.

  • Glantz, L.H. (1998). Research with children, American Journal of Law and Medicine. Retrieved March 1, 2003 from the world wide web at http://www.find articles.com

  • Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 8/16/2001a). Retrieved March 1, 2003 from the world wide web at http://www.courts. state.md.us/opinions/coa/2001/128a00.pdf

  • Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001b). Motion for rehearing denied. Retrieved from the world wide web March 13, 2003 at http://biotech.law.lsu.edu/cases/research/grimes_v_KKI_rehearing.htm (Louisiana State University School of Law website on medical and public health) [see also Brief of Amicus Curiae Association of American Medical Colleges, Association of American Universities, Johns Hopkins University and University of Maryland Medical System Corporation in support of Appellee's motion for reconsideration available on-line at http://www.hopkinsmedicine.org/press/2001/SEPTEMBER/briefs.htm (see especially paragraph 2, under "Introduction")].

  • Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001c). Human experimentation/consent and informed consent: Maryland Court imposes judicial review on non-therapeutic research on children. Retrieved from the world wide web March 1, 2003 at http://biotech.law.lsu.edu/cases/research/grimes _v_KKI_brief.htm

  • Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001d). Lead-based paint study. Retrieved March 1, 2003 from the world wide web at http://www.hopkinsmedicine.org/press/2001/SEPTEMBER/leadfactsheet.htm

  • Grover, S.C. (1980). An examination of Kohlberg's cognitive developmental model of morality, Journal of Genetic Psychology 136, 137–143.

    Google Scholar 

  • Grover, S. (2003a). Social science in the advancement of children's rights, Journal of Academic Ethics (in press).

  • Grover, S.C. (2003b). Human rights considerations in academic research with vulnerable groups: A case analysis. In Proceedings of the UNESCO International Conference on Teaching and Learning for Intercultural Understanding, Human Rights and a Culture of Peace, Jyväskylä, Finland (in press).

    Google Scholar 

  • H.(B.) Next Friend of v. Alberta (Director of Child Welfare) (2002). S.C.C.A. No. 196.

  • ICH (International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use) (2000a). Guidance for industry E11: Clinical investigation of medicinal products in the pediatric population. Retrieved March 1, 2003 from the world wide web at http://www.fda.gov

  • ICH (International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use) (2000b). ICH E6-Guidance. Retrieved March 1, 2003 from the world wide web at http://www.wcuppd.org/pediatric/tsld048.htm

  • Jordan, M.D. (1997). Parents' rights and children's interests, Canadian Journal of Law and Jurisprudence 10, 363–385.

    Google Scholar 

  • Kopelman, L.M. (2000). Children as research subjects: A dilemma, Journal of Medicine and Philosophy 25(6), 745–764.

    Article  Google Scholar 

  • Ladimer, I. (1958). Legal and Ethical Implications of Medical Research on Human Beings, S.J.D. Dissertation, Appendix II (pp. 202–208), George Washington University.

  • McDonnell, K. (1998). Medical research and dependent people. Paper given at the 20th World Congress of Philosophy, Boston, Massachusetts, August 10–15. Retrieved March 1, 2003 from the world wide web at http: //www.bu.edu/wcp/Papers/ bioeMcDo.htm

  • McLean, S. (1992). Medical experimentation with children, International Journal of Law and the Family 6, 173–191.

    Google Scholar 

  • Medical Ethics (2001). Transcript of aired program in which the case of 18 year old Jessie Gelsinger was discussed (the first death due to gene therapy). Retrieved from the world wide web March 1, 2003 at http://net.unl.edu/~swi/pers/medicalethics.html

  • Morin, K. (1998). The standard of disclosure in human subject experimentation, Journal of Legal Medicine 19(June). Cited in Grimes v. Kennedy Krieger (2001a), p. 13.

    Article  Google Scholar 

  • NHMRC (2001). Research involving children and young people. Commentary on the national statement. Retrieved March 1, 2003 from the world wide web at http://www.health. gov.au

  • Nicholson, R. (1986). Medical Research with Children: Ethics, Law and Practice. Oxford: Oxford University Press.

    Google Scholar 

  • Norwegian Children's Ombudsman Office (1999). The best interests of the child in our time: A discussion paper on the concept of the best interests of the child in a Nordic perspective. Retrieved March 1, 2003 from the world wide web at http://www.barneombudet.no/html/english/bestinterest.html

  • Nuremberg Code (1947). Taken from the trials of war criminals before the Nuremberg military tribunals under control council law No. 10, Vol. 2, pp. 181–182. Washington, DC: U.S. Government Printing Office, 1949. Retrieved from the world wide web March 13, 2003 at http://www.med.umich.edu/irbmed/ethics/Nuremberg/NurembergCode html

    Google Scholar 

  • Ramsey, P. (1976). The enforcement of morals: Non-therapeutic research on children, Hastings Center Report 6, 26–28.

    Google Scholar 

  • Re W (1992). 3 WLR 758.

  • Rosato, J. (2000). The ethics of clinical trials: A child's view, The Journal of Law, Medicine and Ethics 28(4), 362–378.

    Google Scholar 

  • (The) Swedish Medical Research Council (1996). Guidelines for ethical evaluation of medical research involving human subjects, MRC Report 2 (English translation 1999). Retrieved March 1, 2003 from the world wide web at http://194.52.62.221/mfr/ publikationer/eng_riktlinjer.html

  • The National Commission for the Protection of Human Subjects of Biomedical and BehavioralResearch (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved March 1, 2003 from the world wide web at http://ohsr.od.nih.gov/mpa/Belmont.php3

  • Tri-Council (1998). Tri-Council (Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada) Policy Statement: Ethical conduct for research involving humans. Retrieved March 1, 2003 from the world wide web at http://www.mrc.gc.ca

  • United Nations Convention on the Rights of the Child (CRC) (1989). Adopted by the U.N. General Assembly, November 20, 1989 and entering into force September 2, 1990.Retrieved March 13, 2003 from the world wide web at http://www.unesco.org

  • United Nations Declaration of Universal Human Rights (1948). Adopted and proclaimed by the U.N. General Assembly under resolution 217A(III) December 10, 1948.

  • United Nations International Covenant on Civil and Political Rights (ICCPR) (1976). Adopted by the U.N. General Assembly December 16, 1966 and entering into force March 23, 1976. Retrieved March 13, 2003 from the world wide web at http://www.unesco.org

  • Villeneuve, P.J. (2001). The placebo standard in regulatory market approval: Why the Declaration of Helsinki has been ignored for 35 years, MJM 6, 52–55.

    Google Scholar 

  • World Medical Association Declaration of Helsinki (2000). Ethical principles for medical research involving human subjects. 52nd WMA General Assembly, Edinburgh, Scotland. Note of Clarification on article 29 added by the WMA general Assembly, Washington, 2002. Retrieved from the world wide web March 1, 2003 at http://www.wma.net

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Grover, S. On the Limits of Parental Proxy Consent: Children's Right to Non-Participation in Non-Therapeutic Research. Journal of Academic Ethics 1, 349–383 (2003). https://doi.org/10.1023/B:JAET.0000025606.40005.bc

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