Hostname: page-component-6bf8c574d5-gr6zb Total loading time: 0 Render date: 2025-02-14T10:29:36.073Z Has data issue: false hasContentIssue false
  • English
  • Français

Adolescents Lack Sufficient Maturity to Consent to Medical Research

Published online by Cambridge University Press:  01 January 2021

Mark J. Cherry
Get access Rights & Permissions [Opens in a new window]

Abstract

This study explores the ways in which adolescents, even so-called “mature minors”, lack adequate development of the intellectual, affective, and emotional capacities necessary morally to consent to medical research on their own behalf. The psychological and neurophysiological data regarding brain maturation supports the conclusion that adolescents are qualitatively different types of agents than mature adults. They lack full adult maturity and personal agency. As a result, in addition to the usual requirements for IRB approval, one or both parents, or a legal guardian, should provide informed consent for minor children to participate in medical research.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue 3: Symposium - Controversies in Clinical Research Ethics , Fall 2017 , pp. 307 - 317
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

“The notion of diminished autonomy of children and adolescents is based on limitations in cognition and judgment. During early and middle adolescence, most teens attain adult cognitive capacity, albeit at varying rates and ages. … This limited but emerging capacity is recognized both in state laws that allow adolescents who are still legally minors to give their own consent for medical care and in the federal regulations governing research.” Society for Adolescent Medicine, “Guidelines for Adolescent Health Research: A Position Paper of the Society for Adolescent Medicine,” Journal of Adolescent Health 33, no. 5 (2003): 396-409, at 398. Here, the Society for Adolescent Medicine committee failed to distinguish between different types of capacities: the intellectual capacity to understand information versus the executive capacity to make a well informed and thought through mature decision.Google Scholar
See, for example, Applebaum, P., Lidz, C. and Meisel, A., Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 1987); President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions (3 vols.) (Washington, D.C.: US Government Printing Office, 1982); Faden, R. and Beauchamp, T. L., A History and Theory of Informed Consent (New York: Oxford University Press, 1986).Google Scholar
In Olmstead v. United States (1928), for example, Justice Louis Brandeis argued in a dissenting opinion that “The makers of our Constitution … sought to protect Americans in their beliefs, their thoughts, their emotions, and their sensations. They conferred, as against the Government, the right to be let alone — the most comprehensive of rights and the right most valued by civilized men.” Olmstead v. United States, 277 U.S. 438 (1928).Google Scholar
Justice Warren Burger argued in the minority opinion in In re President and Directors of Georgetown College, Inc. regarding Justice Brandeis's argument in Olmstead v. United States that “Nothing in the utterance suggests that Brandeis thought an individual possessed these rights only as to sensible beliefs, valid thoughts, reasonable emotions, or well-founded sensations. I suggest that he intended to include a great many foolish, unreasonable and even absurd ideas which do not conform such as refusing medical treatment even at great risk” (In re President and Directors of Georgetown College, Inc. 331 F.2nd 1000, 1017 [D.C. Cir.], cert. Denied, 337 U.S. 978 (1964).) See, generally, Cherry, M. J. and Engelhardt, H. T. Jr., “Informed Consent in Texas: Theory and Practice” Journal of Medicine and Philosophy 29, no. 2 (2004): 237-252.Google Scholar
Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 93, 133 N.Y.S. 1143 (1914).Google Scholar
Office of the Secretary, Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The Belmont Report, available at <www.hhs.gov/ohrp/humansubjects/guidance/belmont.html#xrespect> (last visited July 20, 2017).+(last+visited+July+20,+2017).>Google Scholar
Iltis, A., “Human Subjects Research: Ethics and Compliance,” in Iltis, A., ed., Research Ethics (New York: Routledge, 2006): 1-21, at 8.Google Scholar
See Cherry and Engelhardt, Jr., supra note 4.Google Scholar
United Nations Office of the High Commissioner for Human Rights, Convention on the Rights of the Child (New York: United Nations, 1990). The Ethics Working Group of the Confederation of European Specialists in Paediatrics argued, for example, that “[y]ounger children may, according to the laws of individual states, be able to consent to treatment especially if they have enough maturity and ability to understand the benefits and risks of the proposed treatment and its alternatives. The concept of a ‘mature minor’ has been introduced by some authorities to include groups of children whose age ranges in most EU countries from 14 to 18 years and who are often regarded as being mature enough to give their own consent to treatment. In some countries the age at which children are considered to be potentially competent is even lower. In some jurisdictions competent minors can give their consent without the involvement of parents, assuming the decision is beneficial for the adolescent and he/she does not want the parents involved. …In any case, doctors should always question themselves if the child is mature enough to give consent or assent.” De Lourdes-Levy, M., Larcher, V., Kurz, R., and Ethics Working Group of the CESP, “Informed Consent/Assent in Children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP),” European Journal of Pediatrics 162, no. 9 (2003): 629–633, at 631.Google Scholar
“Decision-making involving the health care of older children and adolescents should include, to the greatest extent feasible, the assent of the patient as well as the participation of the parents and the physician. Pediatricians should not necessarily treat children as rational, autonomous decision makers, but they should give serious consideration to each patient's developing capacities for participating in decision-making, including rationality and autonomy. … As children develop, they should gradually become the primary guardians of personal health and the primary partners in medical decision-making, assuming responsibility from their parents. Committee on Bio-ethics, American Academy of Pediatrics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 95, no. 2 (1995): 314-317, at 315.Google Scholar
“There is usually no chronological ‘age of consent’ for medical care, but a condition of consent, meaning capacity for understanding.” Dickens, B. M. and Cook, R. J., “Adolescents and Consent to Treatment,” International Journal of Gynaecology and Obstetrics 89, no. 2 (2005): 179-184, at 179.CrossRefGoogle Scholar
“A fundamental challenge in selecting an instrument is the lack of consistency across instruments in what is being measured, despite the use of similar labels for these constructs. Definitions of ‘reasoning’ vary from the ability to provide ‘rational reasons’ for one's choice to making the ‘reasonable’ choice in a given situation to the underlying cognitive processes used in reaching a decision.… Definitions and measurements of appreciation are also variable, with the focus ranging from appreciation of the consequences of a choice to acknowledgment of the presence of a disorder and its treatment potential to the absence of ‘patently false beliefs’ driving one's appreciation. Even the assessment of understanding varies from requiring simple repetition of the interviewer's words or the wording on a consent form to more detailed evaluations of deeper comprehension; it may also incorporate the person's ability to retain information.” Dunn, L., Nowrangi, M., Palmer, B., Jeste, D., and Saks, E., “Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments,” American Journal of Psychiatry 163, no. 8 (2006): 1323-1334, at 1331.CrossRefGoogle Scholar
Iltis, A., “Parents, Adolescents, and Consent for Research Participation,” Journal of Medicine and Philosophy 38, no. 3 (2013): 332-346, at 343.Google Scholar
See, e.g., Chan, R. C. K., Shum, D., Toulopoulou, T., and Chen, E. Y. H., “Assessment of Executive Functions: Review of Instruments and Identification of Critical Issues,” Archives of Clinical Neurophysiology 23, no. 2 (2008): 201-216; Gilbert, S. J. and Burgess, P. W., “Executive Function,” Current Biology 18, no. 3 (2008): R110—R114; Casey, B. J., Jones, R. M., and Hare, T. A., “The Adolescent Brain,” Annals of the New York Academy of Science 1124 (2008): 111-126.Google Scholar
See, e.g., Cherry, M. J., “Parental Authority and Pediatric Bio-ethical Decision Making,” Journal of Medicine and Philosophy 35, no. 5 (2010): 553-572; Cherry, M. J., “Ignoring the Data and Endangering Children: Why the Mature Minor Standard for Medical Decision Making must be Abandoned,” Journal of Medicine and Philosophy 38, no. 3 (2013): 315–331. The CDC estimates that nearly half of the approximately 20 million new sexually transmitted disease infections each year occur among the 15-24 year old age group. The Centers for Disease Control, “STDs Today,” Centers for Disease Control National Prevention Information Network (2013), available at <http://www.cdcnpin.org/scripts/std/std.asp#1> (last visited July 20, 2017).CrossRefGoogle Scholar
Casey, B. J., Jones, R. M., and Hare, T. A., “The Adolescent Brain,” Annals of the New York Academy of Science 1124, no. 1 (2008): 111-126, at 112.Google Scholar
American Psychological Association, “Amicus Curiae brief in Miller v. Alabama and Jackson v. Hobbs,” American Psychological Association (2012), at 25, available at <www.apa.org/about/offices/ogc/amicus/index-alpha.aspx> (last visited July 20, 2017).+(last+visited+July+20,+2017).>Google Scholar
See Casey et al., supra note 17; Monk, C. S., McClure, E. B., Nelson, E. E., Zarahn, E., Bilder, R. M., Leibenluft, E., Charney, D. S., Ernst, M., and Pine, D. S., “Adolescent Immaturity in Attention-Related Brain Engagement to Emotional Facial Expressions,” Neuroimage 20, no. 1 (2003): 420-428.CrossRefGoogle Scholar
Steinberg, L., “Does Recent Research on Adolescent Brain Development Inform the Mature Minor Doctrine?” Journal of Medicine and Philosophy 38, no. 3 (2013): 256-267, at 259.CrossRefGoogle Scholar
Id. (Steinberg); see also Figner, B., Mackinlay, R. J., Wilkening, F., and Weber, E. U., “Affective and Deliberative Processes in Risky Choice: Age Differences in the Columbia Card Task,” Journal of Experimental Psychology: Learning, Memory, and Cognition 35, no. 3 (2009): 709-730.Google Scholar
Id., at 259 (Steinberg).Google Scholar
Steinberg, L. and Cauffman, E., “Maturity of Judgment in Adolescence: Psychosocial Factors in Adolescent Decision-Making,” Law and Human Behavior 20, no. 3 (1996): 249-272.CrossRefGoogle Scholar
One study that is often cited in support of adolescent decision making capacity, for example, was structured around a set of hypothetical questions in a written survey. Subjects were presented with a variety of stories describing the subject as having been diagnosed with a medical or psychological problem. They were then presented with proposed interventions, together with the possible consequences of such treatment, including risks and benefits. Participants were asked to indicate which option they would choose. Weithorn concludes from this study that 14 year olds “did not differ significantly from the adults with respect to their consideration of key elements” (Weithorn, L. A., “Children's Capacities to Decide about Participation in Research,” IRB 5, no. 2 [1983]: 1-5, at 3) and thus that “normal adolescents ages 14 and older may be as capable as adults of making competent decisions about such participation, according to the more stringent legal standards of competency” (at 5). This study did not, however, distinguish between the intellectual and the affective components of medical decision making, nor did it test for effective personal agency. There are significant differences between being able to identify what one assumes to be the correct answer on a written survey and being able to make such a choice in real life, when the consequences actually apply to oneself and while under the influence of others.CrossRefGoogle Scholar
Dorn, L., Susman, E., and Fletcher, J., “Informed Consent in Children and Adolescents: Age, Maturation and Psychological State,” Journal of Adolescent Health 16, no. 3 (1995): 185-190; Koocher, G. P. and DeMaso, D. R., “Children's Competence to Consent to Medical Procedures,” Pediatrician 17, no. 2 (1990): 68–73.CrossRefGoogle Scholar
Iltis, A., “Human Subjects Research: Ethics and Compliance,” in Iltis, A. ed., Research Ethics (New York: Routledge, 2006): 1-21; Applebaum, P., Roth, L. H., and Lids, C. W., “The Therapeutic Misconception: Informed Consent in Psychiatric Research,” International Journal of Law and Psychiatry 5, nos. 3-4 (1982): 319-329; Applebaum, P., Roth, L. H., Lids, C. W., Benson, P., and Winslade, W., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report 12, no. 2 (1987): 20–24.Google Scholar
Blustein, J. and Moreno, J., “Valid Consent to Treatment and the Unsupervised Adolescent,” in Blustein, J., Levine, C., and Dubler, N. Neveloff, eds., The Adolescent Alone: Decision-Making in Health Care in the United States (New York: Cambridge University Press, 1999): at 100-110. See also the Society for Adolescent Medicine which argues: “The capacity of an individual adolescent (or adult) to provide informed consent is an empirical question. For adults we assume capacity unless we have evidence to the contrary; for children we assume the opposite. The Guidelines suggest that for research of low risk (e.g., confidential or anonymous survey research), capacity can be assumed based on the reasonable expectation of capacity for the group of adolescents to be studied. For research involving greater risk the Guidelines propose an individual assessment of capacity.” Society for Adolescent Medicine, “Guidelines for Adolescent Health Research: A Position Paper of the Society for Adolescent Medicine,” Journal of Adolescent Health 33, no. 5 (2003): 396–409, at 400.Google Scholar
See Cherry, M. J., “Financial Conflicts of Interest and the Human Passion to Innovate,” in Iltis, A. ed., Research Ethics (New York: Routledge, 2006): 147-164; Francis, L., “IRBs and Conflicts of Interest,” in Spece, R. G. Jr., Shimm, D. S., and Buchanan, A., eds., Conflicts of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): 418-436; Slater, E. E., “IRB reform,” New England Journal of Medicine 346, no. 18 (2002): 1402–1404.Google Scholar
See, e.g., Shah, S., Whittle, A., Wilfond, B., Gensler, G., and Wendler, D., “How do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?” JAMA 291, no. 4 (2004): 476-482; Resnik, D., “The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research,” Accountability in Research: Policies and Quality Assurance 24, no. 1 (2017): 1–29.CrossRefGoogle Scholar
45 CFR 46: §46.102, available at <www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.404> (last visited July 20, 2017).+(last+visited+July+20,+2017).>Google Scholar
Kopelman, L., “When Is the Risk Minimal Enough for Children to be Research Subjects?” in Kopelman, L. M. and Moskop, J. C. (eds.), Children and Health Care: Moral and Social Issues (Dordrecht: Kluwer Academic Publishers, 1989): 89-99, at 91.Google Scholar
See also, Binik, A. and Weijer, C., “Why the Debate over Minimal Risk Needs to Be Reconsidered,” Journal of Medicine and Philosophy 39, no. 4 (2014): 387-405; Wendler, D. and Shah, S., “Involving Communities in Deciding What Benefits They Receive in Multinational Research,” Journal of Medicine and Philosophy 40, no. 5 (2015): 584–600.CrossRefGoogle Scholar
For a good overview of the Richard Curtin case, see: Rubin, R., “Whose Medical History Is It, Anyway?” USA Today, April 8, 2001, available at <http://usatoday30.usatoday.com/news/health/2001-04-08-privacy.htm> (last visited July 20, 2017).+(last+visited+July+20,+2017).>Google Scholar
See 45CFR46 subpart D, section 408.a.Google Scholar
45CFR46.402b.Google Scholar
See, e.g., Cubit, K., “Informed Consent for Research Involving People with Dementia: A Grey Area,” Contemporary Nurse 34, no. 2 (2010): 230-236; High, D. M., “Research with Alzheimer's Disease Subjects: Informed Consent and Proxy Decision Making,” Journal of the American Geriatrics Society 40, no. 9 (1992): 950–957.CrossRefGoogle Scholar
Iltis, A., “Risk-Taking: Individual and Family Interests,” Journal of Medicine and Philosophy 40, no. 4 (2015): 437-450.CrossRefGoogle Scholar
Parental authority, including consent to medical treatment, is coupled with responsibility. The parents who are authorizing treatment are also those individuals who are usually obliged to pay for such care. Some states with legislation permitting so-called mature adolescents to consent to health care on their own behalf have corresponding legislation absolving parents of financial responsibility for care that is provided without their consent. “The 2 predominant rationales for parents' constitutional decision-making rights are that parents are most likely among the potential proxies to make decisions in children's best interests and that they deserve these rights as a quid pro quo for taking on the responsibilities, including the financial responsibilities, of childrearing. In this quid pro quo context, if the decision-making right is taken away, the corollary is that responsibility for the decision is also taken away. … in these states, the mature minor exception ensures that physicians and any health care facility in which the service is provided will not be liable for failure to obtain parental consent, but it does not provide the basis for recovery of fees and costs from parents.” Coleman, D. Lambelet and Rosoff, P. M., “The Legal Authority of Mature Minors to Consent to General Medical Treatment,” Pediatrics 131, no. 4 (2013): 790. See generally Davis, S. M., Scott, E. S., Wadlington, W., and Whitebread, C. H., Children in the Legal System: Cases and Materials, 4th ed. (New York: Foundation Press, 2009).Google Scholar
Coleman, D. Lambelet, “The Legal Ethics of Pediatric Research,” Duke Law Journal 57, no. 3 (2007): 517-624, at 547.Google Scholar
Rosato, J., “The Ethics of Clinical Trials: A Child's View,” Journal of Law, Medicine & Ethics 28, no. 4 (2000): 362-378; id. (Lambelet Coleman).CrossRefGoogle Scholar
Dornbusch, S. M., Ritter, P. L., Leiderman, P. H., Roberts, D. F., and Fraleigh, M. J., “The Relation of Parenting Style to Adolescent School Performance,” Child Development 58, no. 5 (1987): 1244-1257; Steinberg, L., Elmen, J., and Mounts, N., “Authoritative Parenting, Psychosocial Maturity, and Academic Success among Adolescents,” Child Development 60, no. 6 (1989): 1424–1236; Steinberg, L., Lamborn, S., Dornbusch, S., and Darling, N., “Impact of Parenting Practices on Adolescent Achievement: Authoritative Parenting, School Involvement, and Encouragement to Succeed,” Child Development 63, no. 5 (1992): 1266–1281.Google Scholar
Kopelman, L., “When Should Research with Infants, Children, or Adolescents Be Permitted?” in Iltis, A., ed., Research Ethics (New York: Routledge, 2006): at 121-131. See also DeGrazia, D., Groman, M., and Lee, L. M., “Defining the Boundaries of a Right to Adequate Protection: A New Lens on Pediatric Research Ethics,” Journal of Medicine and Philosophy 42, no. 2 (2017): 132–153; Goldschmidt, T., “Shifting the Focus while Conserving Commitments in Research Ethics,” Journal of Medicine and Philosophy 42, no. 2 (2017): 103–113; Wendler, D. and Wertheimer, A., “Why Is Coerced Consent Worse than no Consent and Deceived Consent?” Journal of Medicine and Philosophy 42, no. 2 (2017): 114-131; Press, J. K. and Rogers, C. J., “Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT,” Journal of Medicine and Philosophy 42, no. 2 (2017): 184–198.Google Scholar