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.
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References
1.
“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 Health33, 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.
2.
See, for example, P.Applebaum, C.Lidz and A.Meisel, 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); R.Faden and T. L.Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986).
3.
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).
4.
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, M. J.Cherry and H. T.Engelhardt, Jr., “Informed Consent in Texas: Theory and Practice”Journal of Medicine and Philosophy29, no. 2 (2004): 237-252.
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Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 93, 133 N.Y.S. 1143 (1914).
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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).
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A.Iltis, “Human Subjects Research: Ethics and Compliance,” in A.Iltis, ed., Research Ethics (New York: Routledge, 2006): 1-21, at 8.
8.
See Cherry and Engelhardt, Jr., supra note 4.
9.
D. LambeletColeman and P. M.Rosoff, “The Legal Authority of Mature Minors to Consent to General Medical Treatment,”Pediatrics131, no. 4 (2013): 786-793, at 788. In the United States, the Supreme Court case that guides parental authority over medical decision making is Parham v. J.R.. This case addressed a challenge to Georgia state law permitting parents to commit unwilling minor children to the state mental institutions. The Court argued: “Our jurisprudence historically has reflected Western civilization concepts of the family as a unit with broad parental authority over minor children … Surely, this includes a ‘high duty’ to recognize symptoms of illness and to seek and follow medical advice. The law's concept of the family rests on a presumption that parents possess what a child lacks in maturity, experience, and capacity for judgment required for making life's difficult decisions. More important, historically it has recognized that natural bonds of affections lead parents to act in the best interests of their children. … The same characterization can be made for a tonsillectomy, appendectomy or other medical procedure. Most children, even in adolescence, simply are not able to make sound judgments concerning many decisions, including their need for medical care or treatment. Parents can and must make those judgments. … The fact that a child may balk at hospitalization or complain about a parental refusal to provide cosmetic surgery does not diminish the parent's authority to decide what is best for the child (Parham v. J.R., 422 US 584 (U.S. Supreme Court 1979), Chief Justice Burger for the majority, at 602-604). The Court recognized that its concept of the family rests on the presumption that “parents possess what a child lacks in maturity” and that parents “act in the best interests of their children.” Unfortunately, these are precisely the characteristics of the family and parental authority that advocates of so-called mature minor standards for decision-making seek to undermine. As argued, however, there are no good grounds for such a fundamental shift in law and public policy.
10.
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.”M.De Lourdes-Levy, V.Larcher, R.Kurz, 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 Pediatrics162, no. 9 (2003): 629-633, at 631.
11.
“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,”Pediatrics95, no. 2 (1995): 314-317, at 315.
12.
“There is usually no chronological ‘age of consent’ for medical care, but a condition of consent, meaning capacity for understanding.”B. M.Dickens and R. J.Cook, “Adolescents and Consent to Treatment,”International Journal of Gynaecology and Obstetrics89, no. 2 (2005): 179-184, at 179.
13.
“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.”L.Dunn, M.Nowrangi, B.Palmer, D.Jeste, and E.Saks, “Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments,”American Journal of Psychiatry163, no. 8 (2006): 1323-1334, at 1331.
14.
A.Iltis, “Parents, Adolescents, and Consent for Research Participation,”Journal of Medicine and Philosophy38, no. 3 (2013): 332-346, at 343.
15.
See, e.g., R. C.K. Chan, D.Shum, T. Toulopoulou, and E. Y. H.Chen, “Assessment of Executive Functions: Review of Instruments and Identification of Critical Issues,”Archives of Clinical Neurophysiology23, no. 2 (2008): 201-216; S. J.Gilbert and P. W.Burgess, “Executive Function,”Current Biology18, no. 3 (2008): R110—R114; B. J.Casey, R. M.Jones, and T. A.Hare, “The Adolescent Brain,”Annals of the New York Academy of Science1124 (2008): 111-126.
16.
See, e.g., M. J.Cherry, “Parental Authority and Pediatric Bio-ethical Decision Making,”Journal of Medicine and Philosophy35, no. 5 (2010): 553-572; M. J.Cherry, “Ignoring the Data and Endangering Children: Why the Mature Minor Standard for Medical Decision Making must be Abandoned,”Journal of Medicine and Philosophy38, 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).
17.
B. J.Casey, R. M.Jones, and T. A.Hare, “The Adolescent Brain,”Annals of the New York Academy of Science1124, no. 1 (2008): 111-126, at 112.
18.
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).
19.
See Casey et al., supra note 17; C. S.Monk, E. B.McClure, E. E.Nelson, E.Zarahn, R. M.Bilder, E.Leibenluft, D. S.Charney, M.Ernst, and D. S.Pine, “Adolescent Immaturity in Attention-Related Brain Engagement to Emotional Facial Expressions,”Neuroimage20, no. 1 (2003): 420-428.
20.
L.Steinberg, “Does Recent Research on Adolescent Brain Development Inform the Mature Minor Doctrine?”Journal of Medicine and Philosophy38, no. 3 (2013): 256-267, at 259.
21.
Id. (Steinberg); see also B.Figner, R. J.Mackinlay, F.Wilkening, and E. U.Weber, “Affective and Deliberative Processes in Risky Choice: Age Differences in the Columbia Card Task,”Journal of Experimental Psychology: Learning, Memory, and Cognition35, no. 3 (2009): 709-730.
22.
Id., at 259 (Steinberg).
23.
L.Steinberg and E.Cauffman, “Maturity of Judgment in Adolescence: Psychosocial Factors in Adolescent Decision-Making,”Law and Human Behavior20, no. 3 (1996): 249-272.
24.
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” (L. A.Weithorn, “Children's Capacities to Decide about Participation in Research,”IRB5, 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.
25.
L.Dorn, E.Susman, and J.Fletcher, “Informed Consent in Children and Adolescents: Age, Maturation and Psychological State,”Journal of Adolescent Health16, no. 3 (1995): 185-190; G. P.Koocher and D. R.DeMaso, “Children's Competence to Consent to Medical Procedures,”Pediatrician17, no. 2 (1990): 68-73.
26.
A.Iltis, “Human Subjects Research: Ethics and Compliance,” in A.Iltised., Research Ethics (New York: Routledge, 2006): 1-21; P.Applebaum, L. H.Roth, and C. W.Lids, “The Therapeutic Misconception: Informed Consent in Psychiatric Research,”International Journal of Law and Psychiatry5, nos. 3-4 (1982): 319-329; P.Applebaum, L. H.Roth, C. W.Lids, P.Benson, and W.Winslade, “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,”Hastings Center Report12, no. 2 (1987): 20-24.
27.
J.Blustein and J.Moreno, “Valid Consent to Treatment and the Unsupervised Adolescent,” in J.Blustein, C.Levine, and N. NeveloffDubler, 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 Health33, no. 5 (2003): 396-409, at 400.
28.
See M. J.Cherry, “Financial Conflicts of Interest and the Human Passion to Innovate,” in A.Iltised., Research Ethics (New York: Routledge, 2006): 147-164; L.Francis, “IRBs and Conflicts of Interest,” in R. G.Spece, Jr., D. S.Shimm, and A.Buchanan, eds., Conflicts of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): 418-436; E. E.Slater, “IRB reform,”New England Journal of Medicine346, no. 18 (2002): 1402-1404.
29.
See, e.g., S.Shah, A.Whittle, B.Wilfond, G.Gensler, and D.Wendler, “How do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?”JAMA291, no. 4 (2004): 476-482; D.Resnik, “The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research,”Accountability in Research: Policies and Quality Assurance24, no. 1 (2017): 1-29.
L.Kopelman, “When Is the Risk Minimal Enough for Children to be Research Subjects?” in L. M.Kopelman and J. C.Moskop (eds.), Children and Health Care: Moral and Social Issues (Dordrecht: Kluwer Academic Publishers, 1989): 89-99, at 91.
32.
See also, A.Binik and C.Weijer, “Why the Debate over Minimal Risk Needs to Be Reconsidered,”Journal of Medicine and Philosophy39, no. 4 (2014): 387-405; D.Wendler and S.Shah, “Involving Communities in Deciding What Benefits They Receive in Multinational Research,”Journal of Medicine and Philosophy40, no. 5 (2015): 584-600.
In three separate, but related, holdings the United States Supreme Court rejected the conclusion that adolescents are adult decision makers. The Court concluded that the available scientific evidence supports the conclusion that adolescents do not possess adult capacities for rational mature choice. In Roper v. Simmons 543 US (2005) the Court ruled capital punishment for juvenile offenders to be unconstitutional. Graham v. Florida 560 US 48 (2010) ruled unconstitutional a life sentence for non-homicide offenses, without the meaningful possibility of reform and parole to re-enter society, for juvenile offenders. And, Miller v. Alabama 567 US (2012) concluded that a mandatory life sentence without the possibility of parole was similarly unconstitutional for offenders younger than 18 years-of-age. The Court recognized that the ability of adolescents effectively and adequately to envisage the consequences of important decisions is limited by the turmoil of adolescence, immature emotional responses, and a relatively incomplete capacity to appreciate the consequences of choices that reach beyond the immediate future. In Roper, Justice Anthony Kennedy writing for the majority opinion concluded: “First, as any parent knows and as the scientific and sociological studies respondent and his amici cite tend to confirm, ‘[a] lack of maturity and an underdeveloped sense of responsibility are found in youth more often than in adults and are more understandable among the young. These qualities often result in impetuous and ill-considered actions and decisions.’ See Johnson, infra, at 367; see also Eddings, infra at 115-116 (‘Even the normal 16-year-old customarily lacks the maturity of an adult’).”Roper v. Simmons, 543 US (2005), at 569; citing Johnson v. Texas, 509 US 350, 359—62 (1993) and Eddings v. Oklahoma, 455 US 104, 110—12 (1982). He further argued that “The second area of difference is that juveniles are more vulnerable or susceptible to negative influences and outside pressures, including peer pressure. Eddings, supra, at 115 (‘[Y]outh is more than a chronological fact. It is a time and condition of life when a person may be most susceptible to influence and to psychological damage’). This is explained in part by the prevailing circumstance that juveniles have less control, or less experience with control, over their own environment.”Roper v. Simmons, 543 US (2005), at 569. As noted, these psychological observations are supported with neurophysiological imaging studies on the physical development of the adolescent brain that demonstrate the relative immaturity of the prefrontal cortex, the seat of executive function, as compared to the limbic system, the source of emotional and pleasure-oriented short-term response.
35.
See 45CFR46 subpart D, section 408.a.
36.
45CFR46.402b.
37.
See, e.g., K.Cubit, “Informed Consent for Research Involving People with Dementia: A Grey Area,”Contemporary Nurse34, no. 2 (2010): 230-236; D. M.High, “Research with Alzheimer's Disease Subjects: Informed Consent and Proxy Decision Making,”Journal of the American Geriatrics Society40, no. 9 (1992): 950-957.
38.
A.Iltis, “Risk-Taking: Individual and Family Interests,”Journal of Medicine and Philosophy40, no. 4 (2015): 437-450.
39.
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.”D. LambeletColeman and P. M.Rosoff, “The Legal Authority of Mature Minors to Consent to General Medical Treatment,”Pediatrics131, no. 4 (2013): 790. See generally S. M.Davis, E. S.Scott, W.Wadlington, and C. H.Whitebread, Children in the Legal System: Cases and Materials, 4th ed. (New York: Foundation Press, 2009).
40.
D. LambeletColeman, “The Legal Ethics of Pediatric Research,”Duke Law Journal57, no. 3 (2007): 517-624, at 547.
41.
J.Rosato, “The Ethics of Clinical Trials: A Child's View,”Journal of Law, Medicine & Ethics28, no. 4 (2000): 362-378; id. (Lambelet Coleman).
42.
S. M.Dornbusch, P. L.Ritter, P. H.Leiderman, D. F.Roberts, and M. J.Fraleigh, “The Relation of Parenting Style to Adolescent School Performance,”Child Development58, no. 5 (1987): 1244-1257; L.Steinberg, J.Elmen, and N.Mounts, “Authoritative Parenting, Psychosocial Maturity, and Academic Success among Adolescents,”Child Development60, no. 6 (1989): 1424-1236; L.Steinberg, S.Lamborn, S.Dornbusch, and N.Darling, “Impact of Parenting Practices on Adolescent Achievement: Authoritative Parenting, School Involvement, and Encouragement to Succeed,”Child Development63, no. 5 (1992): 1266-1281.
43.
L.Kopelman, “When Should Research with Infants, Children, or Adolescents Be Permitted?” in A.Iltis, ed., Research Ethics (New York: Routledge, 2006): at 121-131. See also D.DeGrazia, M.Groman, and L. M.Lee, “Defining the Boundaries of a Right to Adequate Protection: A New Lens on Pediatric Research Ethics,”Journal of Medicine and Philosophy42, no. 2 (2017): 132-153; T.Goldschmidt, “Shifting the Focus while Conserving Commitments in Research Ethics,”Journal of Medicine and Philosophy42, no. 2 (2017): 103-113; D.Wendler and A.Wertheimer, “Why Is Coerced Consent Worse than no Consent and Deceived Consent?”Journal of Medicine and Philosophy42, no. 2 (2017): 114-131; J. K.Press and C. J.Rogers, “Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT,”Journal of Medicine and Philosophy42, no. 2 (2017): 184-198.
