Hostname: page-component-78c5997874-xbtfd Total loading time: 0 Render date: 2024-11-02T23:39:50.536Z Has data issue: false hasContentIssue false
  • English
  • Français

Drawing the Line at Age 14: Why Adolescents Should Be Able to Consent to Participation in Research

Published online by Cambridge University Press:  01 January 2021

Robert Schwartz
Get access Rights & Permissions [Opens in a new window]

Abstract

This article argues that teenagers become fully capable of consenting to participation in most IRB-approved research involving human subjects at age 14, four years earlier than they are allowed to consent under virtually all states' laws, and, consequently, four years younger than they are able to consent under currently applicable federal regulations. In determining the age at which person is old enough to have decision-making authority, legal institutions look at the intellectual and emotional maturity of someone of the age of the decision-maker, the risks and benefits of allowing the decision to be made by someone of that age, and the risks and benefits of denying a person of that age the authority to make the decision. Given the high level of safety of participating in IRB approved research, the value of doing so for both the society and the teenage subject, and the psychological and neuropsychological research on the specific nature of emotional and intellectual development during the teen years, the balance comes out in favor of allowing younger teens, by the age of 14, authority to consent to participate as subjects in IRB approved research. The current process requiring both teen assent and parental permission should give way to a process that requires only a teen's consent.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue 3: Symposium - Controversies in Clinical Research Ethics , Fall 2017 , pp. 295 - 306
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

45 CFR 46.101-109, Additional Protections for Children Involved as Subjects of Research (2015). For a comprehensive and helpful analysis of the protection of children as research subjects, see Coleman, D., “The Legal Ethics of Pediatric Research,” Duke Law Journal 57, no. 3 (2007): 517-624.Google Scholar
This has been true at least since Schloendorff v. New York Hospital, 105 NE2d 92, at 93 (N.Y. App. 1914), and the requirement is affirmed by statute or common law in virtually every state. See Furrow, B. et al., Health Law Hornbook, 3d ed. (St. Paul, Minn.: West Academic, 2015): at 121.Google Scholar
Weithorn, L. and Campbell, S., “The Competency of Children and Adolescents to Make Informed Treatment Decisions,” Child Development 53, no. 6 (1982): 1589-1598.Google Scholar
See Kohlberg, L., Essays on Moral Development, Vol. I: The Philosophy of Moral Development (San Francisco: Harper & Row, 1981), and Piaget, J., “The Role of Action in the Development of Thinking,” in Knowledge and Development (Boston: Springer, 1977): at 17-42.Google Scholar
See the discussion below in “What the Supreme Court's Rulings in Roper and Its Progeny Teach about Adolescent Healthcare Decision Making.”Google Scholar
U.S. Const. Amend. viii.Google Scholar
See Mutcherson, K. M., “Minor Discrepancies: Forging a Common Understanding of Adolescent Competence in Healthcare Decision-Making and Criminal Responsibility,” Nevada Law Journal 6, no. 3 (2006): 927-965 (suggesting, “it is logical to conclude that the decision-making process in formal healthcare settings leads to better decisions that the law should support than is the case in the informal settings in which young people decide to participate in criminal activities”).Google Scholar
Id.Google Scholar
American Academy of Pediatrics, “Stages of Adolescence,” available at <https://www.healthychildren.org/English/ages-stages/teen/Pages/Stages-of-Adolescence.aspx> (last visited July 17, 2017).+(last+visited+July+17,+2017).>Google Scholar
See generally Coleman, D. and Rosoff, P., “The Legal Authority of Mature Minors to Consent to General Medical Treatment,” Pediatrics 131, no. 4 (2012): 786-793.CrossRefGoogle Scholar
See Furrow, B. et al., Health Law Hornbook (St. Paul, Minn.: West, 2015): Chapter 14, “Reproduction and Birth,” at 806-823.Google Scholar
“Informed Consent for Minors in Research Studies,” Johns Hopkins Medicine (May 2005), Office of Human Subjects Research — IRB, available at <http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/informed_consent_minors> (last visited July 17, 2017).+(last+visited+July+17,+2017).>Google Scholar
29 U.S. C. § 201 et seq., Fair Labor Standards Act of 1938.Google Scholar
Governors Highway Safety Association, “Highway Safety Laws by State,” State Laws and Funding, available at <http://www.ghsa.org/html/stateinfo/laws/> (last visited July 17, 2017).+(last+visited+July+17,+2017).>Google Scholar
Uniform Anatomical Gift Act (rev. 2006). See generally, Verheijde, J., Rady, M., and McGregor, J., “The United States Revised Uniform Anatomical Gift Act (2006): New Challenges to Balancing Patient Rights and Physician Responsibilities,” Philosophy, Ethics, and Humanities in Medicine 2(2007): 19-27.Google Scholar
N.M.Stat. Ann. 24-7-6.1 (2015).Google Scholar
There has been a policy debate in Colorado, for example, about whether medical marijuana patients between the ages of 18 and 21 should be the subject of special screening. See Fender, J., “Politics: Colorado Lawmakers Back Age Limits for Medical Pot Users,” Denver Post, March 29, 2010.Google Scholar
U.S. Const., Art. 1 Sec. 2.Google Scholar
42 U.S. Code § 300gg—14 (2015); Extension of dependent coverage.Google Scholar
U.S. Const., Art. 1 Sec. 3.Google Scholar
U.S. Const., Art. 2, Sec. 2.Google Scholar
Center for Disease Control and Prevention, “Teen Drivers: Get the Facts. Injury Prevention and Control: Motor Vehicle Safety,” available at <https://www.cdc.gov/motorvehiclesafety/teen_drivers/teendrivers_factsheet.html> (last visited July 17, 2017).+(last+visited+July+17,+2017).>Google Scholar
Id.Google Scholar
See Furrow, , supra note 11.Google Scholar
See Furow, , supra note 11, “Chapter 17: Regulation of Research Upon Human Subjects,” at 986-987.Google Scholar
Id.Google Scholar
45 CFR sec. 46.102 (a)(2015).Google Scholar
“Teaching the Responsible Conduct of Research in Humans,” Dr. Stanley G. Korenman M.D. and, 45 CFR sec. 50, 56.Google Scholar
45 CFR sec. 46.102(b), (c)(2015).Google Scholar
“Federal Policy for the Protection of Human Subjects (“Common Rule”), 45 CFR part 46C (2015).Google Scholar
45 CFR 46.405 (2015).Google Scholar
45 CFR 46.406 (2015).Google Scholar
45 CFR 46.407 (2015).Google Scholar
45 CFR 46.111(a) (2015).Google Scholar
Piaget, J., “The Role of Action in the Development of Thinking,” in Overton, W. and Gallagher, J. McCarthy, Knowledge and development (Boston: Springer, 1977): at 17-42.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Kohlberg, , supra note 4.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Roper v. Simmons, 543 U.S. 574 (2005), Amicus brief, American Psychological Association.Google Scholar
Blakemore, S.-J. and Robbins, T. W., “Decision-Making in the Adolescent Brain,” Nature Neuroscience 15, no. 9 (2012): 1184-1191; Weithorn, and Campbell, , supra note 3.CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
American Academy of Child & Adolescent Psychiatry, Facts for Family -- Teen Brain: Behavior, Problem Solving, and Decision Making No. 95 (2011).Google Scholar
See Weithorn, and Campbell, , supra note 3.Google Scholar
Id.Google Scholar
45 CFR 46.111, 46.116 (2015).Google Scholar
See Wendler, D. and Shah, S., “Should Children Decide Whether They Are Enrolled in Nonbeneficial Research?” American Journal of Bioethics 3, no. 4 (2003): 1-7.Google Scholar
Roper v. Simmons, 543 U.S. 574 (2005).Google Scholar
108 S.Ct. 2687 (1988)Google Scholar
122 S.Ct. 2242 (2002).Google Scholar
See Roper v. Simmons, supra note 55, at 1198.Google Scholar
Atkins v. Virginia, 536 U.S. 304 (2002).Google Scholar
Amicus brief, American Psychological Association, filed in Roper v. Simmons, 543 U.S. 574 (2005).Google Scholar
560 U.S. 48 (2010).Google Scholar
Id.Google Scholar
567 U.S. ____, 132 S. Ct. 2455(2012).Google Scholar
Id., at 2460.Google Scholar
Roper v. Simmons, supra note 55, at 1198.Google Scholar
Id.Google Scholar
Id. And see generally Mutcherson, supra note 7.Google Scholar
Thoughtful writers have suggested that society would benefit from treating those under 24 the way we now treat teenage offenders. See Farrington, D. P., Loeber, R., and Howell, J. C., “Young Adult Offenders: The Need for More Effective Legislative Options and Justice Processing,” Criminology and Public Policy 11 (2012): 729-750.CrossRefGoogle Scholar
122 S.Ct. 2242.Google Scholar
Roper v. Simmons, 543 U.S. 574 (2005), Amicus brief, American Psychological Association.Google Scholar