Guidelines for Adolescent Health Research*1, *2A position paper of the Society for Adolescent Medicine

Abstract

Research is essential to advance health. Participation by specific populations in health research is critical in order for those populations to receive the full benefits of research. Owing to uncertainty about the legal and ethical status of adolescent involvement in research, adolescents are frequently excluded from research that is needed to improve adolescent health care and to inform health policy. Individual adolescents and adolescents as a class of persons may benefit from research; as such, their inclusion in research is essential if adolescents are to fully benefit from research.Protection of adolescents in research should be based on a scientific and empathetic understanding of their developing capabilities and a careful assessment of the risks and benefits of including them. The important roles of parents and communities as protectors of adolescents should be respected and enhanced at the same time as we acknowledge and respect developing adolescent autonomy. The Guidelines for Adolescent Health Research, a consensus product of numerous professional experts and groups that was written in the early 1990s, [1Anonymous. Guidelines for Adolescent Health Research. J Adolesc Health 1995;17:264–9Google Scholar] provides a framework to interpret the federal regulations for protection of human subjects in light of the unique legal, ethical, developmental, contextual, and cultural issues that affect adolescents. The Guidelines are designed to protect individual adolescent research subjects and to promote the inclusion of youth in research that may benefit all adolescents. In revising this Position Paper, we have not revised the 1995 Guidelines for Adolescent Health Research, believing they remain a clear statement regarding the appropriate inclusion of adolescents in health research.Since the Guidelines were published in 1995, the field of research ethics has seen several important developments, many of them directly affecting adolescents. Requirements for broader inclusion in research have emerged at the same time as demands have been made for more rigorous protection of research subjects. Specific developments affecting adolescents include the issuance in 1998 by the National Institutes of Health (NIH) of a policy requiring appropriate inclusion of children in research, the adoption of similarly motivated policies at the Food and Drug Administration (FDA), the promulgation of new regulations concerning the privacy of personal health information (known as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule), and the FDA's adoption of revised regulations concerning children and adolescents (who may be considered children). These changes affect the appropriate involvement of adolescents in research and thus bear on the potential to improve adolescent health.Adolescent health and adolescent health researchNumerous national commissions, panels, and reports have articulated their great concern about adolescent health and the urgent need for research that can guide interventions and inform public policy in this area [2U.S. Congress, Office of Technology AssessmentAdolescent Health-Volume I Summary and Policy Options. U.S. Government Printing Office, Washington, DC1991Google Scholar, 3National Commission on the Role of the School and the Community in Improving Adolescent Health. Code Blue: Uniting for Healthier Youth. City, state: National Association of State Boards of Education and American Medical Association, 1991Google Scholar, 4Task Force on Education of Young Adolescents. Turning Points: Preparing American Youth for the 21st Century. Washington, DC: Carnegie Council on Adolescent Development, Carnegie Corporation of New York, 1989Google Scholar, 5National Commission on AIDSPreventing HIV/AIDS in Adolescents. National Commission on AIDS, Washington, DC1993Google Scholar, 6National Research Council (Miller HG, Turner CF, Moses LE, editors). AIDS: The Second Decade. Washington, DC: National Academy Press, 1990Google Scholar, 7Moolchan E.T. Mermelstein R. Research on tobacco use among teenagers Ethical challenges.J. Adolesc Health. 2002; 30: 409-417Abstract Full Text Full Text PDF PubMed Scopus (67) Google Scholar]. Violence, human immunodeficiency virus (HIV) infection and other sexually transmitted diseases (STDs), alcohol and other drug use, and unintended pregnancy pose continuing and serious challenges to the health and well-being of youth in communities across the country. Many potentially deleterious health behaviors begin in adolescence, including sexual activity, smoking and alcohol consumption, illicit drug use, interpersonal violence, and behaviors that cause unintentional injuries. The timing of pubertal development also affects adolescent health behaviors and health status; an historic decline in the age of puberty has been accompanied by social pressures for extended schooling and delayed marriage.Research with adolescents has produced important benefits for this population in recent years, with significant insights emerging about the ways in which adolescents differ from both children and adults. For example, differences between pediatric and adult patient populations are substantial in drug elimination and therapeutic response [8Milsap RL, Hill MR, Szefler SJ. Special pharmacokinetic considerations in children. In: Evans WE, Schentag JJ, Jusko WJ (eds). Applied Pharmacokinetics. 3rd edition. Vancouver, WA: Applied Therapeutics, 1992:***–***Google Scholar]. In addition, studies of the Human Papillomavirus have demonstrated an unexpectedly high prevalence in sexually experienced adolescents and have informed clinical practice in screening for cervical cancer [9Rosenfeld W.D. Vermund S.H. Wentz S.J. Burk R.D. High prevalence rate of human papillomavirus infection and association with abnormal smears in sexually active adolescents.Am J Dis Child. 1989; 143: 1443-1447PubMed Google Scholar, 10Moscicki A.B. Ellenberg J.H. Vermund S.H. et al.Prevalence of and risks for cervical human papillomavirus infection and squamous intra-epithelial lesions in adolescent women Impact of infection with human immunodeficiency virus.Arch Pediatr Adolesc Med. 2000; 154: 127-134Crossref PubMed Scopus (104) Google Scholar, 11Crowley-Nowick P.A. Ellenberg J.H. Vermund S.H. et al.Cytokine profile in genital tract secretions from female adolescents Impact of human immunodeficiency virus, human papillomavirus, and other sexually transmitted pathogens.J Infect Dis. 2000; 181: 939-945Crossref PubMed Scopus (69) Google Scholar]. Research into adverse pregnancy outcomes (e.g., low birth weight, infant mortality) of young adolescents has demonstrated that these outcomes are related to social deficits and not age or physical maturity and that comprehensive prenatal care can address these deficits and improve outcomes [12Strobino DM. The health and medical consequences of adolescent sexuality and pregnancy: A review of the literature. In: Hayes CD, Hofferth SL (eds). Risking the Future: Adolescent Sexuality, Pregnancy and Childbearing: Working Papers and Statistical Appendices. Vol. II. Washington, DC: National Academy Press, 1987:888–***Google Scholar, 13Korenbrot C.C. Showstack J. Loomis A. Brindis C. Birth weight outcomes with case management in a teenage pregnancy program.J Adolesc Health Care. 1989; 10: 97-104Abstract Full Text PDF PubMed Scopus (27) Google Scholar]. Finally, research on school and community health education has documented an evolution in program efficacy over the past 25 years; from this research have emerged principles for effective prevention that can be incorporated into programs to prevent HIV infection, other STDs, and unintended pregnancy among teens [14Kirby D. Emerging Answers: Research Findings on Programs to Reduce Teen Pregnancy. The National Campaign to Prevent Teen Pregnancy, Washington, DC2001Google Scholar, 15DiClemente R.J. Preventing HIV/AIDS among adolescents. Schools as agents of behavior change.JAMA. 1993; 270: 760-762Crossref PubMed Scopus (36) Google Scholar].Unfortunately, the successes of research involving adolescents are often overshadowed by persisting gaps in knowledge. For example, significant deficits remain in our knowledge of the effects of puberty on a drug's action or elimination [16Rogers A.S. A research agenda for the study of therapeutic agents in adolescents.J Adolesc Health. 1994; 15: 672-678Abstract Full Text PDF PubMed Scopus (7) Google Scholar]. In addition, the optimal design of clinical preventive services for adolescents is limited by a lack of health service research data [17Elster A.B. Kuznets N.J. AMA Guidelines for Adolescent Preventive Services (GAPS): Recommendations and Rationale. Williams and Wilkins, Baltimore, MD1993Google Scholar]. Furthermore, significant gaps remain in the knowledge needed to create effective HIV prevention for gay and bisexual youth, who are often at exceptionally high risk [18Wilson C.M. Houser J. Partlow C. et al.Adolescent Medicine HIV/AIDS Research Network, The REACH Project (Reaching for Excellence in Adolescent Care and Health): Study design, methods, and population profile.J Adolesc Health. 2001; 29: 8-18Abstract Full Text Full Text PDF PubMed Scopus (92) Google Scholar]. Prevention of delinquency and violence [19DuRant R.H. Pendergrast R.A. Cadenhead C. Exposure to violence and victimization and fighting behavior by urban black adolescents.J Adolesc Health. 1994; 15: 311-318Abstract Full Text PDF PubMed Scopus (126) Google Scholar] and treatment for mental health problems have also been hindered by a dearth of research to guide interventions that will help young people successfully navigate the difficult and sometimes deadly challenges to their future health and productivity [20Levine C. Children in HIV/AIDS clinical trials Still vulnerable after all these years.Law Med Health Care. 1991; 19: 231-237PubMed Google Scholar]. Equally disconcerting is the paucity of information about the factors that support the resiliency of adolescents against psychosocial risks or about how to disseminate successful model programs in prevention to other communities [21DuRant R.H. Cadenhead C. Pendergrast R.A. et al.Factors associated with the use of violence among urban black adolescents.Am J Public Health. 1994; 84: 612-617Crossref PubMed Scopus (407) Google Scholar, 22Rutter M. Psychosocial resilience and protective mechanisms.Am J Orthopsychiatry. 1987; 57: 316-331Crossref PubMed Scopus (2867) Google Scholar, 23Resnick M.D. Bearman P.S. Blum R.W. et al.Protecting adolescents from harm Findings from the National Longitudinal Study of Adolescent Health.JAMA. 1997; 278: 823-832Crossref PubMed Google Scholar].Although numerous threats to adolescent health continue to be evident, the ability to conduct research with adolescents remains difficult. A critical problem is the difficulty that researchers and Institutional Review Boards (IRBs) have with interpreting the federal regulations as they apply to research involving adolescents. Not surprisingly, adolescents as a class have often been excluded from participation in clinical trials, studies in public health prevention, and other critical research efforts from which this age group would benefit [24Rogers A.S. D'Angelo L. Futterman D. Guidelines for adolescent participation in research Current realities and possible resolutions.IRB. 1994; 16: 1-6Crossref PubMed Scopus (36) Google Scholar, 25Select Committee on Children, Youth, and Families, US House of RepresentativesA Decade of Denial Teens and AIDS in America. U.S. Government Printing Office, Washington, DC1992Google Scholar, 26Levine C. Dubler N.N. Levine R.J. Building a new consensus Ethical principles and policies for clinical research on HIV/AIDS.IRB. 1991; 13: 1-17Crossref PubMed Scopus (57) Google Scholar]. The result is that treatment options and the design of interventions for adolescents must often be extrapolated from studies involving either children or adults [26Levine C. Dubler N.N. Levine R.J. Building a new consensus Ethical principles and policies for clinical research on HIV/AIDS.IRB. 1991; 13: 1-17Crossref PubMed Scopus (57) Google Scholar, 27Grodin M.A. Alpert J.J. Children as participants in medical research.Pediatr Clin North Am. 1988; 35: 1389-1401PubMed Google Scholar]. The wisdom of this approach is suspect, because the period of adolescence is marked by significant changes in physical and psychosocial development that set adolescents apart from their younger and older counterparts. Adults are often uncomfortable dealing with adolescents and their health issues. As such, research agendas are often vulnerable to the influence of political currents. [25Select Committee on Children, Youth, and Families, US House of RepresentativesA Decade of Denial Teens and AIDS in America. U.S. Government Printing Office, Washington, DC1992Google Scholar, 28Gardner W. Wilcox B.L. Political intervention in scientific peer review Research on adolescent sexual behavior.Am Psychol. 1993; 48: 972-983Crossref PubMed Scopus (33) Google Scholar].Researchers and IRBs have reported a wide variation in the interpretation of the federal regulations as they apply to research involving adolescents [29Mammel K.A. Kaplan D.W. Research consent by adolescent minors and institutional review boards.J Adolesc Health. 1995; 17: 322-329Google Scholar, 30Sieber J.E. Stanley B. Ethical and professional dimensions of socially sensitive research.Am Psychol. 1988; 43: 49-55Crossref PubMed Scopus (166) Google Scholar, 31Janofsky J. Starfield B. Assessment of risk in research on children.J Pediatr. 1981; 89: 842-846Abstract Full Text PDF Scopus (85) Google Scholar, 32Rogers A.S. Schwarz D.F. Weissman G. English A. Adolescent participation in clinical research Eleven sites, one common protocol, and Eleven IRBs.IRB. 1999; 21: 6-10Crossref PubMed Scopus (34) Google Scholar]. Interpretations have been particularly disparate with respect to issues related to an adolescent's capacity to consent to research participation without parental permission, the protection of confidentiality for adolescent research participants, and the conduct of research that addresses “socially sensitive” subjects, such as illicit drug use, violence, and sexuality. These differences are not surprising, because the current federal regulations [33Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Code of Federal Regulations: Title 45-Public Welfare; Part 46: Protection of Human Subjects. November 13, 2001Google Scholar] do not specifically address the inherent differences between adolescents and children.Ethical principlesThe Belmont Report, published in 1978, provides the moral foundation for the ethical conduct of research in the United States, including current federal regulations and discussions about ethics conducted at IRB meetings [34The 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. Washington, DC: US Government Printing Office, DHEW Pub. No. (OS) 78-0012, 1978Google Scholar]. The 1999 Code of Research Ethics of the Society for Adolescent Medicine builds upon the ethical principles in the Belmont Report, recommending standards for the conduct of adolescent health researchers [35Society for Adolescent MedicineCode of Research Ethics A Position Paper of the Society for Adolescent Medicine.J Adolesc Health. 1999; 24: 277-282Abstract Full Text PDF PubMed Scopus (10) Google Scholar]. The Belmont Report emphasizes three basic ethical principles: respect for persons, beneficence, and justice. Respect for persons means treating a person as an autonomous being and not as a means to an end. Special protections are needed for groups with diminished autonomy. Beneficence is the ethical obligation to do good and to avoid harm; for research it means maximizing benefits and minimizing harm. Justice entails a fair distribution of the benefits and burdens of research; it also contains the notion that vulnerable persons should be protected from the burdens of research.With adolescents, respect for persons means balancing respect for the emerging capacity of an adolescent for independent decision-making with the need for continued special protections, where necessary. 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 (see “Adolescent development and capacity to consent to research participation” below.) 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.Beneficence provides an ethical basis for conducting research that may improve health and a basis for maximizing the benefit of research and minimizing its risk. Research with adolescents may have important benefits to individual adolescents, and it may benefit adolescents as a group as well. For example, research on school-based and clinical intervention programs to reduce HIV risk behaviors may benefit individual teens while also helping future generations of teenagers. On the other hand, survey research to understand adolescent HIV risk behaviors may have no immediate individual benefit but may benefit adolescents generally if the research is used to design more targeted or more effective intervention programs. Federal policies to extend the benefits of research to women, minorities, children, and adolescents by including them in studies are motivated by the principle of beneficence.The principle of justice demands a fair sharing of both risks and benefits. If certain groups of persons are systematically excluded from participation in research, these groups may not share in the beneficial results of that research. Promoting full participation by groups that historically have been excluded from research and its benefits is founded on the principle of justice. The interests of justice demand that adolescents not be exploited for the benefits of others, but also that adolescents not be excluded from participation in research that may have direct or indirect benefit. Recent research suggests that adolescents have often been excluded from participation in research, to the detriment of adolescents as a group [7Moolchan E.T. Mermelstein R. Research on tobacco use among teenagers Ethical challenges.J. Adolesc Health. 2002; 30: 409-417Abstract Full Text Full Text PDF PubMed Scopus (67) Google Scholar, 24Rogers A.S. D'Angelo L. Futterman D. Guidelines for adolescent participation in research Current realities and possible resolutions.IRB. 1994; 16: 1-6Crossref PubMed Scopus (36) Google Scholar, 25Select Committee on Children, Youth, and Families, US House of RepresentativesA Decade of Denial Teens and AIDS in America. U.S. Government Printing Office, Washington, DC1992Google Scholar, 26Levine C. Dubler N.N. Levine R.J. Building a new consensus Ethical principles and policies for clinical research on HIV/AIDS.IRB. 1991; 13: 1-17Crossref PubMed Scopus (57) Google Scholar, 36Bleyer WA, Tejeda H, Murphy SB, et al. National cancer clinical trials: Children have equal access; adolescents do not. J Adolesc Health 1997;366–73Google Scholar]. Recent federal policies regarding inclusion of women, minorities, and children, including adolescents, in NIH-supported research are also motivated by the ethical principle of justice [37National Institutes of Health. NIH Policy and Guidelines On The Inclusion Of Children As Participants In Research Involving Human Subjects. March 6, 1998. Available at: http://grants1.nih.gov/grants/guide/notice-files/not98-024.html. Accessed April 10, 2003Google Scholar].Legal contextAn important context for these Guidelines is the legal status of children and adolescents [38Glantz L.H. The law of human experimentation with children.in: Grodin M.A. Glantz L.H. Children as Research Subjects Science, Ethics, and Law. Oxford University Press, New York1994: 103-130Google Scholar]. The legal status of children has evolved from that of property (chattel) under traditional English common law to persons with limited autonomy [27Grodin M.A. Alpert J.J. Children as participants in medical research.Pediatr Clin North Am. 1988; 35: 1389-1401PubMed Google Scholar]. The “personhood” of children was recognized implicitly by states as they enacted child abuse reporting laws and medical consent laws during the 1960s and explicitly by the United States Supreme Court in the 1967 decision In re Gault, which extended the due process protection of the Fourteenth Amendment to children as well as adults. These legal changes acknowledge that there is not always a congruence of interests among children, their parents, and the state. These legal changes seek to protect the welfare of children and adolescents [39Melton G.B. Children's rights Where are the children?.Am J Orthopsychiatry. 1982; 52: 530-538Crossref PubMed Scopus (16) Google Scholar].Limited autonomy for adolescents who are minors includes both the right to consent to disease-specific medical care and to privacy during the course of that treatment. Beginning in the 1960s, laws in many states began to accord minors the right to consent to emergency care and to medical treatment of conditions such as pregnancy, STDs, and drug, alcohol, and mental health problems [40Holder A.R. Legal issues in adolescent sexual health.Adolesc Med: STAR. 1992; 3: 257-268PubMed Google Scholar, 41English A. Treating adolescents Legal and ethical considerations.Med Clin North Am. 1990; 74: 1097-1112PubMed Google Scholar, 42English A. Matthews M. Palamountain C. et al.State Minor Consent Statutes A summary. National Center for Youth Law, San Francisco1995Google Scholar, 43English A. Morreale M. A legal and policy framework for adolescent health care Past, present, and future.Houston J Health Law Policy. 2001; 1: 63-108Google Scholar]. Similarly, state laws have recognized the right of minors with a certain status, such as “mature” or emancipated minors (including those who are married or in military service) to consent to their own care [40Holder A.R. Legal issues in adolescent sexual health.Adolesc Med: STAR. 1992; 3: 257-268PubMed Google Scholar, 41English A. Treating adolescents Legal and ethical considerations.Med Clin North Am. 1990; 74: 1097-1112PubMed Google Scholar, 42English A. Matthews M. Palamountain C. et al.State Minor Consent Statutes A summary. National Center for Youth Law, San Francisco1995Google Scholar, 43English A. Morreale M. A legal and policy framework for adolescent health care Past, present, and future.Houston J Health Law Policy. 2001; 1: 63-108Google Scholar]. Other minors authorized to consent may include those who are parents, are living independently of their own parents, have graduated from high school, or have reached a specific age [42English A. Matthews M. Palamountain C. et al.State Minor Consent Statutes A summary. National Center for Youth Law, San Francisco1995Google Scholar].In addition to the explicit state statutes, minors' autonomy in health care decision-making and privacy has been protected in federal law. In Planned Parenthood of Missouri v. Danforth, 1976, Carey v. Population Services International, 1977, and Belloti v. Baird, 1979, and a long line of other cases, the United States Supreme Court recognized that the constitutional right of privacy protects minors as well as adults, particularly for reproductive health care, including contraceptives and abortion, albeit with some limitations related to abortion that do not apply in the case of adults [44Melton G.B. Ethical and legal issues in research and intervention.J Adolesc Health Care. 1989; 10: 36S-44SPubMed Google Scholar, 45English A. Adolescent reproductive health services for adolescents: Critical legal issues. Obstet Gynecol Clin North Am 2000;27195–211Google Scholar]. Federal law has also provided confidentiality protection for family planning and drug and alcohol treatment services to minors [45English A. Adolescent reproductive health services for adolescents: Critical legal issues. Obstet Gynecol Clin North Am 2000;27195–211Google Scholar, 46Gans J. Policy Compendium on Confidential Health Services for Adolescents. American Medical Association National Coalition on Adolescent Health, Chicago1993Google Scholar].Most recently, the federal government has promulgated broad medical privacy regulations, the HIPAA Privacy Rule, which provides confidentiality protection for the health care information of adolescents as well as adults and younger children [47Department of Health and Human Services. Standards for Privacy of Individually Identifiable Health Information; Final Rule. 65 Fed. Reg. 82462 (2000); 67 Fed. Reg. 53182 (2002) (to be codified at 45 CFR Parts 160 and 164)Google Scholar]. The HIPAA rules contain important provisions that affect the conduct of research and adolescent health researchers must understand and comply with these [48Department of Health and Human Services. Protecting personal health information in research — Understanding the HIPAA Privacy Rule. Department of Health and Human Services. Washington, DC: Department of Health and Human Services, 2003Google Scholar]. The HIPAA Privacy Rule treats adolescents who are minors as individuals who can exercise rights under the rules if they are allowed, by state or other law, to consent for their own care. With respect to the specific issue of disclosure of information to parents and parents' access to protected records, the HIPAA Privacy Rule defers to the provisions of state and other law. If state or other law is silent, the Rule defers to the discretion of health care professionals to determine whether information should be accessible to parents [49Department of Health and Human Services. Standards for Privacy of Individually Identifiable Information; Final Rule, 67 Fed. Reg. 53267 (2002) (to be codified at 45 CFR 164.502(g)(3))Google Scholar].Importantly, only a few states have laws that directly address the involvement of adolescents in research. A review by CDC (Marjorie Speers, personal communication from , formerly Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention, September 5, 2002.) found just four states with statutes that address the participation of minors who are adolescents in research, and these statutes generally deal with some limited aspect of research. The definition of “children” in the federal regulations (which includes adolescents who are minors) specifically references state laws (i.e., “the law of the jurisdiction” in which the research is conducted) on treatment for health care and the age at which an individual can independently consent under these laws to specific treatment or care. Relevant state laws include those addressing age of majority, emancipation status, age to consent for general medical care, and care of minors for specific conditions based on their own consent, discussed above. Researchers in adolescent health need to be cognizant of their own state's law regarding age of majority and emancipation, as well as with minor consent statutes.An ethical basis for these developments in the legal status of children and adolescents can be found in the principle of beneficence. These changes primarily reflect a concern for the health and well-being of children and adolescents, recognizing that it is preferable to provide necessary treatment to an adolescent minor on a confidential basis, independent of involving a parent, than to insist on parental involvement and risk the adolescent's refusal to seek care. Moreover, these legal developments implicitly recognize that under certain circumstances minors are capable of making independent judgments and that this emerging capacity should be respected.Adolescent development and capacity to consent for research participationUnderstanding the emerging capacity of adolescents to provide informed consent is essential to considering their participation in research. The ethical principle of respect for persons demands attention to this emerging capacity. Growth into adolescence is marked by an increasing capacity to make independent and intelligent decisions, and developmental psychologists recognize emerging cognitive abilities (i.e., changes in the ability of the human organism to understand increasingly complex and abstract concepts) [50Leikin S.L. An ethical issue in biomedical research The involvement of minors in informed and third party consent.Clin Res. 1983; 31: 34-40PubMed Google Scholar, 51Weithorn L.A. Children's capacities to decide about participation in research.IRB. 1983; 5: 1-5Crossref PubMed Scopus (59) Google Scholar]. Research ethicists have recognized a related concept, capacity, the ability to provide informed consent (i.e., to appreciate the risks and benefits of participation in research activities and to make reasoned choices) [50Leikin S.L. An ethical issue in biomedical research The involvement of minors in informed and third party consent.Clin Res. 1983; 31: 34-40PubMed Google Scholar, 51Weithorn L.A. Children's capacities to decide about participation in research.IRB. 1983; 5: 1-5Crossref PubMed Scopus (59) Google Scholar]. Capacity is linked to both developing cognition [50Leikin S.L. An ethical issue in biomedical research The involvement of minors in informed and third party consent.Clin Res. 1983; 31: 34-40PubMed Google Scholar] and previous life experiences. Lack of experience with decision-making in real-world situations may reduce adolescent capacity. Conversely, ad