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Informed Consent in Decision- Making in Pediatric Practice Aviva L TECHNICAL REPORT Informed Consent in Decision- Making in Pediatric Practice Aviva L. Katz, MD, FAAP, Sally A. Webb, MD, FAAP, COMMITTEE ON BIOETHICS Informed consent should be seen as an essential part of health care abstract practice; parental permission and childhood assent is an active process that engages patients, both adults and children, in their health care. Pediatric practice is unique in that developmental maturation allows, over time, for increasing inclusion of the child’s and adolescent’s opinion in medical decision-making in clinical practice and research. This technical report, which accompanies the policy statement “Informed Consent in Decision- Making in Pediatric Practice” was written to provide a broader background on the nature of informed consent, surrogate decision-making in pediatric practice, information on child and adolescent decision-making, and special This document is copyrighted and is property of the American issues in adolescent informed consent, assent, and refusal. It is anticipated Academy of Pediatrics and its Board of Directors. All authors have fi led confl ict of interest statements with the American Academy that this information will help provide support for the recommendations of Pediatrics. Any confl icts have been resolved through a process included in the policy statement. approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication. The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking Since the publication of previous American Academy of Pediatrics into account individual circumstances, may be appropriate. 1 2 (AAP) statements on informed consent in 1976 and 1995, obtaining All clinical reports from the American Academy of Pediatrics informed permission from parents or legal guardians before medical automatically expire 5 years after publication unless reaffi rmed, revised, or retired at or before that time. interventions on pediatric patients is now standard within our medical and legal culture. The 1995 statement also championed, as pediatrician DOI: 10.1542/peds.2016-1485 William Bartholome stated, “the experience, perspective and power of PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). children” in the collaboration between pediatricians, their patients, and Copyright © 2016 by the American Academy of Pediatrics parents and remains an essential guide for modern ethical pediatric practice. 2 As recommended in the 1995 publication, the revised policy FINANCIAL DISCLOSURE: The authors have indicated they do not have a fi nancial relationship relevant to this article to 3 statement affirms that patients should participate in decision-making disclose. commensurate with their development; they should provide assent to care whenever reasonable. FUNDING: No external funding. Although some aspects of decision-making in pediatrics are evolving in POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential confl icts of interest to response to changes in information technology, scientific discoveries, and disclose. legal rulings, recent reports have noted that change can be slow. Despite the long-standing stance of the AAP that older children and adolescents should be involved in the medical decision-making and consent process, To cite: Katz AL, Webb SA, AAP COMMITTEE ON BIOETHICS. there still has not been widespread understanding and endorsement Informed Consent in Decision-Making in Pediatric Practice. Pediatrics. 2016;138(2):e20161485 among practitioners of the concept of pediatric assent or refusal. 4 – 6 Downloaded from www.aappublications.org/news by guest on September 30, 2021 PEDIATRICS Volume 138 , number 2 , August 2016 :e 20161485 FROM THE AMERICAN ACADEMY OF PEDIATRICS The discordance between current autonomy was shaped by events the non–health-related interests clinical practice and previously in the 20th century, such as the of their child or adolescent, with published guidance may reflect the distrust of the medical profession the pediatrician and the parents gradual evolution of change within after the Nuremburg trial of Nazi acting as “co-fiduciaries” for health the culture of medicine or perhaps doctors, widespread publicity matters. 10 This provides a conceptual suggests a need to build on the regarding research ethics violations, framework for moving the discussion discussion of informed consent, the turbulence of the civil rights from parental rights to parental assent, and refusal for children and and women’s rights movements, responsibility when considering adolescents. The purpose of this and the long-standing American pediatric medical decision-making technical report is to provide a firm characteristic of individualism. This and informed consent. grounding of the concept of informed long-standing American emphasis Appropriate decisional capacity consent, addressing both the legal on individualism correlated with an and legal empowerment are the and philosophical roots, to provide increased interest in and attention to determinants of decision-making information on a variety of standards the issue of informed consent. 8, 9 authority in medicine. A reliance on applicable for decision-making by Autonomy (from the ancient Greek individual liberties and autonomy surrogates for pediatric patients autos [self] and nomos [rule or in the pediatric patient is not and to discuss how issues of assent, law]) can be seen as derived from realistic or legally accepted, so refusal, and consent affect the care of Kantian moral philosophy, with key parents or other surrogates provide children and adolescents in a variety elements of liberty, the capacity “informed permission” for diagnosis of clinical and research settings. to live life according to your own and treatment, with the assent For purposes of this report, we will reasons and motives, and agency, of the child as developmentally define and use the following terms: a the rational capacity for intentional appropriate. 2 However, the goals pediatric patient or a minor who has action. A formulation of Kant’s of the informed consent process not reached the legal age of majority categorical imperative notes that we (protecting and promoting health- (in most states, 18 years of age) is are obliged to act out of fundamental related interests and incorporating a patient younger than 18 years; an respect for other persons by virtue the patient and/or the family in adolescent refers to a person in the of their personal autonomy. This health care decision-making) are transition between childhood and imperative forms the moral basis similar in the pediatric and adult adulthood, classically defined as 13 to respect others and ourselves as population and are grounded to 18 years of age; a child refers to moral equals and provides moral by the same ethical principles of a person from the ages of 1 through support for the concept of informed beneficence, justice, and respect 12 years; and an infant refers to a consent. Although many, if not most, for autonomy. As we will discuss person in the first year of life. patients in pediatric practice lack further, in pediatric care we often the agency required to be truly need to expand our understanding of autonomous agents, this framework autonomy to recognize the autonomy HISTORY AND NATURE OF INFORMED remains important in providing the of the family unit, allowing respect CONSENT background for continued respect of for both the privacy of the family their moral potential. unit, within limits, and parental The current concept of informed authority and responsibility for consent in medical practice has roots In pediatrics, the duties to protect medical decision-making. within both ethical theory and law. and promote health-related interests The support for informed consent of the child and adolescent by the Although the requirement of in ethical theory is most commonly physician are also grounded in the “simple” consent by patients for found in the concept of autonomy, fiduciary relationship (to act in surgical procedures dates back to the right of an autonomous agent the best interest of the patient and 18th-century English law, it was to make decisions as guided by subordinating one’s own interests) only in the 1950s that the American his or her own reason. 7 As a brief between the physician and patient, courts began to develop the doctrine description, informed consent but these duties may conflict with of true “informed” consent from incorporates 2 duties: disclosing the parent’s or patient’s wishes and patients through disclosure of facts information to patients and their set up tensions either within the by physicians. The term “informed surrogates and obtaining legal family or between the family and consent” is derived from the ruling in authorization before undertaking the physician. Most believe that Salgo v Leland Stanford Jr University any interventions. The historical parents have an ethically parallel Board of Trustees in 1957. 11 This shift in US medical practice from fiduciary obligation to protect and term was adopted verbatim from paternalism to respect for individual promote both the health-related and an amicus curiae brief filed by the Downloaded from www.aappublications.org/news by guest on September 30, 2021 e2 FROM THE AMERICAN ACADEMY OF PEDIATRICS American College of Surgeons: "A educational limitations, or language limitations
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