POLICY STATEMENT Organizational Principles to Guide and Define the Child Health Care System and/or Improve the Health of all Children Informed Consent in Decision- Making in Pediatric Practice 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 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. INTRODUCTION This document is copyrighted and is property of the American Since the publication of previous American Academy of Pediatrics (AAP) Academy of Pediatrics and its Board of Directors. All authors have statements on informed consent in 1976 1 and 1995, 2 obtaining informed fi led confl ict of interest statements with the American Academy of Pediatrics. Any confl icts have been resolved through a process permission from parents or legal guardians before medical interventions approved by the Board of Directors. The American Academy of on pediatric patients has become standard within our medical and legal Pediatrics has neither solicited nor accepted any commercial culture. The 1995 statement also championed, as pediatrician William involvement in the development of the content of this publication. Bartholome stated, “the experience, perspective and power of children” Policy statements from the American Academy of Pediatrics benefi t from expertise and resources of liaisons and internal (American in the collaboration between pediatricians, their patients, and parents Academy of Pediatrics) and external reviewers. However, policy and remains an essential guide for modern ethical pediatric practice. 2 statements from the American Academy of Pediatrics may refl ect the views of the liaisons or the organizations or government agencies that As recommended in the 1995 publication, this revised statement affirms they represent. that patients should participate in decision-making commensurate The guidance in this statement does not indicate an exclusive course with their development; they should provide assent to care whenever of treatment or serve as a standard of medical care. Variations, taking reasonable. Pediatric decision-making continues to evolve in response into account individual circumstances, may be appropriate. to changes in information technology, scientific discoveries, and legal All policy statements from the American Academy of Pediatrics rulings. Continuing limits on the widespread use of pediatric assent/ automatically expire 5 years after publication unless reaffi rmed, revised, or retired at or before that time. refusal makes this review and restatement of AAP policy important. 3 DOI: 10.1542/peds.2016-1484 This policy statement provides a brief review of informed consent, PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). including the ethical and legal roots, frameworks for surrogate decision- Copyright © 2016 by the American Academy of Pediatrics making, and information on special issues in informed consent in pediatric care. Recommendations on informed consent or refusal, parental permission, and assent in clinical practice and research are summarized at the end of this statement. A more detailed review of To cite: AAP COMMITTEE ON BIOETHICS. Informed Consent pediatric consent and decision-making can be found in the accompanying in Decision-Making in Pediatric Practice. Pediatrics. 2016; 138(2):e20161484 technical report to this policy statement. 4 Downloaded from www.aappublications.org/news by guest on October 2, 2021 PEDIATRICS Volume 138 , number 2 , August 2016 :e 20161484 FROM THE AMERICAN ACADEMY OF PEDIATRICS PURPOSE OF INFORMED CONSENT TABLE 1 Elements of Informed Consent for Medical Decision-Making • Provision of information about the following: The current concept of informed o nature of the illness or condition consent in medical practice has roots o proposed diagnostic steps and/or treatments and the probability of their success within both ethical theory and law. o the potential risks, benefi ts, and uncertainties of the proposed treatment and alternative treatments, including the option of no treatment other than comfort measures The support for informed consent • Assessment of patient and surrogate understanding and medical decision-making capacity, including in ethical theory is most commonly assurance of time for questions by patient and surrogate found in the concept of autonomy. • Ensure that there is voluntary agreement with the plan The legal concept of informed consent has its roots in case law addressing issues of battery and TABLE 2 Practical Aspects of Assent by Pediatric Patients for Medical Decision-Making medical malpractice. The law has • Help the patient achieve a developmentally appropriate awareness of the nature of his or her condition evolved to require a full disclosure • Tell the patient what he or she can expect with tests and treatments to the patient of the facts necessary • Make a clinical assessment of the patient’s understanding of the situation and the factors infl uencing to form the basis of a reasonable, how he or she is responding (including whether there is inappropriate pressure to accept testing or therapy) informed consent. Informed consent • Solicit an expression of the patient’s willingness to accept the proposed care incorporates 3 duties: disclosure of information to patients and their surrogates, assessment of patient language during discussions with that challenges obtaining assent and surrogate understanding of minors, and information must be at younger ages. Alternatively, a the information and their capacity provided in a manner that respects developmental approach to assent for medical decision-making, and the cognitive abilities of the child anticipates different levels of obtaining informed consent before or adolescent. Clinicians should understanding from children as they treatments and interventions. use these opportunities to elicit age. 6 At a minimum, assent should information regarding their pediatric include the elements listed in Table This background helps us understand patient’s value-based treatment 2. Note that one should not solicit the conceptual difficulties goals and to assess whether there is a child’s assent if the treatment or encountered in trying to apply the adequate capacity for understanding intervention is required to satisfy framework of informed consent in and decision-making. Only patients goals of care agreed on by the the pediatric setting, in which most who have appropriate decisional physician and parent or surrogate, patients either lack the ability to capacity and who meet legal but the patient should be told that act independently or have limited requirements can give their informed fact and should not be deceived. or no capacity for medical decision- consent to medical care. Parents or Providing disclosure of appropriate making. Nevertheless, the goals of the other surrogates technically provide diagnostic and treatment information informed consent process (protecting “informed permission” for diagnosis and allowing choices about aspects and promoting health-related and treatment, with the assent of the of care, when possible, should be a interests and incorporating the child whenever appropriate. 2 When consistent part of the care plan for patient and/or the family in health defined as agreement with proposed children. care decision-making) are the same interventions, assent from children in the pediatric and adult population even as young as 7 years can foster Completely voluntary choice in and are grounded by the same ethical the moral growth and development treatments may be illusory in principles of beneficence, justice, and of autonomy in young patients. 2, 5 –7 general, but is particularly so in respect for autonomy. This consideration is based on pediatric care. Clinicians should be an understanding that, starting aware that parental decision-making FRAMEWORK FOR INFORMED around 7 years of age, children enter can be influenced by the quality of CONSENT/PERMISSION/ASSENT the concrete operations stage of the clinician-patient relationship, Knowledge about a medical condition development, allowing for limited previous medical knowledge, is critical to making informed health logical thought processes and emotional distress, faith, and critical 12 care decisions. Informed consent the ability to develop a reasoned changes in a child’s health status. 8–11 regarding medical care must decision. Decision-making by children and consistently incorporate several key adolescents is usually influenced components (see Table 1). A stricter interpretation of assent by their parents’ point of view requires that the minor meet and may not be entirely voluntary Pediatricians should be adept at all of the elements of an adult or autonomous. Unless there is using developmentally appropriate informed consent, a requirement significant coercion perceived Downloaded from www.aappublications.org/news by guest on October 2, 2021 2 FROM THE AMERICAN ACADEMY OF PEDIATRICS TABLE 3 Standards for Surrogate Decision-Making in Pediatrics Best-interest standard Surrogate should aim to maximize benefi ts and minimize harms to the patient, while using a holistic view of the patient’s interests Harm principle Identify a harm threshold below which parental decisions will not be tolerated Constrained