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 by guest on October 30, 2016 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 by guest on October 30, 2016 e2 FROM THE AMERICAN ACADEMY OF PEDIATRICS American College of Surgeons: "A educational limitations, or language limitations and generally not truly physician violates his duty to his barriers. available for thoughtful discussion patient and subjects himself to in the informed consent process. 13 Pediatricians should be adept at liability if he withholds any facts Transparency and honesty in explaining information to their young which are necessary to form the discussing provider experience with patients in an age-appropriate and basis of an intelligent consent… patients and families are critical, descriptive manner. This vital skill, if in discussing the element of risk a and there is case law on this issue, not a standard, enhances the assent certain amount of discretion must with the court finding that, in certain and permission process in pediatrics. be employed consistent with the full instances, physician-specific data Although the ability of the child disclosure of facts necessary to an may be material in allowing a fully or adolescent to provide assent or informed consent." informed consent.15 consent changes along with cognitive The judgment in this case identified development and maturation, Although informed consent is usually the need for a full disclosure of the disclosure of the medical condition thought of as linked to surgical or facts necessary to form an informed and the anticipated interventions invasive interventions in health consent. Later cases (Mitchell v in a developmentally appropriate care, the same process of disclosure Robinson, Natanson v Kline)8, 9 shaped manner demonstrates respect for of potential diagnosis, options for our modern understanding of the the patient’s emerging autonomy evaluation and treatment, likely required elements of disclosure and may help enhance cooperation outcomes, and potential associated during the consent process by with medical care. The pediatrician risks is also necessary to ensure that mandating disclosure of risks, the and pediatric medical subspecialist medical decision-making for routine nature of the medical condition, should have an understanding of the or noninvasive clinical treatments is details of the proposed treatment, the spectrum of intellectual disability transparent to patients and families. probability of success, and possible encountered in childhood and alternative treatments. The standard adolescence and should be prepared of what information must be included to provide the individualized support SEEKING INFORMED CONSENT in discussions leading to informed needed to maximize understanding of Knowledge about a medical condition consent or informed refusal of the disease process and therapeutic is critical to making informed health treatment has evolved over time and options. care decisions by and for adults, varies somewhat from state to state. 9 The content of the informed consent adolescents, children, and infants. discussion is closely linked with Informed consent is not satisfied by professional experience. Disclosure merely obtaining a signature on a THE PROCESS OF INFORMED CONSENT of risks may differ between form but is a process of dialog with Several different but common physicians in community and a patient about a planned course of standards for the physician’s academic settings, between younger action. The first part of that dialog disclosure obligation have emerged. and older physicians, or among those is determining whether the patient The professional community who perform minimally invasive and/or his or her family/surrogate standard defines adequate disclosure compared with open procedures. 12 are capable of understanding the by what the trained and experienced During disclosure to the patient and/ information one discloses. The physician tells his or her patient. or the surrogate regarding treatment terms “capacity” and “competence” The objective, reasonable person options, many believe it is important are frequently blurred in medical standard requires the physician for the physician to disclose his or discourse. Capacity is a clinical to disclose information that a her or the facility’s own experience determination that addresses the reasonable person in the patient’s with the proposed intervention and integrity of mental abilities, and condition would need and want to periprocedural complications. The competence is a legal determination know. 9 A small minority of states issue of disclosure of surgeon-specific that addresses society’s interest use the subjective standard of what outcome data has been addressed in restricting decision-making a particular patient would need to recently in the surgical literature. 13, 14 when capacity is in question. 16 know to make a decision to evaluate Although the potential advantages of Pediatricians can determine whether the extent of disclosure. Physicians this disclosure may include enhanced an adolescent is capable of making should make substantial efforts patient autonomy and understanding health care decisions, and the courts to craft disclosures that maximize during decision-making, some critics generally determine competence. understanding by all surrogates or contend the accuracy of surgeon- It is also important to understand patients regardless of developmental specific performance rates is often that an individual can still have maturity, severity of illness, illusory because of a variety of decision-making capacity while

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e3 being declared legally incompetent. 3. Because decisional capacity is a Patient or surrogate comprehension This situation is typically illustrated critical requirement in providing of procedural consent has been when an adult with newly diagnosed consent, the capacity of the patient reported to be <50% in the adult dementia is still able to participate and/or surrogate to make the surgical literature. 19 Similarly, and make health care decisions but necessary decisions should be studies of recall and comprehension is incompetent to manage financial assessed (often, assessment of the by parents and pediatric research affairs, as determined by the courts. capacity to make decisions and subjects after informed consent It is critical to recognize that capacity the understanding of the pertinent discussions reveal that parents is not an all-or-none phenomenon medical information occurs and subjects have far greater and is relatively task specific. simultaneously). understanding of their research A patient may have the capacity to rights than the clinical implications 4. There should be assurance, participate in certain areas of medical of the interventions. 20 New strategies insofar as is possible through decision-making but may not have to improve patient literacy and ongoing dialog, that the consent the capacity to contribute in more recall during consent are being is voluntary and that the patient complex discussions, such as end- developed and include multimedia and/or surrogate has the of-life decision-making. In addition, presentations, requirements for freedom to choose among the it is important to recognize that “repeat back” elements of the medical alternatives without neither capacity nor competence is proposed interventions, and trying undue influence, coercion, or permanent and may fluctuate over to increase the time spent in the manipulation. This condition time and should be reassessed over informed consent discussion. 19, 20 recognizes that we are all the course of illness, as indicated. subject to subtle pressures in How one shares this information is decision-making and that medical As informed consent and, more also crucial to building a successful, decision0making cannot occur in recently, assent in pediatrics have trusting relationship with children, isolation from other concerns and evolved over the 50 years since the adolescents, and their parents/ relationships. Salgo case, certain elements of the guardians and is critical to process listed as follows serve as the The process of informed consent achieving the goals of treatment. framework for conversations with requires participation by the The event model, in which discrete 2 our patients and their families. It is physician or health care provider interventions are seen as a one- vital that throughout the process, the of record. In teaching hospitals or shot encounter and patients and health care professional understands clinics, it is ethically and legally their surrogates are left to accept or that providing information and inappropriate to permit medical reject a physician-formulated plan, obtaining permission, consent, or students to obtain informed consent is inferior to the process model, in assent are 2 different, although from parents or patients without the which medical decision-making is a linked, functions. support and involvement of more longitudinal process over time, with 1. Provision of information: patients senior, knowledgeable staff. Medical information shared between the 9 and their surrogates should students lack the comprehensive physician and the patient/surrogate. be provided explanations, in medical knowledge required to This process model, which recognizes understandable, developmentally provide adequate information for a that a multitude of decisions are appropriate language, of truly informed consent. Junior house made throughout the medical the nature of their illness or staff may also not have sufficient course as new information emerges, condition; the nature of the knowledge to satisfy condition fosters better communication and proposed diagnostic steps and/ number 1 listed above and will need understanding between clinicians or treatments and the probability education from more experienced and patients/surrogates. An example of their success; the existence physicians to assist in the dialog of the importance in framing medical and nature of the risks and with patients and surrogates. Both decision-making as a longitudinal anticipated benefits involved; and medical students and junior house process that takes shape over time the existence, potential benefits, staff benefit from opportunities to is the care of a critically ill child and risks of potential alternative observe attending physicians engage undergoing resuscitation and treatments, including the option of patients and families in informed stabilization in the ICU. A broad no treatment. consent discussions and may assist discussion of the many elements that in providing initial information may be required for resuscitation is 2. The patient’s and/or surrogate’s to patients and families and by clearly required, but individualized understanding of the above answering questions that fall within consent for each element, especially information should be assessed. their level of understanding. 17, 18 in the likely condensed time frame

Downloaded from by guest on October 30, 2016 e4 FROM THE AMERICAN ACADEMY OF PEDIATRICS is not, as long as there has been decision-making. 22 – 24 Parental coping their ongoing health care in a manner an overarching discussion and mechanisms and their perceptions consistent with their cognitive agreement on the goals of care of undue external influence by development and maturity. and an understanding of the likely clinicians or family members on Parents generally are better intensity of interventions required. decision-making may result in situated than others to understand A more interactive role for the hostile and uncertain feelings about the unique needs of their children decision-maker and/or patient in treatment goals for their seriously and family and make appropriate, informed consent and pediatric ill children.24 Clinicians should be caring decisions regarding their assent may improve understanding aware of the effects of stress and children’s health care. This parental and ownership of the medical uncertainty on autonomous parental responsibility for medical decision- condition and its management and decision-making and choose effective making in caring for their child or often improves compliance with communication strategies to limit young adult is not an absolute right, recommended care. these negative effects. however, because the state also has a societal interest in protecting the When compared with surrogate child or young adult from harm and STANDARDS FOR SURROGATE decision-making that uses can challenge parental authority in DECISION-MAKING FOR CHILDREN AND substituted judgment for adults who situations in which the child or young ADOLESCENTS have lost the capacity to make their adult is put at risk (the doctrine of own medical decisions, surrogate A deeper understanding of the issue parens patriae). of assent and consent in childhood decision-making for infants, children, is facilitated by distancing oneself and adolescents draws from Pediatric health care providers have from the potentially confrontational different constructs, such as the best- legal and ethical duties to provide and legalistic approach of interest standard, harm principle, a standard of care that meets the respect for individual autonomy constrained parental autonomy, pediatric patient’s needs and not as an overarching principle in and shared, family-centered necessarily what the parents desire pediatrics. A more nuanced decision-making. With substituted or request. Parental decision-making approach, incorporating respect judgment, a standard often used should primarily be understood as for the pediatric patient’s medical in surrogate decision-making for parents’ responsibility to support experience, for family dynamics, incapacitated adults who previously the interests of their child and to and for emerging data on adolescent had the capacity for medical decision- preserve family relationships, rather cognitive development and decision- making, surrogates “substitute” than being focused on their rights making, allows for alternative their understanding of the patient’s to express their own autonomous models for both child and surrogate known preferences and values in choices. It is important to note decision-making. determining goals of treatment. It that parental authority regarding is important to note that this is an medical decision-making for their Before discussing models and uncommon decision-making model in minor child or young adult who lacks standards for decision-making in pediatrics, because most children and the capacity for medical decision- pediatrics, it is helpful to appreciate many adolescents cannot or have not making is constrained compared the complexity of how decisions are stated known preferences that are with the more robust autonomy in made by parents and surrogates. based on their level of understanding medical decision-making enjoyed by A recent literature review of 55 and are reflective of core values that competent adults making decisions research articles on the process of an adult with capacity may have had regarding their own care. By moving treatment decision-making noted an opportunity to share. In cases the conversation from parental that decisions are influenced by such in which adolescents, usually those rights toward parental responsibility, things as provider relationships, with chronic debilitating diseases, clinicians may help families minimize previous knowledge, changes in a have had the capacity to express conflicts encountered in the course child’s health status, emotions, and wishes about goals of care before of difficult medical decision-making. faith. 21 Parental distress presents deterioration of cognitive function It is important to recognize that just a challenge for good informed or the onset of overwhelming illness, as there may be conflict between the decision-making. Parents who the substituted judgment standard family and the health care team, there receive new diagnoses of cancer or should be respected by families and may also be conflict between the other life-threatening illnesses in the health care team. The opportunity patient’s parents. Conflict between their children report burdensome to provide this guidance about parents may predate the current emotional and psychological their future medical care should be health care concern or crisis or may stress that can interfere with discussed with adolescents during reflect a different understanding of

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e5 what medical intervention is in the physician’s preferred approach but interest. This model reinforces that best interest of their child. These to identify a harm threshold below a parent’s authority is not absolute issues must be acknowledged and which parental decisions will not be but is constrained by their caring addressed in the process of medical tolerated and outside intervention and responsibility for the child. decision-making for the patient. is indicated to protect the child. 27 An important focus in this model In addition, when considering is family autonomy, with the goal Since publication of the 1995 AAP intervention, the potential harm to of promoting long-term autonomy statement, several frameworks the child by the parental decision for the child throughout his or her providing guidance for pediatric must be serious and imminent and development within the family decision-making have emerged in the a greater threat than the potential setting. literature. Historically and legally, harm from state intervention. medical decision-making in children Shared decision-making is a central Diekema 27 stated that if a parental has centered on the best-interest tenet of the family-centered medical refusal places the child at significant standard, which directs the surrogate home, especially with respect risk of serious harm (eg, refusing a to maximize benefits and minimize to children with chronic health potentially life-saving therapy or a harms to the minor and sets a conditions. Shared, family-centered critical therapy of proven efficacy), threshold for intervention in cases decision-making is an increasingly other questions should be asked of abuse and neglect. 25 The focus is used process for pediatric medical to justify state interference: Do the on the pediatric patient rather than decision-making. 29 This process projected benefits of the proposed on the interests of the caregiver is dependent on collaborative intervention outweigh the burdens and, as philosophers Buchanan and communication and the exchange more favorably than the parents’ Brock 26 defined it, “acting so as to of information between the medical option? Would another option promote maximally the good of the team and the family. In addition that is less intrusive to parental individual.” Confusion and concern to the medical team providing autonomy prevent the harm? Can regarding the use of this standard information about the patient’s state interference be generalized to occur if it is interpreted this rigidly, disease process and the risks and all other similar cases? Would the asking the parent to consider the benefits of treatment options, it public agree that state interference child’s absolute best medical interest is important for family members is reasonable? Proponents of the in isolation, without considering to share information regarding harm principle note that it is a more other interests such as finances or their goals and values so that care appropriate standard for determining family. 25, 27 A broader approach for decisions can meet these needs when to interfere with parental using the best-interest standard and address each stakeholder’s decisions than the best-interest acknowledges the pediatric patient’s perception of the disease process. standard, because parents often emotional, social, and medical make decisions that conflict with a concerns along with the interests child’s best medical interest, and this of the child’s family and strives to CULTURAL AND RELIGIOUS INFLUENCE situation is generally tolerated within maximize benefits and minimize ON DECISION-MAKING the context of the overall care of the harms within this framework. Best- child and family. These concerns Medical decision-making in pediatrics interest determination in this “ideal” would also apply in considering is informed by the cultural, social, framework may help establish prima parental decision-making for young and religious diversity of physicians, facie, rather than absolute, duties adults who lack the capacity to patients, and families. Understanding to children. Another option is to participate in their own medical this tenet and embracing culturally view best interest as a standard of decision-making. effective pediatric health care may reasonableness wherein the benefit allow for better incorporation to burden ratio is balanced such that The model of constrained parental of family values in the informed most rational people would agree autonomy 28 allows parents, as consent process. 30 Occasionally, with the choice of action.25 surrogate decision-makers, to parental decisions based on culture The harm principle may be seen balance the “best interest” of or religion may conflict with the as a more realistic framework to the minor patient with their medical recommendations. Low apply in pediatric surrogate medical understanding of the family’s best health literacy in non–English- decision-making, especially when interests as long as the child’s basic speaking families can lead to there is a concern about the child’s needs, medical and otherwise, are unfavorable health outcomes. safety. The goal here is not to identify met. Rather than best interests, The use of appropriately trained a single course of action that is in the there is the promotion of basic interpreters during the informed child’s best interest or represents the interests, with medical care as a basic consent process is vital to obtain

Downloaded from by guest on October 30, 2016 e6 FROM THE AMERICAN ACADEMY OF PEDIATRICS and share relevant information in an THE CHILD/ADOLESCENT AS MEDICAL For more than a decade, considerable easily understandable fashion and DECISION-MAKER neurobiological research in to optimize medical treatment of animals and humans has focused The value of involving children and pediatric patients. 30, 31 on the complex interaction of brain adolescents in their own medical development and remodeling with decision-making is increasingly Other examples of the potential social, emotional, and cognitive recognized around the world. 34 – 37 impact of religious and cultural processes during adolescence. The respect owed to pediatric beliefs on medical care include Although the size of the brain patients as participants in the the risk associated with religious- nearly reaches its adult size in early medical decision-making process based refusals, such as the refusal of childhood, we know from structural is dependent on several factors, blood transfusions as a life-saving MRI studies that much of the brain including cognitive abilities, maturity therapy by patients who practice the has continued dynamic changes in of judgment, and the respect owed Jehovah’s Witnesses faith, and the gray matter volume and myelination to a moral agent, which may not refusal to seek medical care when into the third decade of life. 41 – 44 all proceed to maturation along medically necessary, or declining The prefrontal cortex, where many the same timeline. Children and interventions, even in the face of executive functions are coordinated, adolescents are dependent on their serious illness, by patients who including the balancing of risks and parents for most aspects of their are Christian Scientists. Although rewards, is among the last areas daily life and usually have limited adults with the capacity for medical of the brain to mature, with these experience with making any medical decision-making have the freedom functions continuing to develop and decisions. Although the child or to make decisions that reflect their mature into young adulthood. adolescent should be recognized faith and religious values, even at the as a moral being with all of the Neuropsychological research to risk of serious harm or death, there appropriate dignity and rights, link adolescent behaviors such as is clearly a competing state interest they are more vulnerable decision- sensation seeking and risk taking in protecting a child from significant makers than adults, in significant to brain structure and function risk of serious harm, as noted in the part because of both inexperience is ongoing but still speculative in 1944 US Supreme Court ruling Prince with decision-making and the slow many areas. 45 – 47 One theory is that v Massachusetts. 32 The AAP statement process of maturation of judgment, as adolescents have a dual-systems on religious objections to medical reviewed below. model of decision-making. 48, 49 A care 33 endorses that children, “socioemotional” system located regardless of parental religious Developmental research in the in the limbic and paralimbic brain beliefs, deserve effective medical 1980s concluded that many minors regions is believed to develop treatment when such treatment reach the formal operational stage around puberty, with increased is not overly burdensome and is of cognitive development that dopaminergic activity, and manifests likely to prevent substantial harm, allows abstract thinking and the as reward-seeking behavior. The serious disability, or death. Clinicians ability to handle complex tasks by “cognitive control” system, which must balance the need to work midadolescence. 38, 39 During that promotes self-regulation and collaboratively with all parents/ time, the Tennessee Supreme Court, impulse control, is in the prefrontal families, respecting their culture, in deciding Cardwell v Bechtol in cortices and gradually develops religion, and the importance of the 1987,40 used the “rule of sevens” to into the third decade of life. This family’s autonomy and intimacy, uphold the presumption of decision- temporal imbalance or gap between with the need to protect children making capacity for a 17-year-old the 2 systems can lead to the risky from serious and imminent harm. girl receiving spinal manipulation. behavior seen in adolescence and Clinicians must recognize that failure This “rule” stated that no capacity has been analogized to starting a car to provide appropriate care may exists for children younger than the engine without the benefit of a skilled constitute abuse or neglect, and this age of 7 years, a lack of capacity is driver.50 Or, in other words, the situation should not be unreported presumed but may be rebutted with circuitry of reward-related behavior because of perceived state or federal appropriate evidence between the develops earlier than the control- exemptions for religious groups. This ages 7 and 14 years, and capacity is related brain regions. protection is extended until children presumed but may be rebutted at age are able to make such religious 14 years and older. Newer insight Other contributors to the risky decisions for themselves, recognizing into brain structure and function now choices that some adolescents that some mature adolescents may makes the determination of which may make include peer pressure either endorse or reject the tenets of minors possess the maturity for and highly complex or stressful their parent’s faith over time. decision-making much less clear-cut. situations. Although pubertal changes

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e7 do affect behavior, as has been special health needs may never influencing how he or she is mentioned, all changes cannot be develop the capacity to allow responding (including whether attributed to “raging hormones.” meaningful participation in medical there is inappropriate pressure to On the positive side, late adolescence decision-making. Parents will need accept testing or therapy); and is also a period during which youth to continue to serve as surrogate 4. soliciting an expression of the develop a coherent sense of identity, decision-makers for these patients, patient’s willingness to accept the with an increased understanding even as these adolescents turn 18 proposed care. years of age and become adults. The of their individual beliefs, values, Note that one should not solicit a 51 legal issues involved in securing and priorities. The path toward child’s assent if the treatment or autonomy in the journey from guardianship are beyond the scope of this report. intervention is required; the patient adolescence to adulthood is linked should be told that fact and should to both intellectual maturity and not be deceived. A child is not the 52 moral functioning. Early life ASSENT IN PEDIATRIC final decision-maker, the parent or experiences are paramount in the DECISION-MAKING surrogate is. Many recommended shaping of moral functioning. With Pediatric practice is unique in that medical interventions come with the normal development, the integration likelihood of associated pain, invasive of emotions, reasoning, and self- the developmental maturation of the child allows for increasing procedures, or at a minimum, reflection with physical and social inconvenience. Parents should experiences helps determine the longitudinal inclusion of the child’s voice in the decision-making balance the anticipated benefits with degree of moral intelligence in the the level of burdens and risks of such transition to adulthood. A coherent process. Assent from children even as young as 7 years for medical treatments when making decisions sense of identity and stable, deep- for their children about pursuing seated values are key to making interventions may help them become more involved in their medical therapy. If the likely benefits of reflective, autonomous decisions treatment in conditions with a good required for true informed consent. care and can foster moral growth and development of autonomy in prognosis outweigh the burdens, Some youth navigate this complex young patients. 2, 55 – 59 The 1995 AAP parents may choose a treatment developmental process quite well statement on informed consent plan over the objections or dissent despite the complex interactions of endorses pediatric assent in decision- of the child. A common example of biology and social context. However, making. However, the definition this situation is an appendectomy the research to date articulates and application of assent have for acute appendicitis. Regardless that, in general, adolescents make lacked consistency in both clinical of the child’s degree of participation decisions differently than adults and research arenas. 55, 56 A strict in and/or disagreement with the do, and although they may have interpretation of assent requires that care plan, he or she should still be cognitive skills, they are more likely the child meet all of the elements given as much control over the actual 45,53, 54 to underutilize these skills. of an adult informed consent, treatment as possible: for example, The implications for decision- a requirement that challenges in determining the location for making by adolescents in stressful obtaining assent at younger ages. intravenous catheter placement. health care environments are that Others seek a developmental Dissent by the pediatric patient they may rely more on their mature approach that would require should carry increased weight limbic system (socioemotional) different levels of understanding when the proposed intervention rather than on the impulse- from children as they age. 57 At the is not essential and/or can be controlling, less developed prefrontal very least, assent should include the deferred without substantial risk or cognitive system. As clinicians, we following elements2: discomfort to the patient or family. should look for evidence of stable, A perceived dilemma with assent internalized values in adolescent 1. helping the patient achieve a developmentally appropriate is that parents and clinicians may medical decision-making that is resist incorporating assent into their reflective of the patient’s cognitive awareness of the nature of his or her condition; practice when the stakes are too maturation. These values are key to high if the child dissents, as in the the decision-making process and, in 2. telling the patient what he or case of an appendectomy for acute difficult situations, may help provide she can expect with tests and appendicitis. In 1 recent survey a foundation in developing goals of treatments; example, the majority of pediatricians care. 3. making a clinical assessment would ignore an adolescent’s Some adolescents and young adults of the patient’s understanding refusal of treatment when parents with cognitive impairments and of the situation and the factors are in favor and the prognosis

Downloaded from by guest on October 30, 2016 e8 FROM THE AMERICAN ACADEMY OF PEDIATRICS is good.4 As stated previously in Supreme Court rulings regarding the minor consent to abortion without this report, maintaining honesty constitutional right to privacy for all parental involvement is uncommon: in communications with patients on these matters. It is important for currently, 37 states require parental and families helps to minimize this the clinician to note the significant involvement, although, in general, concern; information should always variability between states in how the there is a mechanism by which the be provided in a developmentally statutes are worded regarding access minor can petition the court for appropriate manner, but assent for these services. The Guttmacher access to abortion services without should only be solicited if some Institute (www. guttmacher. org) is an parental knowledge or consent. element of refusal will be respected. excellent resource for reviewing state There is similar variability among the In situations with a poor prognosis policies on sexual and reproductive states regarding adolescents’ access and interventions associated with health and can be accessed to mental health and substance 62 a heavy patient burden, more electronically. abuse prevention and treatment consideration should be given to the Although all states allow access to services. The majority of states do adolescent’s opportunity to provide treatment of STIs, the protection of allow adolescents to consent to assent or refusal. the adolescent’s confidentiality is less treatment of substance abuse, and Encouraging the patient to actively widespread. Some states permit the importantly, programs receiving explore options and take on a practitioner to disclose information federal funding are governed by greater role in his or her health care to parents/guardians if they believe federal confidentiality regulations may promote empowerment and it is in the minor’s best interest. that prohibit sharing information compliance with a treatment plan. 60 Many states, insurers, and electronic regarding treatment without the There is core philosophical and medical record systems do not make patient’s consent. 64 developmental support for the notion provisions for deferred billing and/ The mature minor doctrine that we all need the opportunity to or payment for STI services, thus recognizes that there is a subset make choices to create ourselves as endangering an adolescent’s desire of adolescents who have adequate moral agents and create a coherent for confidentiality. Practitioners are maturity and capacity to understand 61 sense of identity. best advised to become familiar with and appreciate an intervention’s their state statutes and to consider benefits, risks, likelihood of success, promoting changes in legislation to and alternatives and can reason SPECIAL ISSUES IN ADOLESCENT improve adolescent confidentiality and can choose voluntarily. Under INFORMED CONSENT/ASSENT/REFUSAL 63 protection where appropriate. the mature minor doctrine, the There are 3 broad categories of Human papillomavirus (HPV) age, overall maturity, cognitive circumstances in which a minor can infection is the most common STI, abilities, and social situation of the legally make decisions regarding his and several strains of HPV are known minor are considered in a judicial or her own health care: exceptions to cause cervical cancer, with new determination, finding that an based on specific diagnostic/ data also linking this virus to oral otherwise legally incompetent care categories, the mature minor cancers. Primary prevention is minor is sufficiently mature to exception, and legal emancipation. available in the form of vaccination, make a legally binding decision and The legal ability of adolescents to which is recommended for both provide his or her own consent for consent for health care needs related boys and girls ages 11 through 12 medical care. In contrast, legally to sexual activity, including treatment years by the Advisory Committee emancipated minor statutes do not of sexually transmitted infections on Immunization Practices of the address decision-making ability (STIs) and provision of contraceptive Centers for Disease Control and but rather the legal status of the services, prenatal care, and abortion Prevention. It is unknown whether minor. Adolescents who are living services, has expanded over the past most states will include the HPV separately from their parents and several decades. This change is not primary prevention vaccination are self-supporting, married, or on specifically related to an acceptance in the category of protected STI active duty with the armed forces of the adolescents’ abilities in medical treatment or general vaccination are generally considered legally decision-making. Rather, this is a for which minors may not provide emancipated and competent to make public health decision and reflects consent. their own decisions and provide both the concern that adolescents The majority of states allow consent for medical care. will not seek care for issues that some or all adolescents 12 years Although there are significant reflect sexual activity if required to or older access to contraceptive limitations on adolescents’ legal right involve their parents for consent services and usually do not require to consent to their own medical care, and an extension of the broad US parental notification. In contrast, all states presume adolescent parents

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e9 to be the appropriate surrogate parent and may help safeguard the of the associated risks and benefits decision-makers for their children rights and well-being of the infant. and how these issues affect their and allow them to give informed Although not required by law, medical decision-making. With this consent for their child’s medical care. physicians should provide support process, which includes input from This right reflects the adolescent’s for the adolescent mother, as needed, both the family and the health care status as a parent, rather than his or in selecting someone to help her team, the adolescent should be able her decision-making capacity as a provide informed permission for her to be supported in making either mature or emancipated minor. There infant’s care. 65, 66 an informed assent or refusal of the is clearly a significant and concerning surgical procedure. This procedure paradox encountered in allowing The informed consent process provides an excellent example of a adolescents to take responsibility for surrounding relatively higher situation in which a major medical complex medical decision-making risk, yet elective procedures, such decision must be made but is best for their infants and children while, as pectus excavatum repair and made by carefully supporting the in general, “protecting” adolescents bariatric surgery, highlights the adolescent’s opportunity to provide from providing assent and directing complex issue of adolescent medical assent or refusal, because only he or their own medical care, even in more decision-making. Surgery to repair she can truly weight the risks and controlled, low-risk situations. The pectus excavatum is most commonly benefits as they apply to him or her. case of early adolescent parents of undertaken in adolescent patients. Throughout this process, the surgeon critically ill infants is particularly The evidence to support significant and the health care team must difficult with regard to consent. physiologic improvement in also be aware of balance between These parents, often the mother cardiorespiratory function as a result coercion by the family or health care alone without the involvement of the surgery is limited, and the team as well as the opportunity to or support of the infant’s father, most common indication for surgery support developmentally appropriate are generally charged with the is distress regarding the appearance decision-making. A considered responsibility of making important of the chest wall. Although the refusal of surgery by the adolescent medical decisions for their infants surgery is most often completed in a should be respected, given the that they would never be permitted minimally invasive manner, it is not elective nature of the procedure to make for themselves or for other without the risk of complications, and the associated postoperative relatives. 65, 66 including significant postoperative pain and risks. Parental requests for pain, an extended period surgical intervention must include Although this arrangement meets the postoperatively of limitation of the adolescent in the discussion, and legal responsibility of recognizing activities, the potential for recurrence the need to include the adolescent and respecting the adolescent’s of the pectus excavatum appearance, and respect his or her concerns must status as a parent who has a right and rarely, the risk of cardiac injury be discussed with the family. The and responsibility for decision- and hemorrhage. 67 – 69 These can be surgeon and the health care team making for his or her child, it does extremely difficult concerns for the may also find themselves in the not appropriately address the ethical adolescent, especially the younger situation in which the adolescent issues raised by young adolescent adolescent to consider and balance, is anxious to proceed with surgery, decision-making nor the physician’s because this deliberation includes while the family/parents are reticent ethical responsibility to both the the need to consider both acute to provide consent. Continued adolescent and his or her child. and long-term risks and benefits. In discussion directed at having all Adolescent parents are in a very this situation, the surgeon and the participants clarify their goals for vulnerable situation, facing the health care team must undertake the surgery and their understanding need to care for a child while still thoughtful, developmentally of the risks may allow for a decision completing important developmental appropriate conversations with that all can respect. tasks for themselves. Many both the adolescent patient and pediatricians and neonatologists his or her family to provide the seek permission from the adolescent medical information needed to make INFORMED REFUSAL OF TREATMENT BY parent to involve an adult relative, an informed medical decision. In ADOLESCENTS often the maternal grandparents, in addition, the surgeon and the health Adolescents or older children who crucial decisions regarding the care care team must work to elicit from have experienced serious and/ of the infant. This adult, selected by the family, but especially from the or chronic illnesses often have an the mother as her co–decision-maker, adolescent patient, their beliefs enhanced capacity for decision- can provide mentoring in shared and concerns about the surgery making when weighing the benefits decision-making to the adolescent and their cognitive understanding and burdens of continued treatment,

Downloaded from by guest on October 30, 2016 e10 FROM THE AMERICAN ACADEMY OF PEDIATRICS especially when the likelihood of a Court ruled that a 17-year-old with right to religious belief but found good outcome is low. 70 Refusal of leukemia and who was a member of both less compelling than the life-sustaining therapy by such an the Jehovah’s Witnesses faith was state’s need to protect the child adolescent should be given careful mature and had the right to refuse and to proceed with necessary consideration by parents and the blood transfusions. Importantly, her medical therapy for a treatable, life- health care team. The pediatrician mother agreed with her decision. threatening illness. should work with the health care The judges observed that the age This legal decision is in contrast to team, patient, and family in a of majority “is not an impenetrable previous decisions, such as the case collaborative approach to resolve barrier that magically precludes of Dennis Lindberg. 74 Dennis was any conflicts between the parents a minor from possessing and a 14-year-old with leukemia who and adolescent, and the clinicians exercising certain rights normally practiced the Jehovah’s Witnesses should generally advocate for the associated with adulthood.” A second faith and was allowed to refuse a adolescent’s wishes if they reflect an case, Belcher v Charleston Area blood transfusion after a 2007 court ethically acceptable treatment option. Medical Center (1992),72 heard by ruling by a Mt Vernon, Washington, When conflicts about the goals of the West Virginia Supreme Court judge who found him to be a mature treatment persist, the health care of Appeals, also recognized the minor. Although Dennis’ biological team should enlist the involvement mature-minor doctrine and directed parents objected to this ruling, his of secondary consultants, an physicians to seek input from a long-time guardian, who had raised integrated palliative care team, mature minor before treatment. In him in the Jehovah’s Witnesses faith, ethics consultation, psychologists, this case, a physician wrote a do-not- supported his refusal of transfusions. psychiatrists, or chaplains. Seeking resuscitate order for a 17-year-old He died within hours of the ruling. legal intervention should be a last with muscular dystrophy without In another prominent case in resort. discussion with the patient, despite 2006, Abraham Starchild Cherrix, the family’s request that he do so. In general, it is also reasonable to a 16-year-old with lymphoma, The patient, Larry Belcher, later had respect an adolescent’s refusal of successfully deferred standard a cardiac arrest and died without nonurgent, non–life-threatening care therapy for his lymphoma, supported resuscitation. as long as efforts are directed toward by a Virginia court ruling. This ruling helping the physician and the family centered on the patient’s maturity, Case law continues to evolve on the understand the basis of the refusal understanding of his illness, and issue of a minor’s right to refuse and providing appropriate education parental support of his refusal medical treatment. A recent case 73 for any misconceptions. and quickly resulted in Virginia’s involved 13-year-old Daniel Hauser 2007 “Abraham’s Law” that allows Although age provides a clear legal and his mother, Colleen Hauser. adolescents 14 years of age and definition of majority, there is still Daniel was found to have a very older a decision-making role in life- no bright line demarcating when a treatable form of Hodgkin lymphoma, threatening conditions. 75 minor becomes “mature” enough with an estimated survival of 80% to to independently demonstrate 95% after standard chemotherapy Despite the legal rulings and the capacity for informed consent and radiation therapy. Despite ethical guidance, there is still much or refusal. Courts have weighed receiving an initial course of controversy about informed refusal in on this issue with a variety of chemotherapy, Daniel and his mother by adolescents of life-sustaining outcomes, detailed below. Recent refused further recommended treatments. 5, 76 – 80 A recent statement pressure to generalize functional chemotherapy, insisting instead on from the Confederation of European MRI neurobiological research to using “holistic” medicine based on Specialists in Pediatrics clearly states individual adolescents to prove Native American healing practices. that pediatric patients may not refuse criminal culpability is disturbing, One important aspect of this case was life-saving treatment. 35 Although because the science still struggles to Daniel’s inability to meet elements the Confederation of European separate social and environmental of informed assent/consent, because Specialists in Pediatrics references influences from biological his limited cognitive abilities and the United Nations Convention of 45 determinants of behavior. illiteracy hampered his ability to the Rights of the Child, citing article One of the first mature-minor comprehend his medical condition 12, which provides for “the view of doctrine cases to rule on whether and its recommended treatments. A the child being given due weight in an adolescent has the right to make 2009 Minnesota court order in this accordance with the age and maturity decisions about life-sustaining case considered both a parent’s right of the child,” and finds that this treatments is In re E.G. (1989).71 to raise a child free of interference clearly applies to medical treatment, In this case, the Illinois Supreme and the constitutionally protected they state that the physician has a

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e11 duty to act in the best interest of the palliative care service, may help the this area is found in the AAP policy child. patient, family, and clinical team statement “Consent by Proxy for 81 Many bioethicists support limiting resolve conflict. Nonurgent Pediatric Care.” a child’s or adolescent’s short-term autonomy by overriding a treatment EMERGENCY EXCEPTIONS TO refusal to preserve long-term INFORMED CONSENT/ASSENT/REFUSAL INFORMED CONSENT IN RESEARCH INVOLVING CHILDREN autonomous choice and an open AND ADOLESCENTS future. 28, 54 Although adolescents may Parental consent is usually required possess the capacity for decision- for the evaluation and medical The informed consent process for making, as discussed earlier, it may treatment of pediatric patients. both research and clinical care shares be limited by lack of perspective However, there are situations in similar ethical foundations and or real-life experiences. Some also which children may present with also encounters similar problems argue that parental responsibility emergency medical conditions and in ensuring consistency across in promoting and protecting their a parent or legal guardian is not institutions and practices. Informed child’s life does not abruptly end available to provide consent. The consent and assent obtained from when an adolescent has decision- AAP policy statement “Consent children involved in research are making capacity. They should not for Emergency Medical Services clearly mandated, in contrast to 31 cede sole decision-making authority for Children and Adolescents” the “recommended” guidance in to their minor child. 77 Instead, recommends that a medical screening place in clinical care. This process parental authority and decision- examination and appropriate medical has been closely scrutinized for >3 making are constrained to identify stabilization of the pediatric patient decades since the publication of the and protect the best interests of their with an urgent or emergent condition Belmont Report in 1978. 82 Produced child when he or she refuses medical should never be withheld or delayed by the National Commission for care. because of problems with obtaining the Protection of Human Subjects consent. Although clinicians, courts, In general, adolescents should of Biomedical and Behavioral and parents may differ on what not be allowed to refuse life- Research, the Belmont Report constitutes an emergency, this saving treatment, even when formed the basis of much of the standard should apply when urgent parents agree. 34, 54, 78 However, in work on informed consent in the interventions to prevent imminent circumstances of a life-limiting research setting. Institutional review and significant harm are necessary terminal illness when only boards (IRBs) have incorporated and when reasonable efforts to find a unproven, overly burdensome the Belmont Report, the Report surrogate are unsuccessful. or likely ineffective treatment and Recommendation: Research 83 options exist, some adolescents Clinicians should also be aware Involving Children, the NIH Policy may make an informed choice to that current federal law, under and Guidelines on the Inclusion of forgo interventions to address their the Emergency Medical Treatment Children as Participants in Research 84 underlying disease and instead focus and Active Labor Act, mandates a Involving Human Subjects, and the on measures that provide comfort medical screening examination and, if appropriate federal guidelines (the and support. indicated, treatment and stabilization "Common Rule" [45 CFR §46, 1991]) of an emergency medical condition, into the rules balancing the risk/ The dilemma of an adolescent regardless of consent issues, in any benefit ratio that guide the review of treatment refusal is ethically hospital that receives federal funding. research protocols including children and emotionally challenging. If an emergency medical condition as research subjects. The informed Pediatricians must ascertain the is not identified with a screening permission of the child subject’s capacity of the minor for decision- examination, then Emergency parent(s) must be obtained before making while recognizing that the Medical Treatment and Active Labor enrolling the subject in the research “science” of that determination is still Act regulations no longer apply and protocol. In a distinction from the evolving. The presence of chronic the physician should seek proper usual clinical practice, there are illness can either enhance a child’s consent or assent before further also clear guidelines on the need to decisional skills or contribute to nonurgent care is provided. 31 obtain assent from the child subject regression, emotional immaturity, in research and to respect a minor’s and anger when facing a choice. There also may be situations in which dissent from study participation, with The involvement of psychiatric practitioners seek consent by proxy limited exceptions. counselors, ethicists, child life for nonurgent care (eg, a babysitter specialists, social workers, or other brings a 6-year-old to the doctor’s Although assent is mandated, federal consultants, such as an integrated office). Guidance for clinicians in guidelines on how to obtain assent

Downloaded from by guest on October 30, 2016 e12 FROM THE AMERICAN ACADEMY OF PEDIATRICS and at what age are not explicit. latter or partnering approach may those with medical experience This situation results in variability be the most successful in meeting because of chronic illness, are in requirements of local IRBs of the criteria for parental permission minors with enough decision-making the age at which assent should be and child assent but may not be capacity, moral intelligence, and obtained and what elements of the possible when families or physicians judgment to provide true informed traditional informed consent process exercise authority over the child. consent, or, in non–life-threatening are required from children and A strong push toward endorsing a settings, informed refusal, for their adolescents. 2, 55 – 59 Although the AAP developmentally appropriate assent proposed care plan. Clinicians have and the National Commission for process in research may encourage both a moral obligation and a legal the Protection of Human Subjects of more joint decision-making. responsibility to question and, if Biomedical and Behavioral Research necessary, to contest surrogate and/ The IRB can provide a waiver from recommend assent for children >7 or patient medical decisions that requiring assent if greater-than- years, there is still wide variation in put the patient at significant risk of minimal-risk research has the the inclusion of children in the assent serious harm. Adolescent treatment potential for an important direct process.85 The ability of the capable refusals remain controversial and are benefit that is only available in mature minor to consent to medical ethically and emotionally challenging the context of the research or the research depends on individual for families and clinicians. research carries only minimal risk state laws, but generally, risks must and could not be carried out without be minimal and the research aim LEAD AUTHORS the waiver. 89 This is a critical should center on a medical condition difference from the child’s input into Aviva L. Katz, MD, FAAP for which the minor can legally give decision-making in the clinical world. Sally A. Webb, MD, FAAP consent. More detailed information is found in the AAP clinical report COMMITTEE ON BIOETHICS, 2015–2016 “Guidelines for the Ethical Conduct CONCLUSIONS Aviva L. Katz, MD, FAAP, Chairperson of Studies To Evaluate Drugs in Robert C. Macauley, MD, FAAP Pediatric Populations.” 86 Informed consent should be seen Mark R. Mercurio, MD, MA, FAAP as a constitutive part of health care Margaret R. Moon, MD, FAAP Most research into the assent or practice; parental permission and Alexander L. Okun, MD, FAAP Douglas J. Opel, MD, MPH, FAAP consent process has occurred in childhood assent is an active process Mindy B. Statter, MD, FAAP the pediatric oncology population, that engages patients, adults, and because up to 80% of pediatric children in the health care process. CONTRIBUTING FORMER COMMITTEE patients with cancer are also Pediatric practice is unique in MEMBERS enrolled as subjects in clinical that developmental maturation Mary E. Fallat, MD, FAAP, Past Chairperson research trials. Oncologists may of the child allows for increasing Sally A. Webb, MD neglect to include adolescents in the longitudinal inclusion of the child’s Kathryn L. Weise, MD decision-making process because of opinion in medical decision-making perceived inability of the adolescent in clinical and research practice. LIAISONS to comprehend information when Although new research has shown Mary Lynn Dell, MD, DMin – American Academy of facing a life-threatening situation and that neurologic maturation continues Child and Adolescent Psychiatry the presumed sufficiency of parental into the third decade of life, seeking Douglas S. Diekema, MD, MPH – American Board of Pediatrics permission.87 Children enrolled assent from children and adolescents Dawn Davies, MD, FRCPC, MA – Canadian Pediatric in clinical trials very often have for medical interventions can foster Society limited awareness and appreciation the moral growth and development Sigal Klipstein, MD – American College of of the research trial, do not recall of autonomy in young patients and Obstetricians and Gynecologists having a role in deciding whether is strongly recommended. Surrogate to enroll, and do not feel free to decision-making by parents or FORMER LIAISONS dissent. 59 Observational studies guardians for pediatric patients Kevin W. Coughlin, MD, FAAP – Canadian Pediatric have noted variations in how often should seek to maximize the benefits Society the physician addressed the child for their child by balancing health Steven J. Ralston, MD – American College of Obstetricians and Gynecologists versus the parent during the assent/ care needs with social and emotional Monique A. Spillman, MD, PhD – American College 70,88 permission discussion. Observed needs within the context of overall of Obstetricians and Gynecologists decision-making approaches during family goals, cultural beliefs, and discussion of enrollment include values. Physicians should recognize LEGAL CONSULTANTS patient-centered, parent-centered, that some pediatric patients, Nanette Elster, JD, MPH or joint child-parent decisions. The especially older adolescents and Jessica Wilen Berg, JD, MPH

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e13 STAFF co-fi duciaries of pediatric patients. In: 22. Pyke-Grimm KA, Stewart JL, Kelly KP, Florence Rivera, MPH Miller G, ed. Pediatric Bioethics. New Degner LF. Parents of children with Alison Baker, MS York, NY: Cambridge University Press; cancer: factors infl uencing their 2010:11–21 treatment decision making roles. J Pediatr Nurs. 2006;21(5):350–361 ABBREVIATIONS 11. Salgo v Leland Stanford Jr University Board of Trustees, 154 Cal App 2d 560 23. Benedict JM, Simpson C, Fernandez AAP: American Academy of (1957) CV. Validity and consequence of Pediatrics 12. Berman L, Dardik A, Bradley EH, informed consent in pediatric bone HPV: human papillomavirus Gusberg RJ, Fraenkel L. Informed marrow transplantation: the parental IRB: institutional review board consent for abdominal aortic experience. Pediatr Blood Cancer. STI: sexually transmitted aneurysm repair: assessing 2007;49(6):846–851 infection variations in surgeon opinion through 24. Miller VA, Luce MF, Nelson RM. a national survey. J Vasc Surg. Relationship of external infl uence 2008;47(2):287–295 to parental distress in decision 13. Burger I, Schill K, Goodman S. making regarding children with a life- REFERENCES Disclosure of individual surgeon’s threatening illness. J Pediatr Psychol. 2011;36(10):1102–1112 1. American Academy of performance rates during informed Pediatrics. Consent. Pediatrics. consent: ethical and epistemological 25. Kopelman LM. The best-interests 1976;57(3):414–416 considerations. Ann Surg. standard as threshold, ideal, and 2007;245(4):507–513 standard of reasonableness. J Med 2. American Academy of Pediatrics, Philos. 1997;22(3):271–289 Committee on Bioethics. Informed 14. Jones JW, McCullough LB, Richman BW. consent, parental permission, and The Ethics of Surgical Practice. New 26. Buchanan AE, Brock DW. Deciding assent in pediatric practice. Pediatrics. York, NY: Oxford University Press; 2008 for Others: The Ethics of Surrogate 1995;95(2):314–317 15. Johnson v Kokemoor, 545 NW2d 495, Decision Making. Cambridge, United 3. American Academy of Pediatrics, 199 Wis 2d 615 (Wis 1996) Kingdom: Cambridge University Press; 1990 Committee on Bioethics. Informed 16. Appelbaum PS, Grisso T. Assessing consent in decision-making in patients’ capacities to consent 27. Diekema DS. Parental refusals of pediatric practice [policy statement]. to treatment. N Engl J Med. medical treatment: the harm principle Pediatrics. 2016 1988;319(25):1635–1638 as threshold for state intervention. Theor Med Bioeth. 2004;25(4):243–264 4. Lee KJ, Havens PL, Sato TT, Hoffman 17. Sherman HB, McGaghie WC, Unti GM, Leuthner SR. Assent for SM, Thomas JX. Teaching pediatrics 28. Ross L. Children, Families, and Health treatment: clinician knowledge, residents how to obtain informed Care Decision-Making. New York, NY: attitudes, and practice. Pediatrics. consent. Acad Med. 2005;80(10 Oxford University Press; 1998 2006;118(2):723–730 suppl):S10–S13 5. Talati ED, Lang CW, Ross LF. Reactions 29. Committee on Hospital Care, American 18. Yap TY, Yamokoski A, Noll R, Drotar of pediatricians to refusals of medical Academy of Pediatrics. Family-centered D, Zyzanski S, Kodish ED; Multi-Site treatment for minors. J Adolesc care and the pediatrician’s role. Intervention Study to Improve Consent Health. 2010;47(2):126–132 Pediatrics. 2003;112(3 pt 1):691–697 Research Team. A physician-directed 6. Duncan RE, Sawyer SM. Respecting intervention: teaching and measuring 30. Britton CV; American Academy of adolescents’ autonomy (as long as better informed consent. Acad Med. Pediatrics Committee on Pediatric they make the right choice). J Adolesc 2009;84(8):1036–1042 Workforce. Ensuring culturally Health. 2010;47(2):113–114 effective pediatric care: implications 19. Fink AS, Prochazka AV, Henderson WG, for education and health policy. 7. Beauchamp TL, Childress JF. Principle et al. Predictors of comprehension Pediatrics. 2004;114(6):1677–1685 of Biomedical Ethics. 5th ed. New York, during surgical informed consent. NY: Oxford University Press; 2001 J Am Coll Surg. 2010;210(6):919–926 31. Committee on Pediatric Emergency 8. Faden RR, Beauchamp TL. A History and Medicine and Committee on Bioethics. 20. O’Lonergan TA, Forster-Harwood JE. Consent for emergency medical Theory of Informed Consent. New York, Novel approach to parental permission NY: Oxford University Press; 1986 services for children and adolescents. and child assent for research: Pediatrics. 2011;128(2):427–433 9. Berg JW, Appelbaum PS, Lidz PS, Parker improving comprehension. Pediatrics. LS. Informed Consent: Legal Theory and 2011;127(5):917–924 32. Prince v Massachusetts, 321 US 158 (1944) Clinical Practice, 2nd ed. New York, NY: 21. Lipstein EA, Brinkman WB, Britto Oxford University Press; 2001 MT. What is known about parents’ 33. American Academy of Pediatrics 10. McCullough LB. Contributions of treatment decisions? A narrative Committee on Bioethics. Religious ethical theory to pediatric ethics; review of pediatric decision making. objections to medical care. Pediatrics. pediatricians and parents as Med Decis Making. 2012;32(2):246–258 1997;99(2):279–281

Downloaded from by guest on October 30, 2016 e14 FROM THE AMERICAN ACADEMY OF PEDIATRICS 34. Canadian Pediatric Society. Treatment research in adolescent health policy. 59. Unguru Y, Coppes MJ, Kamani N. decisions regarding infants, children J Adolesc Health. 2009;45(3):216–221 Rethinking pediatric assent: from and adolescents. Paediatr Child Health. 46. Romer D. Adolescent risk taking, requirement to ideal. Pediatr Clin 2004;9(2):99–114 impulsivity, and brain development: North Am. 2008;55(1):211–222, xii 35. De Lourdes Levy M, Larcher V, Kurz implications for prevention. Dev 60. Waller BN. Patient autonomy R; Ethics Working Group of the Psychobiol. 2010;52(3):263–276 naturalized. Perspect Biol Med. Confederation of European Specialists 47. Van Leijenhorst L, Gunther Moor 2001;44(4):584–593 in Paediatrics. Statement of the Ethics B, Op de Macks ZA, Rombouts 61. Korsgaard C. Self Constitution, Agency, Working Group of the Confederation SA, Westenberg PM, Crone EA. Identity and Integrity. New York, NY: of European Specialists in Paediatrics Adolescent risky decision-making: Oxford University Press; 2009 (CESP). Informed consent/ neurocognitive development of reward 62. Guttmacher Institute. Preventing assent in children. Eur J Pediatr. and control regions. Neuroimage. 2003;162(9):629–633 cervical cancer: new resources to 2010;51(1):345–355 advance the domestic and global 36. Larcher V, Hutchinson A. How 48. Dahl RE, Gunnar MR. Heightened fi ght. Guttmacher Policy Review. should paediatricians assess stress responsiveness and emotional Winter 2012;15:1. Available at: www. Gillick competence? Arch Dis Child. reactivity during pubertal maturation: guttmacher.org/ pubs/ gpr/ 15/ 1/ 2010;95(4):307–311 implications for psychopathology. Dev gpr150108. html. Accessed October 28, 37. Michaud PA, Berg-Kelly K, Macfarlane Psychopathol. 2009;21(1):1–6 2013 A, Benaroyo L. Ethics and adolescent 49. Steinberg L. A dual systems model of 63. Ford CA, English A. Limiting care: an international perspective. adolescent risk-taking. Dev Psychobiol. confi dentiality of adolescent health Curr Opin Pediatr. 2010;22(4):418–422 2010;52(3):216–224 services: what are the risks? JAMA. 38. Weithorn LA, Campbell SB. The 50. Steinberg L. Cognitive and affective 2002;288(6):752–753 competency of children and development in adolescence. Trends 64. 42 CFR part 2, Implementing the adolescents to make informed Cogn Sci. 2005;9(2):69–74 Substance Abuse and Mental Health treatment decisions. Child Dev. Administration (42 USC 290dd.2) 1982;53(6):1589–1598 51. Steinberg L, Cauffman E. Maturity of judgment in adolescence: psychosocial 65. De Ville K. Adolescent parents and 39. McCabe MA. Involving children and factors in adolescent decision-making. medical decision-making. J Med Philos. adolescents in medical decision Law Hum Behav. 1996;20(3):249–272 1997;22(3):253–270 making: developmental and clinical considerations. J Pediatr Psychol. 52. Narvaez D. The emotional foundations 66. Mercurio MR. Adolescent mothers of 1996;21(4):505–516 of high moral intelligence. critically ill newborns: addressing the New Dir Child Adolesc Dev. rights of parent and child. Adolesc Med 40. Cardwell v Bechtol, 724 SW 2d 739, 745 2010;2010(129):77–94 State Art Rev. 2011;22(2):240–250, ix (Tenn 1987) 53. Silber TJ. Adolescent brain 67. Nasr A, Fecteau A, Wales PW. 41. Giedd JN, Blumenthal J, Jeffries development and the mature minor Comparison of the Nuss and the NO, et al. Brain development during doctrine. Adolesc Med State Art Rev. Ravitch procedure for pectus childhood and adolescence: a 2011;22(2):207–212, viii excavatum repair: a meta-analysis. longitudinal MRI study. Nat Neurosci. J Pediatr Surg. 2010;45(5):880–886 1999;2(10):861–863 54. Diekema DS. Adolescent refusal of lifesaving treatment: are we asking the 68. Papandria D, Arlikar J, Sacco 42. Sowell ER, Thompson PM, Holmes CJ, right questions? Adolesc Med State Art Casamassima MG, et al. Increasing age Jernigan TL, Toga AW. In vivo evidence Rev. 2011;22(2):213–228, viii at time of pectus excavatum repair for post-adolescent brain maturation in children: emerging consensus? in frontal and striatal regions. Nat 55. Denham EJ, Nelson RM. Self- J Pediatr Surg. 2013;48(1):191–196 Neurosci. 1999;2(10):859–861 determination is not an appropriate model for understanding parental 69. Johnson JN, Hartman TK, Pianosi PT, 43. Sowell ER, Thompson PM, Tessner permission and child assent. Anesth Driscoll DJ. Cardiorespiratory function KD, Toga AW. Mapping continued Analg. 2002;94(5):1049–1051 after operation for pectus excavatum. brain growth and gray matter J Pediatr. 2008;153(3):359–364 density reduction in dorsal frontal 56. Kon AA. Assent in pediatric research. cortex: Inverse relationships during Pediatrics. 2006;117(5):1806–1810 70. Pousset G, Bilsen J, De Wilde J, postadolescent brain maturation. 57. Miller VA, Nelson RM. A developmental et al. Attitudes of adolescent J Neurosci. 2001;21(22):8819–8829 approach to child assent for cancer survivors toward end-of-life 44. Giedd JN. The teen brain: insights nontherapeutic research. J Pediatr. decisions for minors. Pediatrics. from neuroimaging. J Adolesc Health. 2006;149(1 suppl):S25–S30 2009;124(6):e1142–e1148 2008;42(4):335–343 58. Wendler DS. Assent in paediatric 71. In re E.G., 133 Ill 2d 98105549 NE 2d 45. Johnson SB, Blum RW, Giedd JN. research: theoretical and practical 322325 (1989) Adolescent maturity and the brain: the considerations. J Med Ethics. 72. Belcher v Charleston Area Med Ctr, 422 promise and pitfalls of neuroscience 2006;32(4):229–234 SE 2d 827, 838 (W Va 1992)

Downloaded from by guest on October 30, 2016 PEDIATRICS Volume 138 , number 2 , August 2016 e15 73. In the Matter of the Welfare of the 80. Alderson P. Competent children? notice-fi les/not98- 024. html. Accessed Child of Colleen Hauser and Anthony Minors’ consent to health care October 28, 2013 Hauser, JV-09-68, Minn, Brown County, treatment and research. Soc Sci Med. 85. Whittle A, Shah S, Wilfond B, Gensler 5th Judicial District (2009) 2007;65(11):2272–2283 G, Wendler D. Institutional review 74. Ostrom CM. Mount Vernon leukemia 81. McAbee GN; Committee on Medical board practices regarding assent patient, 14, dies after rejecting Liability and Risk Management in pediatric research. Pediatrics. transfusions. The Seattle Times. American, Academy of Pediatrics. 2004;113(6):1747–1752 November 29, 2007. Available at: http:// Consent by proxy for nonurgent 86. Shaddy RE, Denne SC; Committee on www.seattletimes. com/ seattle- news/ pediatric care. Pediatrics. Drugs and Committee on Pediatric health/ mount- vernon- leukemia- patient- 2010;126(5):1022–1031 Research. Clinical report— 14-dies- after- rejecting- transfusions/ . 82. US National Commission for the guidelines for the ethical conduct Accessed June 27, 2016 Protection of Human Subjects of of studies to evaluate drugs in 75. Abraham's Law, VA Code §63.2-100 Biomedical and Behavioral Research. pediatric populations. Pediatrics. (2007) The Belmont Report: Ethical Principles 2010;125(4):850–860 and Guidelines for the Protection 76. Doig C, Burgess E. Withholding life- 87. de Vries MC, Wit JM, Engberts DP, of Human Subjects of Research. sustaining treatment: are adolescents Kaspers GJ, van Leeuwen E. Pediatric Washington, DC: US Government competent to make these decisions? oncologists’ attitudes towards Printing Offi ce; 1979. DHEW publication CMAJ. 2000;162(11):1585–1588 involving adolescents in decision- (OS) 78-0012-78-0014 making concerning research 77. Mercurio MR. An adolescent’s refusal 83. US National Commission for the participation. Pediatr Blood Cancer. of medical treatment: implications of Protection of Human Subjects of 2010;55(1):123–128 the Abraham Cherrix case. Pediatrics. Biomedical and Behavioral Research. 88. Olechnowicz JQ, Eder M, Simon C, 2007;120(6):1357–1358 Report and Recommendation: Zyzanski S, Kodish E. Assent observed: 78. Ross LF. Against the tide: arguments Research Involving Children. children’s involvement in leukemia against respecting a minor’s refusal of Washington, DC: US Government treatment and research discussions. effi cacious life-saving treatment. Camb Printing Offi ce; 1977. DHEW publication Pediatrics. 2002;109(5):806–814 Q Healthc Ethics. 2009;18(3):302–315; (OS) 77-0004 89. Wendler D, Belsky L, Thompson KM, discussion: 315–322 84. National Institutes of Health. NIH Policy Emanuel EJ. Quantifying the federal 79. Johnston C. Overriding competent and Guidelines on the Inclusion of minimal risk standard: implications medical treatment refusal by Children as Participants in Research for pediatric research without a adolescents: when “no” means “no”. Involving Human Subjects. Available prospect of direct benefi t. JAMA. Arch Dis Child. 2009;94(7):487–491 at: http:// grants. nih. gov/ grants/ guide/ 2005;294(7):826–832

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Informed Consent in Decision-Making in Pediatric Practice Aviva L. Katz, Sally A. Webb and COMMITTEE ON BIOETHICS Pediatrics 2016;138;; originally published online July 25, 2016; DOI: 10.1542/peds.2016-1485 Updated Information & including high resolution figures, can be found at: Services /content/138/2/e20161485.full.html References This article cites 66 articles, 25 of which can be accessed free at: /content/138/2/e20161485.full.html#ref-list-1 Subspecialty Collections This article, along with others on similar topics, appears in the following collection(s): Committee on Bioethics /cgi/collection/committee_on_bioethics Ethics/Bioethics /cgi/collection/ethics:bioethics_sub Permissions & Licensing Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: /site/misc/Permissions.xhtml Reprints Information about ordering reprints can be found online: /site/misc/reprints.xhtml

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2016 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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Informed Consent in Decision-Making in Pediatric Practice Aviva L. Katz, Sally A. Webb and COMMITTEE ON BIOETHICS Pediatrics 2016;138;; originally published online July 25, 2016; DOI: 10.1542/peds.2016-1485

The online version of this article, along with updated information and services, is located on the World Wide Web at: /content/138/2/e20161485.full.html

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2016 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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