Authors: Dominic S. Carollo, M.D. et al
ASA Monitor 11 2018, Vol.82, 10-13.
This article is excerpted in part from “Fundamentals of the Pediatric Informed Consent Process.”1
The process of obtaining informed consent for a pediatric patient is distinctly different from the adult patient. Competent patients (i.e., adults with decision-making capacity) act autonomously in the process of providing an informed consent. However, the pediatric patient is presumed to lack competence because they lack either the age of majority, decision-making capacity or both. In these cases, the physician is seeking permission, as informed consent, from the parent(s) or guardian to provide treatment; hence, the word “parent(s)” is used interchangeably with “legal guardian.” It is both ethically and legally presumed (and overwhelmingly true) that parents are invested into making decisions consistent with their child’s best interest. As such, parents are given significant latitude when making decisions for their child; boundaries for this latitude arise when the well-being of the child is at significant risk.
Ideally, medical decision-making in the best interest of a child is a shared responsibility between the stakeholders, the parent(s), the physician and, to the extent possible, the pediatric patient. Fortunately, the goals and choices frequently align; however, when they misalign, conflict results. As a fiduciary obligation, the physician is responsible for recognizing when decisions are being made that may not represent the child’s best interest. This is challenging because physicians are biased toward only two of 13 elements (life and health), identified by Janet Malek, that comprise a child’s best interest; whereas parents are likely weighing all 13 (life, health, basic needs, protection, development, pleasure, education, expression, interaction, parents, identity, self and autonomy).2 When conflict occurs, it is advisable to obtain an ethics consult that includes legal experts at your institution in an attempt to mitigate the potential alienation of either the patient, family or both.
The Easy Part: An Aged-based Approach to Assent
The appropriate degree of participation by a pediatric patient in decisions involving their medical care depends on the following factors: age, cognitive development and their level of interest in the decision-making process.3 A sliding scale for appropriate participation recognizes that children as they mature develop the emotional, psychological and intellectual ability to weigh medical information in relation to their personal values, principles and life goals. These characteristics are necessary prerequisites for medical decision-making capacity, which requires the ability for cognition and communication as well as a stable value set. Through assent, the child (or an incompetent adult) makes choices, at the level of their capacity, regarding their own treatment; and sometimes more importantly, they agree to participate in or at least cooperate with the treatment.
Legally, the anticipated level of capacity to participate in medical decision-making by pediatric patients has been separated into three groups by chronologic age, generally known as the “Rule of 7s.”4
The physician anesthesiologist obtains permission (informed consent) from the parent(s) for any child younger than 7 years of age. This age group, almost without exception, does not have decision-making capacity. Capacity is assumed to be lacking for children between the ages of 7 and 14 years, so again parental permission is obtained. However, this lack of capacity is rebuttable. Based on their age, physiological and emotional development, and life circumstances, some of these children may have developed a context-specific capacity. Finally, capacity should be assumed for children older than 14 years of age. However, this too is rebuttable because some adolescents have not yet developed the psychological and emotional abilities necessary for decision-making capacity. For adolescents, the anesthesiologist should engage them in the decision-making process as appropriate, depending on their decision-making capacity, the relative risk of the decision and their best interest among other factors.3 However, permission (consent) is obtained from the parent(s), with specific exceptions discussed below.
The Not So Easy Part: Assent or a Pseudo-consent
Assent is not required for pre-school and school-aged children, but it should be sought in all pediatric patients, especially for adolescents. This allows the child to participate in decision-making, appropriate for their developmental stage, about their medical care. Factors for determining the level of assent include: age or developmental stage of the patient, complexity of the decision or choice, and the benefits and risks of seeking assent. For example, participating in the decision-making process (assent) for pre-school children might involve little more than choosing between a strawberry- or bubblegum-flavored mask for an inhalational induction. Whereas discussing age-appropriate information about their condition and the procedure should be offered to a developmentally appropriate 12-year-old. Then their opinion and assent could be solicited regarding analgesia options, such as a brachial plexus block versus intravenous narcotics for an open reduction and internal fixation of a radial fracture.
The American Academy of Pediatrics has described the elements of assent in their policy “Informed Consent, Parental Permission, and Assent in Pediatric Practice.”3
- 1. “Provision of information: [pediatric] patients should have explanations, in understandable language, of the nature of the ailment or condition; the nature of proposed diagnostic steps and/or treatment(s) and the probability of their success; the existence and nature of the risks involved; and the existence, potential benefits, and risks of recommended alternative treatments (including the choice of no treatment).
- 2. Assessment of their understanding of the above information.
- 3. Assessment, if only tacit, of the capacity of the patient or surrogate to make the necessary decision(s).
- 4. Assurance, insofar as is possible, that the patient has the freedom to choose among the medical alternatives without coercion or manipulation.”3
Older teenagers (adolescents) and young adults have similar neurobiology and cognitive capacities.5 The legal decision-making authority of the parents, and the ethical sensibility that adolescents deserve to be treated as developing autonomous medical decision-makers, has led to different assent/consent standards as these minors approach the age of majority. Greater participation is sought in medical decision-making and more weight is given to their preferences by providing information consistent with a true informed consent to the adolescent. The extent of their decision-making is limited only by their maturity and the degree of possible harm resulting from the decision.
The Hard Part: Assigning Decision-Making Authority to Adolescents
Decision-making capacity is the ability to substantially understand the relevant features and both the short- and long-term implications of a decision. Four criteria determine decision-making capacity6 :
- 1. Ability to understand and communicate information
- 2. Ability to think and choose with some degree of independence
- 3. Ability to assess the potential for benefit, risks or harms as well as to consider consequences and multiple options
- 4. Achievement of a fairly stable set of values.
Some additional factors are involved in the decision to assess a minor’s decision-making capacity, including, age, ability, experience, education, exhibited judgment, conduct, and a conceptual appreciation of relevant risks and consequences.7 Determining an adolescent’s decision-making capacity is central to the degree of authority granted to them for making their own medical decisions.8 –10
Variable degrees of decision-making authority are appropriate because adolescents are so heavily influenced by their emotions (outside appearance, peer pressure, etc.). Although most adolescents can demonstrate well-developed skills to rationally process information, these age-appropriate emotional influences limit their ability to make objective, rational choices using those skills hey possess. This leaves physicians and surrogates, e.g., parent(s), to determine on a case-by-case basis the degree of decision-making authority granted to an adolescent.
A subtle and nuanced distinction exists between variable degrees of decision-making authority and informed assent. On one hand, any decree of decision-making authority empowers the adolescent to directly make their own treatment choices, without legally providing informed consent. On the other hand, “Informed Assent” enables the adolescent to agree with, to participate in or at least cooperate with, treatment decisions that have been made for them. The age-appropriate emotional, psychological and intellectual abilities that are developing during the transition from pre-teen through adolescence and continuing into young adulthood are characterized by this distinction.
Factors for determining the level of assent include: age or developmental stage of the patient, complexity of the decision or choice, and the benefits and risks of seeking assent.
The Confusing Part: Treatment Without Parental Consent
Adolescents have legal authority to provide their own informed consent for medical treatment in three general categories; 1) an emancipated minor, 2) a mature minor and 3) a potential public health risk or benefit. State law varies with regard to an emancipated minor status. Some require a court ruling, sometimes requiring parental permission. Others grant emancipated minor status when certain conditions are met. And in some states, the law is silent with regard to the emancipation of a minor.11 In general, minors qualify as emancipated in situations such as being married, pregnant, parents caring for their child, active duty military service or by court order. In those states recognizing the mature minor status, on the other hand, an adolescent who shows sufficient decision-making abilities, including consideration of long-term consequences for a specific decision, is authorized to consent for medical interventions.4 In some states, the mature minor status may be granted by the individual clinicians; however, in most states judicial approval is required.
The final exception to parental consent is based on a medical condition that has a public health risk or benefit. In essence, these laws are encouraging and enabling minors to receive medical services, rather than avoid or not receive them for lack of parental consent, as a public health initiative. For example, minors can generally receive medical care without parental consent for mental health issues, pregnancy-related treatment (except abortion) or contraceptive services, testing (and sometimes treatment) for HIV or an acquired immuno-deficiency syndrome, testing and treatment for other sexually transmitted or communicable diseases, drug or alcohol dependency requiring treatment, and sometimes crime-related injuries. It is essential, though, to confirm specific state laws regarding each of these exceptions for issues such as any age criteria at which they apply, any specific parental notification requirements and privacy/confidentiality issues, the judicial (or non-judicial) bypass pathways, and laws pertaining to the emancipated and mature minor status.12
Urgent situations have different criteria for exceptions to the parental consent rule. Common and statutory law generally has supported the physician for providing emergency care.12 In fact, the Emergency Medical Treatment and Active Labor Act (EMTALA) mandates a medical screening regardless of consent for all patients presenting for emergency medical care.12 If a child’s life or health is seriously endangered, treatment can be pursued without parental consent. A good-faith effort should be made to contact the parent(s) at this time, but treatment should not be delayed. If appropriate, the minor may provide informed assent to the procedure, although the decision-making responsibility may shift to the clinician when the minor’s level of maturity precludes even a valid assent. However, all treatments in which delay would have lasting harm on the child should proceed.12
An interesting dilemma arises when parental judgement is impaired by alcohol or drugs. Judgement-impaired parents are not competent (they are incapable) of making decisions in their child’s best interest, so they are unable to provide informed consent for their child.13,14 Elective care for pediatric patients should be deferred when neither the parent nor the patient themselves (under an exception to parental consent requirements) can provide informed consent. Emergent care would be provided in accordance with the EMTALA statute.14
Ideally, physicians, patients and parents are active participants in the informed consent process for adolescents and older children. Agreement among these parties not only allows the procedure to proceed but also develops trust of physicians in the pediatric patient.
1. Carollo D, Waisel DB. Fundamentals of the pediatric consent process. In: Jericho BG, Jacobs J, eds. American Society of Anesthesiologists Syllabus on Ethics. http://www.asahq.org/∼/media/sites/asahq/files/public/resources/asa%20committees/syllabus-on-ethics.pdf?la=en. Published 2016. Last accessed September 10, 2018.
2. Malek J . What really is in a child’s best interest? Toward a more precise picture of the interests of children. J Clin Ethics. 2009;20(2):175-182.
3. American Academy of Pediatrics Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics. 1995;95(2):314-317.
4. Cardwell v Bechtol, 724 S.W.2d 739 (Tenn. 1987).
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5. American Academy of Pediatrics Committee on Bioethics: Guidelines on forgoing life-sustaining medical treatment. Pediatrics. 1994;93(3):532-536.
6. Weithorn LA, Campbell SB . The competency of children and adolescents to make informed treatment decisions. Child Dev. 1982;53(6):1589-1598.
7. Lewis CC . How adolescents approach decisions: changes over grades seven to twelve and policy implications. Child Dev. 1981;52:538-544.
8. Brock DW . Children’s competence for health care decisionmaking. In: Kopelman LM, Moskop JC , eds. Children and Health Care: Moral and Social Issues. Dordrecht, Holland: Springer Netherlands; 1989:181-212.
9. Belcher v Charleston Area Medical Center, 422 S.E.2d 827, 188 W.Va. 105 (1992).
10. English A, Bass L, Boyle AD, Eshrage F . State Minor Consent Laws: A Summary. 3rd ed. Chapel Hill, NC: Center for Adolescent Health & the Law; 2010.
11. Committee on Pediatric Emergency Medicine and Committee on Bioethics. Consent for emergency medical services for children and adolescents. Pediatrics. 2011;128(2);427-433.
12. Committee on Pediatric Medicine. Consent for emergency medical services for children and adolescents. Pediatrics. 2003;111(3):703-706.
13.Fraser JJ, McAbee G , for American Academy of Pediatrics Committee on Medical Liability. Dealing with the parent whose judgment is impaired by alcohol or drugs: legal and ethical considerations. Pediatrics. 2004:114(3):869-873.