The meaning and importance of the informed consent of the patient has evolved in dramatic ways over the past two decades. Although its roots relate largely to the legal aspects of medical practice, the concept has emerged as a fundamental aspect of the ethical practice of medicine. ' It is felt to be expressive of the core ethical values of knowledge and freedom. Informed consent rests primarily on the ethical principle of respect: respect for the patient as a person with basic rights to know or to be informed and to exercise the right of autonomy or self-determination.
Although pediatricians have recognized the importance of this concept to the ethical practice of medicine,2 they have also realized that it had limited direct application in pediatrics since most of their patients lacked the capacity and legal power to give informed consent to their medical care. Clearly the concept can be incorporated into the care of many adolescents and most young adults; this has been acknowledged by the American Academy of Pediatrics in a variety of publications and policy statements.3-4
One practice widely adopted by pediatricians was to attempt to adapt the concept of informed consent by granting the parent the power to give consent by proxy. This seemed appropriate since parents are the legal guardians of the child. However, serious limitations of proxy consent have now been acknowledged. 5,6 One of the more obvious limitations is that the right of consent also encompasses the right to refuse consent. This right has been interpreted as including even the right to refuse a life-sustaining treatment. Allowing a proxy to exercise the right to refuse consent would confer on a parent a right to refuse any medical care their child might need, including life-sustaining medical treatments. Recognition of such a right would mean that a parent would have a right to endanger or even neglect the child. Clearly such a right is incompatible with the most basic understanding of child abuse and neglect, especially the concept of medical neglect.
Another serious objection to parental proxy consent is that pediatric health care providers have a wide range of ethical and legal duties and obligations that are owed to pediatric patients independent of parental desires or "consentings. " The Committee on Bioethics of the American Academy of Pediatrics acknowledged that "the most basic ethical principle" in the context of care of critically ill newborns is that "the pediatrician's primary obligation is to the child."7 Such an understanding of the role of the pediatrician and the nature of the basic ethical relationship in pediatric practice is obviously in serious tension with any concept of a parental right to decide.8
Although it might be possible to formulate a complex concept of proxy conset with built-in exceptions and limitations, another approach would be to use the concept of consent to refer exclusively to the autonomous authorizations provided by those with the capacity and legal power to make such authorizations. This approach was first proposed by the President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its recommendations regarding research involving children:
The Commission uses the term parental or guardian "permission," rather than "consent," in order to distinguish what a person may do autonomously (consent) from what one may do on behalf of another (grant permission).9
Clearly in this context it was inappropriate to conceive of a parent as having the "right to volunteer" the child to be a research subject, particularly in situations where a child was asked to participate in a project not intended to be of direct benefit to himself or herself.
This proposal has now been generalized to include the entire range of decision making involving the health care of infants and young children. It is based on the idea that parents and health care providers have a shared responsibility for the health and welfare of the child. The provider has the legal and ethical obligation to obtain the informed permission of the parents prior to any medical intervention (except in emergency situations when the parent could not be reached). However, such permission would not be treated as a sufficient basis in and of itself to justify medical intervention into the life of a child. In that sense the parent does not have a right of consent (a right and power to authorize the intervention) nor a right to refuse consent (a right and power to "block" the intervention). The ethical principles that justify medical interventions are that they are undertaken in response to demonstrable health needs of the child and are intended to protect and serve the child's interests.
Another important aspect of this change from the language of consent to that of permission is that clearly parental refusal to grant permission does not relieve the physician of duties and obligations to the child. In any such situation a pediatrician would have the duty of working with the parents to help them reassess the situation and, if necessary, to seek permission through involvement of appropriate agencies or the legal system. This is most obvious in cases in which the parent refuses to grant permission and the physician believes that the failure to provide care would be a significant risk to the child's health, ie, would endanger the child's health or welfare.
THE CONCEPT OF CHILD ASSENT
A much more challenging and fundamental aspect of this proposal to replace proxy consent with parental permission is that pediatricians have long recognized that decision making involving the care of children and adolescents must include the perspective and "voice" of the child. Individual advocacy for children assumes that the voice and interests of the child are of paramount concern to pediatricians. Instead of trying to select an arbitrary threshold beyond which children would be considered competent to make their own decisions and to provide consent, pediatricians have attempted to involve children in their medical care to the extent of their capacity.
Child assent allows for the explicit acknowledgment of this important set of ethical issues. Children are respected as persons with a developing capacity for participation in decision making. Assent asks that pediatricians involve children to the extent of their capacity; that children participate in making decisions about their health and health care to the extent that they are able.
Since assent is a relatively new concept, it is important that pediatricians understand the basic "building blocks" or elements. Assent has been defined to include at least three basic elements. The first is an ethical duty that most contemporary pediatricians have recognized and attempted to discharge: the duty to assist the child or adolescent in developing an age or developmentally appropriate awareness of the nature of the illness. It has been assumed that the care of the child is facilitated by this awareness. From an ethical perspective it can also be argued that respect for the child as both a patient and a developing person obligates the physician to play this important role.
The second element of assent is the ethical duty to disclose to the child/adolescent the nature of the proposed treatment and what he or she is likely to experience. Again, many contemporary pediatricians routinely disclose information regarding proposed diagnostic or therapeutic interventions to their patients. It is assumed that children are much more likely to cooperate in undergoing a particular procedure if they are told in advance what to expect. Also, the negative psychological consequences of procedures can be significantly reduced by allowing children to anticipate and to prepare themselves for the intervention. ,0 From an ethical perspective it could be argued that this duty of disclosure is based on the broader duty of truth-telling, or that the child is entitled to this information.
The third element is the most challenging, and again it is one that many pediatricians have attempted to honor.11 It is the obligation to solicit the child's or adolescent's expression of willingness to undertake the proposed treatment. The child's, and particularly the adolescents, willingness to undergo or undertake a particular treatment is a critical determinant of the ultimate success or failure of that treatment. The ethical aspects of this element call attention to the principle of respect for the emerging autonomy and developing capacities of children to make decisions and to serve as the guardians and caretakers of their health.
Proxy consent is replaced by a model of decision making that involves a sharing of decision making authority and responsibility. In the care of the infant, toddler, or preschool child this sharing includes primarily the health care providers and the parents or guardian of the child. It involves the ethical and legal obligations of the health care provider to the child, and the legal and ethical obligation of the provider to seek the informed permission of the parent or guardian. In the case of the school-aged child or adolescent the new model includes the additional ethical requirement of the child's assent as outlined above.
DISSENT OF THE CHILD
What is to be done if the child refuses to assent, or "dissents"? Clearly there are many situations in which children may withhold or temporarily refuse to assent to a proposed treatment in an effort to gain some control. Often they are attempting to understand what is happening to them or trying to deal with fear or the anticipation of a painful experience. The obligation to solicit assent in such a situation functions by asking that we be willing to hear, respect, and respond to these needs even if it might temporarily delay intervention. Manipulation, coercion, or force are to be avoided. However, they may be required in unusual emergency situations or as a last resort when all attempts to gain assent have failed. But even in this context the ethics of assent require an explanation of the need for the treatment and, often, an apology to the child who was asked to undergo the procedure against his/her will.
In some situations, the child's dissent may be ethically binding. Obviously dissent in non-therapeutic research is one example. However, the persistent objection of a child might also demand respect in a wide range of clinical situations in which the intervention was not considered essential or could be deferred to a later date.
CONFLICTING ETHICAL JUDGMENTS
One of the major objections to the model of shared decision making proposed here is the inevitability of conflicting judgments and decisions if provider, parent, and child or adolescent are all to share in this process. One of the most attractive aspects of proxy consent is that it seemingly placed ultimate decision making authority and responsibility in the hands of the parent or guardian. Just as obviously, this was the most dangerous and ethically inappropriate aspect of the concept. However, the proposed model does demand that mechanisms be created and be available to providers, parents, and pediatric patients for addressing ethical conflict. A wide range of such mechanisms should be considered, including medical consultations or "second opinion" provisions; liaison psychiatric, psychological, or social service consultation; "case management" or multidisciplinary conferences; pastoral care consultation; consultation with a clinical ethicist or hospital-based ethics committee; and others. In rare cases of refractory conflict formal legal adjudication may be appropriate.
This brief ethical analysis of informed consent proposes that the concept has a limited direct application in pediatric practice; ie, it can only be directly used in cases involving emancipated minors, adolescents, and young adults who have the capacity and legal power to provide this kind of autonomous authorization. In the care of infants, children, and younger adolescents, the concept should be understood and applied by pediatricians as the combination of two related concepts: the legal and ethical requirement to obtain parental permission to proposed medical interventions; and the ethical requirement to solicit the assent of the child patient whenever feasible. This new model for decision making allows a sharing of ethical responsibility among health care providers, parents, and pediatric patients and respects the important ethical duties, obligations, and rights of each.
1. Faden R. Beauchamp T: Histor» and Trend of lnfirmed Consent. New York. Oxford University Press. I986.
2. American Academy of Pediatrics. Task Force on Pediatric Research. Informed Consent, and Medical Ethics: Consent- Pediatrics I976; 57:414-416.
3. American Academy of Pediatrics: Conference on Consent and Confidentiality in Adolescent Heakh Care. Elk Grove Village. 111. American Academy of Pediatrici. 1982.
4. American Academy of Pediatrics. Committee on Adolescence: Counselling che adolescent about pregnancy options- Pediatrics 1989; 83:135-137.
5. Langham P: Parental consent: Its justification and limitations. Clin Res 1979: 27:1-18.
6. Gaylin W, Macklin R: WAo Speaks far the Child: The Problems of Proxy Ccmieru. New York. Plenum Press. 1982.
7. American Academy of Pediatrics. Committee on Bkierhics: Treatment of critically ill newborns. Adiolrics 1983: 72:565-566.
8. Bartholome WC: The child-patient: Do parents have the "righr ro decide.' in Spicker SF. Healey JM. Engelhardt HT (eds): The Law-Medkme Relation: A ïûlosopnical Exploration. Boston. D. Re ? JeI Publishers^ 1981.
9. National Commission fW the Protection of Human Subjects of Biomedical and Behavioral Research: Report and Recommendations: Research Invulvnui Children. Department of Health. Education and Welfare Publication No. (OS) 77-0004. 1977.
10. Kavanagh C: Psychological intervention with the severely burned child: Report of an experimental comparison of two approaches and their effects on psychological sequelae. J Am Acad ChOd Psychiatry 1983; 22(21:145-156.
11. Leikin SL: Minors assent or dissent to medical treatment. J Pediatrics 1983; 102:169-176.