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Guidelines for Valid Informed Consent and Participative Decision Making

by SIOP Working Committee on Psychosocial Issues in Pediatric Oncology, 2003

Children clearly have a right to participate in medical decisions regarding their own treatment, based on the developmental level of the child. The objective of these guidelines is to encourage physicians to share with the child developmentally relevant medical information specific to that particular child’s health status, in the context of the child’s own culture, so that he or she can actively participate in the decision-making process regarding his or her own health.

ABSTRACT

This is the tenth official document of the SIOP Working Committee on psychosocial issues in pediatric oncology, instituted in 1991. It is addressed to the pediatric oncology community. Children clearly have a right to participate in medical decisions regarding their own treatment, based on the developmental level of the child. The objective of these guidelines is to encourage physicians to share with the child developmentally relevant medical information specific to that particular child’s health status, in the context of the child’s own culture, so that he or she can actively participate in the decision-making process regarding his or her own health. These guidelines, geared toward this objective, discuss the child’s right to medical information, the parents’ legal responsibility for but not exclusive right over the child’s health, and ways of encouraging the younger child’s active participation in his or her own health care at an age-appropriate level of understanding. For adolescents, there should be a full and legally mandated power to make their own decisions regarding medical treatment.
The concept of the adult patient’s right to participate in decisions regarding treatment has come to full awareness in recent years (1-3). There is an increased sensitivity regarding patient choices that are based on a full and adequate understanding and explanation on the part of the treating physician. But what about children? Do children also have a right to participate in medical decisions regarding their own treatment? Clearly the answer to this question depends on the developmental level of the child as well as on that particular culture’s view of the rights of children (4-6).

Syse distinguishes “informed consent” from “valid informed consent”(2). “Informed consent” by itself has often come to mean legally signed documentation without necessarily incorporating understanding on the part of the signer. “Valid informed consent” emphasizes the patient’s understanding of that which is being consented to and the understanding of the reasonable as well as irrational elements of his/her decision. For the purpose of these guidelines, we mean “informed consent” to refer to the patient’s full awareness and understanding as outlined in Syse’s term “valid informed consent.”

The objective of these guidelines is to encourage physicians to share with the child developmentally relevant medical information specific to that particular child’s health status, in the context of his or her own culture, so that the child can actively participate in the decision-making process for interventions regarding his or her own health. The following are guidelines directed toward this objective.

1. The child has a right to be treated with the best medical intervention available.

2. Parents are legally responsible for the health of their children who are under the legal age for giving independent consent. In many countries the freedom of adolescents to make their own decisions regarding their personal health comes at 18 years of age. Others give adolescents partial or full autonomy at younger ages for certain health issues, a reflection of a growing trend toward lowering the age of consent below 18 years of age. In any case, each country’s specific law must be followed.

3. Children under legal age do not have the right legally to refuse a treatment that has been approved by their parents. They do, however, have a moral right to a full and thorough explanation of procedures, based on their developmental level of understanding, and they do have a right to be asked for their assent to the procedures. No procedure should be performed on a minor without the attempt to gain the child’s assent or, at minimum–and depending on age–the child’s awareness and understanding (7-9). The fact that such a discussion took place should be duly recorded along with the reasons for refusal or hesitation regarding that treatment.

4. Parents should be fully informed at the first encounter and children informed as fully as their developmental level allows as soon as possible. However, it should be understood that communication is a continuing process, not a single event. It may take parents and children several meetings and conversations with physicians before they are fully aware of the implications of the treatment process. Taped initial interviews, with the tapes given to the parents, may help parents and their children to develop a more complete understanding as a prelude to a truly valid informed consent (10).

5. Information regarding potential participation in randomised therapeutic trials should be given to parents and to their children in time for them to make reasoned decisions and informed choices. It should not be presented at the last minute under the pressure of the need for prompt intervention. The major distinction between medicine as clinical research (testing the efficacy of new interventions) and medicine as therapeutic application (applying already proven interventions) should be explained carefully and fully to parents and their child. This is essential before they are asked to make a decision for or against inclusion in a randomised trial (11-12).

6. Communication is a continual two-way process over time. A healthy and open level of communication from the very beginning makes continued conversation less burdensome and more helpful when later treatment complexities arise (13). A renewed depth of communication becomes essential when the child relapses, needs a more intrusive intervention such as bone marrow transplantation, or enters into the terminal phase. The issue of pain control becomes central during the palliative phase (14).

7. Parents do not have exclusive rights to be the final decision makers regarding their child’s medical treatment. Court intervention should be sought if necessary to sustain the rights of the child when the parents refuse treatment the health care team deems to be in the best interest of the child. Such a decision can have serious adverse consequences in the relationship between the parents and their children, and family solidarity should be carefully monitored both during and after treatment given under these conditions.

8. The child and his/her parents are often bombarded at the time of diagnosis with unnecessarily complex and confusing information. At the same time they may be given several pages of information to read and sign, thus giving their “informed consent.” In many cases, this is neither informed nor is it consent. Medicine must respect the patient’s autonomy; legal documents should not be geared only toward the protection of the practitioners and the institution.

SUMMARY AND CONCLUSION

Consent comes first and foremost with human interaction, and not only with standardized models and with formalized written documentation. Curative intervention at the clinic must incorporate concern and caring on the part of the physician, as well as a true interest in the child.

For adolescents of legal age, there should be a full and legally mandated power to make their own decisions regarding medical treatment, with all of the rights and privileges accorded to adult patients, which they are in fact. Younger children should be accorded full respect for their capacity to understand and for their desire at an age appropriate level to participate in decisions regarding medical intervention.

Each centre should take it upon itself to put in writing procedures for informed consent to be followed at that particular centre.
ADDITIONAL READINGS
1. Convention sur les Droits de l’Homme et la biomedecine.Convention pour la protection des Droits de l’Homme et de la dignite de l’etre humain a l’egard des applications de la biologie et de la medecine. Oviedo, 1997.

2. Syse A Valid (as opposed to informed) consent. The Lancet 2002; 356: 1347-1348.

3. Habiba MA Examining consent within the patient-doctor relationship. J Med Ethics 2002; 26: 183-187.

4. Bragadottir H Children’s rights in clinical research. J Nurs Scholarship 2002; 32: 179-184.
5. Dickenson D, Jones D True wishes: The philosophy and developmental psychology of children’s informed consent. Philosophy, Psychiatry and Psychology 1995;2: 287-303.

6. Blustein J, Moreno JD Valid consent to treatment and the unsupervised adolescent. In Blustein J, Levine C, et al, editors. The adolescent alone: Decision making in health care in the United States. N.Y.: Cambridge University Press; 1999: p 100-110.

7. Murray JS Conducting psychosocial research with children and adolescents: A developmental perspective. App Nurs Res 2002; 113: 151-156.

8. Masera G Il doppio consenso e una legge morale. Pediatria 2002; 10:5-6.

9. Reder P, Fitzpatrick G What is sufficient understanding? Clin Child Psychol and Psych 1998; 3: 103-113.

10. Masera G, Spinetta JJ, Jankovic M, et al. SIOP Working Committee on Psychosocial Issues in Pediatric Oncology:Guidelines for a therapeutic alliance between families and staff. Med Ped Oncol 1998; 30:183-186.

11. Wiley FM, Ruccione K, Moore IM, et al. Parents’ perceptions of randomization in pediatric clinical trials. Cancer Practice 1999; 7: 248-256.

12. Levi RB, Marsick R, Drotar D, et al. Diagnosis, disclosure, and informed consent: Learning from parents of children with cancer. J Ped Hematol/Oncol 2002; 22: 3-12.

13. Masera G, Chesler MA, Jankovic M, et al. SIOP Working Committee on Psychosocial Issues in Pediatric Oncology: Guidelines for communication of the diagnosis. Med Ped Oncol 1997; 28: 382-385.

14. Masera G, Spinetta JJ, Jankovic M, et al. Guidelines for assistance to terminally ill children with cancer: A report of the SIOP Working Committee on Psychosocial Issues in Pediatric Oncology. Med Ped Oncol 1999; 32: 44-48.

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