Clinical Research involving Children: consideration relating to assent (English)
| Autor | Rita Villena Sarmiento - Marcia Vieira da Motta |
| Cargo | DDS, MS, PhD. International Association of Dental Research. President. Latin America Region - DDS, MS, PhD. Post-Doctoral Fellow. Medical School, University of Sao Paulo. |
| Páginas | 51-61 |
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Informed consent for vulnerable populations is a sensitive subject, especially when involving minors. Parental authorization is always required for clinical interventions to be performed in children and adolescents, even when not related to a clinical trial. However, most of the international ethical guidelines for research with human beings suggests that minors must be involved within the limits of their capacity, on their health related decisions. The idea is not to bureaucratize the process or to create a minor’s consent. Consent, that is the legal condition whereby someone can express agreement or permission for a specific act based upon a clear appreciation and understanding of the facts, is not obtainable from children in this sense, but an affirmative agreement is. This agreement is often called assent, the expressed judgment of minors to refuse or to accept medical care as a patient or as a research subject.
From infancy to adulthood, it is evident that there is a gradual development of emotional, cognitive and social skills that progressively increase a child’s ability to make self-defining autonomous choices. That is not to say that children develop equally in every aspect of their lives or that there is a definite pattern of development that applies to all of them. Those facing serious life threatening conditions or chronic diseases are often more skilled in their health related conditions than healthy overprotected children and also more likely to be involved in an assent context. Today, several jurisdictions legitimize the minor’s participation in shared decision-making, implying that even tough assenting or dissenting to a choice of treatment or participation in a clinical trial does not count as an authoritative wish, it should be weighed on the decision. Though, assent or dissent do not legally bind physicians to accede to the patient´s or subject’s specific requests, they require ethical reflection and commitment to a righteous conduct having the child’s best interest in mind. That is not to say that good care requires informed patient/subject participation, or that it is fundamental for the professional to take a paternalistic conduct when deciding what is best for the patient, particularly in pediatrics where clinical choices in some instances involve conflicting conducts considering opposing values such as quantity and quality of life.
The purpose of this paper was to explore the principles for obtaining assent from minors, based on the relevant literature and international and local regulations and guidelines, to help physicians and clinical investigators in the process of involving children in clinical trials.
Since the Helsinki Declaration in 19641, ethical guidelines in clinical research all over the world have been progressively acknowledging the child’s right, as research subjects and patients, to
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participate in decision-making processes related to their health. The concern with respect to their choice not to participate in a clinical procedure strengthened, in what has been described as expressed dissent. Under these circumstances, understanding is important, but the protection of the child is paramount. In fact, the Helsinki Declaration and its later amendments 2, 3 have addressed
deficiencies in the Nuremberg Code4, particularly in respect to research with the legally incompetent. From a more international perspective, the Council for International Organizations of Medical Sciences (CIOMS) in 19935, and then in 20026 and 20087, issued specific guidelines on ethical conduct in biomedical research with human beings.
In 1976, the American Academy of Pediatrics (AAP)8published their considerations on informed consent, which was a new concept at that time. The document, while ethical in principle, was normative in form: it emphasized the legal implications of informed consent on the daily practice. Practical yet important issues were addressed. Regarding an age for seeking assent, the document avoided chronological standardization as well as strict correlations with maturity or intelligence. Nonetheless, there were references to certain age landmarks. Generally, consent was to be obtained from children over the age of 7, but, for surgical cases and treatment, the recommended age was 13 or older, "a reasonable safeguard for physicians in all elective cases". As for responsibility on signing the consent forms, the minor’s legal representatives, namely one of their parents or a person in loco parentis (acting as parent), was considered sufficient to provide consent, unless a dispute existed between parents. In such cases consent from both parents was necessary. For divorced parents, the parent with legal custody was the one to sign the document. A year later, the National Commission for the Protection of Human Subjects and Biomedical and Behavioral Research published a report on research involving children9. The extensive and well-written report acknowledged the importance of the informed consent as a compromise of the patient’s whole family to the comprehension of the procedures to be undertaken on the minor, and argued that, although based on empirical data, there
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were studies that indicated that at particular ages children demonstrated the maturity to be involved in making ethical judgments. The age of seven was considered a time by which the child could express some reflexive judgment. For procedural reasons, this age was then considered suitable for consulting the child about their willingness or not to participate in research. Beneficence (the doing of good) was the main principle to be addressed in the research protocol and, in terms of non-maleficence (the avoidance of harm) the document considered that the child was protected by several mechanisms: the protocol review by the Institutional Review Board (IRB), the need of formal parental permission, the child’s own consent and their "veto with regard to involvement in a research project" (9).
The ethical principles of research involving human subjects was further developed on the Belmont Report 10, a milestone in the bioethics field, which provided a straightforward expression of what was necessary for obtaining informed consent: information, comprehension and voluntariness. Children, recognized as individuals with limited comprehension on account of their immaturity, were briefly discussed; they had to be considered on their own terms and, out of respect, they had to be given opportunity "to choose to the extent they were able, whether or not to participate in research". The limit of dissent was to be set by the availability of the proposed therapy elsewhere. Again, protection from harm would be ensured by seeking permission from third parties interested in the matter.
Later, the first publication of the CIOMS/WHO undertaking was published11. From this to the latest edition, in 20087, the concept of assent has evolved considerably. The initial 80’s proposition that consent was to be obtained within the limits of the child’s capacity, advanced to obtaining the child’s assent, provided information was given to the extent the child’s maturity and intelligence allowed. The guidelines mention that local legislation in respect of the legal "age of consent" had to be respected, even though normative parameters might not correspond to the child’s maturity and ability to knowingly agree to serve as research subjects. Thus, this informed agreement, occasionally referred to as assent, would be insufficient to permit the child’s participation, unless supplemented with a legal consent (from parents or legal representatives). The right to refuse to participate, which had already been mentioned in the 1982 document11, was also further developed. Younger children, too immature to be able to express assent, would at least be able to register their "deliberate objection", an expression of their disapproval or refusal to...
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