UNIVERSIDAD MILITAR N.G. - Consentimiento informado en niños

Informed consent in children and young people: an introduction Pascal Borry, Louise Stultiëns, Herman Nys, Kris Dierickx Article 5 of the European Convention on Human Rights and Biomedicine, an international treaty ratified by the majority of the Member States of the Council of Europe (1), stipulates: “An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.” This article, is an example of the important ethical and legal right of persons to decide what happens to their bodies and to make decisions about their health. The concept of informed consent has become common practice in the context of European health care delivery and has referred authoritarian medical paternalism to the past. Also when considering the participation of minors in health care decisions, in the last two decades awareness has grown about the importance of providing clear information to children and adolescents about their health and to let them participate in decisions about their own health. In this context article 6 of the Convention on Human Rights and Biomedicine emphasizes that “the opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.” However, the participation of minors in health care decisions remains a delicate and difficult issue. This article wants to give a general overview of the ethical issues of examining and treating minors in relation to their participation in the decision making process: the issues of best interest, consent, and refusal in respect of provision of health care to children and young people will be discussed. Consequently, we will discuss more in particular a controversial situation in which there is a clash of opinions about treatment, i.e. carrier testing in minors. Finally, the issue of consent in the context of clinical research will be shortly addressed. It is clear that there are several elements of informed consent (2), each

presenting distinct issues. The information component refers to the adequate disclosure and comprehension of information, while the consent component refers to the voluntary decision. The focus of this article will be on the consent component and more in particular the competence to consent. The concept of best interest In law, the age of majority is the age at which one acquires full legal rights of an adult. For example the right to vote or the right to enter into contracts. In general, the age of majority is set at 18 years of age. However, the group of persons not yet having attained the age of majority is very diverse. It varies from newborns, babies, toddlers, pre-school children, children to adolescents. It is clear that minors cannot be considered as being a homogenous group, but should be considered as an amalgam of particular individuals with a specific level of knowledge, understanding, ability and competence. Minors are constantly changing, evolving and maturing. Age is therefore not the most adequate factor when considering the participation of minors in decision-making. Competence and maturity are more crucial. As a consequence, health care professionals should be fully aware of the fact that some minors are as able as adults or in some cases even more able to make difficult treatment decisions. From an ethical perspective rigid demarcations of maturity or immaturity based on age demarcation should therefore be avoided. When talking about healthcare decisions involving children, the concept of ‘best interest’ is taking a central position. Parents are responsible for their children and have the authority to make decisions on behalf of their children. This includes the moral and legal right to make decisions about the health of their children. Since parents are in most cases the persons who care most about their children and know them best, parents are expected to make the best decisions for their children, guided by the standard of ‘the best interest of the child’ (“acting so as to promote maximally the good of the individual”). (3) This concept is frequently used in ethical literature (4-8) and international documents (9;10) and it has

been argued that it should be a standard in healthcare decisions involving children. Health care professionals have the ethical and legal responsibility to intervene in the child’s interest only if parents are not able to decide for their child or if parental decisions may harm the health of the child. However, the general character of the concept often creates difficulties in interpretation when applied to concrete cases. (11) Firstly, conflicts may arise between the best interests of an individual child and the best interests of the family as a whole, or the best interests of other family members. Secondly, it is often unclear what type of interests is being promoted and whether there is a hierarchy in interests. (12) Various interests or presumed interests may contrast to each other. Next to the formulation of interest or benefit in terms of physical gains, the British Medical Association (13) for example described also a range of general factors with social and emotional elements that need to be considered when assessing a young patient’s best interests in relation to treatment. E.g., the patient’s own ascertainable wishes, feelings and values; the patient’s ability to understand what is proposed and weigh up the alternatives; the patient’s potential to participate more in the decision, if provided with additional support or explanations; the patient’s physical and emotional needs; the risk of harm or suffering for the patient: the views of parents and family; the implications for the family of treatment or non-treatment; relevant information about the patient’s religious or cultural background; evidence of the effectiveness of the proposed treatment, particularly in relation to other options; the prioritizing of options that maximize the patient’s future opportunities and choices; evidence concerning the likelihood of improvement with treatment; evidence about the anticipated extent of improvement; and risks arising from delayed treatment or non-treatment. According to the British Medical Association, any assessment of best interests should be clearly pursued in a holistic manner, taking into account the various physical, emotional, social, cultural and psychological needs of the whole person. In some situations, non-treatment might be entirely compatible with the patient’s overall best

interests. In concrete cases, the distinction between benefit in terms of physical gains or benefit in terms of social, psychological and emotional gains is often a reason for conflicts. Involvement of minors in the decision-making process While the ‘best interest standard’ is an important determinant in cases where children cannot participate in the decision-making process, this standard is becoming less adequate when children acquire more intellectual and psychosocial capacities and can take part in decisions on their health. Actually most ethical literature (14) on the subject, emphasizes that as soon as children are able to communicate and participate in decisions that affect them, they should be encouraged to participate in all aspects of the decision making process. They should be properly informed about medical issues that affect them, they should be able to express their views, ask questions or communicate their worries. As Rutter expressed it: “The implication is that health care professionals should be expected to talk with children, even during the pre-school period, about medical matters that involve them. This needs to be done in ways that the children can understand but that are no different in principle from the exactly comparable need to do so with respect to adults. Thus, most adults can scarcely be expected to understand all the complex considerations that go into decisions about different forms of medical treatment, or different surgical procedures, for specific conditions. It would make no sense to present the patient with the sort of technical evidence that would be taken into account by an expert in the field. On the other hand, it would be generally accepted that it is the duty of health professionals to provide the patient with as much understanding of these issues as possible and to engage them in the decision-making. Exactly the same applies in childhood.”(15) It is clear that during their development, children are acquiring cognitive, social and emotional skills. (16-18) However intellectual capacity and emotional understanding do not necessarily develop in the same way. There is a huge individual and societal variation regarding the moment particular levels of competence are achieved. As a consequence, from an

ethical perspective a rule about competence that is solely based on age cannot be satisfactory. This is also true with respect to adults considering that the age of majority is not necessarily synonymous for maturity. When assessing competence, it is important not to assess general competence, but to assess a patient’s level of understanding in relation to a specific choice that has to be made. “The nature and complexity of the decision or task, the person’s ability to understand, at the time the decision is made, the nature of the decision required and its implications, are all relevant. Thus the graver the impact of the decision, the commensurately greater the competence needed to make it.”(13) The issue of assessing competence in a young patient is necessary for instance if he/she presents himself for treatment alone, is to make a decision whether to accept or reject a treatment option, or where a young patient must give consent where parents refuse. Formal assessment of competence is less important if decision making involves the whole family and decisions are taken jointly. In the context of healthcare, various countries have integrated in their law that for the purposes of medical treatment people younger than 18 years may be judged competent to consent to treatment independently of their parents. In Scotland for example the age of majority is 18, but young people can make many legally binding decisions before that age. The presumption is made that over the age of 16 years, any person can make most decisions, including whether to consent to medical treatment. In the Netherlands, according to art.7:447 of the Dutch Civil Code a minor of 16 years old is competent to consent in a medical treatment. Conflicts In most cases, decisions about whether or which treatment should be offered to a child are made after having reached consensus between healthcare professionals, the parents and where possible the minor in question: in almost every case, agreement about treatment can be reached between the minor, parents and the team of healthcare professionals. A lack of consensus can be the result of poor communication and inadequate provision of information to those involved

in the decision-making process. Ethical conflicts about children’s ability to participate in medical decisionmaking seems to be dominated by situations where there is a clash between the expressed views of parents and children and/or where one or other of those also clashes with professional opinion. On the one hand questions arise particularly in situations where a child or minor refuses to be treated. In this context the harm caused by violating a competent choice must be balanced against the harm caused by failing to treat. It seems to be unlikely to be ethically justifiable to override a young person’s sustained, competent and informed refusal of treatment unless the treatment is essential to save or significantly enhance life. On the other hand, situations arise where conflict exists about the futility of specific medical treatment.

Case study: carrier testing in minors Various ethical conflicts where minors are involved have already been discussed in scientific literature. E.g., the case of Jehovah’s Witnesses children and the refusal of blood product (19;20) as well as the issue of male and female circumcision (21-24) are often discussed issues. A less discussed issue, but also controversial issue is the debate on genetic testing in minors. (25-27) When a genetic disorder is diagnosed in a family, an immediate question usually asked is whether other family members are at risk. When the relatives in question are adults, they can decide for themselves whether or not to undergo a genetic test. Children at risk, however, are dependent of others, usually the parents, for decisions about their health. Only clear medical and/or psychological benefits have been brought forward as ethical good reasons to test a minor. This cautious approach for testing in childhood originates from the fear that testing could create devastating social, emotional, psychosocial, and educational consequences in the child. It has been suggested that it might harm a child’s self esteem, create depression or anxiety, distort the family perception of a child or stigmatize a child. (28;29) Authors have

also stressed that testing children can breach the confidentiality (30;31) and the privacy of genetic information (32), can ignore the specific moral status of the child, and the respect for the autonomy of the child or adolescent. (33-35) It may also ignore the right of the child not to know (36), and the recent plea to integrate children and adolescents in medical decision making. (13;14;33;37-40) These issues are particularly relevant in the case of carrier testing. (41) Carrier tests are intended for healthy people who have no symptoms of a disease, but who are known to be at high risk because of a family history of a recessive genetic disorder. To be a carrier mostly doesn’t affect the health of the carrier, but could have consequences for the offspring. In the case of carrier testing, there is a discussion whether parents have the authority to request a carrier test for their children. On the one hand some authors have suggested that medical geneticists may have the duty to disclose both current and future information about conditions that are or could be inherited and to perform genetic testing on children on parental requests. (42) They suggest that parents are the most knowledgeable judges of the child’s best interests and should have the parental right and authority to decide for their children. On the other hand authors have stressed that healthcare professionals don’t have to comply with parent’s requests. (43) Healthcare professionals have the duty to promote the wellbeing of children and to react against decisions that have a significant potential for an adverse impact on the health or well-being of the child. (44) With the increasing recognition that minors themselves are entitled to increasing participation and autonomy in deciding about their health care, it has been stressed that parents have responsibilities for their children, but not rights. (33) Various documents (14;38;39;45;46) have emphasized that the wishes of competent older children concerning their health care should be taken seriously. Because carrier tests don’t provide medical benefit to the individual tested, but provide information that might be

important for reproductive decisions of the child later in life, it has been questioned why parents should be entitled to request a carrier test for their children as this information doesn’t provide immediate utility and violates the rights of privacy, confidentiality and autonomous decisionmaking of the child as adult. (47) As carrier testing only has implications for the reproductive health of the child and not for his own health, we advance that it is in the best interest of the child to postpone the decision to perform a carrier test until the moment the child can decide for himself as an adolescent or as an adult. We are convinced of the fact that healthcare professionals and parents should care about the genetic risk of children to have an affected offspring, and should take care of finding an answer to this risk. We do not hold the view, however, that testing children, following a parental request, for a condition that may affect their potential future children is acceptable. Some parents have argued that carrier testing in childhood might help the child to adapt to the knowledge of being a carrier slowly, while receiving the information later could be more shocking. The option to perform a carrier test in childhood does not take into account the alternate option to inform children about their genetic risk, without performing the carrier test in childhood. On the one hand one can intuitively understand that parents feel responsible for the well-being of their children and want to take actions which benefit them and their offspring. On the other hand it should be questioned whether parents could be considered as being responsible for the health of their potential grandchildren. We advance that the responsibility of parents does not go so far that they should be responsible for the health of their potential grandchildren. This would be a moral hypertrophy of responsibility. (48) We do not agree that parents, who do ask to perform a carrier test for their children, should be responsible for the potential harmful or negative consequences of not testing. In this way responsibility is being stretched endlessly (49). We advance, however, that parents are responsible for the health and wellbeing of their children and have the important responsibility to communicate the genetic risk to their children and to support them in dealing with that risk. We underline the familial character of genetic information and emphasize that genetic risk information should be discussed openly in a family context. However, we also emphasize the individual character of this information, the individual decision to undergo a genetic test and the individual choice to share the result of the genetic test with others. Indeed, the application of ethical principles to genetic services has shed light on the need for healthcare professionals to respect the autonomy, privacy, and confidentiality of those undergoing a genetic test. Furthermore psychosocial concerns incite us to caution. Only very few studies have been reported concerning the psychosocial consequences of carrier testing during childhood or adolescence. Even if they did not report long-term negative psychological and social impact, there is no reason to assume that carrier testing in minors should not be assessed with caution. Some studies about carrier testing in adults and screening context incite us to do so. Some adult carriers have been found to have less positive feelings about themselves or their current health and less optimistic views about their future health than non-carriers.(50-52) Some adults seemed to have experienced difficulties in understanding and assessing genetic risks, and in transferring accurate risk information to their children. (53;54) It is important that minors who receive health care should be active in this decision-making process. Minors should participate in health decisions that are affecting their offspring. It would be paternalistic and unrespectful to the minor who is maturing not to take his perspective into account. When an adolescent understands the information given to him and the implications of a positive and negative carrier test for him, his partner and his eventual offspring, he is capable to make a decision about performing a carrier test. It is also possible that adolescents prefer to postpone the carrier test, but it is important that minors are anyhow informed about their genetic risk. This genetic risk information can be used at different moments by those making reproductive choices: in adolescence, before a

couple marries or enter long-term relationships (prenuptionally), before they have children (preconceptionally) or during pregnancy (prenatally). Others may choose not to be tested and/or not to have children. The reasons underlying reproductive decisions are always varied and personal. Some people may for instance be reluctant to terminate a pregnancy because they may share the condition that affects a parent or other members of the family. Others may be anxious that their children would have to suffer from a disease other family members have suffered from. Choices and actions around sex, marriage and reproduction belong to the most personal and intimate aspects of life. Because the goal of a carrier test is situated in reproductive decisions, it is important that children, when growing up to be adults, are able to request a test personally and keep fully control over that information and share the information with who they want. This should, however, not restrain parents from discussing the opportunity of carrier testing openly with their children later in life. Children should be aware of their genetic risk from a young age even though the actual testing is being postponed. Letting children decide about their reproductive health means respecting them as humans with their own individuality and responsibility. Parents and genetic service providers should be supportive so that children at risk are informed about their genetic risk and are able to make decisions about genetic testing opportunities, if necessary. The presence of severe anxieties and uncertainties in parents about the possible carrier status of their child might be an indication for further psychological support in order to address these emotions rather than being a clear indication for testing. Research The issue of children’s capacity to understand and participate in decisions about their own health closely parallels the queries regarding their understanding of decisions about their involvement in (clinical) research. Clinical trials involving minors present a powerful tension between two sometimes conflicting objectives: on the one hand protecting individual children from harm and exploitation, and on the other hand increasing our knowledge about children in order to develop beneficial medical interventions. While research involving adults raises similar questions,

adults can make choices for themselves, regarding whether or not to become research subjects. In the past children have often been subject of medical research. They often participated without, however, adequate protection of their rights or well-being.(55) The Nurenberg Code was created to protect human rights in research studies. This was the first international standard to outline the basic principles in performing research in humans. It called for the informed and voluntary consent of the research participants. Because minors were considered unable to give consent, they were deemed inappropriate to participate in research. The Nurenberg Code therefore did not mention incompetent subjects. The Declaration of Helsinki (1964) was probably the first document to make provisions about the participation of incompetent subjects, including children, in clinical research. In the United States, the first systematic examination of the ethical issues raised by the participation of children in research was the report on children by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1977 (Belmont Report).(56) According to the European Convention on Human Rights and Biomedicine (article 16) research of humans may only be undertaken if there is (i) no alternative of comparable effective to research on humans, if (ii) the risks the risks which may be incurred by that person are not disproportionate to the potential benefits of the research, if (iii) the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability; if (iv) the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection; and (v) the necessary consent been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time. Articles 17 of the European Convention describes the protection of persons not able to consent, and considers that besides the just mentioned criteria (i) the results of the research should have the potential

to produce real and direct benefit to his or her health; (ii) research of comparable effectiveness cannot be carried out on individuals capable of giving consent; (iii) the person concerned does not object. Furthermore it is important to integrate here also the articles 5 and 6 of the Convention on consent, that have been described at the beginning of this text. Without going into detail in current policy and regulation, it is clear that regarding the children’s participation in research the issue of parental permission should be connected to the child’s assent. Firstly, it is impossible to let a child participate in clinical research if the parents or their legal representative are not giving consent to this. As expressed in the most recent version of the Declaration of Helsinki, article 24 stipulates: “For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.” Secondly, children should also be provided with the opportunity to express and discuss their willingness or unwillingness to participate in research. As expressed in the most recent version of the Declaration of Helsinki, article 25 stipulates: “When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. “ Published guidance(57-59) from a range of bodies comes to the same conclusion, namely that competent minors should decide if they want to participate in research, next to the parental permission. Most guidance does not attempt to set an age at which children’s views should be determinative, but refers to the importance of assessing competence. Assent can already be sought at very young age. E.g., the Royal college of Nursing (60) states that “the assent of children over seven years of age

should usually be sought directly.” Conclusion Decisions affecting minors are complex, because they involve three partners in the decision-making process. In decisions affecting young and incompetent children, parents are considered as the best placed persons to decide what is in the best interest of their children. Health care professionals have the ethical and legal responsibility to intervene in the child’s interests only if parents are not able to decide for their child or if parental decisions may harm the child. Since the late 1980s, various organizations and documents have recommended to let minors participate much more in the decisionmaking process about their health. This entails providing children with clear and detailed information (in accordance with their age and maturity), giving them the opportunity to express their views and to explicitly give assent or consent. Acknowledgements The research for this contribution was supported by the Eurogentest Network of Excellence of the EU, FP6-512148, and by EurocareCF, European Coordination Action for Research in Cystic Fibrosis. Reference List (1) Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo: Council of Europe, 1997. (2) Beauchamp TL, Childress JF. Principles of biomedical ethics. 5 ed. New York: Oxford University Press, 2001. (3) Buchanan AE, Brock DW. Deciding for others. Cambridge: University Press, 1989. (4) Dawson A. The determination of the best interests in relation to childhood immunisation. Bioethics 2005; 19(1):72-89. (5) Downie RS, Randall F. Parenting and the best interests of minors. J Med Philos 1997; 22(3):219-231. (6) Ross LF. Health care decisionmaking by children. Is it in their best

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