Islamic Center of Southern California

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 14

Research Involving Children

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Before undertaking research involving children, the investigator must ensure that:

the research might not equally well be carried out with adults;

the purpose of the research is to obtain knowledge relevant to the health needs of children;

a parent or legal representative of each child has given permission;

the assent of each child has been obtained to the extent of the child's capabilities; and

a child's refusal to participate or continue in the research will be respected.

Commentary on Guideline 14

Justification of the Involvement of Children in Biomedical Research. The participation of children is indispensable for research into diseases of childhood and conditions to which children are particularly susceptible (cf. vaccine trials), as well as for clinical trials of drugs that are designed for children as well as adults. In the past, many new products were not tested for children though they were directed towards diseases also occurring in childhood; thus children either did not benefit from these new drugs or were exposed to them though little was known about their specific effects or safety in children. Now it is widely agreed that, as a general rule, the sponsor of any new therapeutic, diagnostic, or preventive product that is likely to be indicated for use in children is obliged to evaluate its safety and efficacy for children before it is released for general distribution.

Assent of the Child. The willing cooperation of the child should be sought, after the child has been informed to the extent that the child's maturity and intelligence permit. The age at which a child becomes legally competent to give consent differs substantially from one jurisdiction to another; in some countries the "age of consent" established in their different provinces, states, or other political subdivisions varies considerably. Often children who have not yet reached the legally established age of consent can understand the implications of informed consent and go through the necessary procedures; they can therefore knowingly agree to serve as research subjects. Such knowing agreement, sometimes referred to as assent, is insufficient to permit participation in research unless it is supplemented by the permission of a parent, a legal guardian, or other duly authorized representative.

Some children who are too immature to be able to give knowing agreement, or assent, may be able to register a 'deliberate objection,' an expression of disapproval or refusal of a proposed procedure. The deliberate objection of an older child, for example, is to be distinguished from the behavior of an infant, who is likely to cry or withdraw in response to almost any stimulus. Older children, who are more capable of giving assent, should be selected before younger children or infants, unless there are valid scientific reasons related to age for involving younger children first.

A deliberate objection by a child to taking part in research should always be respected even if the parents have given permission, unless the child needs treatment that is not available outside the context of research, the investigational intervention shows promise of therapeutic benefit, and there is no acceptable alternative therapy. In such a case, particularly if the child is very young or immature, a parent or guardian may override the child's objections. If the child is older and more nearly capable of independent informed consent, the investigator should seek the specific approval or clearance of the scientific and ethical review committees for initiating or continuing with the investigational treatment. If child subjects become capable of independent informed consent during the research, their informed consent to continued participation should be sought and their decision respected.

A child with a likely fatal illness may object or refuse assent to continuation of a burdensome or distressing intervention. In such circumstances parents may press an investigator to persist with an investigational intervention against the child's wishes. The investigator may agree to do so if the intervention shows promise of preserving or prolonging life and there is no acceptable alternative treatment. In such cases, the investigator should seek the specific approval or clearance of the ethical review committee before agreeing to override the wishes of the child.

Permission of a Parent or Guardian. The investigator must obtain the permission of a parent or guardian in accordance with local laws or established procedures. It may be assumed that children over the age of 12 or 13 years are usually capable of understanding what is necessary to give adequately informed consent, but their consent (assent) should normally be complemented by the permission of a parent or guardian, even when local law does not require such permission. Even when the law requires parental permission, however, the assent of the child must be obtained.

In some jurisdictions, some individuals who are below the general age of consent are regarded as "emancipated" or "mature" minors and are authorized to consent without the agreement or even the awareness of their parents or guardians. They may be married or pregnant or be already parents or living independently. Some studies involve investigation of adolescents' beliefs and behavior regarding sexuality or use of recreational drugs; other research addresses domestic violence or child abuse. For studies on these topics, ethical review committees may waive parental permission if, for example, parental knowledge of the subject matter may place the adolescents at some risk of questioning or even intimidation by their parents.

Because of the issues inherent in obtaining assent from children in institutions, such children should only exceptionally be subjects of research. In the case of institutionalized children without parents, or whose parents are not legally authorized to grant permission, the ethical review committee may require sponsors or investigators to provide it with the opinion of an independent, concerned, expert advocate for institutionalized children as to the propriety of undertaking the research with such children.

Observation of Research by a Parent or Guardian. A parent or guardian who gives permission for a child to participate in research should be given the opportunity, to a reasonable extent, to observe the research as it proceeds, so as to be able to withdraw the child if the parent or guardian decides it is in the child's best interests to do so.

Psychological and Medical Support. Research involving children should be conducted in settings in which the child and the parent can obtain adequate medical and psychological support. As an additional protection for children, an investigator may, when possible, obtain the advice of a child's family physician, pediatrician, or other health-care provider on matters concerning the child's participation in the research. (See also Guideline 8: Benefits and Risks of Study Participation; Guideline 9: Special Limitations on Risks When Subjects Are Not Capable Of Giving Consent; and Guideline 13: Research Involving Vulnerable Persons.)

The Islamic Point of View Concerning Guideline 14

Research Involving Children

1. Since a child under the age of puberty is, in Islamic jurisprudence, entirely incompetent, his "informed" consent to participate in biomedical research is not valid. Legally, such a child does not have the freedom to take an action that is absolutely harmful to him or that wavers between benefit and harm, including the consent referred to above, and if he does take such an action, it is not valid. This rule aims at protecting such a child from misconduct in his own affairs, as he may give permission to something that will cause him absolute harm or harm that outweighs any benefit, being unable to appreciate the potential consequences of his behavior. A jurisprudence (fiqh) rule says, "Statements by a person whose action is not valid are not admitted." 50

2. Moreover, the basic position of Islamic jurisprudence is that the permission of a legal guardian to subject his ward to such research is not legitimate. Article 3/d of resolution 67 (5/7) of the Islamic Jurisprudence Academy says: "It is not permissible to conduct medical research involving subjects with only partial or no competence, even with the consent of guardians."

Exception to this basic principle, however, can be made, when a guardian does give his consent, in either of the following cases:

a. When there is an absolute or outweighing benefit, or when a child urgently needs to participate in research, which is to be determined, confirmed, and cleared by an ethical review committee.

Even if a non-perceptive child resists or objects, his objections are not taken into consideration, so that he can be protected from jeopardizing his interests or harming himself.

On the other hand, if the child is perceptive (he is close to puberty and his perceptive skills have developed sufficiently although he is still under a guardian), any objection on his part should be taken into consideration and should be submitted to review committees for decision.

b. When there is a general, indisputable need to conduct research relevant to children diseases, vaccines, and drugs, and at the same time, the potential risks to the subject child are not greater than, or slightly exceed, those attached to routine medical or psychological examination, and an ethical review committee approves the involvement. This ruling is based on the principle that a special need, i.e. one needed by a group of people with a common attribute, is ranked in Islamic Law as a necessity that renders permissible what is originally forbidden. (See the Islamic point of view for Guideline 13.)

50 Burhaan Al-Deen Ibn Mufleh, Al-Mubde', X: 146. Islamic Center of Southern California