Informed Consent on Behalf of Children

By Ronald L. Scott

When the Food and Drug Administration (FDA) recently announced new rules requiring pharmaceutical companies to test drugs on children see (see ), some drug companies expressed concern that the tests could be unethical, because they might put children at risk. Companies also expressed concern that children injured in drug tests might file lawsuits years later, even though parents gave consent.

Although testing drugs in children is too recent for the law of informed consent for children participating is tests of new drugs to be fully developed, an instructive body of law does exist with respect to informed consent on behalf of children in other settings.

The concept of informed consent arose from the idea of bodily autonomy. A physician has a duty to advise a patient of the benefits and burdens of any proposed treatment, and secure a patientís consent to treatment. The patient has the right to refuse treatment even against medical advice, and the patient has a right to be informed of unusual and/or undesirable outcomes and side effects. In certain circumstances, doctors can be liable for failing to obtain consent altogether or exceeding consent that has been given.

However, implicit in the above concept is the idea that the patient legally has the capacity to consent. What if the person being tested is a child? When a person lacks capacity to consent to (or refuse) medical treatment, two broad questions arise. First, who should decide? In the case of a minor, the usual possibilities are the childís parents or legal guardian, the physician, or the state, i.e., the courts. On what basis should such a decision be made. The two most common tests are asking whether the proposed treatment or refusal is in the "best interests" of the incompetent person, or alternatively what the incompetent person would have decided if he were competent, i.e., a "substituted judgment." The starting point is clearly that the decision to consent to or withhold consent for medical treatment is to be made by the parents. This is the parentsí right and responsibility, and their role as decisionmaker will be respected and supported unless they proceed in a manner inconsistent with applicable law. The courts have overridden parental rights in cases involving parental refusals of life-saving interventions or "medical neglect" (cases involving parental indifference to the well-being of a child). In such cases, courts consider whether a proposed consent to medical treatment or refusal of treatment is in the childís best interests. The difficulty is that most courts have tried to find a "one size fits all" test.

Courts often use a narrow, medical view of what the best interests of the person are. This is the sort of approach that seems desirable in deciding whether a child should be used as an organ donor or enrolled in a research study posing greater than minimal risk and that has no potential to benefit the child. The substituted judgment test is an effort to make the decision the person would have made if competent, even if such decision is not what others would think of as being in the patientís best interests. This standard requires weighing the patientís previously stated preferences, religious beliefs, and lifestyle. For patients that have previously been competent, the substituted judgment standard is quite appropriate. However, for infants, young children, or those that have never been competent, the test is illogical.

Although widespread drug testing on children may have been uncommon in the past, children have been involved in some clinical trials. For example, a majority of pediatric cancer patients are likely to be enrolled in a clinical trial during some stage of their treatment. To obtain legally-enforceable informed consent to participate in such clinical trials, researchers have an obligation to advise the childís decisionmaker about the probability of adverse side effects from the treatment component of the trial and the prognosis with and without treatment. Where children are mature enough to understand, i.e., "mature minors" their consent (or "assent") should also be obtained. Ethical pharmaceutical companies that submit drug trials to external review to ensure scientific validity and subject protection, refrain from any form of coercion, fully inform legal surrogate decisionmakers, and carefully document the informed consent process should not fear a barrage of lawsuits. FDA will convene a panel of pediatric experts and seek its advice on a range of issues, including ethical issues raised by clinical trials of pediatric patients. The benefits of obtaining detailed and accurate information about drugs used by children are substantial. See Why FDA Is Encouraging Drug Testing in Children at