THE NATIONAL ACADEMY OF ENGINEERING

Key Issues in Research With Children

Research Without the Prospect of Direct Benefit to the Child

Federal regulations that govern allowable research on children distinguish research without the prospect of direct benefit to the subject from research that carries the prospect of direct benefit. While the latter kind of research is permitted even if it involves greater than minimal risk, the former is carefully restricted to protect children from possible risk. The morality of research without the prospect of benefit to the child-subject was hotly debated by Paul Ramsey and Richard McCormack more than twenty years ago, and remains a contentious issue to this day. This module will examine critical concepts in research ethics such as risk, benefit, therapeutic intent, therapeutic misconception, and minimal risk to illuminate this controversy in pediatric research ethics.

Parental Rights Versus the Empowerment of Older Children

While parents are generally granted decision-making power with regard to health care for their children, such decisions for the purpose of research participation are more complex. Most parents, pediatricians, and legal authorities consider medical care for children mandatory, and the courts will routinely grant legal orders to administer life-saving interventions if parents or children refuse treatment. In contrast, research participation is considered supererogatory, and refusal to participate stated by parent or child may be deemed authoritative. The recent trend of granting older children more power in the decision about treatment or research may create new ethical conflicts that are difficult to resolve. This module will include scenarios involving such conflict to teach the relevant concepts and provide students with practical experience.

Harm to Children from Overprotection

Current policy that attempts to protect individual children from exposure to research risks may have the unfortunate consequence of harming children as a class by inhibiting research in pediatric health and disease. Based on this concern, children have been termed "therapeutic orphans" in the drug development and pharmaceutical industry. A recent effort by the Clinton administration has prompted the Food and Drug Administration to increase the number of drug studies with children to remedy this problem. This module will focus on the appropriate public policy balance between research protection for children and the need to help future children by conducting pediatric research. It will provide students with both descriptive and prescriptive approaches to the problem.

• Return to Research Ethics Module Supporting Pages

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