ETHICAL ISSUES IN BIOLOGICAL PSYCHIATRIC RESEARCH WITH CHILDREN AND ADOLESCENTS

Objective: This article reviews, discusses, and elaborates considerati ons and recommendations summarized by the biological research working group at the May 1993 NIMH conference on ethical issues in mental heal th research on children and adolescents. Method: Notes from the confer ence were summarized and supplemented by a computer search of relevant literature. Drafts were circulated for comment to national and intern ational experts, some of whom joined as coauthors. Results: Issues add ressed include possible overprotection by policy makers and institutio nal review boards arising out of the recognition of children's special vulnerability without equal recognition of their need for research; t he definition of minimal risk, which has often been equated with no ri sk in the case of children; assessment of the risk-benefit ratio; proc edures for minimization of risk, such as improved technology, ''piggyb acking'' onto clinical tests, and age-appropriate preparation; the dif ficulty of justifying risk for normal controls; age-graded consent; sp ecial considerations about neuroimaging; ''coercive'' inducement, both material and psychological; disposition of unexpected or unwanted kno wledge about individuals, including the subject's right not to know an d parent's right not to tell; and socioeconomic status and cultural/et hnic equity. Conclusions: The working group adopted a position of advo cacy for children's right to research access while recognizing that th is advocacy must be tempered by thoughtful protections for child and a dolescent subjects.