The rules permitted researchers to use children in experiments that posed a possible health risk but no direct benefit, with consent from a family member. The rules did not require that the family member be a parent or guardian. In both situations, the court found the rules violated the due process provisions of the state and federal constitutions. The court forbade all such experiments on children. Different states and the federal government have different rules about experiments on children and incapable adults.
Federal rules are also stricter than the New York rules.
For example, under the federal rules, only a court-appointed surrogate can give consent, not any relative or friend. Moreover, for experiments on children with substantial risk and no direct benefit to the child, the federal rules require parental consent, consent of the secretary of health and human services, approval by an expert panel, and public notice and comment. The New York rules require only the consent of a relative. Officials at the New York State Office of Mental Health, which wrote the rules, declined comment and said they had not decided whether to appeal. Officials at the Department of Health, which oversees the Office of Mental Health, also refused to comment.