Federal Limits Would Prevent Researchers' Abuse Of Children

New federal proposals to regulate the use of children as medical subjects will probably prevent their exploitation without hampering legitimate research, William J. Curran, professor of Legal Medicine at the Medical School wrote in an editorial in today's issue of the New England Journal of Medicine.

The Department of Health, Education, and Welfare drafted the tentative guidelines in response to earlier demands by the National Commission for the Protection of Human Subjects that children be protected from unethical medical researchers.

"You have to be earn careful about what you do to kids," Curran, a pioneer in the field of children's rights in medical research, said yesterday. Though he fears the government could interpret the rules too stringently, Curran still thinks they are reasonable. "It could have been much worse, as there were some radical proposals made which would have stopped most research," he added.

Barbara Mishkin, the former staff director of the commission on human subjects, said yesterday she was disappointed with some aspects of the proposals, particularly the lack of an age limit after which the experiments would need the child's consent. "Children should be given the opportunity to consent as a matter of simple justice," she said.

The regulations would leave local hospitals some latitude in interpreting them. "Gray areas would include drugs tried on children when the drugs may have side effects that could endanger the child," Curran said. "You may have to work with one child to protect other children. There may be some risk, but not a great risk," he added.

Curran said researchers experimented on institutionalized mentally retarded children in order to develop a polio vaccine, and that the new rules would limit such practices.

However, he said researchers need to experiment with children in order to develop vaccines and drugs for various childhood diseases.

The Boston Children's Hospital, which is one of the Medical School's teaching hospitals, already controls the use of minors as subjects. Gwen O'Sullivan, executive officer on the committee of clinical investigation, said yesterday that the federal proposals overlap with the hospital's rules and the changes would have a minor impact on their research.

Most of this research directly benefits the children involved, and many would die without the treatment, O'Sullivan said