Standards for enlisting foster children in federal medical experiments vary widely among the states, and the Bush administration is examining how best to protect “the most vulnerable in our population,” a top government health official says.
“Foster children are certainly vulnerable and failing to protect them will not be tolerated,” Health and Human Services Deputy Assistant Secretary Donald Young said in testimony prepared for delivery Wednesday to a congressional panel investigating the use of foster children in federal research.
The House Ways and Means human resources subcommittee called the hearing to examine the practice after The Associated Press reported earlier this month that federally funded researchers had tested AIDS drugs on hundreds of foster children since the late 1980s, often without providing independent advocates to safeguard the children’s interests.
Young said his agency began surveying states and found a wide variance in how and when permission is given to enlist foster children in research.
“Information gathered from several state foster care agencies suggests that authority to provide permission for other than standard medical treatment typically lies either with the judge supervising the foster care case, with a senior official within the foster care agency or with a guardian” appointed by the court, he explained.
“Some states continue to preclude the enrollment of foster children in experimental trials altogether, or will provide permission on behalf of the child only if the biological parents also give permission for the child’s participation.”
Nonetheless, the administration believes drug testing on children is “essential” to ensure the best medicines for children suffering from ailments like AIDS reach the marketplace and that current federal regulations, if followed, offer adequate protections, he said.
“We also recognize, however, the importance of continued vigilance to ensure the regulations are adhered to by investigators and the IRBs (institutional review boards) that oversee their activities,” he testified.
Independent advocates often not provided
Dr. Alan R. Fleischman, a top medical ethicist, told the panel he believed research on foster children can be conducted safely and ethically and that it would have been wrong to exclude foster kids outright from AIDS drug testing during the height of the U.S. AIDS crisis in the 1990s.
“The only way to provide the best treatment to any child with HIV at that time was through the clinical trials — the drugs were just not available any other way,” he told the panel in prepared testimony.
AP reported that researchers and the review boards that supervised their work often did not provide independent advocates for the foster children enlisted in AIDS drug trials, even in cases where they had signed agreements in New York and Illinois promising to do so in exchange for gaining access to the child wards.
Federal law also requires the appointment of such advocates in studies where there is a greater than minimal risk and the benefits to the patient aren’t as certain as current treatments in the marketplace.
'Special ethical dilemmas'
Marjorie A. Speers, executive director of the Association for the Accreditation of Human Research Protections Programs, told the panel in her prepared testimony that the use of foster wards presents “special ethical dilemmas” to the review boards that oversee federal studies.
The boards “must make specific determinations regarding the level of risk involved in a proposed study and whether there is a prospect of direct benefit to the individual subjects,” she explained.
“These determinations are not easy to make because IRBs must interpret regulatory terms, such as ’minimal risk’ or ’minor increase over minimal risk,’ she added.
It is those concerns that led several states to decline enrolling foster children for medical experiments.
Roberta Harris, a top Wisconsin health official, told the panel that her state has declined to enroll foster children in medical experiments for several reasons, including a desire to protect the mostly poor, disadvantaged families in the system from “giving consent under duress.”
“The types of research that have unfortunately occurred in our nation in the past also make it difficult for us to earn the trust and confidence of the families we are seeking to help,” Harris’ prepared testimony added.