The Child Welfare League of America (CWLA) submits the following comments on the Environmental Protection Agency (EPA) proposed regulations concerning protections for subjects in human research in the Federal Register (Vol. 70, No. 175 September 2, 2005, pages 53837- 53866.)
CWLA represents nearly 900 public and private nonprofit, child-serving member agencies across the country. Our members have responsibility for the 532,000 children in foster care in this country.
The revised proposed regulations do demonstrate an effort to ensure the adequate protection of individuals from pesticide testing. The revised regulations provide great securities against experimental testing of pesticides of human subjects including children and pregnant women.
However, CWLA has serious concerns with Sections 26. 401(2), 26.408(a), and 26.408(c) of the proposed regulations that could allow pesticide testing on children in foster care, children with physical or mental disabilities, or those children residing outside the United States.
Section 26.408(c) allows assent for pesticide testing without the permission of true legal guardianship. The proposed regulation specifically includes “neglected or abused children”.
Allowing children in foster care to receive experimental treatment or be part of research testing without providing an independent advocate to protect and assure the child’s safety and well being is contrary to CWLA’s Standards for Health Care Services for Children in Out-Of-Home Care and our Standards of Excellence for Family Foster Care. CWLA’s standards recommend that “the foster care agency should obtain written consent from the child’s parents, or alternatively, from the court…Parents should grant written consent for their child’s medical care: and for those children whose parent’s rights have been terminated, the agency should obtain written consent from the court.”
Section 26.408(a) of the proposed regulations also states that “If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived….” This section could result in the pesticide testing of children with mental or physical disabilities without the need to gain assent. The additional provision that allows an IRB to waive the assent requirement, even when a child “is capable of assenting”, also poses serious concerns for the well being of these children. CWLA also has concerns about the possibility of increased pesticide testing on children living outside the United States as stated in Section 26.401(2).
CWLA urges the EPA to remove the sections of the proposed regulations that allow pesticide testing on children in foster care, children with physical or mental disabilities, or those children residing outside the United States.
Shay Bilchek President/CEO
Child Welfare League of America