The document is a formal comment letter from the Council on Governmental Relations (COGR), authored by Katharina Phillips, in response to the U.S. Food and Drug Administration's (FDA) interim rule concerning additional safeguards for children in clinical investigations of FDA-regulated products. The letter acknowledges and supports the FDA's efforts to align its regulations with the Department of Health and Human Services (DHHS) rules, particularly regarding definitions related to pediatric research terminology, such as "ward," "permission," "assent," "children," "parent," and "guardian." However, COGR raises concerns about the expanded definition of "guardian," noting that stricter requirements could unintentionally exclude certain children from participating in potentially beneficial research due to state law variations.
The letter provides detailed commentary on aspects of risk assessment and documentation, advocating consistency with DHHS guidelines and expressing confidence in Institutional Review Boards' (IRBs) existing expertise and available resources for evaluating research risks. It supports the appointment of an advocate for wards of the state, the necessity of age-appropriate explanations in assent procedures, and the continued allowance of placebo-controlled trials in pediatric studies, provided they do not increase risk for participants. COGR requests clarification on documentation requirements for ongoing studies and suggests that the FDA may underestimate the additional review burden on IRBs. Overall, the letter underscores the importance of protecting pediatric research subjects while cautioning against regulatory inconsistencies or requirements that may inadvertently restrict valuable research participation.
