The document is a formal comment submitted by the Council on Governmental Relations (COGR) regarding the Food and Drug Administration’s (FDA) interim rule for additional safeguards in clinical investigations involving children and FDA-regulated products. The letter commends the FDA for aligning its regulations (21 CFR Part 50 and 56) with those of the Department of Health and Human Services (DHHS), particularly in definitions related to research with children, but raises concerns about specific aspects. Notably, it questions the FDA’s proposed definition of “guardian,” arguing that the requirement for explicit legal authorization to consent to research could unnecessarily exclude certain children from beneficial studies due to variability in state laws. The letter recommends adopting a definition consistent with DHHS.
Further, the COGR recommends that the determination of risk levels in research, particularly regarding minimal risk, should remain the responsibility of Institutional Review Boards (IRBs), as outlined by DHHS, to avoid inconsistencies and potential conflicts. The submission asserts that current regulations and available guidance are adequate for IRBs to assess risk in pediatric studies and sees no need for additional criteria or definitions. On other issues, the letter supports the continued requirement for a child advocate in cases involving wards of the state, and emphasizes the importance of age-appropriate explanations during assent, considering existing guidance sufficient. Regarding placebo-controlled trials in children, it supports their use under appropriate ethical standards, highlighting their scientific value and the guidance available for safe conduct. Finally, the document requests clarification on documentation standards for the implementation of new regulations, and expresses concern that the FDA may underestimate the administrative burden these requirements place on IRBs, particularly regarding documentation and the appointment of advocates.
