Preserving and Enhancing the Responsible Conduct of Research Involving Children and Youth: A Response to Proposed Changes in Federal Regulations and commentaries

F or the first time in twenty years the U.S. Department of Health and Human Services (DHHS, 2009) is considering changes to federal regulations governing research. The Common Rule provides the basis for government regulations and Institutional Review Boards (IRB). Proposed changes will have a significant impact on Institutional Review Board evaluation of research involving infants, children and adolescents. For example, such a revision can serve to rectify or exacerbate often observed IRB inconsistencies and over-estimation of probable harms when applying “minimal risk” or “exempt” criteria to research involving minors. Proposed revisions may also affect the feasibility of research on adolescent risk that requires waiver of parental or guardian permission to be successfully implemented. Further, recommendations for a new category of “informational risk” based on current and emerging advances in analysis and storage of bio-specimens and information technologies for archival research will have significant influence on ethical procedures required for collection and storage of longitudinal and cross-sectional data. Given the importance of any rule change to the conduct of science related to children, the Society for Research in Child Development (SRCD) convened the SRCD Task Force on Proposed Changes to the Common Rule. The purpose of this report is to alert policymakers, scientists, and participant groups to proposed changes most relevant to research involving children and to provide recommendations for ensuring the responsible conduct of child and adolescent research in the final regulatory changes.