Will Proposed Changes to Federal Regulations Impact Barriers to Research Involving Children and Adolescents?

For the first time in twenty years, the U.S. Department of Health and Human Services (HHS) is considering changes to a portion of federal regulations governing research known as the “Common Rule” (45 CFR 46, 2009; Subpart A). At present, the proposed changes are not sufficiently sensitive to the potential impact on research involving infants, children and adolescents.

Given the importance of any rule change to the conduct of science related to children, The Society for Research in Child Development (SRCD) Task Force on Proposed Changes to the Common Rule, chaired by Fordham University Professor Celia B. Fisher, Ph.D., has written a report to alert policy makers, scientists, and participant groups on the consequences of proposed changes, and to provide recommendations for ensuring the responsible conduct of child and adolescent research in the final regulatory changes.

For example, as a consequence of ambiguities in the current regulatory definition of “minimal risk” and lack of examples for evaluating risk in pediatric research, Institutional Review Boards [IRB] often set up roadblocks to conducting surveys on older children’s alcohol or drug use, based on unsupported and exaggerated beliefs that simply asking such questions increases the likelihood children will engage in these behaviors. Such IRB actions discourage research involving children, and thus create a population of “therapeutic orphans,” unable to accrue the benefits of evidence-based social policies to promote positive development.

A related problem arises when IRBs needlessly require guardian permission for the involvement in clinical trials or research using surveys, interviews, or tests directly related to treatment and procedures for which adolescents designated by state law as “mature” or “emancipated” minors, have obtained legal status to independently consent. To ensure that changes to the Common Rule serve to rectify rather than exacerbate such inequities in approval of pediatric research, the SRCD Report recommends that any modifications to regulations include age-indexed examples of research meeting the “minimal risk” criteria. In addition, the report recommends it must be clarified that adolescents who, by state law, are considered “mature” and “emancipated” minors should be accorded adult status when they are asked to consent to participate in research on biomedical, social or behavioral factors related to medical services and procedures for which they are legally entitled to provide autonomous consent.

Furthermore, the report also provides recommendations for protecting child participants’ rights and welfare under the proposed new regulatory category of “informational risk” in light of current and emerging advances in analysis and storage of bio-specimens and information technologies for archival research.

Click here to read more about these and other issues covered by the SRCD report.

Fisher, C.B., Brunnquell, D.J., Hughes, D.L., Maholmes, V., Plattner, P. Russell, S.T., Liben, S., & Susman, E.J. (2013).  Preserving and enhancing the responsible conduct of research involving children and youth: A response to proposed changes in federal regulations.  Social Policy Report, 27 (1), 1, 3 – 15.


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