Recently established in the summer of 2012, this new SRCD task force was formed to focus on proposed changes to the Common Rule section of the DHHS Protections of Human Subjects. For the first time in 20 years the U.S. Department of Health and Human Services is considering changes to the Common Rule. Such changes will have important implications for the ways in which Institutional Review Boards (IRBs) will evaluate minimal risk, informational risk, informed consent procedures and waiver, confidentiality and privacy of records (included of bio-specimens), and expedited and exempt (“excused”) review of research. Given the importance of the proposed changes to research conducted by SRCD members, it is imperative that government deliberations include perspectives on implications for research involving children, families and youth as well as recommendations for how best to incorporate these considerations in the final regulatory changes. To date these issues have not been addressed.
As a result, SRCD’s Governing Council approved convening a Task Force on Proposed Changes to the Common Rule. The task force is chaired by Celia B. Fisher, Director of the Center for Ethics Education at Fordham University. The task force met in late July 2012 and developed a response to the current proposed changes addressed both to DHHS and the Secretary’s Advisory Committee on Human Subjects Protections (SACHRP). The purpose of this meeting was to formulate implications for research with children and families and begin to draft a response, all of which was accomplished.