The work of this expert panel is intended to inform the current efforts of the federal government to update the Common Rule, last revised in 1991. The discussion at the meetings and workshop plus the summary report offers potential to be transformative for policy making and policy implementation. The proposed revisions to the Common Rule are coming at a much needed time when new technologies in computing environments are presenting new opportunities, questions, and challenges with regard to risks and protection of participants' identification and privacy. They also come at a time of growing concern about the efficiency and effectiveness of our system of human research protections, in part because of the tendency to over-regulate research in the behavioral and social sciences that generally poses low risks to participants (e.g., non invasive surveys and interviews, secondary analyses, record reviews, etc.). The contribution of the NRC work will be to identify, review and assess the most critical issues; to discuss and suggest regulatory language, guidelines, and examples for implementation; and to identify areas of evaluation and study that could be undertaken to assess the appropriateness, quality, efficiency, and effectiveness of the new rules that will be put into regulation.
The Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRN) on July 26, 2011 to solicit comments on how current regulations for protecting research participants under 45 CFR Parts 46 ("Common Rule") could be modernized and revised to be more effective. The National Research Council’s Division of Behavioral and Social Sciences and Education (DBASSE) convened a panel to address the proposed revisions to the Common Rule that have particular relevance to the behavioral and social sciences. The goal of this first phase of a two-phase project was to convene a workshop and develop a workshop summary that would address the following topic areas: Identification of critical issues raised in the proposed rulemaking for the protection of participants and for the advancement of the social and behavioral sciences. Discussion of methods for addressing issues with specific examples and best practice models in the context of behavioral and social sciences research. Discussion of specific topics for future research that will assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation by IRBs and researcher. The workshop was convened on March 21-22, 2013. Eighteen presenters, mainly from academia but also from industry, government agencies, and professional societies, provided their insights in six broad topic areas: Evidence on the functioning of the Common Rule and of institutional review boards (IRBs) to provide context for the proposed revisions The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm The consent process and special populations Issues related to the protection of research participants in studies that involve use of existing data and data sharing Multidisciplinary and multisite studies The purview and roles of IRBs Approximately 60 persons attended the workshop in person, but an additional 60 others participated via a live webcast. The final workshop summary was released in August, 2013 and is available through the National Academies Press at: www.nap.edu/catalog.php?record_id=18383. The workshop provided information not only about how the proposed revisions would affect the diverse research methodologies used in the behavioral and social sciences, but also about possible alternatives or refinement to the proposed revisions that might make them more workable for these disciplines. Thus, the information conveyed at the workshop, the discussions that took place there, and the workshop summary product have the potential to impact the new regulations that will be issued in the future. More immediately, the workshop had the impact of providing input and laying the ground work for a National Research Council consensus study which will produce recommendations for federal agencies' decision-making with regard to the proposed regulatory changes. The potential impact of the workshop and the consensus study will be to enhance a critical component of the infrastructure of research, that being the interpretation and implementation of new rules concerning human research protections for studies in the behavioral and social sciences. More information on the project can be found at: http://sites.nationalacademies.org/DBASSE/BBCSS/CurrentProjects/DBASSE_083619
