The U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) on July 26, 2011 to solicit comments on how current regulations for protecting research participants under the federal government’s so-called Common Rule could be modernized and revised to be more effective. The proposed revisions to the Common Rule are coming at a much needed time when new technologies 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 of our system of human research protections, in part because of the tendency to over-regulate research in the behavioral and social sciences. Many comments from behavioral and social science organizations submitted in response to the ANPRM showed support for much of the proposed new rulemaking, but also raised issues and new questions that should be addressed before the new rules are put into regulation.
The National Research Council’s Division of Behavioral and Social Sciences and Education plans to convene a panel to address the proposed revisions that have particular relevance to the behavioral and social sciences. 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 National Research Council aims 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, and effectiveness of the new rules.
An initial planning meeting was convened on January 15, 2012 to plan the workshop, which will be held on March 21-22, 2013. The purpose of the public workshop is to invite input from selected experts on specific issues related to human research protections in order to engender an active discussion on the topics carefully laid out by the panel, such as: the appropriateness of the Common Rule for different behavioral and social science research methods; the concept of information risk and its relationship to methods and mechanisms developed by the federal statistical community to protect confidentiality while providing access to research data; the concept and appropriate treatment of psychological risk for human research participants; appropriate classification of research projects by the level of scrutiny required by an institutional review board (IRB); revisions to the consent process to facilitate informed decisions by human research participants while minimizing barriers to participation; and training that can effectively instruct researchers, IRB members, and other administrators with a role in IRB processes. The workshop will result in a published workshop summary.