Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences

该专家小组的工作旨在为联邦政府更新1991年修订的《共同规则》的当前努力提供信息。会议和讲习班上的讨论加上总结报告为政策制定和政策实施提供了变革性的潜力。当计算环境中的新技术在风险和对参与者身份和隐私的保护方面提出新的机遇、问题和挑战时，对共同规则的拟议修订是在非常需要的时候提出的。它们也出现在人们越来越关注人类研究保护系统的效率和有效性的时候，部分原因是对行为和社会科学研究的过度监管倾向，这些研究通常对参与者构成低风险（例如，非侵入性调查和访谈，二次分析，记录审查等）。核管理委员会工作的贡献将是确定、审查和评估最关键的问题；讨论和建议监管语言、指导方针和实施实例；并确定可以进行评估和研究的领域，以评估将纳入监管的新规则的适当性、质量、效率和有效性。

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.