The document provides a detailed overview of recent legislative and executive actions impacting federal research regulation as of early 2017, focusing on their implications for regulatory reform in the research sector. It highlights key legislation, notably the 21st Century Cures Act, the American Innovation and Competitiveness Act (AICA), and the National Defense Authorization Act (NDAA), each promoting reduced administrative burden and increased efficiency for research institutions. Major provisions include the establishment of a Research Policy Board, higher micropurchase thresholds, streamlined subrecipient monitoring, harmonization of research regulations, and enhancements to human research subject protections. These reforms aim to simplify compliance, reduce duplication, and promote performance-based approaches.
Additionally, the document addresses executive actions under the new administration, such as a regulatory freeze, a directive to repeal two existing regulations for every new one, and a federal hiring freeze. Specific agency guidance and upcoming reviews focus on reducing administrative overhead for NIH and HHS grantees, revising financial conflict of interest policies, improving data sharing, and better aligning human subject and animal research oversight. The creation of interagency working groups is intended to foster continued regulatory improvement and stakeholder engagement, while addressing broader governance issues such as funding, oversight, and regulatory policy outlooks amid evolving priorities in the new administration.
