The October 2017 Update from the Council on Governmental Relations (COGR) offers an extensive overview of current federal policy, regulatory, and compliance developments affecting research institutions. Central topics include the federal administration's ongoing efforts to reduce Facilities and Administrative (F&A) cost rates and the continued, coordinated advocacy from key associations urging the protection of such essential research infrastructure funding. The Update notes cautious optimism that the sector’s opposition is having an impact, while emphasizing the need for continued vigilance as legislative discussions persist. Additional significant items addressed include the ongoing evolution of Uniform Guidance regulations (particularly around procurement and micropurchase thresholds), recent federal audit practices, and new regulations and guidance from agencies such as NSF, NIH, DOD, FDA, and HHS. Notably, COGR outlines its proactive engagement on issues such as proposed regulatory reforms, the implementation of new cybersecurity requirements for defense contractors, handling of indirect costs, and potential changes to the Bayh-Dole Act.
The document further discusses the complexities of human subjects research compliance, including anticipated delays in the Common Rule implementation, new NIH review criteria for clinical trials, expanded definitions with substantial compliance implications, and updates regarding Certificates of Confidentiality and genomic data sharing. COGR also reports on collaborative efforts to influence open licensing requirements, monitors developments in single IRB mandates and equitable NIH RFA practices, and describes participation in workshops concerning data sharing and dual use research. Finally, the Update covers recent notable audits by the NSF OIG, the formation of an ad hoc committee on research misconduct confidentiality, and ongoing stakeholder engagement initiatives. Collectively, the report underscores the broad and dynamic regulatory landscape facing research institutions, highlighting both the challenges and proactive strategies employed to support effective research administration and compliance.
