The October 2015 Council on Governmental Relations (COGR) meeting report details significant developments across research regulatory reform, costing policies, contracts, intellectual property, and research compliance. Major topics included the Common Rule Notice of Proposed Rulemaking (NPRM), with ongoing discussions around extending the public comment period and SACHRP's anticipated recommendations regarding biospecimens and consent. Updates were also provided on a variety of federal guidance and policy changes, including new FDA and OHRP joint guidance for IRB minutes, FDA guidance on informed consent for device studies using de-identified biospecimens, NIH’s proposed amendments concerning research involving recombinant or synthetic nucleic acid molecules, and changes to the NIH Grants Policy Statement for FY2016. The report further highlights the continuation of efforts to streamline federal award reporting through the DATA Act Section 5 pilot and summarizes audit updates from both HHS OIG and NSF OIG, which target oversight, financial controls, and compliance at higher education institutions.
In the domain of costing policies, the report reviews the outcomes of the FDP Payroll Certification pilots, noting improved faculty acceptance, administrative efficiency, and federal audits affirming the integrity of these alternative payroll reporting systems. Challenges and next steps are outlined for financial closeouts, procurement standards, and Facilities & Administrative (F&A) costs, particularly in the context of ongoing implementation of Uniform Guidance. The report discusses efforts to resolve issues related to the ACA employer mandate and its impact on graduate research assistants, as well as the effect of federal continuing resolutions on institutional grant management. Regarding contracts and intellectual property, the report addresses COGR’s comments and advocacy concerning new DOD information security rules, engagement with NARA on information security, additions to DOE contract clauses on export controls, and ongoing university-industry partnerships. Lastly, the report emphasizes the collective efforts to foster laboratory safety, adjust to evolving Department of Labor regulations, meet open access requirements, and respond to proposed changes in Research Terms and Conditions, indicating COGR’s commitment to advocacy, compliance, and reducing administrative burden for research institutions.
