Policy Perspective
Joint Association Letter on NIH Clinical Trial Case Studies
A number of institutions have contacted COGR over the last several weeks to express concern about clinical trial case studies that NIH has posted to their website to provide guidance on determining whether proposed research meets NIH criteria for a clinical trial.
Joint Association Letter on NIH Clinical Trial Case Studies
The document is a joint letter from four major academic and research associations (Association of American Medical Colleges, Association of American Universities, Association of Public & Land-grant Universities, and Council on Governmental Relations) addressed to the National Institutes of Health regarding the recent expansion of the definition of "clinical trial" through newly publi
COGR Submits Joint Letter with AAU to DOD on DFARS Streamlining Measures
The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) submitted comments to the Department of Defense regarding proposed changes to regulations governing defense contracts, specifically focusing on the definition and treatment of fundamental research under the Defense Federal Acquisition Regulation Supplement (DFARS) clauses. The organizations express appr
HHS and NIH Research Regulatory Reform
The document from the Council on Governmental Relations (COGR) provides a comprehensive analysis of regulatory challenges faced by research institutions under the U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). It details longstanding concerns about the escalating administrative burden and costs associated with federal research regulations, highlight
Recommendations for Non-HHS Research Regulatory Reform
The document from the Council on Governmental Relations (COGR), dated August 24, 2017, presents a comprehensive set of recommendations aimed at reforming non-Health and Human Services (non-HHS) research regulations to reduce administrative burdens and streamline compliance requirements for federally funded research. It urges the consolidation of regulatory oversight—currently fragmented across mul
Recommendations for HHS and NIH Research Regulatory Reform
The document critically examines the expanding regulatory and administrative burdens faced by U.S. academic research institutions engaged in federally funded research, particularly under the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). Despite a series of expert and congressional reports since the late 1990s recommending streamlining and harmonization
Discussion Points on Facilities and Administrative Costs and Regulatory Reform
The document discusses the intersection of facilities and administrative (F&A) costs with ongoing efforts to reform research regulations in the United States. It emphasizes that while research institutions and academic medical centers support reducing unnecessary federal regulations to improve the use of research funds, any anticipated reduction in F&A costs tied to decreased regulatory bu
