Event Materials
University_of_Pittsburgh_Thursday_Morning_Presentation_June_2015
The document, authored by Kelly Cole and Allen DiPalma, outlines the regulatory framework and institutional responsibilities for the oversight of Dual Use Research of Concern (DURC) at the University of Pittsburgh, in accordance with federal policies. It defines DURC as life sciences research that could be intentionally misapplied to pose significant threats to public health, agriculture, the envi
Guest_Speaker_Presentation_Thursday_Afternoon_June_2015
The document presents a summary of a guest speaker presentation by Julia Lane and Jason Owen-Smith, focusing on the value and impact of investments in academic research and education in the United States. The authors discuss the challenge faced by universities in demonstrating the tangible benefits of research expenditures, given the limitations of existing data and models. In response, they intro
Pierce_Presentation_Thursday_Afternoon_June_2015
The document, a presentation by Heather Pierce, addresses the evolution, implementation, and impact of federal regulations on financial conflicts of interest (FCOI) in research, specifically those funded by the Public Health Service (PHS). It outlines the timeline of regulatory revisions, beginning with the original rules from 1995, the advance notice in 2009, proposed changes in 2010, and culmina
Rudofski_Presentation_Friday_Morning_June_2015
The document, authored by Mary Beth Rudofski in June 2015, provides an assessment of the implementation of new federal Uniform Guidance standards—specifically §200.430 regarding compensation for personal services—at the University of Chicago (UChicago). Rudofski highlights the university's efforts to transition from traditional, often burdensome effort certification processes toward a system
Uniform_Guidance_Presentation_Friday_Morning_June_2015
The document summarizes a midterm assessment of the implementation of the Uniform Guidance (UG) as discussed during the June 2015 COGR meeting. Panelists from prominent research institutions provided updates on timelines, logistics, and emerging challenges related to the adoption and operationalization of the Office of Management and Budget’s (OMB) uniform standards across federal agencies. The pr
LeGrand_Thursday_Morning_Presentation_March_2015
The document is a presentation by Michael LeGrand from March 2015, addressing updates and interpretations of the Uniform Guidance (UG) regarding Facilities & Administrative (F&A) cost pools, as discussed at a COGR meeting. Key topics include the effective dates and implementation nuances for F&A rate calculations under the new UG, specifically referencing several regulatory clauses suc
Schrag_and_Gindhart_Thursday_Morning_Presentation_March_2015
The presentation by Naomi Schrag of Columbia University and Joe Gindhart of Washington University in St. Louis, delivered to the Council on Government Relations in March 2015, explores the comprehensive changes and clarifications introduced by federal Uniform Guidance (UG) Section 200.430 regarding compensation practices at institutions of higher education (IHEs). The discussion centers on key the
Wynes_Thursday_Morning_Presentataion_March_2015
The document outlines the key elements of the NIH Genomic Data Sharing (GDS) Policy, which became effective on January 25, 2015. The policy applies to both human and non-human genomic data generated through NIH-funded research and requires investigators and institutions to prepare and submit comprehensive genomic data sharing plans with their funding applications. Central to the policy are measure
Brake_and_Wynes_Thursday_Morning_Presentation_March_2015
The presentation by Lois Brako and David Wynes addresses the NIH’s draft policy proposing the use of a single Institutional Review Board (IRB) for multi-site, NIH-funded research studies. The policy would mandate that all domestic sites in multi-site studies rely on a single designated IRB to streamline oversight and compliance, with exceptions allowed only when justified by specific regulations o
Ward_and_Wilson_Thursday_Morning_Presentation_March_2015
The document authored by Pat Ward and Diane Wilson provides an in-depth examination of the evolution, requirements, and challenges associated with clinical trial registration and results reporting in the United States. Tracing developments from the 1997 Food and Drug Administration Modernization Act (FDAMA), which called for the creation of a public clinical trial registry, the presentation outlin
