External Resource
Final Common Rule
The document provides a comprehensive overview of the significant revisions made to the Federal Policy for the Protection of Human Subjects, widely known as the Common Rule. These revisions, jointly adopted by numerous federal departments and agencies, reflect a concerted effort to modernize and strengthen regulatory protections for individuals participating in research while addressing substantia
Association Responses to Petitions to the USDA
The joint letter from the Association of American Universities (AAU) and the Council on Governmental Relations (COGR) responds to a USDA request for public comment on a petition proposing amendments to the Animal Welfare Act (AWA) regulations. Specifically, the petition asks for the development of specific, ethologically appropriate standards for nonhuman primates used in research. In their respon
Analysis of Common Rule Comments
In January 2016, COGR staff and university and association volunteers began an analysis of the 2,186 comments submitted to regulations.gov in response to the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects (Common Rule).
April 30, 2015 - Abusive Litigation Practices of Patent Trolls
COGR and other higher education associations released a statement expressing the view that bipartisan legislation introduced in the Senate, seeking to address abusive litigation practices of patent trolls while protecting the integrity of our patent system, was a substantial improvement over the pending House version (HR 9).
NIH Definition of Clinical Trial Case Studies
The document provides a detailed analysis of various study designs to clarify the National Institutes of Health (NIH) definition of a clinical trial, using 25 specific case studies as illustrative examples. Each case is evaluated according to three primary NIH criteria: involvement of human subjects, prospective assignment of subjects to an intervention, and identification of health-related biomed
Coalition of Stakeholders, Encouraging Good Guidance – August 28, 2013
The document represents a formal communication from the Coalition in Support of Innovative Grants Reform (CSI), a consortium of prominent organizations representing universities, research institutions, nonprofits, state and local governments, and financial officers. Addressed to key federal officials at the Office of Management and Budget (OMB) and the Department of Health and Human Services, the
Resources
NIH Initiative to Reduce Regulatory Burden (1999)Federal Demonstration Partnership Faculty Workload Survey Reports (2012)
