Policy Perspective
Report_of_the_Working_Group_on_The_Cost_of_Doing_Business
The report by the Council on Governmental Relations (COGR) examines the rising incremental compliance costs faced by U.S. universities in response to new and expanding federal regulations pertaining to research activities, as measured from 2000 to 2005. Despite the need for sophisticated compliance infrastructures to uphold federal requirements—such as protections for human subjects, environmental
DHHS_&_PHS_Policies_on_Research_Misconduct_Summary
The Department of Health and Human Services (HHS) Public Health Service (PHS) finalized its Policies on Research Misconduct in May 2005, establishing comprehensive guidelines and procedures for institutions receiving PHS support and for PHS itself to address allegations of research misconduct. The policy, codified in 42 CFR Part 93 and effective June 16, 2005, aligns PHS regulations with the Feder
Establishment_of_Multiple_Principal_Investigator_Awards
This document is a formal letter from Anthony P. DeCrappeo, President of the Council on Governmental Relations (COGR), addressed to the National Institutes of Health (NIH) regarding the establishment of Multiple Principal Investigator (PI) Awards. The letter acknowledges and commends the NIH’s initiative to adopt a multiple PI model to better support team science, viewing it as a constructive resp
Army_Human_Subjects_Medical_Insurance_and_Reimbursement_-_Clause
The document is a formal letter from Katharina Phillips, President of the Council on Governmental Relations (COGR), addressed to Colonel Kenneth A. Bertram of the U.S. Army Medical Corps. It highlights escalating concerns within the university research community regarding revised requirements imposed by the Army Medical Research and Material Command for the management and reimbursement of costs ar
Army_Human_Subjects_Medical_Insurance_and_Reimbursement_-_Policy
The document is a formal letter from Katharina Phillips, President of the Council on Governmental Relations (COGR), to Colonel Kenneth A. Bertram of the U.S. Army Medical Corps, regarding the human use requirements in the Army’s Congressionally Directed Medical Research Programs (CDMRP). The letter highlights concerns from over 145 research-intensive universities about recent Army policy changes t
University Association Preliminary Analysis of Common Rule Comments_050616
The document presents a detailed preliminary analysis conducted by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) of over 2,100 public comments submitted in response to the 2015 Notice of Proposed Rulemaking (NPRM) regarding revisions to the Common Rule, which governs the protection of human subjects in research. The analysis encompass
General Public
This document presents preliminary findings from COGR and APLU based on a review of 906 responses by individual members of the general public to the Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule, which governs human subjects research in the United States. The majority of public comments primarily addressed proposed regulatory changes concerning the use of biospecimens, incl
Analysis of Common Rule Comments
The COGR and APLU preliminary findings present a detailed analysis of 2,186 public comments in response to the 2015 Notice of Proposed Rulemaking (NPRM) on revisions to the Common Rule, the federal policy governing human subjects research. The main areas of proposed change included expanding the definition of "human subject" to encompass non-identified biospecimens, mandating broad conse
ORIMay9
The document is a formal letter from the Council on Governmental Relations (COGR), an organization representing research universities, addressed to Dr. Kathryn Partin of the Office of Research Integrity (ORI) at the US Department of Health and Human Services. The letter, sent on May 9, 2016, conveys appreciation for ORI's partnership approach and recent engagement with COGR’s Research Complia
COGR_AIRI_Procurement_Survey_June1_2016
The document is a formal letter from the Council on Governmental Relations (COGR) and the Association of Independent Research Institutes (AIRI) addressed to the White House Office of Management and Budget (OMB), reporting the findings of surveys commissioned to assess the administrative and cost impact of a proposed $3,500 micro-purchase threshold for procurement activities at research universitie
