Policy Perspective
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
RIN 0925-AA53, Docket No NIH-2010-0001
The Council on Governmental Relations (COGR), representing 183 major research universities and affiliated centers, submitted comprehensive comments regarding proposed amendments to Public Health Service (PHS) regulations on promoting objectivity in research funded by the federal government. COGR expresses support for the overarching goal of ensuring research objectivity and transparency around fin
RIN 0925-AA53, Docket No NIH-2010-0001
The Council on Governmental Relations (COGR), representing 183 research universities and affiliated institutions, provides a detailed response to the Public Health Service (PHS) proposed amendments concerning the responsibility of applicants to promote objectivity in research, as outlined in federal regulations. COGR underscores the importance of ensuring research objectivity, favoring regulatory
COGR-APLU Analysis of the Common Rule NPRM Comments
The COGR-APLU analysis provided a comprehensive review of public comments submitted to the federal government regarding the Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule, which governs human subjects research. Over 2,100 comments were examined, representing a wide array of stakeholders, including the public, patients, researchers, institutions, industry, advocacy groups, an
NIH Single IRB Policy_Implementation Options
The document discusses the National Institutes of Health (NIH) draft policy mandating the use of a single Institutional Review Board (IRB) of record for multi-site NIH-funded research conducted at domestic sites, while foreign sites are given the option to comply. The policy aims to streamline IRB review processes, shifting regulatory compliance responsibilities—from IRB oversight to obtaining inf
