COGR, representing over 230 U.S. research universities and affiliated institutions, submitted detailed feedback to the Department of Health and Human Services (DHHS)...
Human Subjects
Regulatory requirements and ethical considerations surrounding the conduct of research involving human subjects and provision of institutional oversight for such research by an Institutional Review Board (IRB).
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COGR Submits Comments to Department of Commerce on Ethical Guidelines for Research Using Pervasive Data
COGR, representing over 220 U.S. research institutions, submitted comments to the National Telecommunications and Information Administration (NTIA) regarding the...
UPDATED: Summary of Recent Significant Updates to the NIH Genomic Data Sharing Policy
This document summarizes significant recent updates to the NIH Genomic Data Sharing (GDS) Policy, focusing on new and stricter cybersecurity requirements and access...
COGR Responds to USDOJ’s Notice of Proposed Rulemaking—Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons
COGR, representing over 220 U.S. research institutions, submitted comments on the Department of Justice’s proposed rule aimed at restricting access to U.S. sensitive...
COGR Responds to Centers for Medicare & Medicaid Services February 2024 Request for Information on Research Data Request and Access Policy Changes – Updated March 1, 2024
COGR submitted comments in response to the Centers for Medicare & Medicaid Services’ (CMS) proposed policy changes concerning access to Research Identifiable Files...
COGR Responds to the Request for Information: Clinical Research Infrastructure and Emergency Clinical Trials
The Council on Governmental Relations (COGR), representing over 200 U.S. research institutions, submitted a detailed response to the White House Office of Science...
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All Human Subjects Articles
COGR Submits Comments in Response to DHHS RFI: Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again
COGR, representing over 230 U.S. research universities and affiliated institutions, submitted detailed feedback to the Department of Health and Human Services (DHHS) on streamlining federal research regulations to reduce administrative burden, enhance regulatory consistency, and foster innovation. COGR's letter highlights the need to eliminate duplicative or inconsistent requirements across federa
UPDATED: Summary of Recent Significant Updates to the NIH Genomic Data Sharing Policy
This document summarizes significant recent updates to the NIH Genomic Data Sharing (GDS) Policy, focusing on new and stricter cybersecurity requirements and access terms for researchers and developers accessing controlled-access human genomic data in NIH repositories. Effective January 25, 2025, institutions must ensure that IT systems used for accessing or storing genomic data comply with NIST S
Biden EO on AI: Agencies Perspectives: February 2024 Meeting
The COGR virtual meeting held on February 27–March 1, 2024 focused on the Biden Administration’s Executive Order 14110 regarding artificial intelligence (AI), examining how federal agencies such as NIST and HHS are responding to its directives, and what challenges and opportunities lie ahead. The presentations outlined ongoing federal efforts to promote trustworthy, safe, and ethical AI developmen
COGR's Response to Request for Information (RFI): Re-envisioning U.S. Postdoctoral Research Training and Career Progression within the Biomedical Research Enterprise [NOT-OD-23-084]
The Council on Governmental Relations (COGR), representing more than 200 U.S. research universities and affiliated institutions, submitted this response to the NIH’s Request for Information regarding the enhancement of postdoctoral research training and career progression in the biomedical field. COGR’s comments focus on several key policy areas to improve postdoctoral training pathways. It recomm
COGR Responds to the Request for Information: Clinical Research Infrastructure and Emergency Clinical Trials
The Council on Governmental Relations (COGR), representing over 200 U.S. research institutions, submitted a detailed response to the White House Office of Science and Technology Policy's Request for Information on enhancing clinical research infrastructure for emergency clinical trials (ECR). Drawing on extensive experience from the COVID-19 pandemic, COGR emphasized the necessity for rapid,
COGR Submits Comments to OHRP in Response to HHS-OASH-2022-0011 "Use of a Single IRB for Cooperative Research" Draft Guidance
The Council on Governmental Relations (COGR), representing over 200 U.S. research universities and affiliated medical centers, submitted detailed feedback to the Office for Human Research Protections (OHRP) regarding the July 2022 draft guidance on the use of a Single Institutional Review Board (sIRB) for cooperative research. COGR commends the OHRP for addressing the complexities of sIRB implemen
NSF's Efforts to Support Institutional Diversity: June 2022 Meeting
The document outlines the National Science Foundation’s (NSF) ongoing strategies and initiatives to bolster institutional diversity and broaden participation in science, technology, engineering, and mathematics (STEM). Presented by Dr. Alicia J. Knoedler, Head of NSF’s Office of Integrative Activities (OIA), the content describes the NSF’s university-like organizational structure and the OIA’s cen
COGR Submits Response to NIH on Suggestions on the Draft NIH Chief Officer for Scientific Workforce Diversity Strategic Plan for FY 2022-2026 (NOT-OD-22-061) RFI
The Council on Governmental Relations (COGR), representing nearly 200 U.S. research universities and related institutions, provided formal feedback in response to the NIH’s Request for Information on its Draft Strategic Plan for Scientific Workforce Diversity for 2022-2026. COGR commended NIH’s efforts toward diversity, equity, inclusion, and accessibility (DEIA) and acknowledged alignment between
COGR Submits Comment Letter to NIH on NOT-OD-22-064
The Council on Governmental Relations (COGR), which represents nearly 200 major U.S. research universities and related institutions, submitted formal comments in response to the National Institutes of Health (NIH) Notice NOT-OD-22-064, seeking input on supplemental guidance for data management and sharing, especially regarding research involving American Indian and Alaskan Native (AI/AN) communiti
Strengthening Diversity, Equity, Inclusion and Accessibility at NIH: June 2022 Meeting
The document outlines the National Institutes of Health’s (NIH) comprehensive strategy to strengthen diversity, equity, inclusion, and accessibility (DEIA) within its workforce and the broader biomedical research community. Guided by federal mandates, such as Executive Order 14035 and legislative directives, NIH developed a strategic plan with both broad and specific objectives to address systemic
