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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Kristin West
Director, Research Ethics & Compliance
All Human Subjects Articles
COGR’s September 2025 Update
The September 2025 COGR Update provides an overview of recent federal developments affecting U.S. research institutions, including proposed regulatory changes, executive orders, litigation updates, and agency-specific policy shifts impacting research funding, compliance, security, and administration.
COGR February 2025 Update
The February 2025 COGR Update provides a detailed account of significant regulatory, policy, and administrative changes impacting U.S. research institutions, driven largely by executive orders from the Administration that restrict DEI programs, roll back regulations, and alter research funding and compliance practices. It highlights widespread operational disruptions, legal challenges over reduced
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
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
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
Diversity in Clinical Trials: February 2021 Meeting
The Council on Governmental Relations (COGR) virtual meeting on February 24, 2021, convened a panel of experts from academia, healthcare, and regulatory agencies to address the persistent lack of diversity in clinical trials. Presentations highlighted the ongoing underrepresentation of minority populations, older adults, and women in clinical research, as documented by FDA's Drug Trials Snaps
June 2017 Presentation: State Universities' Sovereign Immunity in PTAB Trials
The document provides an in-depth analysis of the applicability of state sovereign immunity, as established by the Eleventh Amendment of the U.S. Constitution, to state universities in the context of Patent Trial and Appeal Board (PTAB) proceedings, particularly inter partes review (IPR). Historically, states have been shielded from certain types of patent litigation in federal courts absent their
June 2017 Presentation: Continuing Challenges
The document provides a thorough overview of the historical evolution, current complexities, and ongoing challenges and opportunities associated with ClinicalTrials.gov, the primary U.S. registry and results database for clinical trials. Beginning with the system’s initial phase (1997-2000) and gradual regulatory build-up—including milestones such as the enactment of the FDAAA and subsequent ratif
June 2017 Presentation: Key ClinicalTrials.gov Reporting Requirements
The document provides a detailed overview of ClinicalTrials.gov, emphasizing its role as a public registry and results database for clinical studies involving human participants, encompassing interventional trials, observational studies, and expanded access programs across more than 200 countries. Managed by the National Institutes of Health (NIH), ClinicalTrials.gov facilitates transparency, acco
