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
Joint Association & Institutional Letter to President Trump on Fetal Tissue Research Restrictions and COVID-19
The letter, dated March 25, 2020, is a joint appeal from numerous leading scientific, medical, and patient advocacy organizations to President Donald J. Trump. The signatories urge a reconsideration and immediate lifting of federal restrictions on research involving human fetal tissue, emphasizing the critical role such research plays in developing treatments and vaccines during the COVID-19 pande
Recommendations for HHS and NIH Research Regulatory Reform
The document critically examines the expanding regulatory and administrative burdens faced by U.S. academic research institutions engaged in federally funded research, particularly under the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). Despite a series of expert and congressional reports since the late 1990s recommending streamlining and harmonization
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
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
Summary of Changes to the Common Rule
The Council on Governmental Relations provided a detailed overview of the final revisions to the federal Common Rule, which governs the protection of human research subjects, as published in early 2017. The majority of the new regulations take effect on January 19, 2018, with the requirement for single IRB review of multisite cooperative research deferred to January 20, 2020. Significant updates i
COGR Common Rule Summary Table
The Common Rule Summary Table outlines significant revisions to federal regulations governing human subjects research. The final rule, effective from January 19, 2018 (with special provisions for cooperative research effective January 20, 2020), distinguishes between non-identified and identifiable biospecimens, treating identifiable biospecimens and private information equivalently and providing
NPRM Public Comments Overview
The document summarizes public feedback on the Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule, as reviewed in May 2016. Over 2,100 comments were received, a significant increase from earlier rounds, with the majority submitted by individuals without clear affiliations. Institutions, particularly medical and academic entities, also participated. Commenters raised concerns abo
