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
Overview of the Final Revised Common Rule
February 1, 2017: An overview of the changes to the revised Common Rule published in the Federal Register on January 19, 2017, a one page summary table of the changes made, and a link to the final revised Common Rule.
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
