Showing results for IRB

Understand the Difference Between FDA-Cleared and FDA-Approved Medical Devices
U.S. FDA Medical Device Oversight: Overview Distinguishing the terms “FDA-approved” and “FDA-cleared” is important. This article will review ...
Research with Prisoners – SBE
Examines the regulatory definition of “prisoner” and describes the requirements for conducting research with prisoners pursuant to 45 CFR 46 Subpa...
FDA Proposes Revisions to Rules on the Protection of Human Subjects and Cooperative Research
The U.S. Food and Drug Administration (FDA) proposed two new rules that would update regulations 21 CFR 50 (Protection of Human Subjects) and 21 CFR 5...
Overview of the Final Rule Revisions
Comprehensive review of the Final Rule revisions to the Common Rule, including concise, understandable descriptions of changes to 45 CFR 46.101-46.124...
The Cost of Compliance with the New NIH DMS Policy - COGR Survey Results
Introduction The recently released document presenting the results from the Council on Governmental Relations (COGR) survey on the cost of complying ...
Research with Prisoners – SBE
Examines the regulatory definition of “prisoner” and describes the requirements for conducting research with prisoners pursuant to 45 CFR 46 Subpa...
Bruce Gordon, MD
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