This document provides a detailed side-by-side comparison of the regulations under Common Rule and current (and proposed) U.S. Food and Drug Administration (FDA) regulations (21 CFR 50/56 etc.), showing how FDA’s human-subjects-research and IRB requirements could be harmonized — or where they diverge — under the proposals stemming from the 21st Century Cures Act.
Download
Recent Posts
- October, 2024
The Role of AI in Clinical Research: Boosting Efficiency and Addressing Compliance Challenges
- December, 2025
Working with Vulnerable Populations
Summary DOJ NIH Rules on Sensitive Data Access
Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders
Comparison of FDA Regulations (Current and Proposed) & Common Rule
Summary of Proposed Changes – FDA Regulations 21 CFR 50, 21 CFR 56, and 21 CFR 812: Protection of Human Subjects and Institutional Review Boards