Common Rule

HRP is pleased to provide this series of materials to help you and your organization prepare for implementation of the changes to the Common Rule.

Please download for your own use and for sharing with colleagues. This series will continue to be updated over time; if you would like to be notified when new materials are available, please sign up below.

• New! Implementation Tips and Reminders
• New! Sample Communique to Research Community
• UPDATED Sample Temporary SOP Addendum Dec 2018
• Implementing the Revised Common Rule – 10 Ways to Get Started 
  • Appendix A – Thinking Points: Applicability of the Common Rule, Changes to FWAs
  • Appendix B – Thinking Points: Broad Consent
  • Appendix C – Thinking Points: Management of Pre-existing Studies
• Exemptions with Limited IRB Review
  • Appendix A – Exempt Categories
  • Appendix B – Sample Review Checklist, Exempt Category 7
• Pros & Cons – Thinking Points of Implementing the “Three Less-Burdensome Provisions”
• Sample Research Status Report
• Summary of Changes (Table)
• Table Comparison of Common Rule, Revised Common Rule, and FDA

We’re here to help!

We hope this is helpful for you and as always, if you have any questions, please feel free to contact us at any time.  If you would like to be informed as new material or information relevant to the Common Rule revisions becomes available, signup for our list.

What happens next? We will keep you abreast of any updates and provide you with assistance in how to implement these changes. You can also check out the PRIM&R webpage and the OHRP website for additional information and updates.