New Common Rule Resources

The Federal Policy for Protection of Human Research Subjects, also known as “The Common Rule”, defines the processes for IRB review and approval of research with human subjects.
Changes to the Common Rule will take effect on studies starting on or after January 21, 2019.

Video Presentation | Key Changes to the Common Rule

New Rule Packet | Summary and highlights of what’s changed

New Common Rule | Federal text in full

FAQs about the New Common Rule | HHS

Comparison of FDA Regs and New Common Rule (HHS) | FDA 

USC Flexibility with the New Common Rule

New Rule Guidance:

Exemption Checklists

Informed Consent Checklists

Vulnerable Populations in Research Checklist