Key Points for New Common Rule
What is the Common Rule?
The term “Common Rule” refers to the U.S. Department of Health & Human Services policy 45 CFR 46. “CFR” is the Code of Federal Regulations (administrative law that governs research with human subjects and codifies the ethical principles of the Belmont Report.) It defines what constitutes “research” as well as defines “human subject.”
Key Points for the Common Rule:
- The revised Common Rule 45 CFR 46 went into effect on January 21, 2019.
- All new studies submitted after January 21, 2019 must comply with the new regulations.
- There are four main areas of change:
- Exemptions
- Consent Forms
- Continuing Review for Minimal Risk studies
- Other/Miscellaneous changes
Exemptions
There are new and revised categories for the IRB to apply when determining a study exempt from IRB review. Office for Human Research Protections (OHRP) has broadened the kinds of research that will be eligible for an exempt determination. As a reminder, per institutional policy, the Endicott College IRB (not the Investigator) must make the exemption determination. Studies declared exempt by the IRB do not have an expiration date.
New exemption categories can be found here.