Revised Common Rule
What is the common rule?
The Common Rule is the Federal policy put in place to protect human participants in research. It is based on the three ethical principles of the Belmont Report: Beneficence, Justice and Respect for Persons. The Common Rule was first published in 1991, and has remained unchanged since.
Why change the common rule?
With advancements in medicine and technology, and other overlapping Federal policies overseeing research with human participants, the Common Rule failed to properly address current issues in the protection of human participants in research, and further complicated the regulatory landscape.
What are the changes?
- New Exemption and Revised Exemption Categories
- Continuing Review Changes
- Consent Form Changes
- Revisions of Existing Terms and Definitions/Terms Not Added to Definitions
- New Type of Review - Limited IRB Review
Common Rule Implementation Process at SRU
New Submissions: Any new research protocol submissions received on or after January 21, 2019 will be reviewed under the revised Common Rule (45 CFR 46). Please submit the Revised Common Rule Forms and Appendix.
Please review the new information and forms on this website which provides information regarding how the revised Common Rule may impact your protocol submission.
New forms have been developed to comply with the Revised Common Rule. Protocols submitted on the previous forms will be returned without review.
Information / Education on the Revised Common Rule
The Office of Human Research Protections has recently released a series of education videos & resources about the Revised Common Rule.
Video topics include:
- What's New in Informed Consent?
- When Does the Common Rule Apply? Review the Basics Under the Revised Rule
- Overview of Changes to Exemptions in the Revised Common Rule
- What's New in IRB Review Under the Revised Common Rule