Common Rule and Common Rule Changes
The Common Rule is a 1981 rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. The Common Rule is the baseline standard of ethics by which any government-funded research in the U.S. is held. Nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.
Revised Common Rule
In January 2019 the Common Rule revisions went into effect. A tracked changes version of the revised Common Rule is available online (PDF).
UMCIRB and the Revised Common Rule
The UMCIRB has posted a new SOP addressing implementation of the revised Common Rule changes. The UMCIRB’s new SOP titled “Application of Final Common Rule (2018 Requirements): Protection of Human Subjects” is available online (PDF).
Summary of Revised Common Rule Changes
|Revised “Human Subject” Definition||
|Informed Consent Changes||
|Revised Exempt Categories||
|Continuing Review Requirement Changes||
|Single IRB Requirement for Cooperative Research||
|How do these changes affect you?||
UMCIRB Common Rule Revisions Review
The UMCIRB staff has created an overview of the Common Rule revisions. This overview consists of two Power Point presentations which were video recorded so that investigators, key study personnel, and others in the local research community could view them at their convenience. Click below to view the presentations.
Each of the presentations requires a password in order to view them.
- Common Rule Revisions Overview – Part 1 (password – Mc3JWPy*)
- Understand the revisions to definitions contained in the Common Rule;
- Understand the new concept of “limited review” and its application; and
- Understand the changes to the categories of exempt research contained in the revisions to the Common Rule.
- Common Rule Revisions Overview – Part 2 (password – Mk4NVym@)
- Changes to expedited research contained in the revisions to the Common Rule;
- Changes related to elements of consent and waiver of consent and documentation of consent;
- Requirements of new local SOP related to the application of the revised Common Rule; and
- ePIRATE changes related to the revision of the Common Rule
OHRP Education Links
- OHRP Revised Common Rule Q&As: OHRP has developed a list of common questions about the revised Common Rule with answers. These questions and answers are being made available to the public as an educational resource.
- OHRP Revised Common Rule Videos: OHRP has produced a set of videos to help IRB personnel, researchers and others in the research community learn about and understand the revised Common Rule. These videos are for educational purposes. Please refer to the text of the Common Rule for a complete and accurate description of the regulatory requirements.