Common Rule and Other Changes
Revised Common Rule
The revised Common Rule goes into effect on January 21!
Major Regulation ChangeS
- Exemptions - New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process), while others may qualify for "self-determination." For details, see the MU IRB Exemption.
- Informed Consent - A new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. For details, see the MU IRB Informed Consent webpage.
- Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 21, 2020. See Other Regulatory Changes for information about the NIH sIRB policy implementation, as well as other recent NIH policies related to clinical trials.
What to Expect
The new regulations do not impact studies approved prior to the proposed implementation date of January 21, 2019.
For new studies, expect to see:
- IRB application changes
- Informed consent revisions
- MU-IRB Operations updates
For existing studies, after new Common Rule implementation date the MU IRB may choose to apply the new rules to minimize burden for investigators.