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Revised Common Rule

Revised Common Rule Implementation

The revised Common Rule goes into effect on January 21! 

Major Regulation Changes

  • Continuing Review - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. For details, see the Continuing Review webpage.
  • Exemptions - New categories and clarification of existing categories. Some exemptions may require "limited IRB review" (similar to an expedited review process). For details, see the Exemption Changes webpage.
  • 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 Informed Consent webpage and templates.
  • 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 20, 2020. Please see the sIRB guidance.

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:

  1. Informed consent template revisions
  2. UC Merced IRB standard operating procedure and guidance updates
  3. Changes in type of review
  4. A conservative approach as to when UC Merced will be the sIRB, with IRB consultation recommended prior to application submission

For existing studies, the UC Merced IRBs may choose to apply the new rules to minimize burden for investigators. This will require changes to the existing protocol.

UC Merced IRB Decisions on Implementing Revised Common Rule

  • Exemptions – UC Merced will not implement Exemptions 7 & 8 which rely on Broad Consent.
  • sIRB – UC Merced IRB will continue to assess its criteria for whether UC Merced will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.
  • Broad Consent – UC Merced will not implement the new regulatory Broad Consent option as an informed consent process at this time. Exemptions 7 & 8, which rely on Broad Consent, also will not be implemented.