Major Regulation Changes
The U.S. Department of Health and Human Services (DHHS) and fifteen other Federal agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The revised Common Rule is effective January 21, 2019.
The UTEP IRB will not convert existing studies to the revised Common Rule. All studies approved prior to January 21,
- 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.
- Exemption: New categories and clarification of existing categories. Some exemptions may require "flexible IRB review" (similar to an expedited review process). For more information, please see Exemption Categories Changes.
- Informed Consent: New requirements state that a concise statement citing the purpose of the research with key information be included (towards the top of the form) to provide clear content for informed consent.
- 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.
What to Expect
The new regulations do not impact studies approved prior to the proposed implementation date of January 21, 2019. The UTEP IRB will only apply the new regulations to federally funded projects for existing and new studies, the IRB may choose to apply the new rules to minimize burden for investigators.
For new studies, expect to see:
- IRB application changes
- Informed consent template revisions
- HROC Investigator Manual
- Minor IRB jurisdiction changes to facilitate workload changes
- A conservative approach as to when UTEP will be the
sIRB, with IRB consultation recommended prior to application submission
If you need further assistance or information, please contact the IRB office at (915) 747-7693 or via e-mail at IRB.ORSP@utep.edu.