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Institutional Review Board

Human Research Protections (HRP)

 

February 2021: Updates in HRP
Version February 2, 2021

 

In our efforts to create efficiencies and foster compliance, HRP will make the following updates and changes in February 2021:

Effective February 1:

1.IRB Documentation Sharing Update:

oBeginning this month, HRP will provide IRB Application and supporting documentation to Chao Family Comprehensive Cancer Center (CFCCC) to help facilitate their Protocol Review and Monitoring Committee (PRMC) process.  An update to the IRB Application text to reflect this practice is anticipated March 2021. Any questions, contact the PRM unit at .

2.The Investigator Certification of Surrogate Decision Makers for Potential Subject’s Participation in University of California Research Form has been updated to remove signature lines.

3.Translated Short Form Updates:

oRemoval of errant Investigator signature line for all translated languages

oNew Urdu translated Short Form available

oCertificate of Translations  available

4.Appendices O & P updates:

oInstructional text is clarified and better organized

oRemoved the requirement to justify minimal risk

oOpen text fields replaced by appropriate response options

5.Appendix U Updates:

 

oPrompts for additional necessary documentation related to adding a reliance

Effective February 15:

6.Combining the UC HIPAA Research Form with the IRB Approved Consent Form as a single PDF, at the time of IRB approval. Upon UCI IRB approval, only a Word (editable) version of the UCI IRB Approved Consent Form will post to the UCI IRB Document Depot. A Word version of the UCI HIPAA Research Form will not post.

7.Consent Form Updates:

oNew Certificate of Confidentiality language added to address possible access to Epic for UCI Health treatment purposes

oTemplate text added to prompt researchers to include, as applicable, suggested methods of birth control

oTemplate text added to prompt researchers to address subject reimbursement

oTemplate text updated to further define routine care medical costs during a clinical research study vs. standard of care medical costs that occur outside (absent) of a clinical research study    

oTemplate text added to include more specificity when imaging is done for research purposes.

 

*All referenced forms are available on the HRP Apps & Forms page!*