Office for Research Protections | Institutional Review Board (IRB)
January 18, 2024
We will not be holding a full webinar on January 24 due to minimal changes. Have questions about the topics listed below? Join us for a brief Q&A session at noon on 1/24: https://www.research.psu.edu/irb/hrppwebinar.
Updates:
ToolKit Updates (to be released on 2/1/2024):
- Administrative updates made to a few worksheets and forms.
- HRP-103 Investigator Manual: Additional clarity regarding study recruitment expectations added to the Study Recruitment section (pgs. 24-25).
Advarra Institutional Language Review Change:
Effective February 1, 2024, the Advarra IRB will no longer ensure that Penn State required institutional language (e.g., research related injuries, HIPAA) is included in consent forms reviewed by their office. The Penn State HRPP will continue its review of these forms to ensure our institutional language is appropriately included. Study teams who have studies that rely on Advarra should confirm that the consent forms submitted to Advarra contain all required language found in HRP-109 prior to submission. Multiple rounds of revisions to the consent form may result in additional Advarra fees being incurred.
The Penn State HRPP must agree to cede review to projects that will designate Advarra or other external IRBs as the reviewing IRB. All external IRB projects must be submitted in CATS and acknowledged by our office prior to the start of activities with human subjects at our site.
Reminder - sIRB Fees!
The Human Research Protection Program (HRPP) is now charging fees to serve as the reviewing IRB for multi-center and cooperative projects that designate Penn State as the reviewing IRB. The fee structure is based on a number of factors, including the number of relying sites, consent documents to be utilized, years of active study conduct, and anticipated modification submissions. Researchers will need to include anticipated Single IRB (sIRB) fees in their grant application; the HRPP recommends allocating funds for the additional responsibilities that come with being a lead study team.
Researchers should consult with the HRPP before identifying Penn State as the reviewing IRB in a grant application. Researchers should review the HRPP's sIRB information and complete a Reliance Request Form. The HRPP will provide the sIRB cost estimate in a letter of support that should accompany your grant application.