IRB Unification: Human Research Protection Program

Office for Research Protections     |     Institutional Review Board      

The IRB programs at the Human Subjects Protections Office and the Office for Research Protections have reorganized and are now one program, the Human Research Protection Program (HRPP).  The ultimate goals of this merger include streamlining IRB processes across all campuses and reducing burden for investigators and study teams.  

With the recent unification of the former Human Subject Protections Office and the IRB Program at University Park and the COVID-delayed but ongoing efforts to hire additional staff, the IRB’s turn-around times for reviews are currently, unfortunately, longer than we would like them to be. We expect the delays to be alleviated as we streamline our procedures and onboard new staff, and we will update this page once this is resolved. 

Currently, the time from submission to pre-review of a submission by an IRB Analyst is approximately 8 business days. Please note that the time to review is not the same as the time to approval. Incomplete submissions or those that do not adhere to IRB policy requirements may require additional time. Review timelines may also be affected by factors outside of the IRB such as other required ancillary reviews, the FDA, Certificates of Confidentiality, etc. 

Investigators frequently request that the IRB  conduct a priority review. In general, submissions are reviewed in the order in which they are received. The current volume of submissions precludes pulling items out of the queue unless it is a true emergency that will adversely affect study subjects, funding, or if the study is directly related to COVID treatment. Reviewing submissions out of order means that other investigator’s submissions will not receive a timely review. Investigators who believe that their submission requires immediate handling, should contact their assigned IRB analyst and provide justification and a description of the specific circumstances. 

Tips to help decrease the time to approval for a submission: 

  • Start working on the IRB submission well in advance and submit early whenever practicable. 
  • Provide the appropriate study protocol(s) and protocol site addendum, when applicable, for review, along with all supporting documents (e.g., informed consent forms, recruitment materials, data collections instruments, Sponsor protocol and documentation, full grant proposal, etc.) in CATS IRB and ensure that any discrepancies between these documents have been resolved prior to submission.  
  • For student research, ensure that the faculty advisor has reviewed the submission for completeness and accuracy prior to submission to the IRB.  
  • Ensure that all study team members complete their required CITI training prior to submission.  
  • Provide clear, accurate, and complete responses to IRB requests for clarification (frequently, investigators make changes to the study protocol, but those changes are not carried into supporting documents where necessary). 

The HRPP acknowledges that these types of delays interfere with the conduct of research and that many research teams are eager to submit modifications that would allow their research to continue or restart during the pandemic. We are actively working not only to review submissions quickly but also to improve our processes overall. Thank you in advance for your patience.