HRPP Changes in Effect September 1

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Office for Research Protections     |     Institutional Review Board (IRB)


The Human Research Protections Program (HRPP) announces changes to the IRB review process.  As part of the previously announced IRB transformation, the HRPP is working to improve consistency across campuses and reduce burden for researchers.  The following changes are intended to streamline elements of the review process. and were announced in a webinar on August 26, 2021.  Corresponding documents have been updated, including the Investigator’s Manual (HRP-103), are available in the Library in CATS IRB

Study Personnel Requirements 

HRPP will no longer require use of “Study Team Member Qualification Template” (HRP-509) 

  • All study team members will still be listed in CATS IRB, but HRP-509 will only be required for new submissions in limited situations.  
  • HRP-509 should still be completed when study team members will perform research procedures requiring special expertise or credentials above and beyond what is typically expected in the course of research conduct and/or clinical care.  Additional guidance is provided on the revised HRP-509 form found in the Library in CATS IRB.  
  • In the short term, the CATS IRB Contacts section will still require the upload of an HRP-509 prior to submission. Until the technical changes are in place, please do one of the following:

    • Existing studies that no longer require an HRP-509: Change the name of the existing file to include INACTIVE to indicate it no longer requires review.
    • New studies: The revised HRP-509 includes a checkbox on the first page to indicate that review is not required. Include INACTIVE in the name of the file.
  • It remains the Principal Investigator’s responsibility to ensure that all study team members are appropriately trained, credentialed, and supervised. 

Good Clinical Practice (GCP) training requirements 

  • Moving forward, GCP training will only be required for researchers doing FDA-regulated research or whose research meets the definition of a clinical trial.  

    • Those doing FDA-regulated research must complete the biomedical version.
    • Researchers at all campuses will be required to answer the Clinical Trials question in their new and existing CATS IRB submissions.
       

Administrative Review Requirements  

  • Moving forward, for qualified expedited protocols approved under the 2018 Common Rule, the HRPP will no longer require a continuing review; an administrative review will be set at three years out instead of annually.   
  • Study teams should continue to submit continuing and administrative reviews according to the current expiration dates, which will then transition to the new three-year timeline.  
  • Full continuing reviews will no longer be required at the College of Medicine simply because a project is obtaining written consent. If the project otherwise qualifies for administrative review, it will transition a 3-year administrative review at the time of the next Continuing Review. 
  • The IRB may still require a full continuing review, or a shortened administrative review timeframe, at their discretion.
  • Modifications, Reportable New Information, and Study Closures must still be submitted as usual.
     

Required Penn State Consent Form Language 

  • Penn State consent form language has been posted here. This includes language on costs and compensation for injury language that should be included at the time of initial submission, as applicable, rather than waiting for billing review and/or contract negotiation.   
  • Penn State consent templates have been updated accordingly. Template labels have been replaced with HRPP (previously ORP) or HRPP-COM (previously HSPO).
  • Existing consent forms do not need to be updated at this time.
     

Sponsor/Multi-site Consent Form Templates 

  • Study teams will be allowed to use the templates provided by their sponsors/lead sites for any kind of research. They no longer need to be transferred to a Penn State template prior to submission. 
  • Study teams should replace any template language with applicable language from the Penn State consent language document
  • The model consent template (original consent from the sponsor or lead institution) should still be attached to the submission for comparison.

 

College of Medicine Ancillary Review Changes 

  • HRPP analysts will continue to notify the Office of Research Affairs (ORA) when a data transfer agreement (DTA) or data use agreement (DUA) is necessary, but they are no longer holding IRB approval for a response from ORA.
  • HRPP analysts will continue to notify the Center for Medical Innovation (CMI) when a material transfer agreement MTA) is necessary for the transfer of samples, but they are no longer holding IRB approval for a response from CMI.
  • HRP-901 is no longer required for protocols collecting body fluids as part of College of Medicine research. Note: this change was not announced at the webinar but is effective 9/1/21.
  • HRPP staff will only set a Clinical Laboratory ancillary review for protocols involving the use of remnant samples from the clinical lab, and IRB approval will not be held for this ancillary review.
     

Staffing Updates

  • We’re happy to report the HRPP is now fully staffed. The HRPP has hired 11 additional team members since March 2021! 
  • New analyst assignments have been posted. New analysts are the point of contact for study teams and will eventually be inheriting the work associated with those letters, though they may not be currently reviewing all submissions. 

The HRPP is grateful to the research community for their support and continued patience through this transition.  Further updates will be posted at https://www.research.psu.edu/irb.