August 1 HRPP Updates

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Office for Research Protections     |     Institutional Review Board (IRB)

August 3, 2022

The Human Research Protections Program (HRPP) held its quarterly udpate webinar on July 27 to share new processes as well as updates on program changes. The HRPP Quarterly Update was formerly known as the Stakeholders meeting at the College of Medicine, but is now open to the whole University.  Slides and a video recording of the webinar are avaialble.  Below is a summary of the webinar.  

New Updates

Ancillary Review Guidance

  • The HRPP has released a new toolkit document: HRP-309 – WORKSHEET – Ancillary Review Matrix​.  Toolkit documents can be found in the Library in CATS IRB.  
    • HRP-309 includes a full list of ancillary reviews, when the IRB sets ancillary reviews, types of submissions impacted, and more.

Exemption Review Process Streamlined at College of Medicine

  • The review process for Exempt studies at the College of Medicine is now aligned with all other Penn State locations--recruitment materials and consent forms are no longer being reviewed for approval with the following exceptions:​
    • Studies requiring a Limited IRB Review [Exempt Categories 2(iii) or 3(C)]​
    • Studies that must follow the EU’s General Data Protection Regulation (GDPR) or China’s Personal Information Protection Law (PIPL)​
  • Exempt studies involving PHI should refer to HRP-103 and HRP-584.  IMPORTANT: Exempt studies involving PHI and obtaining written authorization must include all HIPAA requirements for authorization; otherwise, authorization is not compliant.​
  • NOTE: The HRPP can request recruitment materials and/or consent forms at any time

Chart Review Guidance

  • New guidance has been developed to offer support for studies conducting chart reviews (studies that use procotol templates HRP-596 or HRP-598): guidance is availabe under "IRB Guidelines": https://www.research.psu.edu/irb/policies 

Conflict of Interest (COI) Disclosures

  • Research studies in which a member of the study staff has a financial interest or where an institutional conflict may exist, as defined by Penn State policies RP06 and AD83, must be reviewed by the appropriate COI committee. 
  • If a conflict of interest is identified, the COI staff member will place a comment into the main study page, which includes the full management plan, to notify the PI, study team and IRB analyst of a COI.​
  • A modification must be submitted to disclose the conflict to the IRB, within 30 calendar days of this notification. Failure to disclose the conflict within this timeframe, may be considered non-compliance​.  ​

Reminders

Single IRB fees

  • The HRPP charges fees to serve as the reviewing IRB for multi-center and cooperative projects that designate Penn State as the reviewing IRB.  The HRPP must be consulted prior to submission of a grant application with subcontract sites.  The HRPP will provide the sIRB cost estimate in a letter of support that should accompany your grant application.  Reliance Request Form.  

Submission volume 

  • The IRB typically experiences a surge in submissions as we approach the start of the fall semester in late August and throughout early September.  Please plan to get your submission in as soon as possible to avoid delays.   

Revised RNI Process

  • A revised Reportable New Information (RNI) process was implemented in early July.  Three main changes for study teams:
    • Only report information that involves Penn State researchers, locations, and participants or external sites relying on the Penn State IRB​.
    • Report non-compliance and researcher error only when the issue potentially impacts the rights, safety, or welfare of a subject, or the integrity of the study​
    • RNIs must be submitted within 10 business days, except unreviewed changes--these must be submitted within 5 business days​ (changes to the protocol to eliminate an apparent immediate hazard​; or emergency use of drugs or devices without IRB approval).
  •  Read more about the revised RNI process.  Watch a video update.

E-Consent

  • Penn State's Clinical and Translational Science Institute has launched access to eConsent through REDCap. 
    • This customizable project can be used in-person or online, though it is not yet Part 11 compliant and therefore cannot be used for FDA-regulated research. 

  • Learn more by navigating to the REDCap Support Portal​ and clicking "Find out more about REDCap."

CATS IRB Upgrade

  • The CATS IRB system upgrade project is underway with implementation expected in early 2023.
  • The upgraded CATS IRB will provide streamlined workflows for External IRB and Single IRB, as well as a modernized ​user interface.  Learn more.