HRPP Quarterly Updates: April 2024

Office for Research Protections      |     Institutional Review Board (IRB)

April 24, 2024

HRPP Transformation

Rachel Lally began the webinar with a brief synopsis of the HRPP transformation process, reviewing the framework and how each of the five stages were executed from stabilization to monitoring.  The program has moved into maintenance to ensure the program's standards. With that, we received information regarding feedback from surveys administered to HRPP users during fiscal year 2022 and 2023. Data was compared between the two years to demonstrate the effectiveness of the program and the transformation process. Future steps include: 1) listening closely to HRPP users; 2) monitoring changing rules and regulations; and 3) modify accordingly, when able, to support HRPP user experience.

 

Updates on Data Storage, etc.

  • Data Storage for University Park and Commonwealth campuses
    • For level one and two data, please ensure your software application or storage platform is approved using datastoragefinder.psu.edu/
      • If your data storage platform is not approved, you will need to submit to Procurement for approval, even if your team is not purchasing the software (staff and faculty are not allowed to sign agreements on behalf of the University, including terms and conditions for free software).  Study teams will need to get approval through Purchasing, who works closely with Information Security to discern if there are any security issues.
    • For level three data: the IRB will set ancillary review for security given the sensitive nature of the data.
  • New guidelines for who can serve as a Primary Investigator have been made available for all researchers, regardless of focus or subject matter.

 

Useful Tips re: Anonymous surveys

  • All surveys, even if participants remain anonymous, must be submitted to the IRB for review, assuming the work meets the definition of research as defined by Health and Human Services).
    • By sending a survey link, the IRB considers this an interaction with participants and, therefore, the IRB must review the protocol.
  • A project being labled as exempt does NOT mean it is exempt from IRB review.
    • Exempt is a federally defined term referring to a level of IRB review and means that it the study is exempt from certain federal requirements.  But it is not exempt from IRB review.
  • Penn State requires approval for all projects that meet the definition of human subjects research.

 

Toolkit Changes/Modifications Effective May 1, 2024:

  • HIPAA Authorization: new flexibility with language
    • As a means of preventing duplicate language for sponsored programs or external IRBs, we have changed the language in HRP-109 from required to recommended. HIPAA language is required to address key components (HRP-330), but Penn State-specific language is no longer required. 
  • Informed Consent Forms (ICFs): For the College of Medicine and Penn State Health, the time field for documenting when an ICF was signed is being removed. The time field was an internal requirement, but not a regulatory requirement. Therefore, the time fields will be removed from all ICFs; short forms are also being revised to remove the time field. 
    • Should a study team's ICFs still have the time field, then they will need to complete that field in order to remain in compliance.
  • HRP-902 - Human Tissue for Research Form no longer requires a PI signature. 
  • Subject Injury Language in HRP-109 and ICF Section 8b has been aligned. Language changed from "no risk" to "no greater than minimal risk."

 

Reliance Updates:

  • Please visit our Resources or the Help Center for most recent Job Aids (R2R and R2S).
  • HRP-880: Updated to account for when Penn State serves as the Privacy Board on a R2R. Will be active starting May 1, 2024.
  • HRP-832: Updated to capture potential need for Enterprise Information Management (EIM). This form will be included with protocols that request medical records. 
  • For multisite/cooperative studies, the research team can use any IRB that Penn State has a contract with as a third party IRB as long as the protocol is non-exempt and the IRB is AAHRPP accredited.

 

    Website Resources: