October 25, 2023 HRPP Updates

 

Office for Research Protections      |     Institutional Review Board (IRB)

October 25, 2023

General Updates:

  • Debra Thurley is the University's Institutional Official for the HRPP in addition to her role as Associate VP for Research, and Director, Office for Research Protections.
  • Experienced analysts have recently joined the HRPP team, and they are able to contribute immediately. Please review our organization chart.
  • Research Vision and turn-around time. We did a bulk import of new team with extensive external IRBs that resulted in zero turn-around time for external IRB. That number is not zero. The remaining numbers have been holding steady for some time.
  • FWA (Federal Wide Agreement) number has changed: learn more. 

 

Continuing Review Duplicate Notices:

  • For studies where continuing review IS REQUIRED:  will continue to receive reminder notices at 90, 75, 60, and 30 days prior to expiration of approval date. Please be sure to submit your continuing reviews.
  • For studies where continuing review IS NOT REQUIRED: with the June upgrade, we removed the administrative review process for studies where continuing reviews are not required. We instead implemented an annual reminder sent to PI, PI Proxy, and primary contacts as a gentle reminder about needed materials. It is possible that these studies teams will receive the annual reminder more than once due to multiple versions transfered during the June upgrade. If you receive the reminder more than once, please know that you do not need to do any extra work for the IRB. 

 

Toolkit Changes:

  • Protocol template change: 
    • Updated screening/recruitment/determining eligibility questions.
      • There are some specific situations in which consent is not required prior to screening activities. See Section 4.2.4 in HRP-591. 
      • This policy has been in place for some time; section has been expanded to better determine if folks are doing these activities as well as determine what is being done with the collected data.
      • Please remember that HIPAA is distinct from consent. Should you be obtaining information from a medical record, then you may still need to obtain HIPAA authorization or request a HIPAA waiver.
    • EIM/Allegra Information added to protocol templates
      • For research utilizing Penn State Health patient data, submissions using EIM (Enterprise Information Management) must now attach EIM Design Specification form
      • Direct contact with patients that does not happen in person will require review of contact list by PSU’s contracted mail company, Allegra 
      • See Sharepoint document for additional information (Penn State Health ePass login to access)
        • Note: this is not an IRB function but a requirement from Penn State Health and the College of Medicine
  • HIPAA Authorization for Research form (HRP-587) has been modified to reflect requests for simpler, more condensed materials
  • Accessiblity changes have been implemented to support more users. Documents modificed include our SOPs, worksheets, and checklists.

 

Advarra consent language change:

  • PSU Institutional language no longer allowed in combined consent form managed by Advarra
  • Applies to new studies, not already approved studies
  • Discussing use of addendum with PSU specific language; discussions on going and will share further information as details emerge

 

Further updates to sIRB website:

  • Now providing greater details on R2S (request to serve) with developed mechanisms to support external sites.

 

HRP-593 Renamed: Individual Expanded Access/Humanitarian Use Device Protocol template:

  • This template is used for individual expanded access or compassion use
  • This form is also for humanitarian use devices for which there is no research component in the submission

Note: This document is not to be used for industry sponsored projects with expanded access. Those projects will still use HRP-595.
 

What is Expanded Access/Compassionate use: 

  • Ability to access a drug or device for an individual
  • No further options available for care or very niche circumstances
  • No research component
  • Treating physician obtains IND/IDE from FDA for individual
  • For additional use of IND/IDE a second FDA application is required--specific to one person 
  • Treating physician must person to obtain consent. They cannot delegate this responsibility to others like in research situations.

Further details available on our Expanded Access Submission website

 

Researcher Guidance for Industry/Sponsored Studies:

  • Job Aid now available in CATS IRB Help Center > Researcher Guides tab
  • Step-by-step instructions for initial industry sponsored-study when PSU is IRB of record

Note:  Not applicable for single or external IRB submissions.

 

New Guidance from Clinical Trials Office:

  • CTO has developed supplemental guidance document for how to prepare HRP-903 (Radiation Review Form) 
  • Provides researchers and study teams with step-by-step instructions