View this email in your browser

Coming 09/14/2020:  Changes to PAF Questions for Human Subjects Research 

What's Changing?


One new required question and a series of contingent sub-questions in the Human Research question-set on the PAF Research Activity page will replace the current "external single IRB-of-Record" question.
  • A new question asks if the human subjects research is "multi-site study" (i.e., the research will be done by collaborators at more than one institution).

  • An "IRB Support" sub-question offers three options to indicate the planned IRB review process with additional sub-questions, as applicable, to identify the specific single IRB-of-Record (sIRB):
    • IRB review by each institution (i.e., sIRB not applicable)
    • External IRB as sIRB
    • A U-M IRB as sIRB

Why does U-M need this information from the PAF?


Human subjects research regulations require review by an sIRB for most federally-sponsored, US-based collaborative research.  As part of the sIRB process, authorization agreements are established among the participating institutions and/or collaborating investigators that outline the roles and responsibilities for the research and the regulatory oversight.  The agreement process takes time to complete, especially for large collaborative projects.  

ReminderAwards involving human subjects research cannot be activated without an approved IRB application.  Any necessary authorization agreements are typically initiated prior to IRB approval of the human subjects research.  

The new "multi-site/IRB Support" PAF questions provide an opportunity for the U-M IRB Offices to identify projects requiring an sIRB and authorization agreements prior to award processing.  Using regular reports of submitted PAFs, the U-M IRBs may contact the U-M Principal Investigator (PI) to validate the Multi-site/sIRB selection on the PAF and initiate the agreement processes.  


Best Practice


Be proactive!  The PAF should not be the first notification to U-M IRBs about the sIRB option.  The PI/project team should contact the appropriate U-M IRB Office to discuss sIRB options well before proposal submission.  
  • IRBMED:  Contact 8 weeks prior to propose U-M as the sIRB / 3 weeks prior to propose an external IRB.
  • IRB-HSBS:  Contact 4 - 6 weeks prior to propose U-M as the sIRB / 3 weeks prior to propose an external IRB.
Use of an sIRB may have project budget considerations.  To avoid rework or delays at just-in-time or award processing due to mis-selection of the sIRB on the PAF, talk to your U-M IRB before submitting the PAF.

What to Expect


The new "multi-site/IRB support" questions are required as of 09/14/2020.  These questions will need to be answered for:
  • PAFs in the state of Proposal Preparation;
  • PAFs that are returned to the project team for changes prior to proposal submission.
If you had answered "yes" to the current "External IRB" question and indicated use of an external IRB, this information will be mapped to the new questions.  That is, the new "Multi-site" question will be marked "yes," and the "external IRB" option will be selected.

Resources


Webinar on 09/10/2020:  Single IRB-of-Record - What RAs Should Know.  Link to Register

U-M Webpages:
IRBMED sIRB and Multi-site Research (MSR) Guidance
Collaborative Research: IRB-HSBS sIRB Process
Single IRB-of-Record (sIRB)
What Expenses Might I Budget For When Using an External (Commercial) IRB?
Authorization Agreement Process

Contact Information:
U-M IRB Contacts
Copyright © 2020 University of Michigan, All rights reserved.


Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.

Email Marketing Powered by Mailchimp