Jefferson Office of Human Research Protection

CONTACT US

Name: Crystal Lijadu
Department: Assistant Director of Operations and IRB Reliance Manager
Contact Number(s):

Leadership

Name: Walter Kraft, MD
Positions:
  • Director, Jefferson Office of Human Research Protection
  • Director, Clinical Research Unit
  • Professor, SKMC Department of Pharmacology & Experimental Therapeutics
Contact Number(s):
Access iRIS
COI-SMART
Electronic Serious Adverse Event Reporting (eSAEy)
Electronic Unanticipated Problem Reporting (eazUP)
JeffTrial & Resources

For Research Activities

Name: Theodore F. Taraschi, PhD
Positions:
  • Senior Associate Provost, Research Integrity, Conduct & Compliance
  • Professor, SKMC Department of Pathology & Genomic Medicine
Contact Number(s):

Academic & Other External IRBs

Investigators that would like to initiate a multi-site study consolidated under single IRB review, where Jefferson will serve as IRB of record, must attend a Zoom meeting prior to finalizing any grant submissions or submitting to the IRB. Please contact ;Jennifer.Polizzi@Jefferson.edu or Lauren.Boccardo@jefferson.edu to schedule this meeting.

Process Flow for Requesting Reliance where Jefferson will Serve as the IRB of Record

  1. iRIS Submitter/PI must attend a Zoom Meeting with OHR Staff prior to submitting any request for Jefferson to serve as the IRB of Record.
  2. Submit protocol for review in iRIS as a single-site study (TJU Enterprise Sites Only). 
    • After Inital Study Approval is provided, the study team may submit an Amendment to add additional participating sites.  
    • Please note: No protocol or main consent modifications may be included in this site addition amendment.    
    • Be sure to complete all parts of Section 5.0 Selecting IRB of Record.
  3. Upload the following documents to the submission 
    • Reliance Agreement (if paper-based)
    • Statement of Work (for non-Jefferson investigators)
    • Certification of Local Context 
    • Local Context Survey Note: Only required if recruitment/consent are part of the study.
    • Protocol
    • External site-specific consent (if applicable)
    • All Ancillary Review Approvals
  4. Route the submission for signatures. 
    • Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator. 
    • If you are not able to route for signature within iRIS, you must attach an iRIS Signature Page with the required signoffs. 
  5.  The Amendment will be reviewed and the study team will be notified of updates via iRIS.
  6. An approval outcome will be issued in iRIS.
    • Please Note: The Jefferson Prinical Investigator and study team are responsible for providing the relying site will all IRB-approved materials.   

 

Process Flow for Requesting Reliance where Jefferson will Rely on an External IRB

  1. Create a New Study Application in iRIS
    • Be sure to complete all parts of Section 5.0 Selecting IRB of Record.
  2. Upload the following documents to the submission
    • Reliance Agreement (if paper-based)
    • Statement of Work (for Jefferson investigators)
    • Protocol 
    • Jefferson-specific Consent From Note: Required if obtaining consent
    • Local Context Survey Note: If Required by IRB of Record
    • Approval Letter from IRB of Record
  3. Route the submission for signatures. 
    • Per Jefferson IRB Policy, signatures are required from the Principal Invesitgator, Department Chair, and Business Administrator. 
    • If you are not able to route for signature within iRIS, you must attach an iRIS Signature Page with the required signoffs. 
  4. The Reliance Team will review and work with the study team to ensure the study receives approval. 
    • The IRB will request the study team to upload the fully executed reliance agreement, Jefferson site addition approval letter, and final approved consent form from the External IRB.
    • Upon receipt of all required documents, Jefferson IRB will provide study team with Study Activation letter, which will allow research activities to commence.
    • The PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study.
    • The PI and study team are required to submit continuing review and closure notices via the External IRB – Annual Update and Closure form in iRIS.

 

SMART IRB Reliance Agreements

The SMART IRB Agreement is a national master agreement that allows institutions to avoid having to negotiate individual IRB authorization agreements per study or group of studies. Participating institutions may cede review of human subjects research to any other participating institution’s IRB under this agreement.

Check the Participating Institutions List to see if your collaborator’s institution is a member of SMART IRB.

sIRB Submission Form (NOT FOR USE)
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