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Research
Research

Jefferson Office of Human Research Protection

CONTACT US

Crystal Lijadu
Assistant Director of Operations and IRB Reliance Manager

Leadership

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

For Research Activities

Theodore F. Taraschi, PhD
  • Senior Associate Provost, Research Integrity, Conduct & Compliance
  • Professor, SKMC Department of Pathology & Genomic Medicine

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 should submit via the the IRB of Record Request Form. If a study team would like to initiate a multi-site study consolidated under single IRB review, where Jefferson will cede review to another academic institution or IRB (other than WCG, Advarra, or NCI-CIRB), please submit the Request to Cede Review Form. You can find the links to submit in the respective process flows below. 

After submission, you will receive communication from a JOHRP Analyst within 24-48 hours. Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB. 

Process Flow for Engaging in Multi-site Research at Jefferson

Step 1: Pre-Review Request via Smart Form

  • Prior to submitting a request for Jefferson to serve as the IRB of Record in iRIS, please submit a request via the Reliance Intake Form. 
  • After submission, you will receive communication from Jefferson IRB within 24-48 hours. 
  • Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB.

Step 2: Initial Submission in IRIS

  • Submit protocol for review in iRIS as a single-site study (Jefferson Enterprise Sites Only). 
    • Please be sure to select No for multi-site study and Yes to inidcate the master application will be revised to indicate the study is multi-site in a subsequent amendment. 

Step 3: Submission of an Amendment

  • After the inital study approval is provided, the study team may submit an Amendment to Study Protocol in iRIS 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.
    • Upload the following documents to the submission:
      • Reliance Agreement (if paper-based)
      • Statement of Work (for each non-Jefferson participating site)
      • Certification of Local Context 
      • Local Context Survey 
        • Only required if recruitment/consent are part of the study.
      • Protocol
      • External site-specific consent (if applicable)
      • All Ancillary Review Approvals
    • 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. 
    •  The Amendment will be reviewed and the study team will be notified of updates via iRIS.
    • 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.   

Step 1: Submission of Request to Cede Review

  • Prior to submitting a request for Jefferson to cede review to another institution or IRB (other than WCG, Advarra, NCI-CIRB, Castle IRB, StrokeNet, or Neals Consortium) in iRIS, please submit a request via the Reliance Cede Request Form. 
  • After submission, you will receive communication from a JOHRP Analyst within 24-48 hours regarding the status of your request. 
  • Please be sure to submit this intake form prior to finalizing any grant submissions or submitting to the IRB. 

Step 2: Submit Initial Submission in iRIS

  • Create a New Study Application in iRIS
    • Be sure to complete all parts of Section 5.0 Selecting IRB of Record.
  • 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
      • You may use the OHR-8 Jeffeson Template or external site template. Please ensure all required language in the Cost, Injury, HIPAA, and MCARE sections are included. 
    • Local Context Survey 
    •     Note: If Required by IRB of Record
  • 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. 
  • The Reliance Team will review the submission and work with the study team to ensure the study receives approval. 
    • The IRB will request that the study team upload the fully executed reliance agreement, Jefferson site addition approval letter, and final approved consent form from the External IRB prior to issuing study activation.

Step 3: Post-Approval Maintenance

  • 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.

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