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Research
Research

Jefferson Office of Human Research Protection

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

Research with LVHN

Jefferson Office of Human Research Protection (JOHRP) and Lehigh Valley Health Network (LVHN) Office of Research Integrity have entered into a Memorandum of Understanding (MOU) to streamline and enhance collaborative research between our institutions. This agreement establishes a framework for cooperation, allowing researchers from both organizations to engage in multi-site studies with reduced administrative burden. The MOU facilitates the use of a single IRB review process when applicable and ensures regulatory alignment to expedite study approvals. If you are engaging with research with an LVHN site, please review the follwing instuctions.

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:
      • LVHN Authorization to Submit to Jefferson (provided by LVHN study team)
      • Statement of Work (for each non-Jefferson participating site)
      • Certification of Local Context 
      • Protocol
      • ICFs (if applicable)
    • 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: Submit a Request to Cede Review to LVHN

  • Prior to submitting a request for Jefferson to cede to LVHN IRB in iRIS, please submit a request via the Reliance Cede Request Form. This will allow us to assess if reliance is appropriate. 
  • 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: Create the Submission in iRIS

  1. Create a New Study Application in iRIS. 
  2. In Section 5.0, indicate LVHN will serve as the IRB of Record. 
  3. In Section 6.0, be sure to include the sponsor. 
  4. Upload the following documents: 
    • LVHN Authorization Agreement with your submission. 
      • The authorizations can be found on the Forms Page under Agreement Templates. 
      • Or by clicking here.
    • ICF to be submitted (can be working draft)
    • Ancillary approval(s) or parallel review memo(s). 
  5. Route submission for review. 
    • 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 may attach an iRIS Signature Page with the required signoffs. 
  6. A JOHRP Analyst will review your submission and sign the Authorization Agreement.  

Step 3: Return Approval Documents

Upon receipt of the Approval Letter from LVHN IRB, please return to iRIS and upload the letter to the stipulation in order for Jefferson IRB to update the local study record. 

  • Note: Research may not commence until JOHRP receives the approval letter from LVHN and issues a study activation letter. 

Step 4: 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.

If you have questions at any time throughout this process, please reach out to Steven Muller or Lauren Boccardo.

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