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Jefferson Office of Human Research Protection
Leadership
- Director, Jefferson Office of Human Research Protection
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
For Research Activities
- Senior Associate Provost, Research Integrity, Conduct & Compliance
- Professor, SKMC Department of Pathology & Genomic Medicine
Commercial IRBs
The Jefferson Office of Human Research Protection maintains service agreements with two independent commercial IRBs: Advarra IRB and WIRB-Copernicus Group (WCG).
These agreements allow Jefferson investigators to apply directly to the commercial IRB to join an existing study that has already received IRB approval. Currently, this option is open for select industry-sponsored phase 1, 2, 3, and 4 clinical trials.
JOHRP will make the final decision on a study-by-study basis as to whether it will permit an investigator to apply to the commercial IRB.
Process Flow for Using Commercial IRBs
Step 1: Create the Submission in iRIS
- Create a New Study Application in iRIS.
- In Section 5.0, indicate who will serve as the IRB of Record.
- In Section 6.0, be sure to include the sponsor.
- Upload the following documents:
- Authorization Agreement with your submission.
- The authorizations can be found on the Forms Page under Agreement Templates.
- ICF to be submitted (can be working draft)
- Ancillary approval(s) or parallel review memo(s).
- Authorization Agreement with your submission.
- 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.
- A JOHRP Analyst will review your submission and sign the Authorization Agreement.
Step 2: Return Approval Documents
Upon receipt of the Approval Letter from the commercial IRB, please return to iRIS and upload the letter to the stipulation in order for Jefferson IRB to update the local study record.
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.
If you have questions at any time throughout this process, please reach out to Steven Muller, Steven.Muller@jefferson.edu or Lauren Boccardo, Lauren.Boccardo@jefferson.edu.
Advarra is the new name for the company created through the merger of Schulman, Chesapeake, and Quorum IRBs. For assistance with legacy studies previously approved by these IRBs, please use the Advarra contact information.
General Submission Questions
Katie Gaiek
585-417-7891
Katie.Gaiek@advarra.com
Study-Specific Questions
Denise De La Sierra
386-222-3034
Denise.DeLaSierra@advarra.com
- Advarra IRB website
- CIRBI (online submission system)
- CIRBI Registration (PDF)
- Submitting an Initial Review in CIRBI (PDF)
Jefferson’s Institution # for WCG is 83645.
WCG Contact
Christopher Gennai, CIP
Account Manager, Institutions
360-252-2460
360-252-2498 fax
CGennai@wirb.com