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 now has 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.
Commercial IRBs
To obtain authorization to submit to a commercial IRB (WCG or Advarra), please follow the following steps:
- 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.
- Please upload the appropriate Authorization Agreement with your submission. The authorizations can be found on the Forms Page under Agreement Templates.
- You will also need to upload any ancillary approvals that apply to your study and copies of the ICF.
A member of the Thomas Jefferson University IRB Reliance Team will then review your submission and sign the Authorization Agreement. 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.
If you have questions at any time throughout this process, you can reach out to Steven Muller, Steven.Muller@jefferson.edu.
Advarra IRB
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)
WCG IRB
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