For Research Activities
The Office of Human Research 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.
OHR 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.
To obtain authorization to submit to a commerical 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 commerical 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 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
Denise De La Sierra
- Advarra IRB website
- CIRBI (online submission system)
- CIRBI Registration (PDF)
- Submitting an Initial Reivew in CIRBI (PDF)