Lab-based, Specimen collection, or Survey-designed Studies
IRB submission requirements (PDF)
There are some cases where the IRB will allow an exemption of a review. However, the protocol will still need to be reviewed by the
Protocol Review and Monitoring Committee for scientific integrity. Please submit all cancer-related protocols to the University of Vermont
Cancer Center Protocol Review and Monitoring Committee even if the IRB deems the protocol exempt from IRB review. If you have questions, call Karen Wilson at the University of Vermont Cancer Center, (802) 656-4414 ext. 2.
Submitting protocols and supporting forms to the PRMC is now available as electronic submission through the UVM Commons. The link
to the PRMC page on the Commons is: https://commons.med.uvm.edu/cp/uvmcc/prmc/default.aspx . Not all research coordinators or PIs currently have access to the Commons. Please contact Karen Wilson at (802) 656-4414 ext. 2 regarding using the Commons to submit protocols electronically.
Additionally, one paper copy of the protocol and forms must be given to Karen Wilson, The Courtyard at Given, N413.
Initial Protocol Submission
Changes to existing protocols, called amendments, are reviewed by the Protocol Review and Monitoring Committee to ensure that the protocol still has scientific validity. Documents may be emailed to the interim PRMC Coordinator, Karen Wilson, at firstname.lastname@example.org.
The following documents are required for PRMC review of amendments to existing lab-based or survey-designed protocols:
- Cover letter with rationale for amendment changess (1 hard copy or by email)
- Amendment cover form (1 hard copy or by email)
- Revised Investigator Drug Brochure (if applicable) (1 hard copy or by email)
- "Clean" or final copy of protocol with revisions incorporated (1 hard-copy or by email)
Study Progress Reports
As part of the University of Vermont Cancer Center's data monitoring process, all cancer protocols must submit Study Progress Reports semi-annually to the University of Vermont Cancer Center. The PRMC monitors study progress of all cancer protocols to ensure proper resources are being distributed.