Lab-based, Specimen collection, or Survey-designed Studies
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 Emily Harwood at the University of Vermont Cancer Center, 802-656-2967.
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 Emily Harwood at 656-2967 regarding using the Commons to submit protocols electronically.
Additionally, one paper copy of the protocol and forms must be given to Emily Harwood, The Courtyard at Given, N403.
Initial Protocol Submission
The following documents are required for a new laboratory protocol (including archived tissue or blood):
- PRMC Protocol Checklist (1 hard-copy and 1 on the Commons)
- Common Protocol Cover Form (1 hard-copy and 1 on the Commons)
- Protocol (1 hard-copy and 1 on the Commons)
- Request for Waiver of Informed Consent/ Authorization/ Documentation (if applicable) (1 hard-copy and 1 on the Commons)
- Modality Sign-Off Sheet (1 hard-copy and 1 on the Commons)
- HIPAA Form (if applicable) (1 hard-copy and 1 on the Commons)
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 PRMC Coordinator, Emily Harwood, at email@example.com.
The following documents are required for PRMC review of amendments to existing lab-based or survey-designed protocols:
- Cover letter with rationale for non-editorial amendments (1 hard-copy or by email)
- Amendment cover form (1 hard-copy or by email)
- Revised protocol with marked edits (e.g. highlighted, underlined, etc) (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.
Last modified November 23 2015 03:09 PM