Laboratory studies are considered Non-Interventional (e.g., only using banked tissue/blood and not requiring consent forms).
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 Committee for scientific integrity. Please submit all cancer-related protocols to the VCC Protocol Review Committee even if the IRB deams the protocol exempt from IRB review. If you have questions, call Emily Harwood at the Vermont Cancer Center, 802-656-2967.
Initial Protocol Submission
The following documents are required for a new laboratory protocol (archived tissue or blood):
- Common Protocol Cover Sheet (5 copies)
- Protocol (5 copies)
- Request for Waiver of Informed Consent/ Authorization/ Documentation (if applicable) (5 copies)
- Modality Sign-Off Sheet (5 copies)
- Laboratory Based Form (5 copies)
- HIPAA Authorization (if applicable) (2 copies)
Changes to existing protocols, called amendments, are reviewed by the entire Protocol Review Committee to ensure that the protocol still has scientific validity. For example, there have been scenarios where an amendment is made to a protocol but the statistical section was not revised.
The following documents are required for PRC review of amendments to existing laboratory protocols:
- Cover letter with rationale for non-editorial amendments
- Amendment cover form (3 copies)
- Revised protocol with marked edits (e.g. highlighted, underlined, etc) (3 copies)
- "Clean" or final copy of protocol with revisions incorporated (1 copy)
Last modified September 04 2013 10:19 AM