Human Subjects Research - Institutional Review Boards - IRBs
Contingencies for Release of Final Approval
Once you have satisfactorily completed the Committee's clarifications we will check the status of the following items:
- Execution of Contracts or Agreement (if applicable)
- Payment of IRB Fees (if applicable)
- Completion of a FAHC Billing Compliance Plan (if applicable)
Execution of Sponsor Contract or AgreementDo you have funding? If the protocol is sponsored, you must detail this within the protocol cover form under Section 6. Source of Support, Contract/Agreements, and Fees.
- Industry Developed and Sponsored: If the funding is industry-sponsored, an executed contract/agreement needs to be completed. You should work with the Office for Clinical Trials Research.
- Investigator Developed but Industory Sponsored: If the protocol is investigator-developed but funded by industry, you should work with Sponsored Project Administration.
- Federal, Foundation, State Sponsored: If the research is funded by any of these, you should work with Sponsored Project Administration.
Note: If the sponsor is providing only test drug or device and no per-patient monetary support, a contract is still required prior to approval release. In most of these cases, you will work with the Office for Clinical Trials Research.
Click on the following link for information about UVM's office of Sponsored Project Administration
Payment of IRB Fees
Institutional Review Boards (IRBs) charge fees for initial and annual
continuing review for all Fletcher Allen Health Care (FAHC) studies
sponsored by pharmaceutical firms and other for-profit entities, and to
review protocols for outside organizations. Fees are not charged for
University or FAHC federal, non-profit foundation, or
departmentally-funded studies. The fees are reviewed each year
by the IRB and are subject to change. Initial approval will not be released until the initial invoice is paid.
IRB Fees as of July 1, 2009
- Initial review: $2,500
- Continuing review: $1,500
Completion of FAHC Billing Plan
- The Affiliation Agreement between the University of Vermont (UVM) and Fletcher Allen Health Care (FAHC) requires approval of a billing plan by FAHC Compliance for all protocols utilizing FAHC resources regardless of whether they are UVM or FAHC studies. The IRB assists FAHC Compliance in identifying protocols that require a billing plan.
- If the study will involve any FAHC patients (including data and or specimens) or any equipment, facilities, supplies or personnel of FAHC, whether standard of care or protocol-driven, such as laboratory, pharmacy, imaging, EKGs, or other diagnostic or therapeutic items or staff a billing plan is required.
- You may work with FAHC Billing Compliance on a billing plan while the protocol is undergoing its IRB review, however the IRB approval will not be released until a sufficient billing plan has been approved by FAHC Compliance.
Last modified February 06 2014 09:02 AM