FAQ

A: No. The OCIS Review Office is a free tool that can be used by any person at MCG conducting research.

A: Prior to submission to the IRB (Human Assurance Committee or Chesapeake Research Review, Inc.), it is required that you have approval of the study
feasibility (if applicable) and IRB component from the OCIS Review Office.
When submitting your IRB materials to the Review Office, please include all
materials that you plan to submit to the IRB. The IRB submission itself must

be complete for us to begin our review. Budget documents may be submitted
after all other components have been approved or can be submitted at the
same time.

Q: My study is not funded by an industry sponsor (i.e. it is departmentally
funded or has no funding), do I need to submit to the Review Office?

A: If your study is using any MCGHI resources (i.e. patients, patients records, personnel, facilities or services), you must submit your documents to the OCIS Review Office. This includes an IRB submission and budget documents. Budget documents are required even when there is no money involved in the project if MCGHI resources will be used.

A: This depends on the type of documents. After the OCIS review of IRB documents is received by the researcher, the documents should be finalized and then routed by the researcher. We do begin the routing process of budgets that require MCGHI approval and contracts that require approval from the Legal Office. We will send you an e-mail confirmation that the OCIS Review Office has approved your documents and indicate the date it was delivered to the appropriate departments (i.e. MCGHI or legal). Once the budget is returned by MCGHI, you will receive an e-mail informing you that your budget is ready for you to complete the routing for remaining signatures. If your budget is not approved by MCGHI you will receive additional information regarding the next steps. When your contract has been approved by the Legal Office, it will be sent to the Division of Sponsored Program Administration (DSPA). DSPA will contact you with any further requirements for final execution of the contract.

Q: What happens if I do not submit my IRB documents to the Review
Office before sending them to HAC?

A: If IRB documents are not first submitted to the Review Office, the HAC will not accept any submissions. OCIS sends the researcher a review confirmation e-mail after the review is complete. This email should be ncluded with your initial submission to the HAC.

Q: What happens if I do not submit my budget to the Review Office before
routing it for signatures?

A: You will need to submit the budget to the Review Office before obtaining any signatures. That way, any revisions can be made prior to obtaining signatures.

A: Researchers will receive a response from the Review Office within 2.5 business days.

A: Revisions or changes of IRB documents from OCIS recommendations are at
the researcher’s discretion. However, suggested changes to the budget require a response in the form of a justification for not making suggested changes or
revised budget forms along with any comments necessary for review and final
approval. Changes to the contract are negotiated between the Legal
department and the sponsor. The Review Office does let the researcher know
of any wording in the contract that might affect the budget.

A: The IRB documents should be submitted to the Review Office prior to
submission to the IRB. The MCGHI/MCGRI budget documents should be
submitted after the award is received (unless otherwise required by DSPA).
The Review Office can assist with development of your budget for the initial
grant submission to ensure that you have budgeted for all possible expenses.

A: Case studies or chart reviews will require the submission of IRB documents,
as required according to HAC requirements
(http://www.mcg.edu/research/ohrp/hac/polsect4.htm#CASE%20STUDIES), as well as a budget for MCGHI approval. The budget will include an intramural
grant routing form and an MCGHI/MCGRI Categorical budget form (which can
be downloaded at http://www.mcg.edu/SPA/).

A: If your study uses MCGHI resources and you do not submit a budget for OCIS and MCGHI approval, the HAC will not release their IRB approval until this step has been completed.

Q: I am doing a physician–initiated study that a sponsor is paying for.
Can I use Chesapeake IRB?

A:         No. Our institution only permits industry-sponsored studies to use
            Chesapeake, IRB. This means that the sponsor must also have
            initiated/developed the protocol. Another requirement when using
            Chesapeake IRB is that the study cannot be conducted at the VA. (The
            federal VA does not permit commercial IRBs.) The study must also be a
            multi-site study.

Q: How do I reflect inflation and cost of living raises when I am creating
my study budget?

A:          You can increase salaries and benefits by a standard rate. For example,
              you could increase study salaries and benefits by 5% for each year on an
              industry-sponsored study. Typically, 3% is the rate permitted on federally
              funded studies. If you are using hospital resources (procedures, tests, etc.)
              MCG Health Inc. expects you to add a 5% annually beginning July 1st of
              each year.

Q:          I heard that some research areas are adding a non-refundable start-
             up fee to their industry-sponsored contracts and study budgets. Is this
             something I should consider?

A:          Absolutely. Your site will incur upfront costs before you ever see your
             first study subject. There is also the chance that the sponsor or FDA may
             terminate the study before you get your first patient. If your payments
             are all tied to patient reimbursement, your site will have put in a lot of
             work for which you will receive no payment. The amount of the non-
             refundable start-up fees is up to your site. A typical range for industry-
             sponsored studies has been $1,200 - $5,000, and should depend on your
             costs, type of study, experience with sponsor and other factors.

Q: My study is getting ready to close. I know what to do with the sponsor
and the IRB, is there anything else I need to do?

A:          Yes! Be sure that all the financial obligations on the study have been
             met. All bills to vendors, including hospital charges need to be paid, as
             well as any subject payments. Verify that you have received all required
             payments from the sponsor. Work with your assigned Sponsored
             Program Administrator to send a final invoice and closeout letter to the
             sponsor

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