Budgets and Payment Terms
The Principal Investigator is responsible for preparation and negotiation of a budget that covers all expenses associated with the conduct of research projects.
Process – Developing Internal Budget
Clinical trials:
A. The Principal Investigator should review the proposed protocol and:
1. determine which procedures and tests are research and which are standard of care, if any
2. for all research procedures and tests, obtain the cost of such procedure or test from the appropriate clinical or laboratory area that will provide that procedure or test
- determine how much effort will be required and by what positions
- calculate the salary and fringe for each person involved in the study based upon the effort determination
- include any appropriate institutional fees including but not limited to non-refundable IRB fee of $2,000 applicable F&A (indirect rate) based on institutional policy.
Basic Research Projects:
A. The Principal Investigator should review the protocol and any other information provided by the company and:
i. Based upon the study design, determine all research procedures, personnel and any animal procurement and/or care expenses needed to complete the project
ii. Contact the appropriate areas that may be assisting with the study (e.g. if another lab is running assays, contact that lab for their expenses; if the Animal Resources Program is helping you obtain research animals and provide ongoing husbandry and care for the animals during the study, contact ARP for those expenses)
iii. Include any appropriate institutional fees including but not limited to:
1. Applicable F&A (indirect rate) based on institutional policy.
Process – Evaluating Against External Offer and Negotiating Additional Funds
Sponsor-initiated studies, clinical or basic:
1. Compare the internal budget with the company proposed budget.
2. If the company’s budget is lower than the internal budget, discuss and negotiate with the company so that all expenses of conducting the study here are appropriately paid for by the company.
3. If the company will not agree to pay the amount required to cover the full institutional expenses, the Principal Investigator/department will be responsible for any difference in the expenses and the amount paid verification of acceptance of this amount is required to execute the agreement for such a study.
Investigator-initiated studies, clinical or basic:
1. Communicate to the company the institutional F&A rate and confirm they will agree to pay that rate
2. If they agree to pay our appropriate rate, provide your proposed budget to them for consideration.
3. If they don’t approve the full budget, discuss and negotiate the budget terms.
4. If the company will not agree to pay the applicable F&A rate, contact Industry Relations. Note - The institution is required to obtain full reimbursement of the applicable F&A rate for the study. Industry Relations can assist you with either discussions with the company to explain these requirements or determining if there are other institutional options that will allow for the project to move forward.
The PI is responsible for the full expenses of the study so in the event the company will not pay the full budget required for the project, the PI must provide verification that he/she will cover any additional expenses before the research agreement is signed.
WFUHS is required to recover the full cost of research conduced for outside sponsors. To do otherwise would result in subsidizing for-profit research. Direct costs are project specific costs that can be identified and assigned with a great degree of precision to a research project. The federal government’s Office of Management and Budget establishes the standards for calculating the indirect cost rate and WFUHS negotiates its rates with United States Department of Health and Human Services audit agency.