Negotiating a Budget with the Corporate Sponsor
The investigator and the clinical department(s) involved are responsible for negotiating with the corporate sponsor concerning the budget and payment schedule. It is advisable to request a payment schedule that provides:
- up-front payment of one-fourth to one-third of the total budget to cover start-up and screening costs
- another payment when half of the target number of patients have been enrolled
- final payment when all case report forms have been submitted and accepted by sponsor
Financial management has approved standard discounts for specific services at UIHC. If you want information on these standard discounts or have questions about the form, call Lori Lawton in the Special Programs Office at 384-2456. To apply for the discount, fill out the Special Programs Questionnaire. (Access to this form is restricted to UI computers.)
Send the budget to DSP with the routing form (more information below), even if the budget is only tentative. Then, as soon as the budget has been finalized, send the final version to DSP. This must be received before the contract can be signed.
University policy requires that corporate sponsors of clinical trials be charged a facilities and administrative (F & A or "indirect") costs of 25% of the direct costs. When developing your budget, keep in mind that your research account will be assessed this amount. All payments from sponsors for clinical trials must be payable to The University of Iowa (not the investigator) and sent to the following address:
The University of Iowa
Grant Accounting Office
118 S. Clinton Street
Iowa City, IA 52242
The University's Federal Tax I.D. Number is 42-6004813.
If the sponsor requests a W-9 form please click here.
This form is the mechanism for an investigator to request University approval of a sponsored research project. In addition to informing the appropriate departmental executive officers and deans about a new project, the routing form provides necessary information for the UI research database and starts the process of initiating a research account in the Grant Accounting Office.
A routing form is required for a new project if any of the following apply:
- The sponsor is providing funds
- The sponsor is providing equipment/devices or other products with a value of at least $2,000
- The sponsor provides or requests that the University provide a contract or letter of agreement
- The sponsor is providing an investigational drug or device, and the University seeks and obtains a letter of indemnification
A new routing form will be required by DSP for continuing projects if the sponsor commits to providing additional funds in a new fiscal year. This is called a "supplement" in the Proposal Type section of the routing form. If the sponsor is also extending the study completion date, it should be coded as a "Non-Competitive Renewal."
The routing form is web-based and must be accessed online.
All elements of the Master File Key (MFK), except the Grant/Program number, should be completed prior to forwarding the form to DSP. Guidelines for completing the various MFK elements follow:
|Fund||500 = nonfederal|
|Org||17 = College of Medicine|
|13 = College of Dentistry|
|19 = College of Pharmacy|
|18 = College of Nursing|
|11 = College of Liberal Arts|
|20 = College of Public Health|
|Dept||Get this from your department administrator|
|Subdept||Get this from your department administrator|
|Grant/Program||Leave blank; will be assigned by Grant Accounting|
|Fn||20 = research|
|Cost Center||Specific for each investigator; department administrator can provide|
In the budget section of the routing form, "direct costs" include all study-related costs, except for IRB review fees. Facilities and Administrative Costs (F&A) are the indirect costs of the study. The University's F&A rate for all industry-sponsored clinical trials is 25% of total direct costs. An example of F&A calculation follows:
Although the routing form must be completed online, it must also be printed, signed, and circulated for signatures. All investigators who are involved in the design, conduct, or reporting of the clinical trial must sign the routing form; this includes the principal investigator, co-investigators, and sub-investigators. Also, the corresponding departmental executive officers and collegiate deans must sign the form prior to forwarding it to the Clinical Trials Office.
If the industry sponsor insists on paying a lower F&A rate (for example, 20%), 25% will still be assessed on the funds. The investigator must decide whether the research can be performed for the amount that is available for direct costs.
Once the clinical trial agreement has been fully executed, our office will prepare the Award Activation Authorization Notice (AAAN) packet for the study and forward it to the Grant Accounting Office (GAO). The GAO will then assign a Grant Program Number (GPN) to the study and will send the copies of the AAAN packet to the principal investigator and the department/college contact(s). If you have questions about issues such as the GPN, checks from the sponsor, or the balance of your account, feel free to contact a GAO staff memeber.
In some clinical trials, research subjects receive financial compensation for their time, parking fees, overnight motel stays, gifts, or other items of value. Such payments should go through Accounting Services. Description of the full policy
All payments to research subjects are process through the Self Service Web Site under the Finance and Operations (FO) crosstab. Direct link to E-Voucher.
The University of Iowa does not require that corporate sponsors pay a fee for IRB review. The University does, however, willingly accept such a fee if the sponsor offers to pay. The standard fee is $1,000, although an individual sponsor may pay what it wishes. This fee goes directly to the office that provides administrative support for the IRB, the Human Subjects Office. Indirect costs (F&A) are not assessed on the IRB review fee.
In order to be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) regulations, the Pharmacy and Therapeutics (P&T) Committee approval of new inpatient medication studies will be contingent on utilization of UIHC Pharmacy Services to store, dispense, label, and distribute study medications. This requirement will also apply to new outpatient investigational (non-FDA approved) medication studies. FDA-approved drugs may be dispensed by the investigator through the study coordinator if the study is conducted in an outpatient setting; however, the investigator may also choose to use the services of the Investigational Drug Service. Questions about this policy should be directed to Barbara Muller, MD or Mary Ross.
Investigators must discuss their study with the Investigational Drug Pharmacist (356-2577) to determine Pharmacy resources and funding required while the study is in the early planning stages. Estimates of the charges for Pharmacy Services can be obtained by contacting the Investigational Drug Pharmacist and/or completing the Investigational Drug Study Standard Charge Worksheet.