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 Contract Information
Topics
| Contract GuidelinesThe University of Iowa Clinical Trials Office (CTO) encourages relationships with the corporate sector and has participated in a wide variety of written agreements related to pre-clinical and clinical research. Questions related to the development, negotiation, and execution of these agreements should be forwarded to the Clinical Trials Office at 319-335-8892. The CTO will either review the contract provided by the company or initiate a contract based on the standard UI Clinical Trials Agreement. The CTO welcomes the opportunity to negotiate master agreements with companies who place multiple clinical trials at the University. The following language describes selected University of Iowa policies contained in the contract terms of the clinical research agreement: All clinical trial agreements and confidential disclosure agreements must be reviewed and signed by a University official. University employees, including faculty members who serve as principal investigators, are prohibited from entering into such agreements without University approval. Therefore, the contracting parties in clinical trials agreements are: the Sponsor and the University of Iowa, a non-profit educational institution, with an address of Iowa City, Iowa 52242. Clinical trials agreements at the University are signed by Dr. Richard D. Hichwa, Associate Vice President for Research. Principal Investigators may sign as "Read and Acknowledged." Publication and
Confidentiality As a public academic institution, the University of Iowa must ensure that its faculty, staff, and students may disseminate results of original research in a timely manner. Such policy protects academic freedom and allows for the proper and necessary recognition of the accomplishments of the University research community. At the same time, the University acknowledges the need to preserve intellectual property and to safeguard sponsors" proprietary information. To accommodate all these interests, the publication clause allows the sponsor a 30-day period to review all proposed publications and presentations. During the review period, the sponsor may request that any of its confidential or proprietary information be deleted, and that the presentation or publication be delayed for a maximum of six months in order to permit the filing of a patent application on the subject matter contained in the material proposed for public dissemination. Since the large majority of industry-sponsored clinical trials are multi-center trials, a time period of one year following the close of the study is permitted in order for the sponsor to prepare a publication compiling data collected from all sites. If after one year no such publication is forthcoming, then the University retains the right to publish the study results obtained at its own site. Rights to inventions, improvements, and/or discoveries are negotiated on a case-by-case basis, depending on whether the corporation or the University investigator initiates the research protocol. The University of Iowa satisfies all claims against it in its capacity as a self-insured agency of state government, as follows: (a) The University of Iowa is covered by Workers' Compensation Program as provided by Chapter 85, Iowa Code; (b) The University of Iowa is covered against liability claims as provided by Chapters 25 and 669, Iowa Code; (c) The University of Iowa maintains medical professional liability insurance (through a self-insurance program) for the Principal Investigator who is a member of the University's Faculty Practice Plan. Coverage is extended to claims based on injury that results from health care professional services provided, or which should have been provided, by Faculty Practice Plan members and participants, with a coverage limit of $5,000,000 per claim. The Iowa Constitution, Article VII, Section I states: "State shall never assume or become responsible for the debts or liabilities of any individual, association, or corporation." The Attorney General of the State of Iowa has interpreted hold harmless clauses as being in conflict with that provision in the Constitution. Bound by the above interpretation of the Constitution, the University of Iowa cannot enter into contracts in which the University holds harmless or indemnifies a corporation. The following language should be substituted: "The University of Iowa shall be liable, to the full extent permitted by Iowa Code Chapter 669, for any and all claims for wrongful death, personal injury, or property damage resulting directly from negligence of the University or its employees and arising from activities under this Agreement." Additionally, the University requires that sponsors of clinical trials provide indemnification for the University, the principal investigator, the Board of Regents, officers, employees, and the University's Institutional Review Board (if that will be the IRB of record for the clinical trial). In the case of a contract between the University and a contract research organization where the sponsor (pharmaceutical or device company) is not signing the clinical trial agreement, a separate letter of indemnification from the sponsor is necessary. Reimbursement
for Research-Related Injury In addition to indemnification, the University requires that sponsors of clinical trials provide language assuring reimbursement to the University for the costs associated with diagnosing and treating injuries caused by the drugs or devices studies in the clinical trial or by protocol-mandated procedures. As with indemnification, this wording must be provided under sponsor signature, not the signature of the contract research organization. Sample wording is as follows: "In consideration of the University conducting this Study, Sponsor agrees that, should any subject suffer injury related to Protocol-mandated procedures, including but not limited to the administration of [the drugs or devices] in accordance with the Protocol, Sponsor will reimburse the University for all hospital and medical costs required for diagnosis and treatment." Clinical trials budgets are negotiated by the research team and the sponsor. The University of Iowa indirect rate for corporate-sponsored clinical trials is 25% of total direct costs. Payments must be payable to The University of Iowa, and sent to the Grant Accounting Office, B5 Jessup Hall, Iowa City, Iowa 52242. The tax identification number is 42-6004813. Beginning November 1, 2005, the University of Iowa will be using Western IRB for corporate-sponsored clinical trials. There will be some exceptions, such as research initiated by our own investigators. Sponsors will pay WIRB directly or will include the WIRB fees plus indirect costs in the University's study budget. In addition, the University of Iowa has a mandatory, one-time fee of $700 for coordinating the initial application materials that are sent to WIRB. No indirect costs will be added to this one-time fee. (top)
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