Alternatively, the relevant hospital or institution may be willing to sign a separate user agreement between the site and the CRO/sponsor. It is not advisable to conclude tripartite agreements between ulrf, the site and cro/sponsor, as tripartite agreements can significantly extend the implementation time of a clinical trials agreement. The University of Louisville Research Foundation, Inc. (ULRF) is the legal entity that conducts clinical study agreements for researchers working at the University of Louisville. ULRF is a limited agent for the university to receive grants and research agreements from external funding sources. The UofL Institutional Review Board (IRB) handles all research with human subjects for the university faculty at all hospital/furnishing sites. The University of IRB has a Federal Insurance (FWA). CROs/sponsors should pay the fees directly to the IRB on account in order to avoid installations and administrative costs of the IRB fee. If payment has not been received before the completion of the IRB audit, the IRB grants conditional authorization to begin the study until the fee has been paid.

For more information, visit the UofL Human Subjects Protection Program website. The university does not offer direct medical/professional liability insurance for its faculty. Health insurance is acquired by the doctor through the professional association/group of practitioners and is separate from the university`s general liability insurance. Model clinical trial agreements should normally be revised to comply with this provision. The university`s institutions and administrative (R&A) fee for industry-sponsored clinical trials is 26%. Exclusions should only apply to the extent that the acts or omissions of the university or IP have contributed to the liability/right. . . .