Heidi,

We could probably spend hours and hours on this one… I’d start at ground level and then I think the rest of your problems can be handled in an orderly fashion.  First, this is human subjects research.  Just because the sponsor has already written the protocols doesn’t necessarily mean that your institution can engage in the research without IRB review and approval of each protocol.  (The one exception to this that I can think of is an existing agreement between your institution and the sponsor to honor the findings of the sponsor IRB, an “iffy” proposition in most cases and especially if the sponsor is geographically distant from you.)

I took a look at your IRB website and IU seems to have very clear guidelines and requirements for engaging in human subjects research, including submission of protocols for each trial, fees for IRB review of protocols, and instructions for developing budgets for the clinical trials.  The scope of work for the entire subcontract can be determined from the protocols submitted by the PI.  The budget, likewise, can be determined from the per patient budget of the respective protocols.  The subcontract can then be written 1) to identify all of the trials in which the PI may choose to participate, 2) for a “not to exceed amount” for each trial and/or for the entire project, based on the PI’s estimate of the number of subjects (s)he is likely to enroll, 3) data reporting requirements and methods, and 4) clear invoicing and payment responsibilities of both parties. 

If the PI doesn’t want to get IRB approval for each protocol at the award stage, be sure that the award clearly states that the PI (and IU) will not undertake participation in any single protocol until IRB approval of that protocol has been obtained.  What you don’t want here is the sponsor, under terms of the agreement, having the ability to “order” the PI to start enrollment in a study within some arbitrary time limit, say within 30 days or 2 weeks, or stand in default of the entire contract.  Some protocols take longer than others to be approved and may even have to be tabled or amended for later approval by the IRB.  Also, unless your IRB is willing to meet for one protocol, the PI may have to wait for the next scheduled IRB meeting.

This response doesn’t address nearly every concern but it may give you a place to start.  I suggest you talk to your IRB administrator who will have lots of information to assist you in writing the contract based on the IRB approved protocols and per patient budgets. 


Rosemary


At 10:15 AM 11/22/2002 -0500, you wrote:
Hello all,

I am working on a subcontract from an oncology group that would allow our institution to participate in multiple protocols.  However, the contract does not specifically identify the protocols.  Instead, if the subcontract is signed, our investigator may opt to participate in any of the sponsor's active protocols any time during the performance period without amendment to the subcontract, addition of task orders, or any acknowledgment by the sponsor that we are enrolling patients on specific protocols.

I would like to find a way to make this arrangement work, but I have concerns about the scope of work and monitoring payments.  The subcontract involves NIH pass-through funds, so I have concerns about record keeping too.  On the other hand, the sponsor says that it has a streamlined process with about 300 institutions already on board and it doesn't want to make exceptions for one site.

Any input on negotiating appropriate contract revisions or administering this type of an agreement would be greatly appreciated.  Feel free to contact me directly if you do not wish to respond to the entire list.

Thanks much,

Heidi Bredemeyer
Contract & Grant Administrator
Research & Sponsored Programs
Indiana University
Voice (317) 274-8285
Fax (317) 274-8744
xxxxxx@iupui.edu


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Rosemary H. Ruff
Office of the Vice President for Research
Associate Director
Review and Compliance
Phone (334) 844-5965
FAX (334) 844-4391

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