Fixed-Fee Arrangements Diane Austin 11 Jun 1998 14:01 EST

First let me thank all of you who have given me help in the past with your responses. Here is my newest dilemna.

We are involved in several fixed-fee arrangements with universities or private organizations in which we receive a fixed amount of money per patient enrolled in a clinical trial or per form completed for patients enrolled in a trial.  The university or private organization receives their original award for these trials from a federal agency, usually an institute within the National Institutes of Health.  While these dollars appear (based on contract language) to be free of federal regulatory restrictions, we struggle with the need for to maintain consistency between these types of projects and federally-funded projects.  For example, we wouldn't allow an investigator with federal funding to charge to the project an expense that was not necessary for the performance of the award (e.g., a staff pizza party).  Should we be more flexible with ivestigator's who do not have these restrictions dictated by federal regulation.  If the investigator on a non-federal fixed-fee contract !
 wants to throw a quarterly pizza party for the staff on the project, should we allow him to charge it to the contract?  What are others doing?

Thanks in advance for your advice.

Diane Austin, CRA
Mgr., Research Review/Reg. Affairs
Marshfield Clinic
Division of Research
1000 N. Oak Avenue
Marshfield, WI 54449
Phone:  715-387-9134
Fax:  715-389-3131