Re: PI Effort on Industry-Sponsored Studies Linda Ward 22 Dec 2009 09:39 EST
We try to require PI effort on the industry sponsored clinical trials (though we don't always succeed), the theory being that they must be contributing in some fashion to the trial. Our stance is that some effort is significant when compare to no effort. They may have 1% on the grant, and it may not be consistent month by month ~ that's ok. A problem I have with 0% effort on the grant is that they receive inflated residual ~ which isn't appropriate. To the extent where residual balances occur, we risk UBIT (unrelated business income tax)which could be substantial, so reporting full cost is necessary for that reason as well. "Children's Grant Accounting office provides quality service backed by over 20 years experience in federal and non federal grant and contract accounting, reporting, and compliance." Linda Ward, MBA Grant Accounting Manager Grant Accounting 35-123A Children's Hospitals and Clinics of Minnesota 2910 Centre Pointe Dr. Roseville, MN 55113 651-855-2603 651-855-2690 Fax email: xxxxxx@childrensmn.org >>> Lesley Zajac <xxxxxx@JAEB.ORG> 12/22/2009 8:29 AM >>> We account for PI effort on industry sponsored trials in the same way that we do for NIH sponsored trials, to ensure that total effort does not exceed 100%. I assume from your question that PI effort was not included in the study budget or was included at a much lower percent FTE? Lesley S. Zajac Director, Research Administration Jaeb Center for Health Research 15310 Amberly Drive, Ste 350 Tampa, FL 33647 Tel: 813.975.8690 Fax: 813.975.8761 email: xxxxxx@jaeb.org -----Original Message----- From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Jamie Kauwell Sent: Tuesday, December 22, 2009 9:18 AM To: xxxxxx@hrinet.org Subject: [RESADM-L] PI Effort on Industry-Sponsored Studies Good Morning, How do you account for PI time and effort for industry-sponsored studies? Do you require time and effort for each trial? We are finding that PI effort is having a significant impact on the study budget. Many of you are probably out of the office, but for those of you still working I would appreciate your feedback. Happy Holidays! Jamie Jamie Kauwell MHA CCRC Administrative Research Coordinator Geisinger Center for Clinical Studies Henry Hood Center for Health Research 100 N. Academy Ave Danville, PA 17822-4400 Phone# 570-214-9405 Fax# 570-271-6944 xxxxxx@geisinger.edu IMPORTANT WARNING: The information in this message (and the documents attached to it, if any) is confidential and may be legally privileged. It is intended solely for the addressee. Access to this message by anyone else is unauthorized. If you are not the intended recipient, any disclosure, copying, distribution or any action taken, or omitted to be taken, in reliance on it is prohibited and may be unlawful. If you have received this message in error, please delete all electronic copies of this message (and the documents attached to it, if any), destroy any hard copies you may have created and notify me immediately by replying to this email. Thank you. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== Confidentiality Statement: This email/fax, including attachments, may include confidential and/or proprietary information and may be used only by the person or entity to which it is addressed. If the reader of this email/fax is not the intended recipient or his or her agent, the reader is hereby notified that any dissemination, distribution or copying of this email/fax is prohibited. If you have received this email/fax in error, please notify the sender by replying to this message and deleting this email or destroying this facsimile immediately. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================