Hello -
At UW -- our policy & guidelines are such that committed effort on
industry clinical trials is required for the PI, the same as for Fed
trials (the same fiduciary responsibilities we have to Fed sponsors are
applied to industry -- instead of having 2 levels of compliance). The
UW effort guidelines talks about this in relation to required effort
contributions from PI's:
Committed effort is required of the principal investigator/project
director for both federal and non-federal
sponsored project proposals, including industry clinical trials and
fixed price agreements. In the case of
these trials and agreements, it is expected that effort has been
committed. Such commitment is implicit in
the reimbursement negotiated with the sponsor.
This requirement is based on an explicit statement in the January, 2001
Office of Management and
Budget (OMB) clarification to Circular A-21 ("Cost Principles for
Educational Institutions"). It is also a
reasonable expectation since a PI has responsibility for the
scientific, administrative and financial
management of a sponsored project; fulfilling these responsibilities
requires time.
For all types of sponsored projects except clinical trials, the
principal investigator's minimum required
commitment to the project is 1% of his or her effort. For a faculty
member who serves as the principal
investigator on more than one clinical trial, the commitment to any
single trial may be less than 1% as
long as the sum of the commitments for all of the trials reflects a
reasonable level of effort.
Hope this helps...
Best Rgds,
David Ngo | UW Effort Team | RSP
DAVID NGO
EFFORT ADMINISTRATOR / ECRT MANAGER
UNIVERSITY OF WISCONSIN-MADISON
OFFICE OF RESEARCH & SPONSORED PROGRAMS
21 N. PARK ST.; SUITE #6158
MADISON, WI 53715-1218
(608) 263-6913 TELEPHONE
(608) 262-5111 FAX
xxxxxx@RSP.WISC.EDU
>>> Linda Ward <xxxxxx@CHILDRENSMN.ORG> 12/22/2009 8:39 AM >>>
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
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