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Policies
and Procedures - Memos and MOUs
September
30, 2008
From: Acting Chairman, TVAREF Board of Directors
Subj.: Indirect Cost for Pharmaceutical and Federal Grants
To: Principal Investigators
- I
would like to share some good news with you! The Tampa
Veterans' Hospital Research and Education Foundation (TVAREF)'s
future plans are to set up a grants program, enhance our
education program and strengthen our infrastructure.
As you know, the Foundation is growing at a rapid pace and
is receiving pharmaceutical and non-profit grants, and federal
grants on a regular basis. This year two VA investigators
were awarded DOD grants totaling over $1.2 million dollars
that are being administered through TVAREF. This is
a first! In addition to administering the grants program,
development ventures (i.e., golf tournament) are being initiated
to raise money for the Foundation. These funds will
be used initially to establish a VA investigator seed grant
program. This is a first! Growth demands more
resources to administer the grants in a more timely manner
and initiate new programs. Additionally, Federal grant
awards demand a great deal more of Foundation resources
to administer. Therefore, after careful deliberations,
TVAREF Board of Directors approved an increase in the Indirect
Cost at the September meeting.
- Indirect
costs are costs which cannot be directly identified with
a single contract or grant. The indirect costs are
applied equitably across all of the business activities
of the organization according to the benefits each gains
from them. Some examples of indirect costs are office space
rental, utilities, and clerical and managerial staff salaries.
Therefore, the Indirect Cost rate for the Foundation will
be increased to 25% for pharmaceutical and non-profit funding;
and the Provisional Indirect Cost rate for Government grants
was determined to be 39% as recommended by an outside consultant
hired by the Foundation. Both rates were approved
by the Board of Directors and will become effective with
study agreements initiated after November 2, 2008.
- Also,
attached for your information is the IRB Fee Schedule for
2008 and Amendment II MOA between JAHVA and USF regarding
payment of IRB fees. I would like to remind you that
both R&D and IRB fees should be negotiated with your
funding source and reflected in the budget at time of submission
to R&D for review.
- If
you have questions concerning this increase, please call
Jack Hern, Executive Director, at 813-780-2623, or visit
the new TVAREF website at www.tampavavref.org.;
Policies and Procedures; Accounting.
William R. Gower, Jr., Ph.D.
Amendment II to Memorandum of Agreement
Between James A. Haley VA Medical Center and University of
South Florida for Human Subjects Research Compliance,
Training and IRB Services
THIS
AMENDMENT NO. II ("Amendment") to Memorandum of Agreement,
entered into on December 15, 2001, between James A. Haley
Veterans' Hospital ("JAHVH") and the University of South Florida
for Human Subjects Research Compliance, Training and IRB Services
("Agreement") is made and entered into by and between JAHVH
(referred to as James A. Haley VA Hospital in the MOA dated
December 15, 2001) and the University of South Florida Board
of Trustees, a public body corporate of the State of Florida
for its Division of Research Compliance ("USF") to be effective
on October 1, 2007.
In
consideration for USF's Institutional Review Board (IRB) review
of Human Studies Research conducted at JAHVH, and in accordance
with the Standard Operating Polices/Procedures of both institutions,
and this MOA and amendments, USF and JAHVH agree to the following:
1.
The USF IRB will provide Full, Expedited and Exempt review
of Initial, Continuing and Modifications to research proposals
that will be or are conducted at the JAHVH. In exchange
for these reviews, JAHVH agrees to compensate USF in accordance
with the USF fee schedule (as attached hereto) provided the
fee schedule is submitted to JAHVH for review 90 days before
the proposed effective date. JAHVH shall review the
provided fee schedule. If there are any issues with
the proposed charges, the two parties shall use all reasonable
attempts to agree on the charges.
2.
Charges for VA funded projects conducted and administered
at the JAHVH will be billed to JAHVH through a contract established
specifically for this purpose. Charges for For-Profit
Entity sponsored projects that are conducted at JAHVH, but
are administered through the Tampa Veterans' Research and
Education Foundation, Inc. (TVAREF) will be billed directly
to TVAREF by USF at the follow address:
Tampa
Veterans Research and Education Foundation, Inc.
P.O. Box 1630
Zephyrhills, Florida 33539
Main Office: 813-780-2623
Fax: 813-779-8652
3.
The following protocols will be exempt from the USF fee schedule:
- All
Student-Initiated Protocols (e.g. undergraduate-, graduate-,
post-doctoral fellow, or resident- initiated studies) regardless
of source of funding
- All
Non-sponsored Investigator-Initiated protocols by investigators
who have a paid or Without Compensation (WOC) appointment
at the James A. Haley Veterans' Hospital.
- All
Protocols sponsored by Federal, State, County, Local, or
Public funds that are administered by TVAREF or the VA Research
Service.
- All
Protocols funded by Not-for-Profit Foundations (e.g., American
Heart Association, American Diabetes Association, American
Cancer Society, etc.)
- All
Protocols approved by the USF IRB prior to the effective
date of this amendment.
Except
as provided in this Amendment No. II contained in the additions
and changes noted above (1-3), all other provisions of the
Agreement will remain in effect.
IN
WITNESS WHEREOF, the parties hereto have executed this Amendment.
| JAMES
A. HALEY VA MEDICAL CENTER |
UNIVERSITY
OF SOUTH FLORIDA BOARD OF TRUSTEES |
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| _____________________________ |
_____________________________ |
|
Stephen
M. Lucas
Director
James A. Haley Veterans' Hospital
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Abdul
S. Rao, M.D., M.A., D.Phil
Professor of Surgery & Molecular Medicine
School of Biomedical Sciences,
College of Medicine
Senior Associate vice President -
USF Health
Senior Associate vice President for
Research - USF
Medical Director - Clinical Research
Tampa General Hospital
University of South Florida - Health
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_____________________________
Date |
_____________________________
Date |
Policy:
IRB Fee Schedule
Effective
Date: January 1, 2008
The
Division of Research Integrity and Compliance is involved
in the oversight of the Human Research Protection Program
at USF and at numerous affiliate sites. This federally-regulated
program has numerous components one of which is the appropriate
review and approval of research protocols by the IRB. Until
recently, with the exception from Moffitt Cancer Center, the
costs of providing these services were largely absorbed by
the University. However, as is practice at other similar institutions,
we will partially recover the cost of these reviews from the
sponsors and/or our affiliate partners. The fee schedule for
review of protocols by the IRB is provided below:
Fee
Schedule
| Type
of Review |
Type
of Review Process |
| Full |
Expedited |
Exempt |
| Initial |
$1500 |
$1000 |
$500 |
| Continuing |
$500 |
$250 |
$250 |
| Modification |
$250 |
$100 |
$100 |
Protocols
for human subject research funded from the following sources
will be subject to the conditions of this policy (with the
exclusion of protocols falling under the Excluded Protocols
category defined below):
- ALL
industry-sponsored protocols (investigators are encouraged
to charge IRB fees as direct cost in their grant budgets)
- Protocols
funded by awards made directly to our affiliates
- Protocols
from our non-affiliate partners
EXCLUDED
PROTOCOLS (i.e., Protocols Not Subject to this Policy):
- H.
Lee Moffitt Cancer Center & Research Institute protocols
will continue to be charged for IRB services according to
our previously negotiated rate and billed on a quarterly
basis to the organization.
- James
A. Haley Veterans Administration Hospital protocols will
be charged according to a negotiated rate (currently in
the process of being negotiated) and billed on a quarterly
basis to the organization.
- Protocols
sponsored by Federal, State, County, Local, or public funds.
- Protocols
sponsored by internally (USF/USF Health) funded grants.
- Student/Trainee-initiated
Protocols (e.g., undergraduate and graduate students, post-doctoral
fellow, residents, etc.).
- Non-Sponsored
Investigator-initiated protocols.
- Protocols
approved by the USF IRB prior to the effective date of this
policy; however, contracts/grants that are currently being
negotiated with the sponsor or funding agencies are subject
to the conditions of this policy.
- Protocols
funded by Foundations and other similar organizations that
do not allow such expenses.
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