Office of Research and
Sponsored Programs
19 Hagood Avenue, Suite 604
MSC 808
Charleston, SC 29425
Fax: 843-792-3061
Medical University of South Carolina (MUSC)
Department of
Division of
Authorization for Regulatory Review Fee and Research Team Preparation of Regulatory Submission
Documents Fee Payments
Date:
Funding Entity (the “Funding Entity”):
Protocol Title (the “Study”):
Protocol Number:
Principal Investigator:
This letter will serve as a Letter of intent (“Letter of Intent”) between the Medical University of South
Carolina (the “Institution”) and the Funding Entity (Individually a “Party” and collectively “Parties”) for
Institution to provide regulatory submission services (the “Services”) in connection with the Study.
The Parties will negotiate, in good faith, the terms and conditions of a mutually acceptable formal
agreement (the “Agreement”) for the participation of Institution and its respective investigator in the
Study. This Letter of Intent will serve as an interim agreement between the Parties to facilitate the
undertaking by the Institution of the necessary preparations for initial regulatory submission, but is not
intended to constitute an Agreement or to cover the performance of the Study. Any fees paid under this
Letter of Intent are not inclusive of all study start-up costs.
Planned Services
Upon signature of this Letter of Intent by the Parties, Institution will prepare and submit all necessary
information to the Institutional Review Board for approval.
In conducting the Services, each agrees that it will comply with all applicable laws and regulations
including without limitation United States Food and Drug Administration regulations and Good Clinical
Practice. Further, the Services will be performed in a manner commensurate with professional
standards generally applicable to the Institution.
No human subject research activities shall begin until the Parties have entered into an Agreement.
Payment for Services
Should the Institution and Funding Entity fail to enter into an Agreement, the Funding Entity, in
consideration for the provision of the Services hereunder, agrees to pay the Institution non-refundable
MUSC regulatory submission fees in accordance with the attached Fee Schedule within 30 days of
receipt of invoice following execution of this Letter of Intent. This amount is to cover Research Team
Preparation of IRB Submission Documents and other required regulatory submissions and review fees.
Funding Entity agrees to pay Central IRBs directly for their review fees. All payments received under this
Letter of Intent shall be incorporated into the payment schedule approved for the Study. All payments
will be made payable to: Medical University of South Carolina and sent to: 19 Hagood Avenue, Room
604, MSC 808, Charleston, SC 29425, Attn: Cynthia L. Brown and will reference the above Protocol
number.
Term and Termination
This Letter of Intent will commence when executed by the Parties and shall continue until the execution
of the definitive Agreement but not longer than 24 months after execution of this Letter of Intent. The
Parties acknowledge that they shall enter into good faith negotiations to finalize and execute the
Agreement at the earliest practicable date. Execution of the definitive Agreement will render this Letter
of Intent null and void, in such case, all costs here-in will be included with the final executed Agreement.
Either Party may terminate this Letter of Intent with or without cause at any time upon thirty (30) days
prior written notice.
PLEASE NOTE:
1) Your protocol will not be submitted for IRB review until we receive this signed authorization
form. Please fax or email your signed copy to the attention of: Cynthia Brown at (843) 7923061 or browncyn@musc.edu.
2) Payment for these fees is not contingent on the outcome of the IRB review or execution of the
study contract with the University.
If this Letter of Intent reflects our mutual understanding, please sign in the space provided below.
The Medical University of South Carolina
Funding Entity
By:
By:
Name:
Name:
Title:
Title:
Date:
Date:
READ AND AGREE TO ABIDE BY THE TERMS CONTAINED HEREIN, BUT NOT AS A PARTY HERETO:
Investigator:
___________________________
Typed Name
Medical University of South Carolina (MUSC)
Department of
Division of
Schedule of Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Hollings Cancer
Center Protocol Review Committee (PRC) and associated research team preparation and submission
fees
Rates effective August 1, 2015
Service
MUSC IRB Initial Review
Central IRB Initial Review
Central IRB Amendment Fee
Research Team IRB Prep and Submission
Research Team IBC Prep and Submission
IBC Safety Protocol Development
Hollings Cancer Center Protocol Review
Committee
MUSC Fee
$2,500.00
$1,000.00
N/A
$2,500.00
$4,000.00
$1,923.00
$1,200.00
Central IRB Fee
N/A
Paid directly by Funding Entity
Paid directly by Funding Entity
N/A
N/A
N/A
N/A
F&A
N/A
N/A
N/A
$750.00
$1,200.00
$577.00
$360.00
Total
$2,500.00
TBD
TBD
$3,250.00
$5,200.00
$2,500.00
$1,560.00