Effective Date: April 1, 2008
Research grants awarded by ICTR are governed by the terms and conditions described below.
Source of Funding
Awards are funded from the Institute for Clinical and Translational Research (ICTR). Resources for ICTR resulted from a Clinical and Translational Science Award (CTSA) from the National Institutes of Health and from various awards made by organizations within the University of Wisconsin.
The Institute For Clinical And Translational Research Program Oversight
This program is under the technical direction of:
Marc Drezner, MD, ICTR Executive Director
Changes in the scope of work, key personnel, and significant budget changes must be approved in writing by the Director.
The Principal Investigator is listed in the letter of award. The PI must notify the Director in writing if they are unable to complete the project and must terminate the award.
Funds received may not be used to supplant other funds available to the PI and the PI has been informed of this requirement. If, at any time, ICTR becomes aware of supplanting, funding for the project will be terminated. Supplanting violations may result in suspension of future funds and recoupment of monies provided under this grant award.
Health Insurance Portability And Accountability Act (HIPAA) Compliance
Funded projects may involve information that falls under the Federal HIPAA privacy rules, a set of federal regulations protecting the privacy of an individual’s health information used in clinical practice, research and operation of health care facilities.
The PI shall agree to use and disclose Protected Health Information in compliance with the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) (45 C.F.R. Parts 160 and 164) under the Health Insurance Portability and Accountability Act of 1996. The definitions set forth in the Privacy Rule are incorporated by reference into this Contract (45 C.F.R. §§ 160.103 and 164.501).
The PI by accepting this grant is certifying that he/she is knowledgeable and compliant with HIPAA. If the PI does not currently comply with this requirement, ICTR must be notified and shall provide advice regarding compliance.
Human Subjects Compliance
Funded projects may require approval of the University of Wisconsin-Madison Institutional Review Board (IRB) before the project can commence or any funding can be provided. The PI is responsible for complying with IRB requirements. Documentation of the UW IRB review will be required before the funds are disbursed.
Any potentially patentable inventions or software arising from the funded project must be disclosed to the University of Wisconsin-Madison. Inventors will, if requested, assign rights to such inventions to the University’s designated intellectual property management organization and will execute all papers necessary to file patent applications on the inventions and to establish the federal government’s rights in the inventions.
Animal Care And Use
The funded project may require approval by the Animal Care and Use Committee (ACUC). Documentation of an ACUC review will be required before funds are disbursed.
The funded project may require the use of radioactive materials or equipment that produces radiation. Authorization to use radionuclides must be secured from the University Radiation Safety Committee (URSC) prior to the initiation of the project. Documentation of URSC approval must be provided before funds are disbursed.
The funded project may require the use of biological materials in which the activities must be reviewed by the Madison Campus Biological Safety Committee prior to the initiation of the project. Documentation of Office of Biological Safety approval must be provided before funds are disbursed.
Progress And Financial Reports
Throughout the project period, written quarterly progress reports are due no later than ten (10) days after the end of each three (3) month period based on the start date of the project on forms provided by ICTR. A Final Report is due no later than thirty (30) days after the end of the project.
Method Of Payment
Funding for the project will be provided by the creation of a separate Fund 233 account. This account will be set up under the ICTR UDDS with expanded edits to allow departmental expenditures. All requisitions should be processed through appropriate UW-Madison channels.
At the end of the project, the PI may request a no cost extension if additional time is required to assure adequate completion of the original scope of work. The no cost extension must be submitted at the same time as the 3rd Quarter progress report on forms provided by ICTR.
Accounting & Audit
Accounting policies for the project will be those of the UW-Madison campus. All expenses must be allowable under UW-Madison standards and consistent with the budget for this project. Departments must maintain financial records consistent with UW-Madison guidelines. If requested, the PI must be able to describe the nature of project expenses, and establish the relatedness of the expenses to the project.
Limitation On Costs
ICTR through the UW-SMPH is not, in the absence of a modification, obligated to reimburse costs incurred in excess of the approved budget of the award amount.
PI must acknowledge ICTR as the funding source in any press releases, articles or publications relating to the funded project or its results using the following language: “The project was supported by the Clinical and Translational Science Award (CTSA) program through the National Center for Advancing Translational Sciences (NCATS), grant UL1TR002373.”
Suspension Of Project
The grant may be suspended in whole or in part by:
- ICTR on written notice to the PI if the PI has materially failed to comply with the terms and conditions of the grant award as outlined herein and as identified in the approved application;
- ICTR and PI by written agreement; or
- PI on written notice to ICTR setting forth the reasons for such action, the effective date, and, in the case of partial suspension, the portion to be suspended.
Suspension of this grant may include discontinuation of grant payments to PI by ICTR and/or discontinuation of further spending of grant funds by PI. PI agrees to comply with the directions of ICTR regarding the unexpended grant funds when this grant is suspended.
Termination Of Contract
The grant may be terminated in whole or in part in writing by either party provided that no such termination may be effected unless the other party is given not less than thirty (30) days written notice of intent to terminate. Final payment will be adjusted to reflect actual work completed.
Any notice required or permitted by the terms and conditions of this grant must be in writing and be delivered personally or sent by certified mail, return receipt requested and postage prepaid, to the following at the addresses indicated:
To: UW ICTR
Marc Drezner, MD, Director
750 Highland Avenue
Health Sciences Learning Center; Room 4246
Madison, WI 53705
To: Principal Investigator at the address listed in the grant application