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Conflicts of Interest in Research
Vinita Witanachchi
Assistant Director
HIPAA
Research Privacy Officer
COI Administrator
Mailing Address:
12901 Bruce B. Downs Blvd., MDC35
Tampa, FL 33612-4799
Office Location:
3702 Spectrum Blvd.
Suite 155
USF Research Park
Tampa, FL
Map
Phone:
(813) 974-5478
Fax: (813) 974-5618
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Conflicts of Interest
in Research
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Introduction
The principal objective of conflict of interest review in research is to protect the integrity of the research. For research involving human subjects, there is an even greater responsibility which is to protect the safety and welfare of the human subjects who participate in research. Any conflict that threatens these objectives must be eliminated or managed. By working together to manage these conflicts, the investigator, responsible administrators, and review committees can achieve these objectives.
Investigators should keep in mind that
- Financial or other interests and external commitments are not, in and of themselves, unethical or prohibited.
- A conflict of interest arises from the situation, and is not a reflection on the actions or character of an individual investigator.
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Policies and Procedures
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Form for Reporting Interests
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How do I determine whether I have a reportable conflict of interest related to a sponsored research project?
A conflict of interest related to research may exist when you or your spouse, domestic partner, or dependent children ("family members") have a financial interest or business relationship in an entity that is related to a research project. These interests and relationships must be disclosed. [For more on the reporting and review process please see Conflicts of Interest in Sponsored Research - USF Policy 0-309]
To determine whether you have a financial interest or relationship related to the project answer the following questions. If you can you answer "YES" to any one of them you may have a conflict and must disclose your financial interest or relationship.
- Do you own stocks, stock options, real estate or have other ownership interests in an entity related to the sponsored research project?
- Do your spouse, domestic partner, or dependent children ("family members") own stock, stock options, or other ownership interest in an entity related to the sponsored research project?
- During the next 12 months, will you or your family member receive salary, consulting fees, royalties, honoraria, dividends or other payments from an entity (other than USF or a government or nonprofit entity) related to the sponsored research project?
- Do you or a family member hold a management position in (director, officer, partner, or trustee) an entity related to the sponsored research project?
An entity "related" to the sponsored research includes but is not limited to:
- The sponsor(s) or funding source(s) of the research;
- A supplier of equipment, materials, products, or services related to the research;
- The holder of any ownership interest in a product being investigated;
- A business commercializing a product that the research is intended to evaluate or further develop;
- A party whose financial interests would seem to be directly and significantly affected by the proposed research.
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What is meant by financial interests?
In the context of sponsored research, financial interests are anything of monetary value, including, but not limited to
- Salary or other payments for services, consulting fees, honoraria, reimbursements of expenses, dividends, or any other payments or consideration;
- Equity interests (stocks, stock options, or other ownership interests);
- Intellectual property rights (patents, copyrights, royalties).
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How are interests reported?
If you have a role in the design, conduct and/or reporting of a sponsored research project (either proposed or funded) and also have a financial interest or business relationship related to the proposed project, you must follow the following procedures for reporting those interests:
- Complete the Financial Relationships Disclosure Form (FRDF)
- The form must be signed by your supervisor or program leader.
- Submit the completed form and your research proposal to:
Dr. Liz O'Connell
Division of Sponsored Research (DSR)
USF Mail Code: 30338 USF Holly Dr.
Physical Location: 3650 Spectrum Blvd., Suite 160
Tampa, FL 33612-9446
For more on the reporting requirements and submission procedures please see Conflicts of Interest in Sponsored Research - USF Policy 0-309]
This requirement applies to all investigators on the study. It is the PI's responsibility to inform all key personnel on the study of this policy.
Release of funding may be delayed if documentation from all relevant personnel is not submitted.
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Where can I get more information?
- If the research involves human subjects or if the investigator is an employee of USF Health (COM, CON, COPH), please refer to Conflicts of Interest and Commitment - USF Health Policy. If additional information is needed, please contact Camille McWhirter, J.D., by e-mail or telephone at (813) 974-6676.
- If the research does not involve human subjects and the investigator is not an employee of USF Health (COM, CON, COPH), please refer to Conflicts of Interest in Sponsored Research - USF Policy 0-309. If additional information is needed, contact Vinita Witanachchi, J.D., by e-mail or by telephone at (813) 974-5478.
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NIH Resources
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