What do I need to know about conflict of interest regarding my clinical trial?
Federal regulations and Mercy policy require that investigators disclose any significant financial interests that may present an actual or potential conflict of interest in relationship to externally sponsored projects prior to initiation of the study. If you answer, “Yes” to any of the questions on the “Significant Financial Interests in a Sponsored Project – Addendum B” form you must reveal those financial interests on a separate submission before the protocol is reviewed by the full committee.
Federal Code Part 54 requires that investigators disclose financial interests in sponsors of clinical trials. Typically, the corporate sponsor will provide its own disclosure form which details what must be disclosed (royalties, patents, equity interest, etc.) The company’s disclosure form does not serve as a replacement or substitute for the Mercy Financial Disclosure for, and the company’s form should be sent directly to the company, not to the IRB office.
Who is covered?
“Investigator” means the principal investigator, co-investigator, and any other person at Mercy Medical Center who is responsible for the design, conduct, or reporting of research or educational activities funded, or proposed for funding, by an external sponsor. In this context, the term “Investigator” includes the investigator’s family (spouse, domestic partner, and dependent children).
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What must be disclosed?
Each investigator shall disclose all significant financial interests in the funding sponsor that would reasonably appear:
- To be affected by the research, educational, or service activities funded, or proposed for funding, by an external sponsor, or
- To present a conflict of interest or the appearance of a conflict of interest in the objective performance of the project.
“Sponsor” means the organization or other entity providing funds.
“Significant financial interests” means anything of monetary value, including, but not limited to, salary or other payments for services (i.e. consulting fees or honoraria); equity interests (i.e. stocks, stock options, or other ownership interests); and intellectual property rights (i.e. patents, copyrights, and royalties from such rights). The term “significant financial interest” includes the following:
- An entity interest that when aggregated for the investigator and the investigator’s family, meets both of the following tests: exceeds $10,000 in value a determined through reference to public prices or other reasonable measures of fair market value, or, constitutes more than a 5 percent ownership interest in any single entity.
- Other salary, royalties, or other payments that when aggregated for the investigator and the investigator’s family over the past 12 months does exceeds $10,000 or is anticipated to exceed $10,000 over the 12 month period immediately following the submission execution of the clinical trial agreement.
The term “significant financial interest” does not include the following:
- Salary, royalties, or other remuneration from Mercy Medical Center.
- Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
- Income from service on advisory committees or review panels for public or nonprofit entities.
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What is the disclosure procedure?
The principal investigator is responsible for seeing that all investigators disclose their significant financial interest by completing and signing the “Significant Financial Interests in a Sponsored Project – Addendum B” form found with the application. The completed form(s) must be submitted with the Clinical Trial application. By signing the Clinical Trial application the principal investigator certifies that he/she has requested such information from all investigators.
Disclosure material will be considered confidential information to the extent permitted by law.