Please review the frequently asked questions related to managing conflicts of interest.
What is the role of the Financial Conflicts of Interest in Research Committee?
This standing Committee of the Dean reviews disclosure statements submitted by project investigators and senior key personnel as part of the Grants and Contracts Office application. The Committee: assesses the potential risks posed by outside financial interests; determines whether to allow financially conflicted investigator(s) to participate in the proposed research project; and develops study-specific management plans to manage, reduce, or eliminate potential financial conflicts. The Committee also reviews and develops management plans for institutional conflicts of interest. The Conflicts of Interest Office maintains records of all decisions.
What is the Rebuttable Presumption in human subjects research?
The Rebuttable Presumption states that covered persons with individual financial interests may not conduct research involving human subjects unless the Financial Conflicts of Interest in Research Committee determines that the conflicted individual’s participation will not compromise the research. This determination is facilitated through completion by covered persons of a Convincing Reasons form for the Committee. The Rebuttable Presumption does not apply to Phase II or Phase III multi-center trials for which there is an independent data monitoring organization and Icahn School of Medicine at Mount Sinai is not the coordinating site. The Rebuttable Presumption also does not apply to intellectual property that has not yet been commercialized and commercialization is not imminent.
Are all financial interests considered conflicts of interest?
No. Not all financial interests are judged to be a conflict of interest. The Financial Conflicts of Interest in Research Committee works to evaluate all financial interests in relation to the study and assess whether the financial interest could reasonably affect the design, conduct, or reporting of the research findings. If the financial interest is deemed a conflict of interest, the COI office will work with the investigator to develop a management plan.
What limitations are placed on investigators with financial conflicts of interest that are engaged in human subject research?
Principal investigators are held to a higher standard than co-investigators. They are responsible for the design, conduct, and reporting of the research.
An individual generally cannot serve as principal investigator if he/she has any of the following individual financial interests relating to the research project:
- Individual interest of any kind greater than $10,000 with the study sponsor
- Equity of any amount in a privately held financially interested company
- Equity representing five percent or more of the ownership in a publicly traded financially interested company
- Intellectual property related to the proposed research where the intellectual property has been commercialized or commercialization is imminent
If I own option stock in a privately held company that has not been exercised and currently holds no value, would that still be considered a financial conflict of interest?
Yes. While the equity interest you hold currently may have no value, it could potentially gain value in the future. Per the Financial Conflicts of Interest in Research policy, all equity ownership in privately held companies must be disclosed. We require disclosure of equity ownership in publicly held companies if it is greater than five percent; anything below five percent would be a voluntary disclosure.
What limitations are placed on investigators with institutional conflicts of interest?
For investigators engaged in research where an institutional conflict has been identified, restrictions are placed on the use of the Icahn School of Medicine at Mount Sinai as the Study Site:
- If a principal investigator has equity interest or intellectual property that is or will soon be commercialized, the research cannot be conducted with the Icahn School of Medicine at Mount Sinai as the sole site and the Icahn School of Medicine at Mount Sinai cannot serve as the data coordinating center for a multisite study
- If an Institutional Official or the Icahn School of Medicine at Mount Sinai owns intellectual property (most often, when the Icahn School of Medicine at Mount Sinai has licensed a patent to a company or commercialization is imminent) or has equity interest in a privately held company, the Icahn School of Medicine at Mount Sinai cannot be the sole site for conducting the research and the Icahn School of Medicine at Mount Sinai cannot serve as the data coordinating center for the study
When I disclose a financial interest, will it affect my ability to obtain grant funding or participate in the research?
No. Disclosures must be made. The Financial Conflicts of Interest in Research Committee makes every effort to develop appropriate, effective management plans that will allow research to proceed.
Would pending patents be considered a financial interest?
- Pending patents are considered financial interests but do not represent financial conflicts of interest unless they are commercialized or commercialization is imminent
- Patents filed through the School of Medicine are considered as institutional conflicts, not individual investigator conflicts
How does the Financial Conflicts of Interest in Research Committee handle royalty income?
Royalty payments from any source must be disclosed for both faculty members and their related parties. How they are classified and managed differs, depending on whether the royalties are paid through the Icahn School of Medicine at Mount Sinai or through an outside source.