Disclosure - What Do I Need To Do?
What is disclosure?
Disclosure is your reporting of compensation or other relationships that you have with a company that has a financial interest in a particular research project or its results. Because such a company's financial situation - or your own financial situation -- could conceivably be affected by the outcome of the research, it is essential that Mount Sinai know through the disclosure form about the existence of such interests.
Who must complete disclosure forms?
Anyone who meets the policy definition of a "covered person" must disclose. This includes the Principal Investigator, Co-investigator, team members and any other Health System personnel who are either responsible for or involved in the design, conduct or reporting of the research. The Principal Investigator must also obtain disclosures of relevant financial interests of spouses, partners and dependent children of covered persons. Institutional officials, such as senior managers and members of institutional research-related committees (e.g., IRB, IACUC) must also disclose. The policy provides a comprehensive definition of Covered Persons who must disclose their financial interests relating to a particular research project.
What must be disclosed?
All financial interests with the study sponsor or any other extramural entity that might have a financial stake in the research or its outcome must be disclosed. These interests must be disclosed no matter how small the monetary value of the interests might be. Some of the most common types of financial interests are consulting and director's fees, honoraria, gifts, equity such as stocks and stock options, and intellectual property rights such as patents, pending patents, copyrights and royalties. The policy provides additional examples of financial interests that must be disclosed.
How do I disclose financial interests in research?
As part of the process of submitting a grant application to the Grants and Contracts Office, the Principal Investigator is responsible for making sure that all Covered Persons (see policy definition) complete "GCO Form 6". This form asks whether the respondent has a financial interest relevant to the project to disclose. If yes, then the individual must complete a Financial Interest in Research Disclosure Form provided electronically by the Program for the Protection of Human Subjects (even for research that doesn't involve human subjects). Anyone who completes a Financial Interest in Research Disclosure Form will place the form in a sealed envelope for the P.I. to submit to the GCO along with the rest of the grant application.
When do I disclose financial interests in research?
Covered persons are always required to complete disclosure forms as part of a grant application submission to the Grants and Contracts Office, as described above in "How do I disclose financial interests."
In addition, Covered Persons must promptly disclose any new financial interests relevant to the project that are undertaken during the life of the project. (Remember that faculty cannot enter into a financial relationship with an extramural organization/business without a written contract that has received the required internal approvals as described in Mount Sinai's Policy on Financial Relationships with Extramural Entities).
Note: The disclosure requirement for individual research projects submitted to the Grants and Contracts Office is different from the annual disclosure requirement for faculty set forth in the Business Conflicts of Interest Policy. You must submit an annual institutional disclosure form and you must also submit a disclosure form focusing on research-related interests for each research project in which you are involved.
Why do I need to complete another disclosure form if I already submitted my annual institutional conflict of interest disclosure form on-line?
The institutional disclosure form captures information about all of your financial interests relevant to all of your work at Mount Sinai. In order to protect your privacy, the Financial Interest in Research Disclosure Form is narrower in scope, and focuses on interests relating to a specific research project; that way, the Financial Conflicts of Interest in Research Committee only sees information relevant to your research project, and does not see information that is unrelated to the project.
If I disclose a financial interest, what is the likelihood that I won't be allowed to participate in the research or that the project will be stopped?
Mount Sinai encourages scientific collaboration with industry as a means of developing new and improved scientific, diagnostic and therapeutic products. The Financial Conflicts of Interest in Research Committee makes every effort to develop appropriate, effective management plans that will allow research to proceed. The types of issues that the Committee takes into consideration in devising a management plan are described in the following section on Review of Disclosure Forms.