Mount Sinai’s commitment to protect the safety and welfare of human subjects participating in research projects is reflected in the additional scrutiny imposed by the FCOIRC in its systematic and rigorous review and management of financial interests. If an Investigator has an actual or perceived conflict of interest, he/she will be automatically subject to certain requirements and/or restrictions for the conduct of human subjects research that will depend upon:
- the investigator’s role in the study team
- the nature of the science
- the stage of the research
- the nature of the Individual Financial Interest
- how closely the Individual Financial Interest is related to the research
- the degree to which the Individual Financial Interest may be affected by the research
These heightened standards for human subject research apply regardless of whether the research is funded by a public agency, a non-profit entity, a commercial sponsor or a private source, and wherever the research is carried out.
- Limitations on Principal Investigators
In general, investigators may not serve as the PI of a Human Subjects Research study if any of the following conditions related to the proposed research exist:
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- Individual Financial Conflicts of Interests greater than $10,000 with the study sponsor
- Equity Interest of any size in a privately-held Financially Interested Company
- Equity Interest representing 5% or more of the ownership in a publicly–traded Financially Interested Company
- Intellectual Property related to the proposed research or service
2. Rebuttable Presumption
- Definition and Application
Mount Sinai applies the Rebuttable Presumption for human subjects research. Under the Rebuttable Presumption, an individual with an Individual Financial Interest may not conduct research involving human subjects unless the FCOIRC determines that the conflicted individual’s participation will not in any way compromise the research. This presumption is not designed to suggest that every financial interest jeopardizes the welfare of human subjects or the integrity of research. Rather, it ensures that Mount Sinai will carefully review any financial interest that might give rise to an actual or perceived conflict of interest, and allows the FCOIRC to consider the Investigator’s Convincing Reasons (see Section A-1-c below) that might justify participation in the research project.
- Exemptions from the Rebuttable Presumption
Exempt from the Rebuttable Presumption are:
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- Phase II or Phase III multi-center trials for which there is an independent data monitoring organization and Mount Sinai is not the coordinating site
- Intellectual Property that has not yet been commercialized and commercialization is not imminent
3. Convincing Reasons:
Investigators with Individual Financial Interests may be asked to complete a Convincing Reasons form, a set of questions designed to help the FCOIRC assess possible participation in the study. The FCOIRC considers the following factors in making its determination:
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- the stage and nature of the research and the extent to which the research could be performed at other centers
- the degree of risk to the human subjects involved that is inherent in the research protocol
- the extent to which the investigator and/or the institution is uniquely qualified to perform the study; the magnitude and type of Individual Financial Interest and the degree to which it is related to the research
- the extent to which the Individual Financial Interest could be directly and substantially affected by the research, such as increasing financial gains for the investigator
- the extent to which the FCOI can be minimized by effective oversight and management
If the FCOIRC determines that the Convincing Reasons justify the individual’s participation in the research project, the FCOIRC will develop a management plan that describes any restrictions and/or requirements imposed on the individual.
Additional specific restrictions may also be mandated depending upon the nature of the science, the stage of the research, the nature of the Individual Financial Interest, how closely the Individual Financial Interest is related to the research, and the degree to which the Individual Financial Interest may be affected by the research.