Review of Disclosure Forms

Who reviews my disclosure form?
Disclosure forms submitted with research applications will be reviewed by the Financial Conflicts of Interest in Research Committee. Voting members of the Committee include senior faculty, administrators and Trustees with experience in basic science research and in clinical research. Ex-officio members of the Committee include representatives from the Compliance Department, the Dean's Office and Legal Affairs.

Will the information I disclose remain confidential?
Yes. Your responses will only be seen by members of the Financial Conflicts of Interest in Research Committee and may be reviewed by the Office of the Dean. If the research project is funded by the Public Health Service, e.g., NIH or the National Science Foundation, Mount Sinai is obligated to report the existence of the conflict and to provide assurances that the conflict has been reviewed and appropriately managed; Mount Sinai will not release specific information to the funding agency unless asked to do so, which is unusual. Note that the management plan developed for your conflict may require that you disclose certain aspects of your financial relationships to colleagues, trainees or the public.

What does the Financial Conflicts of Interest in Research Committee consider in evaluating my disclosure form?
The Committee considers the type of research and the nature of the financial interests in order to evaluate the potential risks that the conflict poses for the integrity of the study (and the risks to its subjects, if applicable). Risk differs depending on a variety of factors including:

• Whether human subjects are involved - Studies of human subjects, e.g., clinical trials that evaluate the safety and efficacy of a drug, medical device or treatment, are subject to the most rigorous review and stringent conditions in order to ensure the safety of the subjects and the quality of the data.
• Whether the financial interests are individual or institutional - Individual financial interests are those held by a Covered Person (see policy definition or "Who Must Disclose" above). Institutional interests take two forms: financial interests held by a Covered Person who holds a significant administrative role at Mount Sinai, e.g., Department Chair, Division Chief or an IRB member; or financial interests held by Mount Sinai, e.g., through patents (active or pending) and royalty income. The risk is often higher for institutional than for individual interests, and so the level of scrutiny and the controls implemented tend to be greater.
• Whether the financial interest is "significant"- The policy provides comprehensive descriptions of types of interests and value of interests that qualify as significant. Significant financial interests are subject to great scrutiny and controls.

What is the rebuttable presumption?
In human subjects research it is essential to minimize any risk to subjects. Any Covered Person who discloses a significant financial interest (as defined in the policy) is immediately considered to have a conflict that precludes him/her from participating in the research. However, the conflicted individual can contest, or rebut, the presumption that he/she cannot participate, by offering convincing reasons that justify participation.

Are there any circumstances in which the rebuttable presumption doesn't apply?
Yes. The rebuttable presumption doesn't apply to Phase II or Phase III multi-center clinical trials, provided there is an independent data monitoring group and Mount Sinai is not the coordinating site.

What are the convincing reasons that will be considered when contesting the rebuttable presumption?

• The nature of the research
• Whether the research could be performed at another institution
• The degree of risk that the research protocol poses for its human subjects
• Unique qualifications of the individual and/or Mount Sinai to perform the study
• The size and type of the financial interest
• The degree to which the financial interest is related to the research
• The extent of the potential financial gains for the investigator and/or Mount Sinai
• The potential for effective oversight and management to minimize the financial interest

Based on evaluation of such factors, if the Committee is persuaded that there is a sufficiently strong rationale for investigator and/or institutional participation, it will develop a management plan with safeguards to protect both the subjects and the data collected and analyzed in the study. Conflicted individuals are invited to propose management plans for the Committee to consider.

How will my research project, which doesn't involve human subjects, be evaluated by the Committee?
Many of the same factors will be considered, including:

• The nature of the research
• The size of the financial interest, the degree to which it is related to the research and the extent to which the financial interest could be affected by the research
• The extent to which an effective management and oversight plan can be developed to eliminate, reduce or control the conflict

For research that doesn't involve human subjects, the timeframe in which the financial interest might come to fruition is also considered. For example, a patent application without certainty of commercial viability for at least five years would be seen in a different light from a patent that has already been licensed to a commercial entity.

Are the disclosure and review processes the same regardless of who the sponsor of the research is?
Yes, the same issues would be considered regardless of sponsorship.

How quickly are disclosures reviewed and acted upon?
The Grants and Contracts Office, in conjunction with the Program for the Protection of Human Subjects, alerts the Financial Conflicts of Interest in Research Committee when a disclosure form is received. Often, if the financial interests do not meet the threshold of significance and the study does not involve human subjects, the case can be reviewed and approved by a subgroup of the Committee that meets weekly. However, the more risk posed by the financial interests or by the nature of the research, the more scrutiny is required, and the greater the likelihood that the full Committee will need to review and discuss the case. Frequently an individual with financial interests will be asked to talk with or meet with the Committee Chair or with a Committee subgroup to clarify issues and help expedite the process. The full Committee typically meets monthly to review cases.