Note: All of these issues are covered in detail in the policy. Please refer to the policy for complete information on definitions, requirements and processes.
What is a financial conflict of interest in research?
A conflict of interest may be arise in several ways: a) when a "Covered Person" -- an investigator responsible for design, conduct or reporting of research as well as the investigator's spouse and dependent children (see policy for complete definition) -- might benefit financially from the outcome of a research study (this is known as an "individual conflict"); b) when Icahn School of Medicine might benefit from the outcome of a research study (this is known as an "institutional conflict"); or c) when an Institutional Official (a member of the Mount Sinai community with a substantial decision-making role, e.g. Dean, Chair, or Division Chief) might benefit financially from the outcome of the research study (this is another kind of "institutional conflict"). Sometimes, one or more of these types of conflicts may be present for the same study.
Why is financial conflict of interest in research so important?
As an academic medical center, Mount Sinai stands by the integrity of its research. We cannot allow the prospect of personal, institutional or commercial gain to cloud our judgment or influence research results, nor can we risk even the appearance of a possible conflict. The collection, analysis and reporting of data in research studies must always be objective, scientifically sound and defensible. Breaches of integrity can cause a loss of public confidence in our research programs, and could affect our ability to secure extramural support for research. Sometimes, even the perception of a possible conflict may put our reputation at risk. In order to protect our research programs and our institution, Mount Sinai has implemented a comprehensive policy governing conflict of interest in research. This policy was developed with careful consideration of guidelines from the National Institutes of Health and the Association of American Medical Colleges.
Do financial interests always create a conflict?
Theoretically, yes. But some types of interests are of more concern than others because the risks are greater. The key is to assess the risks to determine how best to manage the conflict.
How are conflicts of interest in research identified?
Individual conflicts must be disclosed by "Covered Persons" as part of the research application submission to the Grants and Contracts Office. The principal investigator and all co-investigators must review the policy and, when necessary, complete the disclosure forms as part of the GCO submission. Disclosures citing financial interests relating to the research project will be reviewed by the Financial Conflicts of Interest in Research Committee.
Institutional conflicts are identified in several different ways. First, institutional officials may themselves be study investigators, and if so they will disclose their financial interests relevant to the project through the grant application submission to the Grants and Contracts Office. Second, the financial interests of institutional officials who are not directly involved with the proposed research study but who are responsible for the supervision of study investigators will be reviewed; all institutional officials are required to declare all outside financial interests as part of an annual compliance process. Third, institutional conflicts stemming from the medical school's potential financial benefits relating to a particular research project will be identified through data resources maintained by the Compliance Department, the Office of Technology and Business Development and other core groups.
What is the role of the Financial Conflicts of Interest in Research Committee?
This standing Committee of the Dean reviews financial disclosure statements submitted with the Grants and Contracts application by individual investigators with the GCO application in order to: assess the potential risks posed by outside financial interests; determine whether to allow financially conflicted investigator(s) to participate in the proposed research project; and to develop study-specific management plans to eliminate, reduce or control potential financial conflicts. The Committee also reviews and develops management plans for institutional conflicts of interest. The Committee maintains records of all decisions that it makes.
Are all conflicts treated identically?
No. Although there may be similarities among conflicts and situations, all conflicts are unique and are handled on a case-by- case basis. The nature and size of the interest and the type of research are some of the factors that will influence how the Financial Conflicts of Interest in Research Committee handles a conflict. The policy itself and the 'Review of Disclosure Forms' and 'Resolution Conflicts: Management Plan' sections of this website provide details on how conflicts are evaluated and resolved.
What types of conflicts are of greatest concern?
Conflicts relating to human subjects research undergo the greatest level of scrutiny because of the need to protect the subjects. Financial interests could influence the way in which a conflicted individual enrolls subjects, obtains consent, or analyzes data; such biased performance could have implications for the safety of the study subjects as well for the conclusions drawn from the study, e.g., the efficacy of a particular treatment. It is therefore essential that Mount Sinai take measures to ensure that such conflicts are eliminated or appropriately managed.
How does the review of conflicts in studies involving human subjects differ from review of conflicts in studies that don't have human subjects?
Some of the preliminary analysis is the same, for example: the nature of the research; the size of the financial interest; the degree to which the interest is related to the research; the extent to which the financial interest could be affected by the research; and the extent to which an effective management and oversight plan can be developed to eliminate, reduce or control the conflict.
However, when a significant financial interest (see policy definition) is identified in a study involving human subjects, the rebuttable presumption often will apply. This means that the conflicted individual cannot participate in the research project unless he/she provides convincing reasons for participation to the Financial Conflicts of Interest in Research Committee. Similarly, if the significant interest is institutional, the research cannot go forward at Mount Sinai unless the Committee is persuaded that there is strong justification for doing so. In reviewing convincing reasons, the Committee performs the preliminary analysis described above and also considers such factors as: the degree of risk that the research protocol poses for its human subjects; whether the research could be performed at another institution; unique qualifications that the individual and/or Mount Sinai can bring to the study; whether an effective management and oversight plan can be implemented.
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 Medical Center 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.
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.
RESOLUTION OF CONFLICTS: MANAGEMENT PLANS
How will I know when and how my issues have been resolved?
You will receive e-mail notification of the management plan from Mount Sinai's Program for the Protection of Human Subjects (PPHS), even if your research doesn't involve human subjects.
What is a Management Plan?
A Management Plan is developed by the Financial Conflicts of Interest in Research Committee when it determines that imposing specific restrictions can effectively reduce or eliminate a financial conflict, whether individual or institutional, so that the research can proceed.
What elements typically comprise a Management Plan?
A Management Plan often contains one or more of the following features (see the policy for more details):
- Disclosure Requirement - A conflicted individual will be required to disclose relevant financial interests to the public, e.g., in publications and at presentations, to other members of the research team, to trainees, and to human subjects (via consent forms).
- Limitations on Role of a Covered Person with a Financial Interest - Role limitations for the conflicted individual may include: removal as P.I. on the study; restrictions on access to data and/or to subjects; prohibition against determining whether adverse events can be reported.
- Equity Restrictions - A conflicted individual may be asked to place stock in escrow or not to exercise stock options without prior permission from the Committee.
- Divestiture - A conflicted individual may be instructed to relinquish specified financial interests by a certain date.
- Data and Safety Monitoring - The Financial Conflicts of Interest in Research Committee might ask Mount Sinai's Program for the Protection of Human Subjects (PPHS) to review/revise the proposed safety monitoring in light of the financial conflict
- Implementation of Good Laboratory Practices - Guidelines for the sound collection, storage and analysis of data will help ensure that financial interests do not bias the study.
- Severance of Relationships - A conflicted individual may be asked to end a relationship that poses an actual or potential conflict, e.g., terminate a consulting arrangement or resign from an advisory board.
- Oversight - An impartial third party, e.g., an oversight team, may be assigned to monitor the research activity.
- Audit - For human subjects research, periodic audits of clinical trial conduct (recruitment, consent, subject-staff interaction, research staff-PI interactions, and reporting of SAEs) may be conducted. For laboratory research, periodic audits for adherence with good laboratory practices may be conducted.
Once I agree to the Management Plan, is there anything else I need to do regarding conflict of interest and the research project?
You will need to: a) Follow the actions outlined in the management plan; b) promptly report any changes in relevant financial interests by submitting an updated disclosure form; and c) cooperate in any project audit undertaken by the Office of Compliance.