FAQ Key Issues

What is a financial conflict of interest in research? 
A conflict of interest can arise in several ways: a) when a “Covered Person” -- an investigator responsible for design, conduct or reporting of research as well as senior key personnel on the project (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 Icahn School of Medicine at 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, Icahn School of Medicine at Mount Sinai stands by the integrity of its research. We cannot allow the prospect of personal or institutional gain to cloud our judgment or influence research results, nor can we risk even the appearance of a 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 conflict may put our reputation at risk. In order to protect our research programs and our institution, Icahn School of Medicine at Mount Sinai has a comprehensive policy governing conflict of interest in research. This policy was developed with careful consideration of guidelines from the Public Health Service and the Association of American Medical Colleges. 

Do financial interests always create a conflict?
Not always. Some types of interests are of more concern than others because the risks are greater. The key for the Financial Conflicts of Interest in Research Committee is to learn about the financial interests, determine whether those interests create a conflict and if so, develop the best approach to manage the conflict.

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 GCO 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. 

Are all conflicts treated identically?
No. Although there may be similarities among conflicts and situations, each conflict and project is unique. The Financial Conflicts of Interest in Research Committee review includes consideration of many factors, including the nature and size of the financial interest and the type of research.

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; if such performance were biased, it 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. Icahn School of Medicine at Mount Sinai takes great care to ensure that such conflicts are eliminated or appropriately managed.

Why do I need to complete a research disclosure form if I already submitted my annual Report on Relationships with Outside Entities on Sinai Central?
The institutional disclosure form captures information about all of your financial interests relevant to your work outside of Icahn School of Medicine 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.

Will the information I disclose remain confidential?
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. Although generally Icahn School of Medicine at Mount Sinai will not release specific information unless asked to do so by the funding organization, we are required by the Public Health Service to provide them with information about the nature of the conflict, the value of any individual financial interest and the management plan. Also, 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, but not specific dollar amounts.

What happens if I acquire new financial interests during the course of the study?
Covered Persons are strongly discouraged from acquiring new financial interests during the course of the study. If you do acquire new financial interests, you must disclose them immediately (by updating your on-line annual form as well your research disclosure form, both on Sinai Central) so that the Financial Conflicts of Interest in Research Committee can evaluate the potential relevance to and impact on the study. Remember that acquiring new interests could affect your ability to participate in the study, and could have other repercussions such as alterations in patient consent forms.

What must I report for the new NIH travel disclosure requirement? 
If you are currently named on an NIH grant or think you might become involved on an NIH-funded project, you should keep complete records of all of your travel (transportation, food, hotels, etc.) paid for or reimbursed by an outside entity other than another academic institution or the government. Even if the travel is not done in connection to your NIH studies, there are indications that the NIH may still consider some travel as a relevant financial interest. We are waiting for the NIH to provide additional guidance on their requirements regarding the reporting of travel, and as their expectations become clearer, we will in turn give you more information.

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

What is the timeframe for review of disclosures forms? 
Once all Covered Person disclosures required for a project are submitted in Sinai Central, the Financial Conflicts of Interest in Research Committee staff begins the review process. Often, if the financial interest is under $10,000 and the study does not involve human subjects, the case can be reviewed and approved by a working group of the Committee that meets weekly. However, large interests and high risk projects require more scrutiny, increasing the likelihood that the full Committee will need to review the case. Sometimes a conflicted individual will be asked to talk with the Committee Chair or with a Committee work group to clarify issues and help expedite the process. The full Committee typically meets monthly to review cases.

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? 
Icahn School of Medicine at 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. 

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. 

What restrictions might be placed on investigators conducting human subjects research? 
Unless the Financial Conflicts of Interest in Research Committee accepts convincing reasons:

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 5% 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

Restrictions on 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 Icahn School of Medicine at Mount Sinai as the sole site and Icahn School of Medicine at Mount Sinai cannot serve as the data coordinating center for a multisite study
  • If an Institutional Official or Icahn School of Medicine at Mount Sinai owns intellectual property (most often, when 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, Icahn School of Medicine at Mount Sinai cannot be the sole site for conducting the research and Icahn School of Medicine at Mount Sinai cannot serve as the data coordinating center for the study

How does the Financial Conflicts of Interest in Research Committee handle patents?
Both pending patents and issued patents with relevance to your research project are considered to be financial interests and must be disclosed on your Financial Interest in Research Disclosure Form. However, they are managed differently:

  • Pending patents – Pending patents are not considered to pose conflicts of interest. Even so, the Committee generally recommends that in the spirit of transparency you voluntarily disclose these pending patents in presentations and in publications.
  • Issued patents – Issued patents may be deemed to pose conflicts of interest and may require a management plan, particularly if licensing or other commercialization is imminent.

Is all royalty income treated in the same way? 
Royalty payments from any source must be disclosed by Covered Persons on their Financial Interest in Research Disclosure Form. How they are classified and managed differs depending on whether the royalties are paid through Icahn School of Medicine at Mount Sinai:

  • Royalties Through Icahn School of Medicine at Mount Sinai – Royalties paid by Icahn School of Medicine at Mount Sinai to Covered Persons are not considered individual financial interests. However, royalties which Icahn School of Medicine at Mount Sinai receives are considered institutional financial interests and will be managed as such by the Committee.
  • Royalties Outside Icahn School of Medicine at Mount Sinai – Royalties paid to a Covered Person by any entity other than Icahn School of Medicine at Mount Sinai are considered individual financial interests. If they have relevance to a particular research project the Committee will manage them as conflicts.

How will I know when and how my issues have been resolved?
For human subjects studies, the PPHS/IRB will inform you if a management plan has been developed for you to sign. For studies that do not involve human subjects, you will be notified directly by the Financial Conflicts of Interest in Research Committee staff.

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 Research Compliance. 

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 Icahn School of Medicine at 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 Icahn School of Medicine at 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 Icahn School of Medicine 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?
Icahn School of Medicine at 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. 

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, Icahn School of Medicine at Mount Sinai is obligated to report the existence of the conflict and to provide assurances that the conflict has been reviewed and appropriately managed; Icahn School of Medicine at 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 Icahn School of Medicine at Mount Sinai, e.g., Department Chair, Division Chief or an IRB member; or financial interests held by Icahn School of Medicine at 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 Icahn School of Medicine at 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 Icahn School of Medicine at 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 Icahn School of Medicine at 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.