Policy: Financial Conflict of Interest
Effective Date: August 24, 2012
Revised : August 24, 2013
As an independent academic research institution, VGTI Florida encourages its staff to start companies or and participate in sponsored research in order to foster VGTI Florida’s core mission of advancing human health and wellbeing through scientific discovery and translation to the clinic. While the complexity of the research relationships that VGTI Florida and its employees have with industry, government and other entities is increasing, the overriding principle that financial and other personal considerations cannot compromise, or appear to compromise, an employee’s professional judgment in conducting or reporting research results remains a priority at VGTI Florida. VGTI Florida is committed to ensuring and promoting that objectivity of its employees is never threatened by obligations owed to individuals, companies or organizations that provide goods and services or sponsor research at VGTI Florida.
Many of VGTI Florida employees support administratively or conduct research that is supported by public funds and thus incur a specific obligation to preserve the public trust. The Federal Government requires that VGTI Florida ensure that such employees are aware of potential conflicts of interest arising from interrelationships with Federal agencies and commercial sponsors and vendors as well as their obligation to notify VGTI Florida of all outside activities that may have conflict of interest implications. The central governing principles are that financial interests such as equity positions are not necessarily a conflict but must be disclosed and managed if necessary per VGTI policies.
To further these goals in compliance with all applicable Federal policies, VGTI Florida has developed this policy which establishes clear guidelines and principles to enable its employees to appropriately structure and maintain their relationships with industry in a manner that is ethically and legally appropriate, and in no way whatsoever compromises the integrity of the research conducted at VGTI Florida. This Policy is designed to increase awareness of the VGTI Florida employees of the potential for financial conflicts of interest, and to establish procedures for identifying and addressing financial conflicts of interest, to protect both the institution and its employees.
This policy governing financial conflict of interest at VGTI Florida is modeled after the Public Health Service 42 CFR Ch. 1 Subpart F – Promoting Objectivity in Research. It applies to all employees but most particularly to PHS-sponsored Investigators of the Institution engaged in sponsored or contracted research, whether government funded or otherwise.
The Institute Official is responsible for ensuring implementation of this policy and may request a suspension of all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institute Official is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to Institute policy.
This policy promotes the objectivity in research by establishing standards pursuant to the Code of Federal Regulations, Title 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought and Title 45 CFR Part 94.
For the purposes of this VGTI Florida Institute Conflict of Interest Policy (“Policy”) the following definitions shall apply.
Clinical Trial means any research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.
Conflict of Interest Committee (COI Committee) means VGTI Florida’s committee that advises the Institute Official on conflict of interest matters.
Entity is any domestic or foreign, public or private, entity or organization (excluding a Federal agency) from which an Investigator (defined below) or any member of his/her family receives remuneration or in which any such person has an ownership or equity interest.
Covered Individual(s) means any person or persons who is/are responsible for the design, conduct, or reporting of research, educational or service activities funded (or proposed for funding) by an external sponsor. Also includes an executive position that has authority to direct or controls a material segment of the operation.
Family means any member of an Investigator’s immediate family, specifically, any dependent children and spouse.
Financial Conflict of Interest or “FCOI” occurs when VGTI Florida, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a research project that he or she is conducting at VGTI Florida and could directly and significantly affect the design, conduct or reporting of such research project.
Financial Interest (FI) is anything of monetary value or potential monetary value received or owned by the individual, their spouse, and their dependent children, which reasonably appears to be related to the individual’s duties and responsibilities, including, but not limited to:
• Salary, commissions, consulting fees, or other payment for services (e.g., lecture payment, other honoraria);
• An equity interest (e.g., stock, stock option, security, or other ownership interest);
• An intellectual property right (e.g., a patent, copyright, or royalty from such right);
• Reimbursed or sponsored travel related to Institute responsibilities, except if funded by any U.S. government agency or institution of higher learning, including academic research institutions and teaching hospitals; a gift (e.g., money, hospitality, or a physical item excluding those of de minimis value).
The term does not include:
• Salary or other remuneration for services from VGTI Florida, from a U.S. institution of higher education, or from a government agency within the U.S. Such services can include, for example, giving seminars or lectures, teaching engagements, being on a non-profit advisory committees, or review panels.
• Income from, or ownership of, shares of a mutual fund, pension, or other investment fund where the individual does not exercise control over the management and investments of such fund.
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator or covered individual does not directly control the investment decisions made in these vehicles
Institute Official means the individual within the Institution that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s Institute responsibilities.
Institute responsibilities means the Investigator’s professional responsibilities associated with his or her Institute appointment or position, such as research, teaching, clinical activities, administration, and Institute, internal and external professional committee service.
Investigator is the project director or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded (or proposed for funding) by the NIH. Investigator may include, for example, collaborators or consultants.
Public Health Service (PHS) means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institute of Health, and Substance Abuse and Mental Health Services Administration.
Significant Financial Interest (SFI) is defined as
1. Salary or payment for any amount for services over the preceding twelve months for an investigator, covered individual or employee or his/her family;
2. Equity or ownership interests of any amount held by an investigator, covered individual, or employee or covered individuals or his/her family that represents an equity or ownership
3. Travel paid on behalf of the investigator and not reimbursed to the investigator from a source other than a sponsored local, state or federal source or institution of higher education.
Conflict of Interest
VGTI Florida’s Investigators, employees or covered individuals must ensure the integrity of research by taking steps to avoid conflicts of interest or even the appearance of conflicts of interest. It is recognized that due to the complexity and diversity of personal relationships as well as the fact that the perception of a conflict of interest varies from one individual to another, best practices teaches that the most effective means to address conflicts of interest at VGTI Florida is to establish a system under which employees disclose their conflicts of interests and VGTI Florida evaluates them. All external consulting arrangements are to be disclosed for review by the Institute Official prior to the commencement of consulting services.
Circumstances in which Financial Conflicts of Interest may arise
A Financial Conflict of Interest may arise in the relations of a VGTI Florida Investigator, covered individual(s), employee, or employees’ immediate family members with any external Entity:
1. that supplies goods and services to VGTI Florida;
2. from whom VGTI Florida leases property and equipment;
3. with whom VGTI Florida is dealing or planning to deal in connection with a gift, purchase or sale of real estate, securities or other asset;
4. that donates funding or otherwise supports VGTI Florida;
5. that sponsor or support research at VGTI Florida;
6. anyone influencing negotiations or participating in the negotiation of a contract between VGTI Florida and a Business in which the Covered Individual has or seeks to have a Significant Financial Interest.
Circumstances that may be allowable with special safeguards
1. A covered individual having a Significant Financial Interest in a Business that licenses or seeks to license VGTI Florida technology.
2. A covered individual(s) having a Significant Financial Interest in a Business that has entered into or seeks to enter into an agreement to support Sponsored Research to be conducted under the direction of the covered individual(s).
3. A covered individual(s) conducting sponsored basic research (that is not Clinical Research) relating to a VGTI Florida invention on which the covered individual(s) receive, or has the right to receive, royalties and that has been licensed to a Business in which the Covered Individual has a Significant Financial Interest.
External Consulting Arrangements
VGTI Florida recognizes and agrees that its Investigators, employees, or covered individuals may be engaged by industry to provide external consulting services in connection with the design, development, testing, evaluation, regulatory review and approval of products or to be a member of a scientific advisory board or other such safety board or to make presentations. The performance of such external consulting services in compliance with this Policy is permitted provided that the VGTI Florida staff member does not utilize VGTI Florida’s equipment or resources, or violate VGTI Florida’s Policy HR1.23.01 External Commitments and Conflicts of Interest.
Implementing Guidelines for Conflicts of Interest
The Institute Official or Designee shall consider the purposes for managing conflicts of interest. The first purpose is to maintain the integrity of professional judgment. In the research context, this means to prevent significant financial interests from affecting the design, conduct, or reporting of research. The second purpose is to maintain public confidence in professional judgment by minimizing conditions that would cause reasonable persons to believe that professional judgment has been improperly influenced, whether or not it has.
The Institute Official’s obligation is to implement this Policy in a way that creates an environment of integrity and confidence. The Remedy Options will depend on, among other things, the severity of the conflict. The Institute Official will examine both the possibility for bias and the seriousness of the possible harm.
Factors affecting the possibility for bias may include, for example:
• Value of financial interest;
• Nature of relationship;
• Length of time it has existed;
• Role of individual in the activity
Factors affecting the possibility for harm may include, for example:
• Direct or indirect possibility for harm;
• Nature of activity;
• Research-basic vs. clinical
• Will the Conflict affect research of others or harm VGTI Florida;
• Is the Conflict deemed as fraud;
• Extent of accountability.
Proper use of assets
Investigators, employees, or covered individuals are responsible for the proper use, conservation and protection of VGTI Florida assets. Assets are to be used only for the legitimate purpose of VGTI Florida. Assets include intellectual property such as patents, trademarks, copyrights, proprietary information, designs, databases, laboratories, laboratory notebooks, computers, websites, social media outlets, networks and information related to how VGTI Florida conducts its business. An Investigator or covered individual may not directly or indirectly use, lease, rent, trade, or sell real property, personal property, or intellectual property belonging to VGTI Florida for their personal benefit or an affiliate of Investigator of covered individual.
All Investigators, employees, or covered individual(s) are required to disclose their outside financial interests to VGTI Florida on an annual and on an ad hoc basis, as described below. The Institute Official Designee is responsible for the distribution, receipt, processing, review and retention of disclosure forms.
Regardless of the disclosure requirements, the Investigator, in his or her own best interest, is encouraged to disclose any other financial or related interest that could present an actual Financial Conflict of Interest or be perceived to present a Financial Conflict of Interest.
a) Annual Disclosures
All Investigators employees, or covered individual(s) must disclose their Significant Financial Interests that are related to their Institute responsibilities to the Institution, through the Institute Official, on an annual basis. All forms should be submitted to the Institute Official or designee.
b) Ad hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure. All Investigators, employees, or covered individual(s) must disclose their Significant Financial Interests to the Institution, through the Institute Official, within 30 days of their initial appointment or employment.
Prior to entering into PHS-sponsored projects or applications for PHS-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirm the currency of the annual disclosure or submit to the Institute Official an ad hoc updated disclosure of his or her Significant Financial Interests with the outside entity. The Institution will not submit a research proposal unless the Investigator(s) have submitted such ad hoc disclosures.
In addition, all Investigators employees, or covered individual must submit to the Institute official an ad hoc disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.
Investigators, employees, or covered individuals must also disclose reimbursed or sponsored travel related to their Institute responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Institute Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.
Review of Disclosures
Disclosures of financial and obligatory interests and level of significance will be reviewed by the Institute Officer and the COI committee to determine whether an actual or potential COI exists. The COI committee includes but is not limited to the Institute Director, Chief Operating Officer, two Research Program Directors, the Executive Director of Marketing and Business Development, Medical Director, and the Director of Human Resources. The Chair of the COI committee will be appointed by the Institute Director and the composition of the COI committee can be changed from time to time as needed to perform its duties. The designees will determine what conditions or restrictions, if any, should be imposed by the Institute to manage or eliminate such COIs. The COI committee is responsible to submit a management review report and implement the management plan and if necessary, a retrospective review and mitigation report.
Clinical trials involve particularly sensitive issues if the Investigator has a Financial Interest related to the clinical trial. Financial Conflicts of Interest related to research involving human subjects pose special concerns. VGTI Florida and its Investigators have ethical obligations to honor the rights and protect the safety of persons who participate in research conducted at VGTI Florida. Where the proposed research project involves human subjects, the presumption against permitting a VGTI Florida-related startup company to sponsor the research is particularly strong as is permitting a VGTI Florida Investigator to conduct a clinical trial involving intellectual property (IP) for which said VGTI Florida Investigator is a bona fide inventor. Any equity interest in the startup company (including stock options, warrants and instruments convertible into equity) could preclude the financially interested Investigator from conducting a human subject’s research project sponsored by the startup company. The presumption may be overcome only in rare and compelling circumstances, as judged by the Conflict of Interest Committee and the Institute Official, and where effective controls are implemented in order to mitigate any possible effects of such Financial Conflict of Interest. Such circumstances may include, for example, that the Investigator is uniquely qualified to perform the experimental procedure.
Decision of the Institute Official
If a disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institute Official or designee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institute Official will take action to eliminate, reduce, or manage the conflict, as appropriate. The Institute Official may consult the COI Committee for guidance in specific cases, or in the application of this Policy to particular situations.
A Financial Conflict of Interest will exist when the Institute Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of research. If the Institute Official determines that there is a Financial Conflict of Interest that can be managed, he or she must require and approve a written management plan before any related research goes forward. The affected Investigator or the COI Committee is responsible for developing and submitting a proposed management plan, in consultation with the Institute Official.
To address complex situations, oversight committees may be established by the Institute Official to periodically review the ongoing activity, to monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.
Reporting to PHS
For all PHS funded awards, prior to the expenditure of any funds under the award, VGTI Florida shall submit to the funding agency a report of any Financial Conflict of Interest. VGTI Florida is required to submit additional reports annually during the award period and within sixty (60) days of any subsequently identified Financial Conflict of Interest. If the funding for the research is made available from a prime PHS-awardee, such reporting shall be made available to the prime awardees such that they may fulfill their reporting obligations to the PHS.
If a proposed PHS funded research project is to be carried out in whole or part by a sub recipient, VGTI Florida will incorporate as part of a written agreement with such sub recipient terms that establish whether this policy or that of the sub recipient will apply to the sub recipient’s Investigators, as well as the time frames within which the sub recipient must provide to VGTI Florida information necessary to ensure that VGTI Florida is meeting its reporting obligation to the relevant PHS funding agency.
Non-Compliance and Remedy Options
In the event of an Investigator’s or covered individual failure to comply with this Policy, the Institute Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institute Official is implemented.
An Institute Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institute Official, will be described in a written explanation of the decision to the Investigator, COI Committee, and, where applicable, the IRB, and will notify the Investigator of the right to appeal the decision. Examples of conditions or restrictions that might be imposed to manage a Conflict of Interest include, but are not limited to: (i) public disclosure of the Conflict of Interest; (ii) for Clinical Research, disclosure of Conflicts of Interest consent form directly to participants; (iii) monitoring of research by independent reviewers; (iv) modification of research plans; (v) change of personnel or personnel responsibilities, or disqualification from participation in Federally funded research; (vi) reduction or elimination of the Significant Financial Interest.
In addition, if the Institute Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an employee, covered individual, or Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an employee, covered individual, or Investigator to materially comply with a management plan for a Financial Conflict of Interest, a committee appointed by the Institute Official will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.
Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the Entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The Institute Official will update any previously submitted report to the PHS or the prime PHS-awardees relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the report will include a mitigation report in accordance with the PHS regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. Disciplinary action in cases of extreme violation of this Policy may include dismissal for cause by the Institute Director.
Each Investigator must complete training on this Policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institute Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.
VGTI Florida will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardees. To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, VGTI Florida may make such information available to an agency funding research of an Investigator, to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary entity who made the funding available to VGTI Florida, if requested or required by law. If VGTI Florida is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may be required to make such information available to the PHS Awarding Component and/or Human Health Services, to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary Entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside Entity, the Investigator will be informed of this disclosure. All requests for information should be directed to the Institute Official.
Prior to the expenditure of funds, VGTI Florida will publish either on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
a) The Significant Financial Interest was disclosed and is still held by the employee, covered individual, or Investigator;
b) A determination has been made that the Significant Financial Interest is related to the PHS-funded research;
c) A determination has been made that the Significant Financial Interest is related to the employee, covered individual, or Investigator’s responsibilities and duties; and
d) A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.
The information to be made available shall be consistent with the requirements of the PHS policy.
Revision of this Policy
This Policy may be revised at any time by action of the authorized members of VGTI Florida and/or Board of Directors. Such revisions shall not affect the rights accrued prior to the date of such action.