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UVM Financial Conflict of Interest in Sponsored Research Policy

A. General Questions

  1. What is the purpose of this policy?
  2. What is the most significant difference between this policy (Financial Conflicts of Interest in Sponsored Research) and the previous policy (Policy on Related Significant Financial Interest in Research and Scholarly Activity)?
  3. To whom does this policy apply?
  4. What are the responsibilities of the Designated Institutional Official?
  5. Is an Investigator involved in the Designated Institutional Official’s determination of whether a Significant Financial Interest is related to the funded research?
  6. Does this policy apply to all sponsored projects?
  7. Does the policy apply to conference grants in support of sponsored and directed international, national, or regional meetings, conferences and workshops?
  8. I am a post-doctoral fellow receiving funding from the NIH. Does this policy apply to me?
  9. What are the consequences of non-compliance with this policy?

B. Definitions

  1. Who is considered an “Investigator” for the purpose of this policy? Is it only the Principal Investigator?
  2. What are “institutional responsibilities?”
  3. What is meant by the term “Research” as used in this policy?
  4. What is a “Financial Conflict of Interest (FCOI)?”
  5. What financial interests are covered by the policy and what is a Significant Financial Interest?
  6. How is a “new” Significant Financial Interest (SFI) defined?

C. Disclosure

  1. What information must Investigators disclose and when?
  2. How do I disclose my financial interests?
  3. What about financial interests acquired or discovered during the award period subsequent to the submission of the initial report?  
  4. What about payments to or assets held by my spouse or dependent children? Must these financial interests to be disclosed? 
  5. How long does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest?
  6. Do I need to disclose salary paid to me by UVM or Fletcher Allen Health Care?
  7. Do I need to disclose the occurrence of any reimbursed or sponsored travel related to my institutional responsibilities?
  8. When must I disclose my financial interests to the Institution?
  9. What happens if my financial interests change during the award period?
  10. I am an Investigator in an NIH-supported clinical trial network. My network has developed a study-wide policy for the trial that requires me to disclose my Significant Financial Interests to my network’s steering committee/operations office on an annual basis. Do I need to disclose my Significant Financial Interests to my Institution as well?
  11. Is income from all non-profit institutions excluded from the definition of Significant Financial Interest?
  12. What must be disclosed by an Investigator who has equity interest in a for-profit company?  
  13. Am I required to disclose interests in mutual funds or retirement accounts?
  14. What about stock and stock options?
  15. Are foreign investments (e.g., shares in a foreign corporation) covered by the financial disclosure requirement?
  16. What about “blind trusts?” Are those included?
  17. Is income from royalties subject to this policy?
  18. Is an Investigator required to disclose all financial interests received from a foreign Institution of higher education or the government of another country?
  19. Does an individual who participates as a subrecipient “Investigator” under a Phase I SBIR/STTR award need to disclose his/her significant financial interest to his/her Institution (e.g., University)?
  20. Does the policy require the Investigator to keep up with day-to-day changes in value of publicly traded stock or other similar interests with fluctuating value?
  21. Is an Investigator required to disclose remuneration received in excess of $5,000 from an outside entity for services performed (e.g., data analysis) when the payment is made directly to the Investigator’s Institution?
  22. What must an Investigator disclose for his/her first financial disclosure under policy related to intellectual property rights and interests? 
  23. If an Investigator receives a new royalty payment from the same source but for a different patent, is this considered a “new” Significant Financial Interest (SFI)?
  24. Must an Investigator disclose royalty payments received in the previous year from the same source for two different patents when the value of each payment is below $5,000 but the aggregated value is in excess of $5,000?

D. Review and Management

  1. Are all Significant Financial Interests disclosed considered Financial Conflicts of interest?
  2. How is it determined when a Significant Financial Interest has the potential to pose a financial Conflict of Interest?
  3. How will UVM Manage conflicting financial interests?
  4. What must a Management Plan include? 
  5. Are Management plans communicated to the research sponsor?

E. Public Accessibility

  1. Is UVM’s policy on Financial Conflict of Interest publicly accessible?
  2. What are the requirements for making information on Financial Conflict of Interest of senior/key personnel publicly accessible?

F. Retrospective Review

  1. What is a retrospective review and when is it required?

G. Training Requirements

  1. Does the policy require Investigator training?
  2. When is an Investigator required to complete Financial Conflict of Interest training if they are currently funded under a NIH grant or cooperative agreement at the time the Institution’s FCOI policy is implemented and posted?
  3. How do Investigators receive this required training?
  4. What does the module entail?

A. General Questions

  1. What is the purpose of this policy?
The policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under sponsored agreements will be free from bias resulting from Investigator financial conflicts of interest. This policy is required by the PHS Financial Conflict of Interest (FCOI) policy, as well as policies of the National Science Foundation and other sponsors.
  1. What is the most significant difference between this policy (Financial Conflicts of Interest in Sponsored Research) and the previous policy (Policy on Related Significant Financial Interest in Research and Scholarly Activity)?
This policy:
  • Broadens the definition of Significant Financial Interest,
  • Broadens the extent of Investigators’ disclosures of their Significant Financial Interests to those that relate to all their UVM duties,
  • Makes conflict of interest training mandatory for all investigators, and
  • Requires the disclosure of additional information about reimbursed travel for PHS-funded investigators.
  1. To whom does this policy apply?
This policy applies to all investigators participating in externally funded research at the University of Vermont, including awards for research, career development, center grants and program projects, individual research fellowships, institutional research training grants, research resource awards, and awards for conferences.  Investigators on Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) grants are excluded.
  1. What are the responsibilities of the Designated Institutional Official?
The Associate Vice President for Research Administration is the designated institutional official for this policy.  The Designated Institutional Official, working with the investigator’s department chair and ad hoc committee of faculty, is responsible for the review all Investigator financial disclosures to determine (a) whether a Significant Financial Interest is (a) related to funded research (2) whether the Significant Financial Interest could reasonably be expected to be affected by the funded research or is in an entity whose financial interest could be affected by the research.
  1. Is an Investigator involved in the Designated Institutional Official’s determination of whether a Significant Financial Interest is related to the funded research?
Yes. When an investigator discloses a Significant Financial Interest, he or she answers questions about how the interest relates to the funded research. The designated official works with the Investigator and his/her department chair to clarify the relationship.
  1. Does this policy apply to all sponsored projects?
No. The policy does not apply to Phase I Small Business Innovative Research (SBIR) Small Business Technology Transfer (STTR) applications. The policy applies to funded research and includes any grant, contract or cooperative agreement under which research is carried out, such as a research grant, career development grant, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
  1. Does the policy apply to conference grants in support of sponsored and directed international, national, or regional meetings, conferences and workshops?
Yes. Such conferences usually involve the reporting of funded research.
  1. I am a post-doctoral fellow receiving funding from the NIH. Does this policy apply to me?
Yes. If you meet the definition of an “Investigator,” the policy applies to you.
  1. What are the consequences of non-compliance with this policy?
In cases of a deliberate breach of this policy, including failure to file; knowingly filing incomplete, erroneous or misleading disclosure forms; or failure to comply with procedures prescribed in fulfillment of this policy, the Dean may impose appropriate sanction. Possible sanctions include: formal admonition; letter to the investigator's personnel file; suspension of privileges to apply for external funds or seek IRB approval or supervise graduate students; non-renewal of appointment; or dismissal. Sanctions are subject to otherwise applicable grievance rights.

B. Definitions

  1. Who is considered an “Investigator” for the purpose of this policy? Is it only the Principal Investigator?
No. “Investigator” means the project director (PD) or principal investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of sponsored research or research proposed for sponsored funding. For the purpose of this policy, “investigator” includes principal investigators, co-investigators, key personnel, post-doctoral associates, statistical analysts, and others with independent responsibility for these tasks.
  1. What are “institutional responsibilities?”
“Institutional Responsibilities” means an Investigator’s professional responsibilities on behalf of the University, or on behalf of the University and Fletcher Allen Health Care for Investigators with dual appointments, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, or service on panels such as institutional review boards or data and safety monitoring boards.
  1. What is meant by the term “Research” as used in this policy?
“Research” means a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development.
  1. What is a “Financial Conflict of Interest (FCOI)?”
“Financial Conflict of Interest” (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of funded research.
  1. What financial interests are covered by the policy and what is a Significant Financial Interest? 
Significant Financial Interest (SFI) means:

A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:

(a) For any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship), and equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

(b) For any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or if the investigator (or the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to those rights and interests, if that income in the twelve months preceding the disclosure, when aggregated, exceeds $5,000.

(d) For PHS funded research only, any travel expenses reimbursed directly to an investigator or paid directly on the investigator’s behalf, regardless of amount or value, related to his/her institutional responsibilities, excluding travel that is reimbursed or paid by a federal, state, or local government agency, an institution of higher education (including the University of Vermont), an academic teaching hospital (including Fletcher Allen Health Care), a medical center, or a research institute that is affiliated with an institution of higher education.

The term does not include the following types of financial interests:

(a) salary, royalties, or other remuneration paid by the University (and by Fletcher Allen Health Care for investigators with dual appointments) to the investigator if the investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to those rights;

(b) income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;

(c) income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or

(d) income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
  1. How is a “new” Significant Financial Interest (SFI) defined?
A new SFI is a different type or nature of SFI (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source that meets or exceeds the threshold. In addition, a “new” SFI is also considered to be the same type or nature of SFI (e.g., royalty payment) from a different source (e.g., company A versus company B).

C. Disclosure

  1. What information must Investigators disclose and when?
Investigators must disclose whether or not they have Significant Financial Interests (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities:
  • no later than at the time of application for funded research;
  • within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
  • at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
  1. How do I disclose my financial interests?
Financial interests are disclosed using the Sponsored Project Administration (SPA) Significant Financial Interest Disclosure system.  An Investigator must use his/her UVM NetId and password to access the system.  Making a disclosure is a two-step process.  First, the Investigator declares whether or not she/he has a Significant Financial Interest to disclose.  If the answer is “yes,” the investigator is taken to another screen to retrieve a form to fill out with additional information about the Significant Financial Interest.  The online system has a separate module for PHS-funded investigators to disclose reimbursed travel.  Here is the link for the system.
  1. What about financial interests acquired or discovered during the award period subsequent to the submission of the initial report?
Investigators have an ongoing obligation to disclose Significant Financial Interests throughout the awarded project period. Investigators must update financial disclosures of Significant Financial Interests to their Institutions within thirty (30) days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest. .
  1. What about payments to or assets held by my spouse or dependent children? Must these financial interests to be disclosed? 
Yes. Please see the question on the definition of “Significant Financial Interests.” The financial interests that must be disclosed by the Investigator include the aggregated amounts or values of financial interests held by the Investigator and his/her spouse and dependent children.
  1. How long does an Investigator have to disclose a newly acquired or discovered Significant Financial Interest?
Each Investigator who is participating in funded research must submit an updated disclosure of Significant Financial Interests within thirty (30) days of acquiring or discovering a new Significant Financial Interest or a Significant Financial Interest that was not disclosed timely.
  1. Do I need to disclose salary paid to me by UVM or Fletcher Allen Health Care?
No. Salary, royalties, or other remuneration from your employing institution is not included.
  1. Do I need to disclose the occurrence of any reimbursed or sponsored travel related to my institutional responsibilities?
If you are participating in PHS-funded research, yes. The policy requires Investigators to disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator’s institutional responsibilities, regardless of amount or value of the reimbursement. However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

(a) a federal, state, or local government agency,

(b) an Institution of higher education as defined at 20 U.S.C. 1001(a),

(c) an academic teaching hospital,

(d) a medical center, or

(e) a research institute that is affiliated with an Institution of higher education.
  1. When must I disclose my financial interests to the Institution?
Significant Financial Interests must be disclosed by the time an application is submitted to the sponsor for funding, within thirty (30) days of discovering or acquiring a new Significant Financial Interest, and on an annual basis thereafter for as long as an Investigator is funded.
  1. What happens if my financial interests change during the award period?
Each Investigator who is participating in funded research must submit an updated disclosure of Significant Financial Interest within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.
  1. I am an Investigator in an NIH-supported clinical trial network. My network has developed a study-wide policy for the trial that requires me to disclose my Significant Financial Interests to my network’s steering committee/operations office on an annual basis. Do I need to disclose my Significant Financial Interests to my Institution as well?
Reporting your Significant Financial Interests to a steering committee or other entity overseeing an NIH-supported clinical trial does not fulfill your responsibilities under your Institution’s Financial Conflict of Interest policy. If you are an Investigator as defined by the policy then you must disclose your Significant Financial Interests to UVM in accordance with this policy.
  1. Is income from all non-profit institutions excluded from the definition of Significant Financial Interest?
No. The only exclusions are for income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Income from all other sources is included in the definition of Significant Financial Interest and, accordingly, must be disclosed.
  1. What must be disclosed by an Investigator who has equity interest in a for-profit company?
If an Investigator is supported by a funded grant through the University (i.e., the University is the grantee), the Investigator must disclose the equity interest in the for-profit company to the University if the interest is related to the Investigator’s institutional responsibilities.
  1. Am I required to disclose interests in mutual funds or retirement accounts?
Not usually. The policy does not require the disclosure of income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
  1. What about stock and stock options?
Stock option assets are to be reported by the time an application for funding is submitted, and then reported annually or as new stocks are obtained, in the same manner as all other assets. The documentation needed to determine the value of a stock option is defined by the Institution.
  1. Are foreign investments (e.g., shares in a foreign corporation) covered by the financial disclosure requirement?
Maybe. Foreign investments are covered financial interests under the policy, if the investments satisfy the definition of Significant Financial Interest. The Investigator must disclose Significant Financial Interests (and those of the Investigator’s spouse and dependent children).
  1. What about “blind trusts?” Are those included?
No.  Blind trust assets not known to the Investigator that are managed by an independent fiduciary are not included. Because such assets would not be known to an Investigator, they could not reasonably be determined directly and significantly affect the design, conduct or reporting of the research.
  1. Is income from royalties subject to this policy? 
It depends.  Royalties are potentially subject to disclosure, as are other interests related to intellectual property. Royalties from, and agreements to share in royalties, related to intellectual property rights paid to an Investigator (or his/her spouse or dependent children) are covered by the policy and are subject to the $5,000 threshold. If the royalties paid to the Investigator (or his/her spouse and dependent children) satisfy the definition of “Significant Financial Interest,” then they must be disclosed. However, if the royalties or agreement to share in royalties relate to intellectual property owned by UVM and are licensed or potentially licensed UVM (i.e., they are not personally owned by the Investigator), they are considered remuneration from the Institution and would not be considered a Significant Financial Interest of the Investigator. Royalties received by the Investigator from the Institution would be excluded from the definition of Significant Financial Interest if the Investigator is currently employed or otherwise appointed by the Institution.

Unlicensed intellectual property that does not generate income is also excluded from the definition of Significant Financial Interest. Nonetheless, such interests have the potential to become significant and generate income, at which point they would become subject to the policy.
  1. Is an Investigator required to disclose all financial interests received from a foreign Institution of higher education or the government of another country?
Yes. In each case when the policy refers to exclusions of higher education as defined in 20 U.S.C. 1001(a) or a federal, state or local government agency, the reference is made to a United States (U.S.) Institution of higher education or a federal, state or local government agency within the U.S.
  1. Does an individual who participates as a subrecipient “Investigator” under a Phase I SBIR/STTR award need to disclose his/her significant financial interest to his/her Institution (e.g., University)?
Not as long as that was the Investigator’s only source of funding.
  1. Does the policy require the Investigator to keep up with day-to-day changes in value of publicly traded stock or other similar interests with fluctuating value?
No. Generally, the annual disclosure requirement will be sufficient to allow the Investigator to disclose updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).
  1. Is an Investigator required to disclose remuneration received in excess of $5,000 from an outside entity for services performed (e.g., data analysis) when the payment is made directly to the Investigator’s Institution?
No. Since the payment for services is paid to the Institution, Investigator disclosure is not required. However, if payment for services is paid directly to the Investigator, the remuneration must be disclosed by the Investigator, no matter if the Investigator turns the money over to the Institution or if the money will be used to support the Investigator’s future research activities.
  1. What must an Investigator disclose for his/her first financial disclosure under policy related to intellectual property rights and interests?
Upon the receipt of income, the Investigator is required to disclose the aggregated value of income received in excess of $5,000 from the entity in the twelve months preceding the disclosure. Because this income is subject to the definition of “Significant Financial Interest,” the following disclosure considerations apply:

(a) Investigators who are planning to participate in funded research must disclose their SFIs over the previous twelve-month period no later than at the time of application for PHS-funded research.

(b) Each Investigator who is participating in funded research must submit an updated disclosure of SFIs at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.

(c) Each Investigator who is participating in funded research must submit an updated disclosure of SFIs within 30 days of discovering or acquiring a new SFI.
  1. If an Investigator receives a new royalty payment from the same source but for a different patent, is this considered a “new” Significant Financial Interest (SFI)?
No. Since the nature of SFI and source of SFI is the same, the SFI is not considered “new”. At the time of the annual disclosure, the Investigator must disclose the current aggregated value of the SFIs received over the previous 12 months so that the Institution can determine if any changes to an existing management plan are warranted. Any annual FCOI report would need to provide the status of the existing FCOI and any changes to the management plan resulting from the increase in value.
  1. Must an Investigator disclose royalty payments received in the previous year from the same source for two different patents when the value of each payment is below $5,000 but the aggregated value is in excess of $5,000? 
Yes, at the time of the annual disclosure, the Investigator must disclose the aggregated value of the royalty payments to the Institution because the income received from the same source in the previous year exceeds $5,000 and, therefore, represents a significant financial interest.

D. Review and Management

  1. Are all Significant Financial Interests disclosed considered Financial Conflicts of interest?
No.  In order for a disclosed interest to be considered a Financial Conflict of Interest, it must be (a) related to an Investigator’s funded research and, (b) determined to have the potential to directly and significantly affect the design, conduct, or reporting of funded research.
  1. How is it determined when a Significant Financial Interest has the potential to pose a financial Conflict of Interest?
The Designated Institutional Official works with the investigator and his/her department chair to determine if the interest is related to funded research.  If it is, then the Designated Official works with an ad hoc faculty committee to determine the potential impact on the design, conduct, or reporting of the research.  Factors considered include:

(a) The nature, magnitude and stability of the financial relationship.

(b) The likelihood that the research outcome could impact the interest.  For example, is the research so basic that possible research outcomes would require significant further study and development before any impact would become apparent?

(c) The investigator’s role in the project and its relationship to the research outcomes, i.e., how likely is it that the investigator could introduce bias.

(d) Other factors the Committee determines to be relevant.
  1. How will UVM Manage conflicting financial interests?
Examples of conditions or restrictions that might be imposed to manage an Investigator’s Financial Conflict of Interest include, but are not limited to:

(a) Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to Institution’s Institutional Review Board(s);

(b) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

(c) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;

(d) Modification of the research plan;

(e) Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;

(f) Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

(g) Severance of relationships that create financial conflicts.
  1. What must a Management Plan include?
Management plans must include the following elements:
  • The role and principal duties of the conflicted Investigator in the research project;
  • Conditions of the management plan;
  • How the management plan is designed to safeguard objectivity in the research project;
  • Confirmation of the Investigator’s agreement to the management plan;
  • How the management plan will be monitored to ensure Investigator compliance; and
  • Other information as needed.
  1. Are Management plans communicated to the research sponsor?
Management plans are reported to research sponsors when required.  PHS requires that management plans be reported before an award is accepted and annually thereafter.  The National Science Foundation requires that Financial Conflicts of Interest that cannot be managed are reported.  Other sponsor requirements vary.

E. Public Accessibility

  1. Is UVM’s policy on Financial Conflict of Interest publicly accessible?
Yes. The Policy is available, along with other University policies, on the policy section of UVM’s website.
  1. What are the requirements for making information on Financial Conflict of Interest of senior/key personnel publicly accessible? 
For PHS-funded research, information about any Significant Financial Interest related to the funded research that UVM determines to be a Financial Conflict of Interest will be made available as follows:  By written response within five days of the request, the following information will be made available:
  • Investigator’s name;
  • Investigator’s title and role with respect to the research project;
  • Name of the entity in which the Significant Financial Interest is held;
  • Nature of the Significant Financial Interest; and
  • Approximate dollar value of the Significant Financial Interest
  • (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

F. Retrospective Review

  1. What is a retrospective review and when is it required?
Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:
  • Failure by the Investigator to disclose a Significant Financial Interest that is determined to constitute a Financial Conflict of Interest;
  • Failure by UVM to review or manage such a Financial Conflict of Interest; or
  • Failure by the Investigator to comply with a Financial Conflict of Interest management plan;
UVM may conduct a retrospective review.  For PHS-funded research, UVM in all cases will conduct such a review within 120 days of the Institution’s determination of noncompliance. The purpose of the retrospective review is to determine whether any funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.

G. Training Requirements

  1. Does the policy require Investigator training?
Yes. Each Investigator must complete initial training prior to making his or her first disclosure under this policy, at least every four years thereafter, and at other times when UVM requires, for example, if:
  • The policy changes in a manner that affects Investigator requirements,
  • An Institution finds that an Investigator is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.
  1. When is an Investigator required to complete Financial Conflict of Interest training if they are currently funded under a NIH grant or cooperative agreement at the time the Institution’s FCOI policy is implemented and posted? 
Investigators are expected to complete required training by the issue date of the Notice of Award issued subsequent to the Institution’s implementation date.
  1. How do Investigators receive this required training?
Sponsored Project Administration has developed an on-line training module and it may be accessed by logging into UVM’s on-line disclosure system. Here is the link.
  1. What does the module entail?
The module reviews the background and federal regulations leading to the University's conflict of interest disclosure and management requirements, key definitions, the disclosure process and responsibilities of investigators engaged in sponsored research. It also presents several conflict of interest scenarios to consider.

Last modified August 23 2012 03:14 PM

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