What is Financial Conflict of Interest?
Financial Interests means anything of monetary value, whether or not the value is readily ascertainable, in any one of the following categories: compensation, compensation for management, advisory, or consulting roles; gifts, services, loans; payments or in-kind gifts for services; licensing, patent, royalty, and other intellectual property agreements; equity interests in a public or private company (e.g., stocks, stock options, bonds, property interests, dividends, convertible securities, or other ownership interest); a position in an external entity giving rise to a fiduciary duty such as director, officer, partner, trustee, employee or any position of management; or, for researchers with funding from the Public Health Service, any reimbursed or sponsored travel.
A Financial Conflict of Interest arises when a financial interest, or other opportunity for personal financial gain, is likely to compromise or influence the objective design, conduct, reporting, or direct administration of research.
Policy and Guidelines at UPR
The University of Puerto Rico in its firm commitment to uphold integrity, transparency and accountability in its conduct of research; and, to harmonize its existing conflict of interest (COI) policies and procedures with the new federal norms, and any applicable local and state laws and regulations, has established a Policy and Guidelines for Financial Conflict of Interest and Commitments in Research and Sponsored Programs. [Certification Number 8 (2012-2013)]
The objective of the present Policy and Guidelines is to identify, eliminate, or manage any possible threat to the integrity of the research and sponsored programs conducted at the University of Puerto Rico. The Policy and Guidelines set forth policy and procedures that are to be followed by the University in resolving or managing actual and potential faculty conflicts of interest and commitment pertaining to all research projects, independently of their source of funding.
The UPR establishes and enforces standards to guarantee that the design, conduct, and reporting of all federal and non-federal research will be free from bias resulting from Investigator financial conflicts of interest and commitment. Accordingly, this policy further provides the mechanism(s) for ensuring the integrity of University research when such conflicts arise.
New Changes in the FCOI Policy
The U.S. Department of Health and Human Services (HHS) has amended the Public Health Service (PHS) regulations on “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 CFR 50) and Responsible Prospective Contractors (45 CFR 94).
These regulations apply to any institution receiving funds from PHS/NIH entity. The University of Puerto Rico must be in compliance with all the 2011 revised Federal regulation on Financial Conflict of Interest (FCOI) for grants or cooperative agreements no later than August 24, 2012.
Who Needs to Submit an FCOI Disclosure?
Any Investigator planning to participate, or participating in the research, independently of its source of funding. Provided, however, that several provisions of the Policy and Guidelines apply only to investigators applying for or conducting research funded by the Public Health Service (including the National Institutes of Health). Phase I SBIR/STTRs are exempt.
Education and Training (NIH Tutorial on Financial Conflicts of Interest)
All investigators must complete training on the investigator obligations under this policy. This training must be repeated at least every four (4) years and must be completed immediately if this policy is revised so as to affect the investigator obligations, if an investigator is new to the University, or if the University finds an investigator to have violated this policy or any applicable management plan.
All UPR investigators and research personnel are required to complete prior to August 24, 2012, the web-based NIH Tutorial on Financial Conflicts of Interest.
Investigators must submit a copy of the certificate of completion to UPRM's FCOI Official to: email@example.com and complete a Financial Interest Disclosure Form (Form 1A) for each proposal.
Disclosure of Financial Interest
1. PRIOR TO SUBMISSION/INITIATION OF RESEARCH
Prior to the investigator's submission of a grant application or the University's execution of a cooperative agreement or sponsored research contract, or prior to initiation of any human subjects research, whether funded or not, each investigator is required to submit a disclosure form describing any financial interest held by the investigator, the investigator's spouse, or any dependent child of the investigator that the investigator determines to be reasonable related to the investigator's institutional responsibilities.
In those cases where the University has determined that a financial conflict of interest exists, no research funds may be expended and no research may begin until the investigator has agreed in writing to any management plan required by the University for this research.
Each Investigator who submits a financial interest disclosure form to the University is required to update that disclosure annually during the period of the award or, for non-sponsored research, annually during the conduct of the project. Annual updates must be submitted by September 1st of each calendar year.
3. UPDATING OR SUBMITTING A NEW DISCLOSURE IN AN ONGOING PROJECT
When changes occur related to a financial interest in an ongoing research project, the Investigator is required to update the disclosure describing that interest. A disclosure is also required when a new investigator is added to an existing project. Such disclosures must be submitted to the UPRM COIO for evaluation within 30 days of the event requiring the disclosure.
REVIEW BY CONFLICT OF INTEREST OFFICER (COIO)
Initial review of the investigator's disclosure and significant financial interest (if any) will be done by the campus' Conflict of Interest Officer (COIO). The COIO will in turn present the cases to the campus' Conflict of Interest Committee designated by the Chancellor for expedited or regular review.
1. Determination of Significant Financial Interest
Prior to the investigator's expenditure of any funds, or prior to the initiation of the research in the case of research with no external funding, the COIO will review the disclosed financial interest to determine whether it constitutes a significant financial interest.
2. Determination of Financial Conflict of Interest
Upon concluding that the disclosed financial interest constitutes a research related significant financial interest, the COIO will review the disclosed significant financial interest to determine whether a financial conflict of interest exists and thus whether further review and management is required.
REVIEW BY CONFLICT OF INTEREST COMMITTEE (COIC) AND MANAGEMENT PLAN
REQUIREMENT OF MANAGEMENT PLAN
Where the Conflict of Interest Officer has determined that a financial conflict of interest exists, the campus Conflict of Interest Committee will develop and recommend for implementation to the investigator, unit head, dean, and chancellor a management plan that specifies the actions that have been and/or will be taken to manage the financial conflict of interest.
Management strategies may include, but are not limited to:
a) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
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, or the appearance of bias, resulting from the financial conflict of interest;
d) Modification of the research plan;
e) Change of personnel or personnel responsibilities, or disqualification 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); and
g) Severance of relationships that create actual or potential financial conflicts.
MANAGEMENT PLAN DEVELOPMENT AND MONITORING
The COIO will review the COIO's preliminary determinations of real or apparent financial conflicts of interest and oversee development of proposed management plans. Where full committee review is advised, the COIC votes on whether a real or apparent financial conflict of interest exists, and, if so, whether to approve the recommended management plan as presented by the subcommittee or with modifications.
RESPONSIBILITY FOR OVERSEEING
The management plan will state who is responsible for overseeing the implementation of the plan, and for reporting on compliance at stated intervals to the COIC. If the management plan prescribes monitoring of the activity, it will describe specifically how the monitoring shall be performed, who shall perform it, what records are to be kept, and what reports are made to the COIC.
MANAGEMENT PLAN NOTIFICATION
The COIC communicates this determination to the investigator, who must accept the requirements of the management plan in writing before beginning work on the project. Copies of the signed management plan will also be provided to the research personnel, unit head, those responsible for implementation of the management plan, and in the case of research involving human participants, to the Institutional Review Board. In addition, sponsors will be notified of the existence of a managed conflict if the regulations of that agency or award so require.
Any failure by research personnel to adhere to an approved management plan will be cause for one or more of the sanctions noted in Sanctions for Noncompliance. In addition, where such failure is not remedied, the non-compliance may be reported to the pertinent sponsor, if applicable, and disciplinary action may be commenced, including academic misconduct proceedings, and in severe cases, termination. Any academic misconduct or termination proceedings will be conducted in accordance with the applicable University policies and codes.
SPECIFIC PROVISIONS APPLICABLE TO HUMAN SUBJECTS RESEARCH
As a general policy, the University will not allow an investigator with a financial conflict of interest to conduct a clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment.
SPECIFIC PROVISIONS APPLICABLE TO PHS-FUNDED RESEARCH
The University will apply the following specific provisions to research funded by PHS:
For PHS-funded research, the investigator's management plan will be monitored on an ongoing basis until the completion of the research project.
If the University carries out the PHS-funded research through a sub-recipient, the University will incorporate as part of a written agreement with the sub-recipient terms that establish whether the University's or the sub-recipient's policy on conflict of interest in research will apply to the sub-recipient Investigators.
If the sub-recipient's policy will apply, the sub-recipient will certify as part of the agreement that its policy complies with the PHS regulations on Objectivity in Research. Additionally, the agreement shall specify time period(s) for the sub-recipient to report all identified financial conflicts of interest to the University to enable the University to provide timely reports to PHS.
Alternatively, if the University's policy on conflict of interest will apply, the agreement shall specify time period(s) for the sub-recipient to submit all sub-recipient Investigator disclosures of significant financial interests to the University. Such time periods shall be sufficient to enable the University to comply with timely review, management, and reporting obligations under the PHS regulations.
3. Restrospective Review
In the event the University identifies a significant financial interest that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed by the University during an ongoing research project, and where the COIO has determined that the undisclosed significant financial interest constitutes a financial conflict of interest related to a PHS funded research project, the COIC will review the financial conflict of interest and the University will implement a management plan for the project within 60 days of identification of that interest. In addition, the COIC will, within 120 days of its determination of noncompliance, complete a retrospective review of the investigator's research activities associated with the project to determine whether the research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research.
4. Mitigation Plan
If the COIC determines in the conduct of its retrospective review of PHS funded research that the research or any part of it was biased, the COIC will recommend a mitigation plan to address any such issues. The University will notify the PHS Awarding Component of its determination and subsequently follow up with the mitigation report for the project.
5. Public Access of Disclosed Significant Financial Interest
The UPR will make available to the public upon request information concerning any significant financial interest disclosed to the University that meets the following criteria:
a) The disclosed significant financial interest is still held by the senior/key personnel of the active PHS project;
b) The University determines that the significant financial interest is related to the PHS funded research; and
c) The University determines that the significant financial interest is a financial Conflict of Interest.
The information request must be addressd to the corresponding campus Conflict of Interest Officer who will respond within five (5) business days of receipt of the request.
1. Required Procedure
When in the course of an ongoing research project an investigator new to the project discloses a significant financial interest or an existing investigator discloses a new or changed significant financial interest, and where the COIO has determined that the disclosed significant financial interest constitutes a financial conflict of interest subject to management under this policy, the COIC will review the disclosure and the University will implement a management plan for the project within 60 days of the submission of the disclosure to the University.
2. Special Cases
Depending on the nature of the financial conflict of interest, the University may determine that additional interim measures are necessary with regard to the investigator's participation in the research project between the date of disclosure and the implementation of the University's management plan Particular consideration will be given to any additional interim measures that the University's Institutional Review Board views as necessary for the protection of human participants in any ongoing research.
Any investigator adversely affected by the decision of the COIC regarding management of a financial conflict of interest may appeal in writing, first, to the Vice-President for Research and Technology, subsequently to the President of the University, and thereafter to the Board of Trustees of the University of Puerto Rico.
Failure to file a complete and truthful disclosure as required by this policy or to comply with the conditions or restrictions imposed in the resolution, management, or elimination of financial conflicts of interest constitutes a violation of University policy and may violate state and/or federal law. In such cases, the investigator will be subject to appropriate sanctions consistent with University policies relating to faculty, staff, or other applicable disciplinary policies. In addition, the University may suspend an ongoing research project, halt the expenditure of funds, or suspend technology transfer activity to prevent continued violation of this policy. In any case in which the investigator does not comply with any applicable conditions or restrictions imposed pursuant to this policy, the University will withdraw any affected applications for funding if the project cannot otherwise be completed without the services of the investigator.
In the event the University discovers that a failure to comply with this policy has biased the design, conduct, or reporting of the research in accordance with the process outlined in section VII.C, the UPR will promptly notify the sponsor of the research as required by applicable law and describe the corrective action(s) taken or to be taken.