MarPam Pharma, LLC
Financial Conflict of Interest Policy
July 1, 2021
PURPOSE: The purpose of this policy is to establish standards and procedures to be followed in the conduct of Public Health Service (PHS) (e.g., NIH) -funded projects so that the design, conduct, or reporting of research funded by the PHS/NIH will not be biased by any conflicting financial interest of those responsible for the research. The intent of this policy is to ensure compliance with government regulations by ensuring that individual financial interests are disclosed and that individual financial conflicts are reported and managed according to federal regulations, including, but not limited to 42 CFR Part 50.604 “Responsibilities of Institutions regarding Investigator financial conflicts of interest”, 42 CFR Part 50.605, “Management and reporting of financial conflicts of interest” and 42 CFR Part 50.606, “Remedies”.
Financial Conflict of Interest (FCOI): Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research
Investigator: the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators, consultants and Subrecipient Investigators.
Management Plan: A plan that specifies the actions that have been, and will be, taken to manage an FCOI.
Research: a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Retrospective Review: A review of past activities of an Investigator with an FCOI that was not identified or managed in a timely manner or there was failure by the Investigator to comply with a FCOI Management Plan and the PHS-research project to determine whether any PHS-research conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
Significant Financial Interest (SFI): 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:
(1) With regard to any publicly traded entity, SFI 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); 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;
(2) With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(3) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(4) 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 their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a US Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. All financial interests received from a foreign institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).
The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the MarPam to the Investigator if the Investigator is currently employed or otherwise appointed by the MarPam, including intellectual property rights assigned to the MarPam and agreements to share in royalties related to such rights; any ownership interest in the MarPam held by the Investigator, if the Institution is a commercial or for-profit organization; 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; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Subrecipient Investigator: An Investigator that is participating in PHS-funded research through a subaward or subcontract from or consortium with MarPam.
MarPam is committed to conducting research with the highest scientific and ethical standards. It is the policy of MarPam to comply with the government Financial Conflict of Interest Rules to ensure that PMS-funded research is carried out in a manner that is free from any bias which may result from FCOI. All Investigators for PMS-funded research must be trained on FCOI policy and must disclose any Significant Financial Interests (SFI) to MarPam. Investigators must complete or update a disclosure survey at least annually during the period of the award and must disclose any new SFI’s within thirty (30) days of discovering or acquiring the SFI. Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for PMS-funded research.
If MarPam determines that a SFI constitutes a Financial Conflict of Interest (FCOI), MarPam will establish and monitor a Management Plan to manage or eliminate the conflict of interest. The CEO of MarPam will be the conflict of interest official responsible for evaluating and managing the conflict of interest process for PMS-funded research projects. No government funds may be expended unless the CEO has determined that no FCOI exists or that any FCOI is manageable and enforced in accordance with the terms of a Management Plan.
Compliance with the requirements of this policy is a condition of employment with MarPam for employed Investigators and a condition of funding for subrecipient Investigators.
Public Posting of Policy: This policy will be posted on the MarPam Pharma website.
Public Availability of FCOI: For PHS-funded projects, MarPam will make FCOI information available to those who submit a request by sending an email to firstname.lastname@example.org or by writing to the address below. Responses will be sent within five business days. At a minimum, the following information will be disclosed: the Investigator‘s name; the Investigator‘s title and role with respect to the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI (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.
Review of Policy: This policy will be reviewed no less frequently than every other year.
Training: Each Investigator will complete training regarding the policy of FCOI prior to engaging in research related to any PHS-grant, at least every four years, and immediately when any of the following circumstances apply:
(1) MarPam revises its FCOI policies or procedures in any manner that affects the requirements of Investigators
(2) An Investigator is new to MarPam or to a subrecipient
Training may be completed at https://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm, by the CEO of MarPam and/or by the subrecipient’s institution, provided that their FCOI policy complies with this policy. Training will inform each Investigator of MarPam’s policy, the Investigator’s disclosure responsibilities and federal regulations. Training will be documented.
Compliance by Subrecipient Investigators: Reasonable steps will be taken to ensure that any Subrecipient Investigator complies with the policy by incorporating as part of a written agreement with the subrecipient terms that establish whether the FCOI policy of MarPam or that of the subrecipient will apply to the subrecipient’s Investigators.
(1) If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with government regulations. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the FCOI policy of the MarPam for disclosing SFI that are directly related to the subrecipient’s work for MarPam
(2) Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified FCOI to MarPam. Such time period(s) shall be sufficient to enable the MarPam to provide timely FCOI reports, as necessary, to PHS as required by this policy
(3) Alternatively, if the subrecipient’s Investigators must comply with the MarPam’s FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of SFI to MarPam. Such time period(s) shall be sufficient to enable MarPam to comply timely with its review, management, and reporting obligations
Reporting: FCOI reports will be provided to the PHS regarding all FCOI of all Investigators and MarPam will ensure that it has implemented a Management Plan at the following times:
prior to the expenditure of funds
within sixty (60) days of identification for an Investigator who is newly participating in the PHS-funded project
within sixty (60) days of any subsequently identified FCOI
After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review
For any SFI that MarPam identifies as conflicting subsequent to the MarPam’s initial FCOI report and during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), MarPam will provide to the PHS awarding component, within sixty (60) days, an FCOI report regarding the FCOI and ensure that MarPam has implemented a Management Plan.
Any FCOI report will include sufficient information to enable the PHS awarding component to understand the nature and extent of the financial conflict, and to assess the appropriateness of MarPam’s Management Plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:
Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
Value of the 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
A description of the key elements of MarPam’s Management Plan, including:
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
Other information as needed
The annual FCOI report, if needed, will address the status of the FCOI and any changes to the Management Plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the FCOI no longer exists. MarPam shall provide annual FCOI reports to the PHS awarding component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS awarding component.
If the FCOI is reimbursed or sponsored travel, the report will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration and the monetary value.
Designated Official: The CEO of MarPam, Dr. Maria Athanasiou, is the designated official, who will solicit and review disclosures of SFI from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.
Timing of Disclosure: Each Investigator must disclose to MarPam’s Designated Official their SFI (and those of their spouse and dependent children) at each of the following times:
no later than the time of application for the PHS-funded research
annually on July 1, during the period of the award. Such disclosure shall include any information that was not disclosed initially to MarPam or disclosed in a subsequent disclosure and any updated information regarding previously disclosed SFI.
Within 30 days of discovering or acquiring (e.g. through purchase, marriage or inheritance) a new SFI.
Determination of SFI as FCOI: A FCOI exists when MarPam, through its designated official(s), reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. An Investigator‘s SFI is related to PHS-funded research when the MarPam designated official reasonably determines that the SFI:
could be affected by the PHS-funded research; or
review the disclosure of the SFI
determine whether the disclosure is related to PHS-funded research
Depending on the nature of the SFI, MarPam may determine that additional interim measures are necessary with regard to the Investigator‘s participation in research project between the date of disclosure and the completion of the MarPam‘s review.
MarPam will take actions to manage FCOI. The following restrictions will be imposed to manage a FCOI:
Public disclosure of FCOIs (e.g., when presenting or publishing the research)
The following restrictions may be imposed to manage a FCOI:
Modification of the research plan
Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
Reduction or elimination of the financial interest (e.g., sale of an equity interest)
Severance of relationships that create financial conflicts
Delayed Disclosure/ Review: When MarPam identifies an SFI that was not disclosed timely by an Investigator, or, for whatever reason, was not reviewed by MarPam during an ongoing PHS-research project, the designated official(s) will, within sixty (60) days:
review the disclosure of SFI
determine whether it is related to PHS-research
determine whether a FCOI exists; and, if so implement, on at least an interim basis, a Management Plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward
Conduct a retrospective review
Noncompliance: If an Investigator fails to comply with a FCOI management plan, MarPam will conduct a retrospective review. If the failure of an Investigator to comply with MarPam’s FCOI policy or a FCOI Management Plan appears to have biased the design, conduct, or reporting of the PHS-funded research, MarPam will promptly notify the PHS awarding component of the corrective action taken or to be taken.
Retrospective Review: When an FCOI is not identified or managed in a timely manner or if there is failure by the Investigator to comply with an FCOI Management Plan, MarPam shall, within 120 days of MarPam’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-research project to determine whether any PHS-research conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Depending on the nature of the FCOI, MarPam may determine that additional interim measures are necessary with regard to the Investigator‘s participation in the PHS-funded research project between the date that the FCOI or the Investigator‘s noncompliance is determined and the completion of MarPam’s retrospective review.
Retrospective Review Documentation and Reporting: MarPam will document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:
(1) Project number
(2) Project title
(4) Name of the Investigator with the FCOI
(6) Reason(s) for the retrospective review
(7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
(8) Findings of the review
(9) Conclusions of the review
Based on the results of the retrospective review, if appropriate, MarPam will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, MarPam is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and MarPam’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, MarPam will submit FCOI reports annually.
Enforcement: Whenever MarPam implements a Management Plan, MarPam shall monitor Investigator compliance with the Management Plan on an ongoing basis until the completion of the PHS-funded research project. Employee sanctions or other administrative actions will be undertaken to ensure Investigator compliance as appropriate and as deemed by the Designated Official (e.g. letters of reprimand, restriction in use of funds).
Funding Certification: MarPam will certify in each application for PHS funding that MarPam:
Shall manage FCOI and provide initial and ongoing FCOI reports to PHS
Make information available, promptly upon request, to PHS relating to any Investigator disclosure of financial interests and MarPam’s review of, and response to, such disclosure, whether or not the disclosure resulted in MarPam’s determination of a FCOI.
Maintenance of Records: The following records will be maintained for at least three (3) years from the most recent update:
Related to investigator disclosures of financial interests
Related to MarPam’s review and/or response to these disclosures
Related to all actions under MarPam’s policy or retrospective review
Maria Athanasiou, PhD
MarPam Pharma, LLC
W6368 Grove Street, Fond du Lac, WI 54935