GLYCOMANTRA FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY
Under this policy, GlycoMantra Inc. strives to ensure that all work performed under Public Health Service (PHS) Awards (e.g., NIH grants) meets the highest standard of integrity and is free of any real or perceived conflicts of interest. This policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in PHS Awards. It is intended to comply with the requirements of federal regulations, including, but not limited to, the conflict of interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Subpart F (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).
The GlycoMantra FCOI policy consists of two parts:
- Policy and Procedure for FCOI in PHS (NIH) Funded Projects.
- Protocol for Handling FCOI.
Policy and Procedure for FCOI in PHS (NIH) Funded Projects
GlycoMantra strives to create a research climate that promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements is free from bias resulting from Investigator FCOI.
This policy is applicable to PHS (e.g., NIH) grants and cooperative agreements and to researchers meeting definition of “Investigator”. The policy is also applicable to each employee who is planning to, or is, participating in research activity that is either partially or wholly supported by the NIH funds.
Each such Investigator must:
- Disclose his or her (and those of the Investigator’s spouse and dependent children) significant financial interests (SFI) in non-GlycoMantra entities that would appear to be related to the Investigator’s “institutional (GlycoMantra) responsibilities”;
- Comply with a FCOI management plan, if a FCOI is identified; and
- Undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for GlycoMantra to determine if a FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the employee to employment discipline including, without limitation, suspension or termination of employment.
Investigator means the project director or principal investigator, co-principal investigator and any other person, regardless of title or position (important is the role, rather than the title), who is responsible for the design, conduct, or reporting of research funded by the PHS/NIH, or proposed for such funding, which may include, for example, collaborators or consultants. Institutions determine who meets the definition of Investigator.
Employee’s Professional Responsibilities (EPR) on behalf of GlycoMantra include but are not limited to research, development, presenting data internally or in outside conferences, submitting patent applications, and publication.
Excluded Source means a source of remuneration that is excluded from disclosure. Excluded
Sources are – United States federal, state, or local government agency, a US Institution of higher education, a US academic teaching hospital, a US medical center, or a US research institute that is affiliated with an Institution of higher education.
Financial Interest means anything of value, whether or not the value is readily ascertainable.
Financial Conflict of Interest (FCOI) means a significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. “Significantly” means the financial interest would have a “material effect” on the research.
Significant Financial Interest (SFI) means the value of remuneration received by the employee, employee’s spouse or dependent children that reasonably appear to be related to the employee’s responsibilities exceeds the SFI threshold. The GlycoMantra SFI threshold is $5,000.
III. DETERMINING OCCURRENCE OF SIGNIFICANT FINANCIAL INTREREST (SFI)
SFI occurs when any of the following criteria are met and in aggregate meet or surpass the SFI threshold:
A) Salary or other payments for services (e.g., consulting fees or honoraria) received in the twelve months preceding disclosure;
B) Equity interests (e.g., stocks, stock options or other ownership interests); however, equity interest in a non-publicly traded entity, no matter the amount, constitutes an SFI;
C) Income from intellectual property rights owned by the employee: and
D) Externally funded, reimbursed or sponsored travel that would appear to be related to employee’s GlycoMantra responsibilities, however, that is not funded by GlycoMantra. Such travel must be disclosed, no matter the amount, except when the expenses are covered by any of the Excluded Sources.
SFI Excludes the following:
E) Salary, royalties, stock options or other remuneration from GlycoMantra;
F) Income from seminars, lectures, teaching engagements, service on advisory committees or review panels, derived from Excluded Sources;
G) Income from investment vehicles, such as mutual funds and retirement accounts, as long as the employee does not directly control the investment decisions; and,
H) Unlicensed intellectual property owned by the employee that does not generate income. Note that Intellectual property owned by GlycoMantra is excluded.
Employees who are planning to or participating in research activity that is either partially or wholly supported by government funds must disclose their SFI in a timely fashion to the designated GlycoMantra FCOI official. The designated GlycoMantra FCOI official will determine whether the SFI constitutes an FCOI, based on guidance set by the GlycoMantra Management Team (MT). The designated GlycoMantra FCOI official him- or herself shall disclose SFI to the MT. Consistent with the attached Protocol for Handling Financial Conflict of Interest, if the SFI is determined to be an FCOI, the GlycoMantra FCOI official will take actions to discuss and approve the implementation of an FCOI management plan consistent with government regulation and, furthermore, to promptly notify the government funding component (e.g., NIH) via a FCOI report.
As a part of the FCOI management plan, the designated GlycoMantra FCOI official will decide one or more actions depending upon the situation, including requiring certain disclosure in public presentations, employee role reassignment, reduction or elimination of the financial interest sanctions (e.g., sale of an equity interest) or severance of relationships that create financial conflicts. Employees with an identified FCOI must comply with the FCOI management plan.
The designated GlycoMantra FCOI official is responsible for administration of this policy. As of now, Dr. Hafiz Ahmed will be in charge of this.
IV. Protocol for Handling FCOI
This protocol along with the policy and procedure titled, “Policy and Procedure for Financial
Conflict of Interest in PHS (NIH)-Funded Projects,” constitute the GlycoMantra FCOI policy. Capital terms in this protocol shall have the same meaning as set forth in the policy. This protocol outlines the procedure that will be followed as per regulation (Title 42 CFR Part 50 Subpart F).
This document specifies the FCOI protocol for the PHS (e.g., NIH)-funded research: that is the step-by-step implementation of the GlycoMantra FCOI policy.
- Who is required to disclose financial interests
Investigators planning to or participating in research activity that is either partially or wholly supported by the PHS (e.g., NIH) funds are required to disclose financial interests.
- SFI disclosure
The PHS (NIH)-funded Investigators are required to disclose SFIs to the designated GlycoMantra FCOI official, as follows:
A. Investigators planning to participate in the NIH-funded research are required to disclose all SFI’s prior to submission of an application.
Sample disclosure can be found below:
I am an inventor of a patent related to the technology described in this (define situation; i.e. publication, proposal, research award, presentation, etc.) for which I am entitled to receive royalties ORI have an ownership interest in GlycoMantra, Inc, that has licensed the technology described in this (define situation)…
B. Once the research project has been funded, the NIH-funded investigator shall submit SFI Disclosures within thirty (30) days of acquiring any new or increased SFI,
C. When a new investigator joins an ongoing NIH-funded project, the investigator shall submit SFI disclosures within thirty (30) days of joining the project.
D. All PHS (NIH)-funded investigators shall submit an updated SFI disclosure annually.
E. SFI disclosures (except travel) must include the following information:
Identity of the sponsor/organizer; and Nature of SFI (e.g., salary, license income, stock).
F. Externally funded travel also constitutes SFI, and therefore the disclosure requirements shall apply. That is, the NIH-funded investigators shall submit SFI Disclosures for externally funded travel: prior to submission of an application for NIH-funded research; and for NIH-funded projects within thirty (30) days of externally funded travel and in an annual update. The following travel related information must be disclosed: Purpose, Identity of the sponsor/organizer, Destination, and, Duration.
- Review of disclosures
All SFI disclosures, including those submitted by a new investigator who joins an ongoing PHS (NIH)-funded project, will be reviewed by the designated GlycoMantra FCOI official. The review will determine:
- Is the SFI related to the PHS (NIH)-funded research?
- Could the SFI be affected by the research? Or
- Is the SFI in an entity whose financial interest could be affected by the research?
If the SFI is related to the research and if the answer is “yes” to either of those two questions above, an FCOI exists. The designated GlycoMantra FCOI official may consult with the relevant investigator and/or request additional information from the investigator when making this determination.
What is required when there is noncompliance?
Noncompliance may occur whenever an FCOI is not identified or managed in a timely manner including:
- Failure of an Investigators to disclose his/her SFIs to the GlycoMantra;
- Failure by the GlycoMantra to review or manage such an FCOI; or
- Failure by the Investigator to comply with the management plan.
In that case, the designated GlycoMantra FCOI official will conduct a Retrospective Review within one hundred twenty (120) days of determining noncompliance (Review the activities conducted during period of noncompliance to determine bias in the NIH-funded research). The designated GlycoMantra FCOI official will document the key elements of the Retrospective review including:
- Project number
- Project title
- Contact PD/PI
- Name of the Investigator with the FCOI,
- Name of the entity with which the Investigator has an FCOI
- Reason(s) for the retrospective review
- Detailed methodology used for the retrospective review
- Findings and conclusions of the review
If results of the retrospective review warrant, GlycoMantra FCOI official will update the previously submitted FCOI report.
- Management of FCOI
For each disclosure that leads to determination of FCOI, the GlycoMantra MT will discuss and approve the implementation of a management plan developed by the designated GlycoMantra FCOI official. PHS (NIH)-funded Investigators with an identified FCOI must comply with the management plan. The management plan will include the following elements at a minimum:
A. The role and principal duties of the conflicted PHS-funded Investigator in the research project;
B. Conditions of the management plan (see examples below);
C. How the management plan is designed to safeguard objectivity in the research project;
D. Confirmation of the PHS-funded Investigator’s agreement to the management plan; and
E. How the management plan will be monitored to ensure PHS-funded Investigator compliance.
Examples of conditions or restrictions that might be imposed to manage a PHS (NIH)-funded Investigator’s FCOI include, but are not limited to:
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));
For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
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;
Modification of the research plan;
Change of personnel or personnel responsibilities, or disqualifications 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); or Severance of relationships that create financial conflicts.
- Reporting FCOI to Government Awarding Component (e.g. the NIH)
Based on the FCOI management plan, the designated GlycoMantra FCOI official will submit an initial FCOI report to the Government-funding component, for example, NIH. The report will be submitted, for example using eRA Commons for NIH, and consist of all elements required by the regulation.
The FCOI report will be submitted prior to the expenditure of funds under the Notice of Award.
FCOIs identified during the period of award will be submitted to the Government entity within sixty (60) days of identification, including for new investigators joining an ongoing Government funded project.
Annual FCOI reports (or revised reports as a result of retrospective reviews) will also be submitted and will include the status of financial conflict, i.e., whether the financial conflict is still being managed or explains why the financial conflict no longer exists. These FCOI reports will also include a description of any changes to the management plan since the last FCOI report.
- Training for FCOI
PHS (NIH)-funded Investigators must undergo training with respect to this Policy and PHS FCOI rules and regulations, as follows:
When a new employee joins GlycoMantra;
Prior to participating in PHS-funded research, and at least once every four years;
When the GlycoMantra FCOI policy changes in a manner that effects PHS-funded Investigator disclosure or compliance requirements; and,
If PHS-funded Investigator is determined not compliant with the FCOI Policy or an FCOI Management Plan.
In fulfillment of the training requirement, GlycoMantra requires its investigators to complete the NIH’s FCOI tutorial located at:
http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and expectations of this Policy. All investigators must print a certification of completion at the end of training and retain it for audit purposes.
- Sanctions for violation of policy
Disclosure of SFI is essential for GlycoMantra to implement its FCOI policy. If a PHS (NIH)-funded Investigator fails to comply with this policy (with regard for instance to the SFI disclosure requirement or implementation of an FCOI management plan), and appears to have biased the PHS (NIH)-funded research, the GlycoMantra MT will implement a mitigation plan and require that the Investigator disclose the FCOI in each public presentation of the results of the research, and to remedy previously published presentations with an FCOI disclosure addendum. In addition, the employee may be subject to employment discipline including, without limitation, suspension or termination of employment.
In any case, the PHS-funding agency (NIH) will be promptly notified.
- Retention of records
Records of financial disclosures and any resulting action will be maintained by the Institution for at least three (3) years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations. GlycoMantra will retain records for each competitive segment as provided in the regulation.
- Sub-recipient compliance
A subrecipient relationship is established when federal funds flow down from or through GlycoMantra to another individual or entity and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to GlycoMantra for programmatic outcomes and compliance matters. Subrecipients, who include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors and subawardees, are subject to GlycoMantra’s terms and conditions, and as such, GlycoMantra will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the federal FCOI regulation. GlycoMantra will incorporate, as part of a written agreement with the subrecipient, terms that establish whether GlycoMantra’s FCOI Policy or that of the subrecipient’s institution will apply to the subrecipient Investigator.
If the subrecipient’s FCOI policy applies to the subrecipient Investigator, the subrecipient institution will certify as part of the agreement with GlycoMantra that it is in compliance with the federal FCOI regulation and that the institution’s portion of the project is in compliance with the FCOI policy. If the subrecipient cannot provide the certification, the agreement shall state that the subrecipient Investigator is subject to GlycoMantra’s FCOI Policy for disclosing SFI that are directly related to the subrecipient’s work for GlycoMantra. GlycoMantra will, if applicable, submit a FCOI report to the NIH through the eRA Commons FCOI Module for any FCOIs identified for a subrecipient Investigator.
If the subrecipient’s conflict of interest policy applies to the subrecipient Investigator, the agreement shall specify the time period for the subrecipient to report all identified FCOIs to GlycoMantra. Such time period must be sufficient to enable GlycoMantra to provide timely FCOI reports to the NIH as necessary, through the eRA Commons FCOI Module.
If the subrecipient Investigator is subject to GlycoMantra’s Investigator FCOI Policy, the agreement shall specify the time period for the subrecipient to submit all Investigator disclosures of SFI to GlycoMantra. Such time period shall be sufficient to enable GlycoMantra to comply with its review, management, and reporting obligations under the regulation. GlycoMantra will submit any NIH FCOI reports for a subrecipient Investigator through the eRA Commons FCOI Module.
- Public accessibility
As required by the PHS regulation, the GlycoMantra FCOI policy is being made accessible on GlycoMantra web site.
If a PHS (NIH)-funded investigator holds financial interests that are determined to be FCOI, as required by PHS regulation, these will also be posted on the web site, as follows:
A. Include the minimum elements required by the regulation;
B. Update within sixty (60) days of a newly identified FCOI;
C. Update annually; and
D. Remain available for three (3) years