January 2023
Policy on Conflict of Interest in Research
I. Introduction
DataJoint Inc. dba DataJoint (“DataJoint”) is committed to maintaining a research environment that promotes attention to the highest ethical standards for research. This commitment includes compliance with regulatory requirements set forth by the Public Health Service (PHS), the National Science Foundation (NSF), and other regulatory and ethical bodies. It is the responsibility of DataJoint to promote objectivity in research through the establishment of this Financial Conflict of Interest Policy.
A conflict of interest might take various forms, but includes any circumstance where personal, professional, financial, or other private interests of a person or institution compromise or have the potential to compromise the exercise of professional judgment or obligations, or may be perceived as doing so. It is important to note that a conflict of interest depends on the situation and how it can be perceived, not necessarily on the character or the actions of the individual.
The purpose of this policy is to educate individuals about situations that generate research-related financial conflicts of interest, and to provide means for DataJoint staff to identify, manage, reduce, and/or eliminate actual or potential conflicts of interest. Every member of the research team at DataJoint has an obligation to become familiar with, and abide by, the provisions of this policy.
II. Key Definitions
Investigator - This policy applies to all individuals who meet the definition of Investigator. Specifically:The project director or principal Investigator, and any other persons, regardless of title or position, who are responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding. In addition, any research team member who indicates a financial interest related to the submission of a human or animal research protocol will be asked to complete a certification.
This policy, therefore, can apply to collaborators, consultants, and others who meet the threshold for responsibility.
At a minimum, all individuals listed as an investigator or key personnel on a research project must file a Significant Financial Interest (SFI) / Financial Conflict of Interest (FCOI) Disclosure form on an annual basis. It is the responsibility of the Principal Investigator (PI) to determine if other research team members meet this threshold based on their role in the research.
Research - An activity is considered research if it meets the definition of research provided by the agency funding the project, or any agencies that oversee the project. If unfunded or not otherwise defined, the following definitions apply:
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
Systematic study directed toward fuller scientific knowledge or understanding of the subject studied. Research is classified as either basic or applied according to the objectives of the sponsoring agency.
Certification/Disclosure Process - All individuals who meet the definition of Investigator as defined above must provide certification of their knowledge of and compliance with this policy on an annual basis. The certification process involves either a certification that no significant financial interests exist, or the disclosure of existing significant financial interests to DataJoint. In addition to the annual requirement, the acquisition or discovery of new financial interests requires disclosure within 30 days. All disclosures are reviewed by the Designated Official.
Significant Financial Interest (SFI) - Anything of monetary value, whether the value is readily ascertainable, that 1) is related to the Investigator's professional responsibilities on behalf of DataJoint; and 2) belongs to the Investigator or the Investigator's spouse or dependent children. Additional details regarding what constitutes a Significant Financial Interest are specified in Section III.
Financial Conflict of Interest (FCOI) - A significant financial interest that could directly and significantly affect the design, conduct, or reporting of research. Similarly, if a significant financial interest could reasonably appear to be affected by the research, or the interest is in entities whose financial interests would reasonably appear to be affected by the research, review and elimination or management of the conflict is required.
Institutional Responsibilities - Investigators' professional responsibilities on behalf of DataJoint including, but not limited to, activities such as research, research consultation, professional practice, management, and administration.
Designated Official - The individual at DataJoint responsible for the solicitation and review of disclosures of significant financial interests from each Investigator who is participating in, or is planning on participating in, research. The Designated Official for DataJoint is the CEO and/or COO of DataJoint. If a position is vacant, the alternate reviewer shall be the Science Projects Director.
III. Certification of Compliance
All individuals meeting the definition of Investigator as defined in this policy must certify their knowledge of and compliance with this policy by completing a Conflict of Interest Certification at least annually. Certifications and associated disclosures must also be actively updated:
At the time of submission for new funding.
If unrelated to proposals for funding, at the time of submission of human or animal protocols if financial relationships related to the research exist.
Within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.
All significant financial interests held by investigators and their immediate family members must be disclosed. For clarity, remuneration from DataJoint to an employee is excluded from this disclosure requirement, however, remuneration of the forms outlined below from DataJoint to an immediate family member must be disclosed. A Significant Financial Interest (SFI) is a financial interest that falls into one of the following categories and is reasonably related to any of an investigator’s institutional duties:
Remuneration in excess of $5,000 from a publicly-traded entity during the preceding 12 months. 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 (stock, stock options, or other ownership interest) in a publicly traded company valued in excess of $5,000 at the time of certification,;
Any combination of the above two items (equity and income) that exceeds $5,000 during the preceding 12 months;
Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity, including a start-up company;
Remuneration that exceeds $5,000 from a non-publicly traded entity in the past 12 months, or
Intellectual property rights and interests (e.g. patents and copyrights), upon receipt of such income related to such rights and interests Income related to intellectual property rights in excess of $5,000 paid by any source other than the Investigator's current employer.
All disclosed significant financial interests that have a potential relationship to the discloser’s engagement in research on behalf of DataJoint are reviewed by the CEO and/Or COO to determine if these interests conflict, or appear to conflict, with the research.
The following DO NOT require disclosure:
Salary, royalties, or other remuneration paid by DataJoint to the Investigator if the Investigator is currently employed by DataJoint,
Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local government agency, or an Institution of higher education within the United States 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,
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 service on advisory committees or review panels for a federal, state or local government agency or Institution of higher education within the United States 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
Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights
A disclosure MUST include:
The investigator's current or pending relationship with the outside enterprise or entity in which a significant financial interest exists;
The relationship of the research to the enterprise or entity,
The means by which the investigator proposes to address actual or potential conflicts of interest that arise from his/her (or immediate family members) dual University and enterprise or entity roles;
The dollar amount of the financial interest in specified ranges; and
Direct Income from sources external to the United States
Common sense must prevail in the interpretation of these provisions. That is, if a reasonable, disinterested person would question the relationship, it should be disclosed and approval sought for the proposed arrangement.
Travel
With some exceptions, PHS-funded investigators must disclose reimbursed or sponsored travel paid for by a third-party entity, including non-profit organizations.
Disclosure is not required for travel sponsored by or reimbursed by a government agency, a U.S. Institution of higher education or a research institute affiliated with such, a U.S. medical center, or a U.S. academic teaching hospital.
When a travel request indicates that an employee’s travel is sponsored or reimbursed by a third party and the traveler is listed on a PHS award, the Designated Official must review the sponsored travel arrangement to review any potential FCOI.
Travel disclosures must include, at a minimum: the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Designated Official will determine if further information is required, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with PHS-funded research.
Procurement
In accordance with DataJoint policy, all employees who are involved in procurement or contract management must disclose if they plan to purchase, or recommend or approve the purchase of, goods or services for DataJoint from an entity with which they or a family member have a direct or indirect financial or other interest. In cases where a financial interest is disclosed may lead to the procurement of goods or services for DataJoint, The Designated Official will be notified and the disclosure will be forwarded for their review; this review may result in additional management requirements.
IV. Disclosure Review Process
All disclosures indicating a significant financial interest will be reviewed by the Designated Official. This review will take into consideration any comments or concerns provided by the signatory.
An actual or potential conflict of interest exists when the Designated Official reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research conducted on behalf of DataJoint. Additional information may be required by the Designated Official to make this determination.
Management Plans
If it is determined that a conflict exists, a final written agreement to manage the conflict is established by the Designated Official. The investigator is required to accept the plan provided by the Designated Official. A specific individual will be assigned to monitor adherence to this plan and report to the Designated Official on a routine basis until the conflict no longer exists.
Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate actual or potential conflicts of interest can include, but are not limited to:
Public disclosure of the conflict in publications and presentations
Disclosure to human subjects participating in the research
Disclosure to other research team members
Appointment of an independent third party to monitor the research
Modification of the research plan, with approval by the sponsor
Change of personnel or personnel roles so that the individual in conflict does not participate in the part of the research that could be affected
Reducing or eliminating the financial interest (e.g., sale of an equity interest)
Severance of relationships that create financial conflicts
DataJoint may also request active monitoring of relationships that are determined not to represent direct and significant conflicts of interest if there is a reasonable potential for a conflict to develop in the future, based on the direction of the research and/or the relationship with the financial interest.
V. Training
All individuals meeting the definition of Investigator in Section II must take an FCOI training course before utilizing research funds and at least once every four years. Additional training may be required more often under certain circumstances (e.g., failure to disclose significant financial interests, noncompliance with approved management plan).
VI. Responsibilities
A. InstitutionDesignated Official (DO)
The DataJoint Designated Official, for purposes of this policy, is the CEO and/or COO. The Designated Official is responsible for the solicitation and review of disclosures of significant financial interests from each Investigator at DataJoint. The CEO disclosure and certification shall be reviewed by the COO. If a position is vacant, the alternate reviewer shall be the Science Projects Director.
B. Investigator
Being familiar with and abiding by federal regulations and UH Policy regarding FCOI.
Ensuring that FCOI training is complete prior to utilizing research funds and at least once every four years, as outlined in section V.
Filing an FCOI Certification and disclosure (if appropriate) to DataJoint annually and within 30 days of discovering or acquiring a new significant financial interest.
Confirming agreement to and complying with any management plan issued by DataJoint; retaining documentation that demonstrates compliance with the management plan, such as but not limited to: notices to journal editors or conference audiences, consent forms from human subjects research, and notices to laboratory personnel.
VII. Awardees and Subrecipients
When DataJoint is the primary awardee of a collaborative PHS- or NSF-funded project, it must assure that the financial interests of all subrecipients are reviewed and eliminated or managed properly. During the proposal stage and during the negotiation of a subaward, all subrecipients/potential subrecipients of PHS funding will be required to certify the following in writing via a Letter of Compliance:
The subrecipient Institution has a policy in place to review and manage Significant Financial Conflicts of Interest that meets regulatory requirements.
The subrecipient's policy applies to the subawarded portion of the research project, and
The subrecipient must agree that the identification of and management plan of any FCOI identified will be submitted to the awardee Institution for required reporting purposes.
If the subawardee Institution does not have a compliant FCOI program in place, the agreement must indicate that the subrecipient will follow DataJoint policy, including the pre-award and annual submission of a Certification (and disclosure, if applicable) to DataJoint within 30 days of the submission of the proposal.
VIII. Reporting
The Division of Research is responsible for reporting Financial Conflicts of Interest to funding agencies, as applicable:
Public Health Service (PHS)-Funded Projects
Initial Report
Prior to the expenditure of funds under a PHS-funded research project, DataJoint must report any Investigator Significant Financial Interests that are determined by Designated Official, or a subrecipient Institution, to constitute a Financial Conflict of Interest.
Interim Reports
DataJoint must submit an FCOI report within sixty (60) days after its determination that an FCOI exists for an Investigator who is newly participating in the project or for an existing Investigator who discloses a new Significant Financial Interest to DataJoint during the period of award.A FCOI report is required in cases of noncompliance (when an Investigator does not disclose a previously existing Significant Financial Interest in a timely fashion or DataJoint fails to review a previously existing Significant Financial Interest during an ongoing NIH-funded project).
Annual Report
For any Financial Conflict of Interest previously reported by DataJoint, DataJoint shall provide an annual FCOI report that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports must specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists. Annual FCOI reports must be submitted to the NIH for the duration of the project period (including extensions with or without funds) at the same time DataJoint is required to submit the annual progress report, but through an alternative mechanism.
National Science Foundation (NSF)-Funded Projects
DataJoint must notify NSF's Office of the General Counsel if it determines that it is unable to manage a Conflict of Interest related to an NSF-funded project satisfactorily. If DataJoint determines a financial conflict with NSF research to be unmanageable (i.e. imposing conditions or restrictions would be either ineffective or inequitable, and the potential negative impacts that may arise from a significant financial interest are outweighed by the interests of scientific progress, technology transfer, or the public health and welfare), the NSF Office of the General Counsel (“OGC”) will be notified. DataJoint will cooperate with the OGC’s review of DataJoint’s conflict of interest policy, actions taken by DataJointwith respect to the unmanageable conflict, and NSF requests for confirmation that proposed actions have been accomplished.
Other Funding Agencies
DataJoint will make other required FCOI reports based on applicable funding agency requirements.
IX. FCOI Record Retention
DataJoint is responsible for the maintenance and retention of all financial disclosure documentation and of all actions taken to resolve conflicts of interest for at least three years beyond the date of submission of the final expenditures report of the grant to which they relate, or until the resolution of any funding agency action involving those records, whichever is longer. Additional retention might be required under 45 CFR 74.53(b) and 92.42 (b) for different situations.
X. Noncompliance
Failure of any investigator to comply with this policy shall constitute grounds for disciplinary action.
Disciplinary action is based upon a reasonable investigation of the noncompliance and is consistent with the severity of the violation. A range of examples includes, but is not limited to, the requirement for additional training/monitoring for minor violations up to the imposition of restrictions on an academic staff member's participation in sponsored research for severe or continuing violations.
Additional PHS Requirements
If an investigator fails to disclose a SFI in a timely manner or if for any reason DataJoint fails to review a SFI, DataJoint must, within 60 days, determine whether the SFI is related to the research, and whether it rises to the level of a FCOI. If found to be an FCOI, a management plan, even if interim, must be implemented. A FCOI report must be made to PHS at this time.
In addition, where it is discovered that DataJoint has failed to manage a FCOI or where a researcher has failed to comply with a management plan, DataJoint must, within 120 days, complete a retrospective review of research to determine whether the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research. If bias is identified, a mitigation report must be developed that outlines a plan of action to eliminate or mitigate the effect of the bias. The results of that determination and the mitigation report must be submitted to PHS.
XI. Public Accessibility
DataJoint is required to make its policy on Financial Conflict of Interest publicly accessible via its website. In addition, responses to public information requests for information concerning Significant Financial Interests must be disclosed within five business days in writing. Disclosures must meet the following criteria:
The significant financial interest was disclosed and is still held by the senior/key personnel as related to the PHS-funded project,
DataJoint determines that the Significant Financial Interest is related to the PHS-funded research, and
DataJoint determines that the Significant Financial Interest is a Financial Conflict of Interest.
The information that must be disclosed includes the following:
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 in increments of $50,000) or a statement that the interest is one for which the value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
Written Requests for information may be made through:
Via email at info@datajoint.com.
XII. Related Resources
Department of Health and Human Services Code of Federal Regulations:
● 42 CFR Part 50; 45 CFR Part 94 (PDF)
● 21 CFR Part 54
Policy Effective Date: January 1, 2023
Policy Approved By:
Dimitri Yatsenko, CEO, DataJoint
Jason Kirkpatrick, COO, DataJoint