Financial Conflict of Interest (FCOI) Policy — Lumen Bioscience, Inc.
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Financial Conflict of Interest (FCOI) Policy and Disclosure Form
Date: Jul 1, 2021
Purpose
The purpose of this policy is to comply with applicable law and to ensure the objectivity of the research conducted by Lumen Bioscience, Inc., (“Lumen”) its employees, contractors, and consultants by establishing standards regarding the design, conduct and reporting of PHS-funded research to ensure that it is free from bias resulting from FCOI. Investigators applying for and working on PHS-funded research projects must disclose SFIs that are related to the investigator’s institutional responsibilities. This policy provides the framework to identify, evaluate and correct or remove real, apparent and potential conflicts of interest.
This policy requires that each investigator, subrecipient, subgrantee, collaborator and consultant affiliated with Lumen on a PHS-funded project be in compliance with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). This legislation states NIH’s commitment to ensure that the NIH-supported research is conducted without bias and with the highest scientific and ethical standards.
Lumen intends to use this same FCOI standard for all other Federal agency grants and contracts, as tailored or amended accordingly.
Who does this policy apply and who must submit this form?
If you are submitting a proposal to any of the below agencies, whether Lumen is the applicant or, subcontractor, you and anyone defined as an “investigator” on the proposal must submit a Financial Conflict of Interest Disclosure Form:
1. Annually
2. Prior to the submission of an application for external research support to a PHS-funded agency
3. Within 30 days of a change in financial status (acquisition of new significant financial interest)
What must be disclosed?
All significant financial interests related to an investigator’s institutional responsibilities.
Organizations requiring compliance with PHS regulations
U.S Public Health Services Agencies include: – Agency for Healthcare Research and Quality (AHRQ) – Agency for Toxic Substances and Disease Registry (ATSDR) – Centers for Disease Control and Prevention (CDC) – Food and Drug Administration (FDA) – Health Resources and Services Administration (HRSA) – Indian Health Services (HIS) – National Institutes of Health (NIH) – Office of Global Affairs (OGA) – Office of Assistant Secretary for Health (OASH)
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– Office of the Assistant Secretary for Preparedness and Response (OASPR) – Substance Abuse and Mental Health Services Administration (SAMHSA)
Exclusions
PHS regulations exclude applications for Phase | support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs from FCOI disclosure requirements.
PHS required financial conflicts of interest training and compliance (based on 42CFR Part F, §50.604)
Lumen will inform each investigator of its policy on FCOI, the investigators responsibilities regarding disclosure of SFls, and of these regulations, and require each investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant.
Each investigator must complete financial conflicts of interest training:
• Prior to engaging in research to any PHS-funded grant or, contract;
• At least every four years; and
• Immediately under the following circumstances:
– Institutional FCOI policies change in a manner that affects investigator requirements:
– An investigator is new to Lumen; or
– Lumen finds an investigator noncompliant with the policy or management plan of Lumen.
If Lumen carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Lumen shall take reasonable steps to ensure that any subrecipient investigator complies with this policy by:
1. Incorporating as part of a written agreement with the subrecipient terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s investigators.
(i) 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 this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient investigators are subject to the FCOI policy of the awardee Institution for disclosing SFls that are directly related to the subrecipient’s work for the awardee institution;
(ii) 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 FCOls to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart;
(iii) Alternatively, if the subrecipient’s investigators must comply with the awardee institution’s FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all investigator disclosures of SFls to the awardee institution. Such time period(s) shall be sufficient to enable the awardee institution to comply timely with its review, management, and reporting obligations under this subpart.
2. Providing FCOI reports to the PHS Awarding Component regarding all FCOI of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
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Records Management
Lumen shall maintain records relating to all investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the institution’s determination of an FCOl) and all actions under the institution’s policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.
Enforcement
Lumen shall:
1. establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure investigator compliance as appropriate;
2. certify, in each application for funding to which this policy applies, that Lumen:
(i) Has in effect an up-to-date, written, and enforced administrative process to identify and manage FCOls with respect to all research projects for which funding is sought or received from the PHS;
(ii) Shall promote and enforce Investigator compliance with this subpart’s requirements including those pertaining to disclosure of SFIs;
(iii) Shall manage FCOls and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with this subpart;
(iv)Agrees to make information available, promptly upon request, to the HHS relating to any investigator disclosure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of an FCOI; and
(v) Shall fully comply with the requirements of 42CFR Part F, §50.604.
Remedies and Penalties for Non-Performance (based on 42CFR, Part F, §50.606)
If the failure of an investigator to comply with Lumen’s FCOI policy or an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, Lumen shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken.
Management and reporting of financial conflicts of interest (based on 42CFR, Part F, §50.605)
1. Prior to Lumen’s expenditure of any funds under a PHS-funded research project, Lumen’s program manager will review all investigator disclosures of SFls; determine whether any SFls relate to PHS-funded research; determine whether an FCOI exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:
(i) Public disclosure of FCOls (e.g., when presenting or publishing the research);
(ii) For research projects involving human subjects research, disclosure of FCOls directly to participants;
(ii) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
(iv) Modification of the research plan;
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(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
(vi) Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
(vii) Severance of relationships that create financial conflicts.
2. Whenever, in the course of an ongoing PHS-funded research project, an investigator who is new to participating in the research project discloses an SFI or an existing investigator discloses a new SFI to Lumen, its designated FCOI official(s) shall, within sixty (60) days: review the disclosure of the SFI; determine whether it is related to PHS-funded research; determine whether an 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. Depending on the nature of the SFI, Lumen may determine that additional interim measures are necessary with regard to the investigator’s participation in the PHS-funded research project between the date of disclosure and the completion of the Institution’s review.
3. Whenever Lumen identifies an SFI that was not disclosed in a timely fashion by an investigator or, for whatever reason, was not previously reviewed by Lumen during an ongoing PHS-funded research project (e.g., was not reviewed or reported by a subrecipient in a timely fashion), the designated official(s) shall, within sixty (60) days: review the SFI; determine whether it is related to PHS-funded research; determine whether an FCOI exists; and, if so:
(i) 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; (ii) (a) In addition, whenever an FCOI is not identified or managed in a timely manner including failure by the investigator to disclose a SFI that is determined by the Institution to constitute an FCOI; failure by the Institution to review or manage such an FCOI; or failure by the investigator to comply with an FCOI management plan, Lumen shall, within 120 days of the determination of noncompliance, complete a retrospective review of the investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
(ii) (b) Lumen shall 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; (3) PD/PI or contact PD/PI if a multiple PD/PI model is used; (4) Name of the investigator with the FCOI; (5) Name of the entity with which the investigator has an 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; and (9) Conclusions of the review.
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4. Whenever Lumen implements an FCOI management plan, Lumen shall monitor investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.
5. Prior to Lumen’s expenditure of any funds under a PHS-funded research project, Lumen shall ensure public accessibility, via a written response to any requestor within five (5) business days of a request, of information concerning any SFI disclosed to Lumen that meets the following three criteria:
(A) The SFI was disclosed and is still held by the senior/key personnel as defined by this subpart;
(B) Lumen determines that the SFI is related to the PHS-funded research; and
(C) Lumen determines that the SFI is an FCOI.
6. Information concerning the SFls of an individual subject to this section shall remain available, for responses to written requests for at least three years from the date that the information was most recently updated.
Point of Contact: If you have questions or concerns regarding FCOI (or potential FCOI), please contact Lumen’s program manager.
Definitions (based on 42 CFR Part 50, Subpart F, §50.603)
Family means any member of the investigator’s immediate family, specifically, any dependent children, spouse or registered domestic partner.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Significant financial interest means:
1. 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: (i) with regard to 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); 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;
(ii) with regard to 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 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 (iii) intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2. Investigators also must 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 their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or 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
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teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy 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, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. 3. The term significant financial interest does not include the following types of financial interests: (i) salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; (ii) any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; (iii) 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; (iv) 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; (v) 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.
Financial conflict of interest (FCOI) means a significant financial interest (or, where the institutional official required disclosure of other financial interests, a financial interest) that the institution reasonably determines could directly and significantly affect the design, conduct or reporting of PHS-funded research.
Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.
Institutional responsibilities means the investigator’s responsibilities on behalf of Lumen which are defined by Lumen as research, research consultation, teaching professional practice, institutional committee memberships, and service on panels such as institutional review boards (e.g., IACUC, IBC, IRB).
Investigator means any individual who is responsible for the design, conduct, or reporting of PHS-sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral scientists, senior scientists, or graduate scientists. The definition many also include collaborators or consultants as appropriate.
PD/PI means a project director or principal investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and investigator under this subpart.
Public health service or PHS means Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the National Institutes of Health and Centers for Disease Control.
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Research means a systematic investigation, study, or experiment designed to 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).
Senior/key personnel means the PD/PI and any other person identified as a senior/key personnel by Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
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Financial Conflict of Interest Disclosure Form
Persons completing this form are expected to have read and understood Lumen Bioscience, Inc’s., Financial Conflict of Interest (FCOI) Policy on Federal Grants and Contracts. If you have any questions regarding that policy, please contact Lumen Bioscience, Inc’s., program manager.
Project information Name:_________________ Department:__________________ Email:__________________
Lead PI:__________________
Lead PI organization (if not Lumen Bioscience, Inc.)___________________________________
Role on project:____________ Sponsor:________________ Project dates:______ to _________
Project title:_____________________________________________
Are subrecipients involved in the project? ☐ No ☐ Yes
If yes, provide name(s) of the subrecipient organization(s):____________________________________
Type of proposal / disclosure
☐ New proposal ☐ Update disclosing new significant financial interests.
☐ New investigator added to project ☐ Required annual update.
1. Do you or any member of your immediate family (spouse, registered domestic partner and/or dependent children) have any significant financial interest (SFI) in a publicly-traded entity that might reasonably appear to be related to your institutional responsibilities? An SFI for publicly-traded entities exists if the value of any equity interest as of the date of disclosure combined with any remuneration in the past 12 months exceeds $5,000.
☐ Yes ☐ No
2. Do you or any member of your immediate family (spouse, registered domestic partner and/or dependent children) have any significant financial interest (SFI) in a privately-held entity that might reasonably appear to be related to your institutional responsibilities? An SFI for privately-held entities exists if the value of any remuneration in the past 12 months exceeds $5,000, or when the investigator or immediate family holds any equity interest.
☐ Yes ☐ No
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3. Have you or any member of your immediate family (spouse, registered domestic partner and/or dependent children) received any income related to intellectual property rights and interests that might reasonably appear to be related to your institutional responsibilities? (Do not included any intellectual property that has been assigned to Lumen Bioscience, Inc.)
☐ Yes ☐ No
4. In the past 12 months, have you undertaken any travel related to your institutional responsibilities that was either reimbursed or paid for by an individual or entity other than a federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 100(s), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education?
☐ Yes ☐ No
Acknowledgement and Certification
I acknowledge that by signing my name below, it is my responsibility to disclose, within 30 days, any new significant financial interests obtained during the term of the above proposed project. I certify, to the best of my knowledge, that this disclosure of significant financial interests is complete and accurate.
Investigator name:_________________________ Date:______________________
Investigator signature:______________________________________________________