FCOI Policy
Revision Date: August 1, 2021
Financial Conflict of Interest (FCOI) Policy for Matchstick Technologies, Inc.
Document outline:
1. Background
2. General Policy
3. Definitions
4. Procedures
5. Training
Background
Matchstick Technologies has, and will continue to apply for, funding from NIH. Federal regulations require that financial interests at awardee institutions like Matchstick do not affect the design, conduct, or reporting of research funded by NIH grants, contracts, or cooperative agreements (SBIR and STTR phase I awards are exempt). The NIH is committed to preserving the public’s trust that the research supported by them is conducted without bias and with the highest scientific and ethical standards.
Matchstick Technologies must manage, reduce, or eliminate financial conflicts of interest on NIH–funded research. Matchstick must also have a written agreement with subawardees to ensure all parties comply with conflict of interest regulations. The NIH may suspend funding if Matchstick does not adhere to financial conflict of interest rules.
Matchstick Personnel receiving funding from NIH must divulge potential Financial Conflicts of Interest (FCOI) in accordance with federal agency regulations as defined in 42 CFR part 50 subpart F (Promoting Objectivity in Research). An electronic version of the regulation is found here: http://www.gpo.gov/fdsys/pkg/FR–2011–08–25/pdf/2011–21633.pdf.
General Policy
No research occurring at Matchstick Technologies (hereafter ‘Company’) shall be adversely affected by the financial interests of Company personnel carrying out those activities. Prior to participating in a research activity, Company personnel having a potential conflict of interest shall disclose the details to the Company. An official designated by the Company shall be responsible for reviewing disclosures and instituting an adequate plan for reducing, managing or eliminating any potential financial conflicts of interest. Regardless of whether an FCOI exists, all investigators and key personnel are required to submit a FCOI Disclosure Form annually.
It is the Principal Investigator’s responsibility to ensure those with potential FCOI are identified and make the required disclosures in a timely manner. Annual updates are required of all Investigators and key personnel participating in research. Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately using the FCOI Disclosure form.
Definitions
For purposes of this Policy, the following definitions shall apply:
1.“Compensation” means any remuneration, including, without limitation, salary and payment for services not otherwise identified as salary, such as consulting fees. Compensation shall not include any of the following:
a. Salary, royalties, consultant fees or other remuneration paid by the Company to an Investigator or Innovator if the Investigator or Innovator is currently employed by the Company;
b. Payments or the entitlement to payments from the Company derived from royalties and fees paid to the Company by a third–party for Intellectual Property assigned by an Investigator or Innovator to the Company;
2. “Conflict Management Plan” means a written plan instituted by the Company for the management, reduction or elimination of a Financial Conflict of Interest.
3. “Entity” means any domestic or foreign, public or private, for profit or not–for–profit legal entity or organization other than the Company, any agency of the State of Washington, or the federal government.
4. “Equity” means any interest in the profits of or other ownership interest in any commercial or non–profit enterprise, including common stock and other equity securities, and any right to acquire any of the foregoing such as an option, warrant or other security convertible into an equity security.
5. “Financial Conflict of Interest” or “FCOI” means a Significant Financial Interest of an Investigator or Innovator that could directly and significantly affect the design, conduct, or reporting of Research.
6. “Financial Interest” means anything of monetary value, including but not limited to Compensation, Equity, Gifts, and Intellectual Property, of an Investigator or Innovator or the Immediate Family Member of an Investigator or Innovator, whether or not the value is readily ascertainable.
7. “Financial Interest Disclosure System” means a Company maintained and operated system for reporting SFI Disclosures and Travel Disclosures.
8. “Gift” means anything of economic value for which no consideration is given but shall not include those items excluded from the definition of gift as set forth in RCW 42.52.010(9).
9. “Immediate Family Member” means a person’s spouse, domestic partner, parent, grandparent, grandchild, sibling, child, or anyone who qualifies as the person’s dependent under the U.S. Internal Revenue Code.
10. “Innovator” means any Company personnel regardless of title or position, including a Company Research Employee, who has created in whole or in part any Intellectual Property in which the Company has any right or interest.
11. “Institutional Official” means one or more persons designated by the Company as having responsibilities and authority under this Policy.
12. “Institutional Responsibilities” means any professional activity carried out by an Investigator or Innovator for which the Investigator or Innovator is compensated by the Company.
13. “Intellectual Property” means the rights comprising a patent, trademark, copyright, trade secret, know–how or other similar intangible property right, including but not limited to, inventorship.
14. “Investigator” means any Company personnel regardless of title or position, including a Company Research Employee, responsible for the design, conduct, or reporting of CompanyResearch. Investigator includes, but is not limited to, the Principal Investigator, project director, co–principal investigator, and may also include other Senior/Key Personnel, trainee, staff member, collaborator, or consultant, depending on the person’s role in the Research. The primary factors to be used in determining who is an Investigator are the significance of the tasks assigned to the individual with regard to the design, conduct and reporting of the Research and the degree of independence that individual may have in performing such Research–related tasks.
15. “Non–PHS–Funded Investigator” means an Investigator who is neither applying for nor participating in any PHS–Funded Research.
16. “PHS” means the Public Health Service of the U.S. Department of Health and Human Services and any PHS awarding components to which authority may be delegated, including
without limitation the National Institutes of Health.
without limitation the National Institutes of Health.
17. “PHS–Funded Investigator” means an Investigator applying for or participating in any PHS–Funded Research. For the avoidance of doubt, PHS–Funded Investigator includes an Investigator applying for or participating in both PHS–Funded Research and non–PHS–Funded Research.
18. “PHS–Funded Research” means any Research or sponsored activity for which funding is available from a PHS awarding component through a grant or cooperative agreement, however authorized, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award. Notwithstanding the foregoing, PHS–Funded Research does not include any Phase I SBIR Program application or award.
19. “Policy” means this Financial Conflict of Interest Policy.
20. “Principal Investigator” means any person designated by the Company with the title of “Principal Investigator” of a Research or other sponsored project or otherwise having primary responsibility for the management and conduct of a Research or other sponsored project, including a project director.
21. “Reimbursed Travel” means travel activity for which the Travel Expenses are paid directly by the Investigator, who is then reimbursed by an Entity for such Travel Expenses. Notwithstanding the foregoing, Reimbursed Travel shall not include Travel Expenses that are reimbursed by the Company, a federal, state or local government agency, an Institution of Higher Education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of Higher Education.
22. “Research” means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. 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) and also includes any activity for which research funding is available through a grant or cooperative agreement, research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
23. “Senior/Key Personnel” means the Principal Investigator and any other person identified as senior or key personnel by the Company in a grant application, award, or contract or in any progress report, or any other report submitted to the PHS or other funding source.
24. “SFI Disclosure” means a disclosure of a Significant Financial Interest as provided in this
Policy.
25. “Significant Financial Interest” or “SFI” means any of the following Financial Interests related to the Institutional Responsibilities of an Investigator or Innovator:
a. With regard to any Entity whose Equity securities are publicly–traded, a Significant Financial Interest exists if the aggregate value of one or more of the following exceeds $5,000: (i) any Compensation received during the twelve (12) months preceding the date of SFI Disclosure, (ii) any Compensation reasonably anticipated to be received in the twelve (12) months following the date of SFI Disclosure, (iii) the value of any Equity interest in the Entity as of the date of SFI Disclosure;
b. With regard to any Entity whose Equity securities are not publicly–traded, a Significant Financial Interest exists if (i) the value of any Compensation received from the Entity in the twelve (12) months preceding the date of SFI Disclosure and/or reasonably anticipated to be received in the twelve (12) months following the date of SFI Disclosure, when aggregated, exceeds $5,000, or (ii) the Investigator or Innovator holds any Equity interest (e.g., stock, stock option, or other ownership interest);
c. With regard to any Entity, a Significant Financial Interest exists if the Investigator or Innovator has received income related to any Intellectual Property during the twelve (12) months preceding the date of SFI Disclosure and/or reasonably anticipated to be received in the twelve (12) months following the date of SFI Disclosure which, when aggregated with other Financial Interests in the Entity, exceeds $5,000;or
d. With regard to any Entity, a Significant Financial Interest exists if during the twelve (12) months preceding or following the date of SFI Disclosure, the Investigator or Innovator receives or reasonably anticipates receiving one or more Gifts (including but not limited to Reimbursed Travel or Sponsored Travel meeting the definition of Gift) having an aggregate value of $50 or more from the Entity.
26. “Small Business Innovation Research Program” or “SBIR Program” means an extramural federal program providing financial sponsorship or support for small businesses through PHS awarding components and certain other federal agencies established under Public Law 97–219, the Small Business Innovation Development Act, as amended. For purposes of this Policy, SBIR Program also includes the Small Business Technology Transfer Program, established under Public Law 102–564.
27. “Sponsored Travel” means travel activity, the Travel Expenses for which are paid directly by an Entity on behalf of an Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available to the Investigator. Notwithstanding the foregoing, Sponsored Travel shall not include Travel Expenses that are paid by the Company.
28. “Travel Disclosure” means a disclosure of Sponsored Travel or Reimbursed Travel as provided in this Policy.
29. “Travel Expenses” means expenses incurred for the purpose of engaging in travel activity, including but not limited to, costs for transportation, parking, food, drink, lodging, and related amenities.
30. “Company Research Employee” has the same meaning as set forth in RCW 42.52.010(23). For purpose of this Policy, Company Research Employee shall include Company research scientists and other Company employees who have been specifically assigned by the Company to Research projects and whose work contributes to the design or conduct of Research or to the analysis or reporting of Research results.
Procedures
A. Use of FCOI Disclosure form; Identification of Investigators
Investigators shall be personally responsible for ensuring that their SFI Disclosures and Travel Disclosures required to be disclosed under this Policy are submitted in a complete and timely manner and in accordance with procedures and guidelines established by the Company. For all Research projects, the Principal Investigator shall be responsible for identifying all Senior / Key Personnel who are also Investigators as they become known and reporting their identity within ten (10) days thereafter.
Procedures
A. Use of FCOI Disclosure form; Identification of Investigators
Investigators shall be personally responsible for ensuring that their SFI Disclosures and Travel Disclosures required to be disclosed under this Policy are submitted in a complete and timely manner and in accordance with procedures and guidelines established by the Company. For all Research projects, the Principal Investigator shall be responsible for identifying all Senior / Key Personnel who are also Investigators as they become known and reporting their identity within ten (10) days thereafter.
B. Authority of Institutional Official
The Institutional Official is authorized to administer and enforce this Policy. Such authorization includes the authority to (i) obtain and review SFI Disclosures and Travel Disclosures under this Policy, (ii) develop and implement Conflict Management Plans, (iii) conduct any required late or retrospective FCOI reviews, including issuance of reports of findings and onclusions and development and implementation of conflict mitigation plans, (iv) communicate with federal and other sponsors on matters pertaining to this Policy; (v) make recommendations to the Company with respect to matters covered by this Policy; and (vi) develop and implement reasonable and appropriate summary procedures for the disposition of matters involving compliance with this Policy.
The Institutional Official is authorized to administer and enforce this Policy. Such authorization includes the authority to (i) obtain and review SFI Disclosures and Travel Disclosures under this Policy, (ii) develop and implement Conflict Management Plans, (iii) conduct any required late or retrospective FCOI reviews, including issuance of reports of findings and onclusions and development and implementation of conflict mitigation plans, (iv) communicate with federal and other sponsors on matters pertaining to this Policy; (v) make recommendations to the Company with respect to matters covered by this Policy; and (vi) develop and implement reasonable and appropriate summary procedures for the disposition of matters involving compliance with this Policy.
C. SFI Disclosures by Investigators
All SFI Disclosures required to be disclosed by Investigators under this Policy shall be submitted in accordance with the following:
1. PHS–Funded Investigators are required to disclose all SFI’s within thirty (30) days of acquiring the SFI, but in no event later than submission of an application for PHS–Funded Research.
2. Non–PHS–Funded Investigators are required to disclose only those SFIs that are related to their Research no later than submission of an application for the related Research.
3. Once a Research project has been funded, Investigators shall disclose, prior to participating in the project, all SFI’s that have arisen since the time of application and all changes to SFI’s previously disclosed.
4. With regard to ongoing Research projects –
a. all Investigators shall submit SFI Disclosures within thirty (30) days of acquiring any new or increased SFI, and
b. when a new Investigator joins an ongoing Research project, the new Investigator shall submit SFI Disclosures within thirty (30) days of joining the project.
5. All Investigators shall submit an updated SFI Disclosure annually.
All SFI Disclosures required to be disclosed by Investigators under this Policy shall be submitted in accordance with the following:
1. PHS–Funded Investigators are required to disclose all SFI’s within thirty (30) days of acquiring the SFI, but in no event later than submission of an application for PHS–Funded Research.
2. Non–PHS–Funded Investigators are required to disclose only those SFIs that are related to their Research no later than submission of an application for the related Research.
3. Once a Research project has been funded, Investigators shall disclose, prior to participating in the project, all SFI’s that have arisen since the time of application and all changes to SFI’s previously disclosed.
4. With regard to ongoing Research projects –
a. all Investigators shall submit SFI Disclosures within thirty (30) days of acquiring any new or increased SFI, and
b. when a new Investigator joins an ongoing Research project, the new Investigator shall submit SFI Disclosures within thirty (30) days of joining the project.
5. All Investigators shall submit an updated SFI Disclosure annually.
D. Travel Disclosures
All Travel Disclosures required by this Policy shall be submitted by Investigators via the FCOI Disclosure Form in accordance with the following. PHS–Funded Investigators are required to disclose all potential FCOI Sponsored Travel and Reimbursed Travel. All Travel Disclosures by PHS–Funded Investigators shall include information regarding:
i. the purpose,
ii. the identity of the sponsor/organizer,
iii. the destination,
iv. the duration,
v. the inclusion of any Immediate Family Member, and
vi. an estimate of the approximate value of the travel.
All Travel Disclosures required by this Policy shall be submitted by Investigators via the FCOI Disclosure Form in accordance with the following. PHS–Funded Investigators are required to disclose all potential FCOI Sponsored Travel and Reimbursed Travel. All Travel Disclosures by PHS–Funded Investigators shall include information regarding:
i. the purpose,
ii. the identity of the sponsor/organizer,
iii. the destination,
iv. the duration,
v. the inclusion of any Immediate Family Member, and
vi. an estimate of the approximate value of the travel.
E. Review of Disclosures; Aggregation and Entity Rules
1. All SFI Disclosures and Travel Disclosures will be forwarded to the Institutional Official for review.
2. If an SFI Disclosure or Travel Disclosure is related to a Research Transaction, the Institutional Official shall review the SFI Disclosure or Travel Disclosure to determine whether the Financial Interest constitutes an FCOI. Reviews will generally not be conducted until after a Research proposal has been funded. Most reviews are completed within thirty (30) days following submission of all information required for the conduct of the review as determined by the Institutional Official.
3. No Investigator having an FCOI may participate in Research without prior written approval from the Institutional Official. All FCOI reviews, including any required Conflict Management Plan, must be completed before any Research activity begins or Research expenses are incurred under an award and before any Technology Transfer Transaction can be completed. In the event the Institutional Official concludes that a FCOI cannot be reduced, eliminated or managed, the Research project or Technology Transfer Transaction will not be allowed to proceed.
1. All SFI Disclosures and Travel Disclosures will be forwarded to the Institutional Official for review.
2. If an SFI Disclosure or Travel Disclosure is related to a Research Transaction, the Institutional Official shall review the SFI Disclosure or Travel Disclosure to determine whether the Financial Interest constitutes an FCOI. Reviews will generally not be conducted until after a Research proposal has been funded. Most reviews are completed within thirty (30) days following submission of all information required for the conduct of the review as determined by the Institutional Official.
3. No Investigator having an FCOI may participate in Research without prior written approval from the Institutional Official. All FCOI reviews, including any required Conflict Management Plan, must be completed before any Research activity begins or Research expenses are incurred under an award and before any Technology Transfer Transaction can be completed. In the event the Institutional Official concludes that a FCOI cannot be reduced, eliminated or managed, the Research project or Technology Transfer Transaction will not be allowed to proceed.
G. Management of Financial Conflict of Interests
1. If the Institutional Official determines that an SFI Disclosure or Travel Disclosure constitutes an FCOI relating to either Research or a Technology Transfer Transaction, a Conflict Management Plan shall be developed and implemented by the Institutional Official. The FCOI review and Conflict Management Plan shall be completed prior to a conflicted Investigator participating in the Research.
2. Conflict Management Plans shall consist of measures that in the reasonable judgment of the Institutional Official will reduce, eliminate, or manage the effects of the FCOI. The terms of a Conflict Management Plan shall be consistent with all legal and regulatory requirements, the requirements of this Policy, and may include one or more of the following:
a. Disclosure of FCOIs, including to the public, human subjects, researchers and other participants, publishers, and conference organizers;
b. Monitoring or oversight of Research by independent co–researchers, reviewers, disinterested individuals, or committees;
c. Maintaining copies of Research data with a neutral party;
d. Restricting participation in activity affecting or affected by a Research project or Technology Transfer Transaction;
e. Requiring that the SFI creating the FCOI be divested, restructured, or placed in a blind trust;
f. Modification or severance of relationships that create or are likely to create FCOI’s;
g. Modifying the terms of written agreements relating to the Research or Technology Transfer Transaction;
h. Requiring compliance with other relevant Company policies;
i. Requiring that the Investigator or Innovator not participate in any business transactions between the Company and parties to agreements involving sponsored Research or Technology Transfer Transactions.
3. Submission of an SFI Disclosure by an Investigator or Innovator shall not constitute approval for purposes of this policy.
1. If the Institutional Official determines that an SFI Disclosure or Travel Disclosure constitutes an FCOI relating to either Research or a Technology Transfer Transaction, a Conflict Management Plan shall be developed and implemented by the Institutional Official. The FCOI review and Conflict Management Plan shall be completed prior to a conflicted Investigator participating in the Research.
2. Conflict Management Plans shall consist of measures that in the reasonable judgment of the Institutional Official will reduce, eliminate, or manage the effects of the FCOI. The terms of a Conflict Management Plan shall be consistent with all legal and regulatory requirements, the requirements of this Policy, and may include one or more of the following:
a. Disclosure of FCOIs, including to the public, human subjects, researchers and other participants, publishers, and conference organizers;
b. Monitoring or oversight of Research by independent co–researchers, reviewers, disinterested individuals, or committees;
c. Maintaining copies of Research data with a neutral party;
d. Restricting participation in activity affecting or affected by a Research project or Technology Transfer Transaction;
e. Requiring that the SFI creating the FCOI be divested, restructured, or placed in a blind trust;
f. Modification or severance of relationships that create or are likely to create FCOI’s;
g. Modifying the terms of written agreements relating to the Research or Technology Transfer Transaction;
h. Requiring compliance with other relevant Company policies;
i. Requiring that the Investigator or Innovator not participate in any business transactions between the Company and parties to agreements involving sponsored Research or Technology Transfer Transactions.
3. Submission of an SFI Disclosure by an Investigator or Innovator shall not constitute approval for purposes of this policy.
H. Access to SFI Disclosures and Travel Disclosures
Company individuals and groups shall have access to all SFI Disclosures and Travel Disclosures submitted under this Policy, including the President, CEO, Board of Directors, and counsel;
Company individuals and groups shall have access to all SFI Disclosures and Travel Disclosures submitted under this Policy, including the President, CEO, Board of Directors, and counsel;
I. Annual Update Reporting
All Investigators and Innovators who are subject to a Conflict Management Plan shall provide annual update reports using the Financial Interest Disclosure System in a form and in a manner specified by the Company.
All Investigators and Innovators who are subject to a Conflict Management Plan shall provide annual update reports using the Financial Interest Disclosure System in a form and in a manner specified by the Company.
J. Disclosure and Review of Increased SFI’s and New Investigators
1. Any Investigator participating in an existing Research project who acquires a new or increased SFI that would otherwise be required to be disclosed under this Policy shall submit a new SFI Disclosure within thirty (30) days of the acquisition of the new or increased SFI through the Financial Interest Disclosure System. The Company shall complete its review of the new or increased SFI within sixty (60) days of the submission of the SFI Disclosure.
2. Any Company personnel joining an existing Research project who has an SFI that would otherwise be required to be disclosed under this Policy shall submit an SFI Disclosure prior to participating as an Investigator in the Research project and shall not participate as an Investigator in the Research project until an FCOI review has been completed.
1. Any Investigator participating in an existing Research project who acquires a new or increased SFI that would otherwise be required to be disclosed under this Policy shall submit a new SFI Disclosure within thirty (30) days of the acquisition of the new or increased SFI through the Financial Interest Disclosure System. The Company shall complete its review of the new or increased SFI within sixty (60) days of the submission of the SFI Disclosure.
2. Any Company personnel joining an existing Research project who has an SFI that would otherwise be required to be disclosed under this Policy shall submit an SFI Disclosure prior to participating as an Investigator in the Research project and shall not participate as an Investigator in the Research project until an FCOI review has been completed.
K. Retrospective Reviews of PHS–Funded Research; Mitigation Plans
1. For PHS–Funded Research, if an FCOI is not identified or managed in a timely manner due to noncompliance by the Investigator or the Company, the Company shall, within one–hundred twenty (120) days from the date the non–compliance was identified, complete a retrospective review of the Investigator’s activities and the Research project and make a reasonable determination whether there was any bias in the design, conduct or reporting of the Research resulting from the FCOI.
2. If an FCOI is identified in the course of a retrospective review, the Institutional Official shall develop and submit a mitigation plan to the PHS funding agency. The mitigation plan shall include, at a minimum, the key elements documented in the retrospective review, a description of any impact of the bias on the Research, and the Company’s plan to mitigate the effect of the bias.
1. For PHS–Funded Research, if an FCOI is not identified or managed in a timely manner due to noncompliance by the Investigator or the Company, the Company shall, within one–hundred twenty (120) days from the date the non–compliance was identified, complete a retrospective review of the Investigator’s activities and the Research project and make a reasonable determination whether there was any bias in the design, conduct or reporting of the Research resulting from the FCOI.
2. If an FCOI is identified in the course of a retrospective review, the Institutional Official shall develop and submit a mitigation plan to the PHS funding agency. The mitigation plan shall include, at a minimum, the key elements documented in the retrospective review, a description of any impact of the bias on the Research, and the Company’s plan to mitigate the effect of the bias.
L. Training for Investigators Participating in PHS Funded Research
Prior to engaging in PHS–Funded Research, and no less often than every five (5) years, all PHS–Funded PIs must complete training with respect to this Policy and the then–current PHS FCOI rules and regulations.
Prior to engaging in PHS–Funded Research, and no less often than every five (5) years, all PHS–Funded PIs must complete training with respect to this Policy and the then–current PHS FCOI rules and regulations.
L. Record Retention
Records created and maintained under this Policy shall be retained by the Company for a period of no less than three (3) years after the termination or completion of the Research.
Training
All personnel subject to FCOI policies are required to take an online NIH training course. The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes FCOI. This course is available for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Company engaged in NIH–funded research or its compliance. The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
Records created and maintained under this Policy shall be retained by the Company for a period of no less than three (3) years after the termination or completion of the Research.
Training
All personnel subject to FCOI policies are required to take an online NIH training course. The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes FCOI. This course is available for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Company engaged in NIH–funded research or its compliance. The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
