Financial Conflict of Interest (FCOI) Policy

Purpose

Adaptelligence LLC (“Adaptelligence”) is committed to objectivity in research, free from bias resulting from an Investigator’s financial conflicts of interest. This Financial Conflict of Interest (FCOI) policy promotes objectivity in research by establishing standards in compliance with 42 CFR Part 50 Subpart F that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This FCOI policy is applicable to each Investigator who is planning to participate in, or is participating in, such research conducted by Adaptelligence.

This FCOI policy is publicly available on the web at https://adaptelligence.com/fcoi/policy.html. Questions about this FCOI policy can be directed to the Policy Coordinator at compliance@adaptelligence.com.

Definitions

Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of Adaptelligence research funded by the PHS, or proposed for such funding, which may include subrecipients, for example, collaborators or consultants.

Significant financial interest (SFI) 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 SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

                       ii.         With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

                      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 teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure, the Policy Coordinator will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.

3.     The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Adaptelligence to the Investigator if the Investigator is currently employed or otherwise appointed by Adaptelligence, including intellectual property rights assigned to Adaptelligence and agreements to share in royalties related to such rights; any ownership interest in Adaptelligence held by the Investigator; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Institutional Responsibilities

As part of its responsibilities under this FCOI policy, Adaptelligence will do the following.

a.     Inform each Investigator of Adaptelligence’s FCOI policy, the Investigator’s responsibilities regarding disclosure of SFIs, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply:

1.     Adaptelligence revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

2.     An Investigator is new to Adaptelligence; or

3.     Adaptelligence finds that an Investigator is not in compliance with Adaptelligence’s financial conflict of interest policy or management plan.

b.     If PHS-funded research is carried out through a subrecipient (e.g., subcontractors or consortium members), Adaptelligence will take reasonable steps to ensure that any subrecipient Investigator complies with this FCOI policy by incorporating as part of a written agreement with the subrecipient terms that establish whether this FCOI policy or that of the subrecipient will apply to the subrecipient’s Investigators in accordance with the following.

1.     If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this FCOI policy. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to this FCOI policy for disclosing SFIs that are directly related to the subrecipient’s work for Adaptelligence;

2.     Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to Adaptelligence. Such time period(s) shall be sufficient to enable Adaptelligence to provide timely FCOI reports, as necessary, to the PHS as required;

3.     Alternatively, if the subrecipient’s Investigators must comply with Adaptelligence’s FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of SFIs to Adaptelligence. Such time period(s) shall be sufficient to enable Adaptelligence to comply with its review, management, and reporting obligations.

c.     Manage Financial Conflicts of Interest. If an Investigator’s SFI is determined to be a FCOI, then the Policy Coordinator, in collaboration with Adaptelligence officials, will develop, implement and monitor a FCOI Management Plan to ensure the FCOI does not bias the design, conduct, and reporting of PHS-funded research.

d.     Enforce the FCOI policy. If an Investigator fails to report a SFI which is determined to be a FCOI, Adaptelligence will submit a FCOI report to the PHS Awarding Component within 60 days of identification. Within 120 days, Adaptelligence will submit a retrospective review of the Investigator’s research activities to determine whether any PHS-funded research conducted during the time period of the noncompliance was biased in the design, conduct or reporting of the research. If bias is found, Adaptelligence will promptly notify the PHS Awarding Component and submit a mitigation report.

Investigator Responsibilities

Before participating in the application for PHS funding or in PHS-funded research, Investigators must do the following.

a.     Read, understand, and agree to comply with this FCOI policy.

b.     Complete the “NIH FCOI Training Module” available at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html, and submit their certificate of completion to the Policy Coordinator.

c.     Disclose SFIs according to the conditions below using the FCOI Disclosure Form available at https://adaptelligence.com/fcoi/disclosure-form.pdf. Even if the Investigator has no SFIs, they are still required to complete and submit the Disclosure Form.

1.     Submit to the Policy Coordinator a disclosure of the Investigator’s SFIs (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.

2.     Submit to the Policy Coordinator an updated disclosure of SFIs at the time of the award and at least annually thereafter during the period of the award. Such disclosure shall include any information that was not disclosed initially to Adaptelligence, or in a subsequent disclosure of SFIs (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

3.     Submit to the Policy Coordinator an updated disclosure of SFIs within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.

Records and Reporting

a.     The Policy Coordinator will maintain the following records regarding this FCOI policy for at least three years from the date the final expenditures report is submitted to the PHS.

1.     All Investigator disclosures of financial interests.

2.     Adaptelligence’s review of, and response to, such disclosures.

b.     Upon written request, the Policy Coordinator will, within five business days, provide information concerning any SFI disclosed to Adaptelligence that meets the following three criteria:

1.     The SFI was disclosed and is still held by the Investigator;

2.     Adaptelligence determines that the SFI is related to the PHS-funded research; and

3.     Adaptelligence determines that the SFI is a FCOI.

The information shall include, at a minimum, the following: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

c.     The Policy Coordinator will provide the following reports regarding this FCOI policy to the PHS Awarding Component.

1.     Description of all financial conflicts of interest of all Investigators prior to the expenditure of funds, at least annually during the award, and within 60 days of any subsequently identified FCOI.

2.     Description of all management plans, retrospective reviews, and mitigation reports.

Policy Coordinator

The FCOI Policy Coordinator can be contacted at compliance@adaptelligence.com. The duties of the Policy Coordinator include the following:

a.     Solicit and review disclosures of SFIs from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.

b.     Determine if a SFI constitutes a FCOI. A FCOI exists when Adaptelligence, through its Policy Coordinator and designated officials, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

c.     If a FCOI is identified, the Policy Coordinator and designated officials will develop, implement and monitor a FCOI Management Plan and, if necessary, perform a retrospective review and a mitigation report as prescribed in 42 CFR Part 50 Subpart F Section 50.605. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:

1.     Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

2.     For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

3.     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;

4.     Modification of the research plan;

5.     Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;

6.     Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

7.     Severance of relationships that create financial conflicts.