Financial Conflict of Interest Policy

01Purpose and scope

This Policy applies to any research funded in whole or in part by a grant or cooperative agreement from the Public Health Service ("PHS") of the U.S. Department of Health and Human Services, including the National Institutes of Health ("NIH"), for which the Regulation applies. Under 42 CFR 50.601 the Regulation does not apply to Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications and awards.

It applies to every Investigator, as defined below, who is planning to participate in or is participating in PHS-funded research on the Company's behalf, whether that person is an employee, officer, consultant, contractor or collaborator.

In each application for PHS funding, the Company certifies that it has in effect an up-to-date, written and enforced administrative process to identify and manage financial conflicts of interest; that this Policy is posted on its public website and submitted to NIH through the eRA Commons Institution Profile Module; that it promotes and enforces Investigator compliance; that it manages identified conflicts and provides initial and ongoing FCOI reports; that it will make FCOI and SFI information, including related reviews and determinations, available to the PHS Awarding Component promptly on request; and that it fully complies with the Regulation.

02Definitions

Terms used in this Policy carry the meanings given in 42 CFR 50.603. The ones that matter most in practice are set out here.

Investigator

The project director or principal investigator ("PD/PI") and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of PHS-funded research, or proposed for such funding. This may include collaborators or consultants. At the Company this ordinarily includes the PD/PI, any person named as senior/key personnel in the application or progress reports, and any other person the PD/PI or Designated Official identifies as having independent responsibility for the design, conduct or reporting of the research.

Institutional responsibilities

An Investigator's professional responsibilities on behalf of the Company, including research, research consultation, product development related to the research, teaching, professional practice, committee membership and service on advisory or review panels.

Financial interest

Anything of monetary value, whether or not the value is readily ascertainable.

Significant Financial Interest (SFI)

A financial interest, foreign or domestic, of the Investigator (and of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities, and that falls into one of these categories:

• Publicly traded entity. 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. Remuneration includes salary and any payment for services not otherwise identified as salary (consulting fees, honoraria, paid authorship). Equity interest includes stock, stock options or other ownership interest, valued by reference to public prices or other reasonable measures of fair market value.
• Non-publicly traded entity. The value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000; or the Investigator (or spouse or dependent children) holds any equity interest in the entity, of any value.
• Intellectual property. Intellectual property rights and interests (for example patents or copyrights), upon receipt of income related to those rights and interests. The Company applies no dollar threshold to this category.
• Reimbursed or sponsored travel. Any travel related to the Investigator's institutional responsibilities that is reimbursed or sponsored (paid on the Investigator's behalf rather than reimbursed, so the exact value may not be readily available), regardless of amount. Travel reimbursed or sponsored by a U.S. federal, state or local government agency, a U.S. institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education is excluded from this requirement. Travel paid by a foreign institution of higher education or a foreign government is not excluded and must be disclosed.

A Significant Financial Interest does not include:

• Salary, royalties or other remuneration paid by the Company to the Investigator who is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share royalties related to those rights.
• Any ownership interest in the Company held by the Investigator, the Company being a commercial, for-profit organization.
• Income from investment vehicles such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in those vehicles.
• Income from seminars, lectures or teaching engagements sponsored by a U.S. federal, state or local government agency, a U.S. institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
• Income from service on advisory committees or review panels for a U.S. federal, state or local government agency, a U.S. institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

Payments and interests from foreign entities, including foreign institutions of higher education and foreign governments, are not covered by these exclusions and must be disclosed when they meet the thresholds above.

Financial Conflict of Interest (FCOI)

A Significant Financial Interest that the Company, through its Designated Official, reasonably determines could directly and significantly affect the design, conduct or reporting of PHS-funded research. "Significantly" means the financial interest would have a material effect on the research.

Manage

Taking action to address a Financial Conflict of Interest, which can include reducing or eliminating the interest, to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.

Senior/key personnel

The PD/PI and any other person identified as senior/key personnel by the Company in the grant application, progress report or any other report submitted to the PHS under the Regulation.

Designated Official

The Company officer responsible for soliciting and reviewing disclosures, determining whether an FCOI exists, and administering this Policy, as described in Section 03.

PHS Awarding Component

The organizational unit of the PHS that funds the research (for NIH awards, the awarding Institute or Center).

03Designated Official

The Company designates its Chief Executive Officer as the Designated Official under 42 CFR 50.604(d). The Designated Official solicits and reviews Investigator disclosures (including those covering an Investigator's spouse and dependent children), determines whether a disclosed SFI is related to PHS-funded research and, if so, whether it constitutes an FCOI, develops and monitors management plans, submits reports to the PHS Awarding Component, and maintains the records described in Section 13.

If the Designated Official is the Investigator whose disclosure is under review, or otherwise holds a financial interest in the outcome of a review, that review is conducted by another officer or director of the Company who has no such interest (the "Alternate Reviewer"). The Alternate Reviewer has the full authority of the Designated Official for that matter, and the record identifies who performed the review. The Designated Official may seek advice from outside counsel or an independent expert without delegating the decision.

04Training

Before engaging in research related to any PHS-funded grant or cooperative agreement, and at least every four years thereafter, each Investigator must complete training on financial conflicts of interest. The training informs the Investigator of this Policy, of the Investigator's responsibility to disclose all foreign and domestic Significant Financial Interests as defined above, and of the Regulation. The Company uses the NIH's FCOI training resources to satisfy this requirement unless the Designated Official approves an equivalent.

An Investigator must also complete training immediately when:

• the Company revises this Policy in a way that affects the requirements placed on Investigators;
• the Investigator is new to the Company; or
• the Company finds that the Investigator is not in compliance with this Policy or with a management plan.

The Designated Official keeps a record of the date and content of each Investigator's training.

05Disclosure of Significant Financial Interests

When to disclose

Each Investigator must submit a written disclosure of Significant Financial Interests (their own and those of their spouse and dependent children) that are related to the Investigator's institutional responsibilities:

• no later than the time of application for PHS-funded research;
• at least annually during the period of the award, on the schedule the Designated Official sets; the annual disclosure must include any information not previously disclosed and any updated information on previously disclosed interests, such as changes in value;
• within thirty (30) days of discovering or acquiring a new Significant Financial Interest, for example through purchase, marriage or inheritance; and
• within thirty (30) days of each occurrence of reimbursed or sponsored travel that meets the definition in Section 02.

What to disclose

Disclosures are made on the Company's SFI disclosure form, or in another written form the Designated Official accepts, and must include for each interest:

• the Investigator's name, and whether the interest is held by the Investigator, their spouse or a dependent child;
• the name of the entity, and whether it is publicly traded or non-publicly traded, or is a foreign institution of higher education or foreign government;
• the nature of the interest (for example salary, consulting fees, honoraria, paid authorship, royalties, equity, intellectual property income, or reimbursed or sponsored travel);
• the value of remuneration received in the twelve months preceding the disclosure and the value of each equity interest as of the date of disclosure, or a statement that the value cannot be readily determined;
• for travel: the purpose of the trip, the identity of the sponsor or organizer, the destination and the duration. The Designated Official may request the monetary value once it is known;
• whether the Investigator believes the interest is related to any PHS application or PHS-funded project, and why. The Investigator may take part in the relatedness determination, but the determination itself is the Designated Official's.

A disclosure that is incomplete, late or inaccurate is treated as noncompliance under Section 10. When in doubt about whether an interest must be disclosed, Investigators are expected to disclose it.

06Review of disclosures and determination of an FCOI

Before the Company spends any funds under a PHS-funded research project, the Designated Official reviews every Investigator's SFI disclosure and, for each interest, decides two questions in order.

Is the SFI related to the PHS-funded research?

An SFI is related when the Designated Official reasonably determines that it could be affected by the PHS-funded research, or that it is in an entity whose financial interest could be affected by the research.

If related, is it an FCOI?

An FCOI exists when the Designated Official reasonably determines that the SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research, meaning it would have a material effect on the research. In making that judgment the Designated Official considers, among other things, the nature and value of the interest, the Investigator's role in the research, how the results of the research could affect the value of the interest, and whether the entity is a sponsor, competitor, licensee, supplier or intended commercial partner in relation to the research.

Timelines

• Before expenditure of funds. All disclosures are reviewed, determinations made and any management plan implemented before the Company spends funds under the award.
• Within 60 days for new Investigators and new interests. When an Investigator who is new to a project joins it, or when an existing Investigator discloses a new SFI, the Designated Official reviews the disclosure, makes the relatedness and FCOI determinations and, if an FCOI exists, implements a management plan, at least on an interim basis, within sixty (60) days.
• Within 60 days for interests not disclosed or reviewed on time. Whenever the Company identifies an SFI that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed during an ongoing PHS-funded project (including where a subrecipient did not review or report it), the Designated Official completes the same review within sixty (60) days and, if an FCOI exists, implements at least an interim management plan going forward. A retrospective review under Section 09 also follows.

Every determination, including a determination that an SFI is not related or is not an FCOI, is documented in writing with its reasons.

07Managing a Financial Conflict of Interest

Where the Designated Official determines that an FCOI exists, the Designated Official develops and implements a written management plan specifying the actions that have been and will be taken to manage the conflict. The Investigator must agree to the plan in writing before the Company expends funds on the research, or, for conflicts identified later, within the sixty-day period in Section 06.

Conditions and restrictions a plan may impose

Examples include, alone or in combination:

• public disclosure of the FCOI, for example when presenting or publishing the research, and to the PHS Awarding Component;
• for research projects involving human subjects, disclosure of the FCOI 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 conflict;
• modification of the research plan;
• change of personnel or personnel responsibilities, or disqualification of the Investigator from participation in all or a portion of the research;
• reduction or elimination of the financial interest, for example sale of an equity interest; or
• severance of the relationship that creates the conflict.

The Company may add further conditions at its discretion.

Contents of a management plan

Each plan records the Investigator's role and principal duties in the research; the conditions of the plan; how the plan is designed to safeguard objectivity; confirmation of the Investigator's agreement; how the plan will be monitored to ensure compliance; and any other information the Designated Official considers relevant.

Monitoring

The Designated Official monitors the Investigator's compliance with the management plan on an ongoing basis until completion of the PHS-funded project, and takes any further action needed to manage the FCOI, including a conflict held by a subrecipient Investigator.

08Reporting to the PHS Awarding Component

The Company reports each identified FCOI, including those of its subrecipients' Investigators where applicable, to the PHS Awarding Component through the eRA Commons FCOI Module (for NIH awards) or as the PHS Awarding Component otherwise directs:

• Initial report: before the Company spends any funds under the award, for any FCOI identified at that time, together with the management plan;
• Within 60 days of identifying an FCOI for an Investigator who is newly participating in the project;
• Within 60 days of identifying a new, or newly identified, FCOI for an existing Investigator;
• Annually, at the same time the Company is required to submit its annual progress report, multi-year progress report if applicable, or at the time of extension, for the duration of the project period including extensions with or without funds. The annual report states whether the FCOI is still being managed, or explains why it no longer exists, and describes any changes to the management plan; and
• Revised report after a retrospective review, if new information is discovered that updates a previously submitted report.

Each FCOI report includes, at a minimum: the project number; the PD/PI or contact PD/PI if the multiple-PD/PI model is used; the name of the Investigator with the FCOI; the name of the entity in which the Investigator has the interest; the nature of the financial interest (for example equity, consulting fee, travel reimbursement, honorarium); the value of the interest in the dollar ranges set out in Section 12, 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; a description of how the financial interest relates to the PHS-funded research and the basis for the Company's determination that it conflicts with the research; and a description of the key elements of the management plan listed in Section 07.

If the Company determines that an FCOI was not identified or managed in a timely manner, or that bias was found under Section 09, or that an Investigator failed to comply with this Policy or a management plan, the Company notifies the PHS Awarding Component promptly, as described in Sections 09 and 10.

09Retrospective review and mitigation

Whenever an FCOI is not identified or managed in a timely manner, including when an Investigator fails to disclose an SFI that the Company later determines constitutes an FCOI, when the Company fails to review or manage such an FCOI, or when an Investigator fails to comply with a management plan, the Designated Official completes a retrospective review of the Investigator's activities and the PHS-funded research project within one hundred twenty (120) days of the Company's determination of noncompliance, to decide whether any PHS-funded research, or portion of it, conducted during the period of noncompliance was biased in its design, conduct or reporting.

The retrospective review is documented and includes, at a minimum:

• project number;
• project title;
• PD/PI, or contact PD/PI if the multiple-PD/PI model is used;
• name of the Investigator with the FCOI;
• name of the entity with which the Investigator has an FCOI;
• reasons for the retrospective review;
• detailed methodology used, including the review process, the composition of any review panel, and the documentation reviewed;
• findings of the review; and
• conclusions of the review.

Based on the results of the review, the Company updates any previously submitted FCOI report if appropriate. If bias is found, the Company notifies the PHS Awarding Component promptly and submits a mitigation report that includes the key elements of the retrospective review, a description of the impact of the bias on the research project, and the Company's plan of action, or actions already taken, to eliminate or mitigate the effect of the bias, for example impact on the research project, extent of harm done, whether the research is salvageable, and any corrective actions. The Company then submits FCOI reports annually as described in Section 08. Depending on the nature of the FCOI, the Company may decide that additional interim measures are needed with regard to the Investigator's participation between the date the FCOI is identified and the completion of the review.

10Noncompliance, enforcement and remedies

Investigators are required to comply with this Policy and with any management plan that applies to them. Failure to do so, including failure to complete training, failure to disclose an SFI on time, an incomplete or inaccurate disclosure, or breach of a management plan, is grounds for sanctions or other administrative action. Depending on the seriousness of the failure, these may include a letter of reprimand, required re-training, a restriction on the use of funds, removal from the research project, disqualification from serving as an Investigator on future PHS-funded research, suspension, or termination of employment or engagement, in addition to the corrective steps in Sections 06 through 09.

If the Company determines that an Investigator (or a subrecipient Investigator) has failed to comply with this Policy or a management plan, and the noncompliance appears to have biased the design, conduct or reporting of the PHS-funded research, the Company promptly notifies the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component may take its own action, including requiring the Company to enforce corrective measures before a grant is awarded or continued, imposing special award conditions under 2 CFR 200.208, or suspending funding under 2 CFR 200.339 until the matter is resolved.

The PHS Awarding Component and HHS may inquire at any time, before, during or after an award, into any Investigator disclosure of financial interests and the Company's review of, and response to, that disclosure, whether or not the disclosure resulted in the Company's determination of an FCOI. The Company will make the requested records and information available promptly.

Clinical research

In any case in which HHS determines that a PHS-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with an FCOI that was not managed or reported by the Company as required by the Regulation, the Company will require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

11Subrecipients

If the Company carries out PHS-funded research through a subrecipient (for example a subcontractor, consortium member or collaborating institution), the Company enters into a written agreement with the subrecipient before the subrecipient's work begins that establishes:

• whether the subrecipient's Investigators will follow this Policy or the subrecipient's own FCOI policy;
• if the subrecipient's policy applies, a certification from the subrecipient that its policy complies with the Regulation, and a requirement that the subrecipient report identified FCOIs for its Investigators to the Company in a time frame (in any event no later than the times required for the Company's own reports under Section 08, and ordinarily within 45 days of identification) that allows the Company to report them to the PHS Awarding Component as the Regulation requires; or
• if this Policy applies, a requirement that the subrecipient's Investigators submit their disclosures to the Company's Designated Official on the timelines in Section 05, so that the Company can identify, manage and report any FCOI.

Subrecipient agreements also meet the consortium requirements of the NIH Grants Policy Statement Section 15.2.1 where NIH is the awarding component.

12Public accessibility

This Policy is posted on the Company's public website at remycamera.com/financial-conflict-of-interest-policy.html, and a copy is submitted to NIH through the eRA Commons Institution Profile Module.

Before the Company spends funds under a PHS-funded research project, it also makes publicly available information about any Significant Financial Interest that meets all three of these conditions: it was disclosed and is still held by senior/key personnel; the Company determines it is related to the PHS-funded research; and the Company determines it is an FCOI. The Company satisfies this requirement by posting the information in Section 16 of this page. Where the information has instead been made available by written response, the Company responds within five (5) business days of receiving a written request sent to the address in Section 17.

For each such FCOI the public information includes, at a minimum: 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 in one of the following ranges, 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.

Posted information is updated at least annually and within sixty (60) days of the Company identifying a new FCOI, and remains available for at least three (3) years from the date it was most recently updated. A written response to a request always contains the most current information.

13Record retention

The Company maintains records of all Investigator disclosures of financial interests and of the Company's review of, and response to, each disclosure, whether or not the disclosure resulted in a determination of an FCOI, together with all actions taken under this Policy or under a management plan, all retrospective reviews and mitigation reports, training records, subrecipient agreements and certifications, and all FCOI reports submitted to the PHS Awarding Component.

These records are kept for at least three (3) years from the date the final expenditures report (the Final Federal Financial Report) for the award is submitted to the PHS, or, where applicable, from the other dates specified in 2 CFR 200.334 for particular situations, such as litigation, claims or audits begun before the end of the three-year period, in which case records are kept until all such matters are resolved and final action taken.

14Confidentiality

Disclosures and related records are treated as confidential and are shared within the Company only with those who need them to administer this Policy. They are disclosed outside the Company as this Policy or the Regulation requires, including to the PHS Awarding Component and HHS on request, in FCOI reports, and in the public information described in Section 12, and as otherwise required by law.

15Maintaining this Policy

The Designated Official reviews this Policy at least annually, and whenever the Regulation or NIH guidance changes, to confirm that it remains accurate and complete. Material revisions are approved by the Company's officers, posted here with an updated "Last reviewed" date, submitted to NIH through the eRA Commons Institution Profile Module, and communicated to Investigators, who complete training on the revised Policy as Section 04 requires.

16Public disclosures of identified FCOIs

This section carries the public information described in Section 12 for any Financial Conflict of Interest identified by the Company and held by senior/key personnel on PHS-funded research. Each entry lists the Investigator's name, title and role on the project, the entity, the nature of the interest and its approximate dollar range, and is posted before funds are spent, updated at least annually and within sixty days of a new determination, and kept for three years from its last update.

If no entries appear below, none have been posted as of the "Last reviewed" date shown at the top of this page. Written requests for this information may be sent to the address in Section 17 and are answered within five business days.

No entries have been posted.

17Contact

Questions about this Policy, disclosure forms, training, and written requests for FCOI information under Section 12 go to the Designated Official:

Designated Official, Financial Conflict of Interest
Remy Camera, Inc.
625 2nd Ave, Excelsior, MN 55331, United States
Email: jacob@remynecklace.com

Useful references: the Regulation at 42 CFR Part 50 Subpart F; the NIH Financial Conflict of Interest page, which links its policy development checklist, FAQs and training; and the 2011 Final Rule at 76 FR 53256.