Financial Conflict
of Interest Policy

Advanced Footcare for the 21st Century



DIApedia, LLC – Financial Conflict of Interest Policy

I. Purpose

The purpose of this financial conflict of interest policy is to promote objectivity in research by establishing standards 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 policy establishes the standards for disclosure, review, and management of actual or potential financial conflicts of interest in research at DIApedia, LLC in accordance with Title 42 C.F.R. Part 50, Subpart F and Responsible Prospective Contractors (45 C.F.R. Part 94).

II. Definitions

Conflict of Interest (COI) means an interest that might affect, or might reasonably appear to affect, the judgment of any director, officer, committee member or executive manager in an adverse manner.

Designated Institutional Official (DIO) means the designated person within DIApedia who will solicit and review financial disclosure statements from each Investigator who is or plans to participate in PHS-funded research.

Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution.

Financial conflict of interest (FCOI) means a financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

FCOI report means DIApedia's report of a financial conflict of interest to a PHS Awarding Component.

Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

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 research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Investigator’s Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

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.

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.

Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

Research means a systematic investigation, study or experiment designed to develop or 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). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.

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 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: 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; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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.

Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.

III. Policy,

A. It is DIApedia, LLC’s policy to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under Public Service Grants (PHS) grants or cooperative agreements (or contracts, as applicable) will be biased by any conflicting financial interest of an Investigator.

B. This policy is applicable to each Investigator who is planning to participate in, or is participating in research to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a financial conflict of interest of the individual.

C. This policy shall be available via DIApedia’s publicly accessible Web site. In addition, information regarding any identified FCOIs held by Senior/Key personnel will also be posted on the website and updated at least annually or within 60 days of each newly identified FCOI.

D. Each Investigator will be informed of DIApedia, LLC’s policy on financial conflicts of interest, and the Investigator's responsibilities regarding disclosure of significant financial interests. Each Investigator will be required 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) DIApedia, LLC revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

(2) An Investigator is new to DIApedia, LLC; or

(3) DIApedia, LLC finds that an Investigator is not in compliance with the financial conflict of interest policy or management plan.

E. If DIApedia, LLC carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), DIApedia will take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by:

(1) Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest 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 financial conflicts of interest 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 financial conflicts of interest policy of DIApedia, LLC for disclosing significant financial interests that are directly related to the subrecipient's work for DIApedia, LLC;

(ii) Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to DIApedia, LLC. 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 DIApedia, LLC’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to DIApedia, LLC. Such time period(s) shall be sufficient to enable DIApedia, LLC to comply timely with its review, management, and reporting obligations under this subpart.

(2) Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest 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.

F. DIApedia, LLC has a designated Institutional official(s) to solicit and review disclosures of FCOI from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.

G. (1) Each Investigator who is planning to participate in the PHS-funded research is required to disclose to the DIApedia's designated official(s) the Investigator's any FCOI (and those of the Investigator's spouse and dependent children) related to the Investigator’s institutional responsibilities no later than the time of application for PHS-funded research.

(2) Each Investigator who is participating in the PHS-funded research is required to submit an updated disclosure of any FCOI annually during the period of the award. Such disclosure shall include any information that was not disclosed initially to DIApedia, LLC pursuant to paragraph G(1) of this section, or in a subsequent disclosure of significant financial interests (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 FCOI (e.g., the updated value of a previously disclosed equity interest).

(3) Each Investigator who is participating in the PHS-funded research is required to submit an updated disclosure of FCOIs within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new related financial interest.

H. An Investigator's financial interest is related to PHS-funded research when the financial interest: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research. DIApedia, LLC may involve the Investigator in the designated official(s)'s determination of whether a financial interest is related to the PHS-funded research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

I. DIApedia, LLC will take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a Subrecipient Investigator pursuant to paragraph E of this section pursuant to §50.605(a).

J. DIAPedia, LLC will provide initial and ongoing FCOI reports to the PHS as required pursuant to §50.605(b).

K. DIApedia, LLC will maintain records relating to all Investigator disclosures of financial interests and DIApedia, LLC's review of, and response to, such disclosures (whether or not a disclosure resulted in the determination of a financial conflict of interest) and all actions under the 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 74.53(b) and 92.42 (b) for different situations.

L. DIApedia, LLC will impose employee sanctions or other administrative actions to ensure Investigator compliance as appropriate including:

(1) Formal warning;

(2) Letter to employee’s file;

(3) Suspension;

(4) Corrective action up to and including termination.

(5) Disclosure of the FCOI in each public presentation of the results.

M. In each application for funding under PHS grants, cooperative agreements or contracts (as applicable) DIApedia, LLC shall certify that the company:

(1) Has in effect an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects for which funding is sought or received from the PHS;

(2) Shall promote and enforce Investigator compliance with this subpart's requirements including those pertaining to disclosure of significant financial interests;

(3) Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with this subpart;

(4) 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 a financial conflict of interest; and

(5) Shall fully comply with the requirements of 42 CFR 50, Subpart F and 45 CFR 94 pertaining to FCOI.