Medable is committed to promoting objectivity in research by establishing and enforcing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under Public Health Service of the U.S. Department of Health and Human Services (PHS)
contracts will be free from bias resulting from Investigator financial conflicts of interest. Medable complies with the requirements of 45 CFR part 94 and 42 CFR part 50, which detail regulations regarding Investigator financial conflicts of interest (FCOI), and the promotion of objectivity in PHS-funded research.
Determining Financial Conflicts of Interest
Medable will first determine whether an Investigator's significant financial interest is related to PHS-funded research and, secondly, if so related, whether the significant financial interest is a FCOI. An Investigator's significant financial interest is related to PHS-funded research when Medable, through its designated official(s), reasonably determines that the significant financial interest could be affected by the PHS-funded research, or is in an entity whose financial interest could be affected by the research.
A FCOI exists when Medable, through its designated official(s), reasonably determines that an Investigator’s significant financial interest is related to a PHS-funded research project and could directly and significantly affect the design, conduct or reporting of the PHS-funded research. All financial interests that have monetary value are covered, whether or not the value is readily ascertainable.
Medable follows federal regulations that define A “Significant Financial Interest” (SFI) as follows:
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:
(1) 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;
(2) 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
(3) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
Subcontractor and consortium members
If Medable carries out PHS-funded research through a subcontractor or consortium members, Medable ensures they will take reasonable steps to ensure that any subrecipient Investigator complies with Medable’s FCOI Policy and the related Federal Regulations by:
(1) Incorporating as part of a written agreement with the subrecipient terms that establish that the FCOI policy of Medable will apply to the subrecipient's Investigators.
(2) Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
(3) All financial disclosures must be submitted by the subrecipient to Medable prior to the expenditure of any project funds by subrecipient to provide Medable with sufficient time to review, manage, and report their obligations to PHS.
Medable requires that Investigators 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 must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration of the trip. Medable 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.
Investigators are required to disclose significant financial interests to Medable as detailed in this policy. Medable has designated an institutional official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.
(1) Medable requires that each Investigator who is planning to participate in the PHS-funded research disclose to the Medable's designated official(s) the Investigator's significant financial interests (and those of the Investigator's spouse and dependent children) no later than the date of submission of the Institution's proposal for PHS-funded research.
(2) Medable requires each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by Medable, during the period of the award. Such disclosure shall include any information that was not disclosed initially to Medable 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 significant financial interest (e.g., the updated value of a previously disclosed equity interest).
(3) Medable requires each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.
Medable will take such actions as necessary to manage FCOI, including any financial conflicts of a subrecipient Investigator. Medable will manage an identified FCOI through the development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to 45 CFR §94.5(a). In the case of a FCOI, Medable will provide initial and ongoing FCOI reports to the PHS as required pursuant to 45 CFR §94.5(b).
Additionally, Medable has established adequate enforcement mechanisms and provides for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.
Medable maintains records relating to all Investigator disclosures of financial interests and Medable’s review of, and response to, such disclosures (whether or not a disclosure resulted in Medable's determination of a financial conflict of interest), and all actions under Medable’s policy or retrospective review, if applicable, for at least three years from the date of final payment or, where applicable, for the time periods specified in 48 CFR part 4, subpart 4.7.
Medable requires each Investigator (defined as 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 under NIH contracts, or proposed for such funding, which may include, for example, collaborators or consultants) to complete training regarding Medable’s FCOI policy prior to engaging in research related to any PHS-funded contract and at least every four years. In lieu of completing this training through Medable, Investigators may complete FCOI training through their own Institute/University if the training complies with NIH standards. Investigators who choose this route must provide a signed and dated certificate of completion for this training, and written certification from the Institute/University that this training complies with NIH standards
More frequent training is required (within 30 days of discovery) upon any of the following circumstances:
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