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Financial Conflict of Interest Policy in Research

Purpose

Cast has developed the Financial Conflict of Interest Policy (FCOI Policy) to comply with the requirements in 42 CFR Part 50 Subpart F, and in 45 CFR part 94, which promotes objectivity in
research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of federally-funded research will be free from bias resulting from Investigator financial conflicts of interest. The purpose of this policy is to identify and manage financial conflicts of interest, and to manage conflicts of interest between an Investigator’s Research project obligations and their private interest or obligations.

Scope

This policy applies to all Cast staff who propose, conduct, or report research on behalf of Cast, regardless of funding source. This policy applies to all research projects at Cast. Investigators are not permitted to begin any research activity until they have disclosed all outside significant financial interests and have received a written determination from Cast Executive Leadership as to how to manage any financial conflicts of interest in research identified by Cast.

Definitions

Disclosure of significant financial interests: Investigator’s disclosure of significant financial interests to an Institution.

Financial conflict of interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of federally-funded research.

FCOI report: Cast’s report of a financial conflict of interest to an Awarding Agency. Financial interest: Anything of monetary value, regardless if the value is readily ascertainable.

Institutional Responsibilities: An Investigator’s professional responsibilities for which such Investigator was hired and which are conducted at or undertaken on behalf of Cast, which may
include, but is not limited to, activities such as research, research consultation, teaching, outreach/extension, professional practice, institutional committee memberships and service on panels. Includes investigation of 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 federal awarding agency, or proposed for such funding, which may include, for example, collaborators or consultants.

Management Plan: A plan to Manage a Financial Conflict of Interest. Manage actions taken 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: A project director (PD) or principal Investigator (PI) of a federally-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under
this subpart.

Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and socialsciences
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 federally-funded component through a grant or cooperative agreement, 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: 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 federal funder by the Institution under this subpart.

Significant Financial Interest (SFI):

    1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse or domestic partner 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.
    2. 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 term significant financial interest does NOT include the following types of financial
      interests:

      • salary, royalties, or other remuneration paid by Cast to the Investigator if the Investigator is currently employed by Cast, including intellectual property rights assigned to Cast and agreements to share in royalties related to such rights;
      • 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;
      • 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

Training

  1. All Investigators are informed of this Policy, and their responsibilities regarding disclosure of significant financial interests, and of these regulations.
  2. Each Investigator planning to participate in, or who are participating in, federally funded research are required to complete training related to FCOI, regardless if a FCOI exists. Financial Conflict of Interest reviewers will also be required to complete training related to FCOI, regardless if a FCOI exists. This training is not required for Cast staff who are not participating and do not plan to participate in federally-funded research unless they are involved in the FCOI policy review process. Training must be completed in the following circumstances:
    • Prior to engaging in federally-funded research or conducting a review of a FCOI;
    • At least every four (4) years;
    • If an Investigator is new to Cast, within the sixty (60) days of commencement of employment
      (but not later than the beginning of federally-funded research by the Investigator);
    • If there are revisions to the FCOI Policy or procedures in any manner that affects the requirements of Investigator;
    • Cast finds that an Investigator is non-compliant with the FCOI Policy or Management Plan.

Training, or access to training, shall be provided by Cast and shall include information regarding the FCOI Policy and the Investigator’s responsibilities under the FCOI Policy and the Regulations to disclose Significant Financial Interests of the Investigator (and of the Investigator’s spouse and dependent children).

Disclosure

Investigators are required to disclose all SFI (and those of the Investigator’s spouse or domestic partner and dependent children) that reasonably appear to be related to their Institutional Responsibilities OR if no such SFI exists. The Investigator shall disclose as follows:

At time of Application

Each Investigator, including a subrecipient Investigator, if applicable, planning to participate in federally-funded research must disclose if an SFI exists or certify a SFI does not exist by submitting a Financial Conflict of Interest Disclosure Form to the Chief Impact & Operating Officer (CIOO) prior to submission of an application for federally-funded research.

Annual Updates

Each Investigator, including a subrecipient Investigator, if applicable, must submit an updated Financial Conflict of Interest Disclosure Form at least annually, during the period of the award,
beginning with the anniversary date of the award. The annual disclosure shall include: (a) any new information that was not disclosed to the CIOO either initially or subsequently (e.g. any FCOI identified on a federally-funded research project that was transferred from another institution); and (b) updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest).

Annual updates shall be required of all Investigators participating in a federally-funded research project, regardless of whether an SFI was previously disclosed.

Within 30 days

Each Investigator, including a subrecipient Investigator, if applicable, must disclose a SFI by submitting an updated Financial Conflict of Interest Disclosure Form to the CIOO within thirty days of discovering or acquiring (e.g., through purchase, marriage/domestic partnership, or inheritance) a new SFI.

Review

Prior to Cast’s expenditure of any funds under a federally-funded research project, the CIOO will
review all Financial Conflict of Interest Disclosure Forms and determinations shall be made, as
applicable, and consistent with the FCOI Policy and regulations. The CIOO shall determine with
reasonable discretion, whether any SFI is related to federally-funded research. An SFI is related
to federally funded research if (as reasonably determined by the CIOO):

  • the SFI could be affected by the research; or
  • the SFI is in an entity whose financial interest could be affected by the research

If the SFI is related to federally funded research, the CIOO, shall then determine, with reasonable discretion, whether a FCOI exists.

  • A FCOI exists if the SFI could directly and significantly affect the design, conduct, or reporting of federally-funded research.

If it is determined that (a) an SFI is related to federally-funded research and (b) an FCOI exists, the CIOO shall communicate the determination to the Investigator.

Management of FCOIs (Management Plan)

If an FCOI has been identified, the CIOO will work with the Investigator to implement a Management Plan to manage, reduce, or eliminate any actual or potential FCOI presented by an
SFI within 60 days. Possible approaches include, but are not limited to the following:

  • Public disclosure of significant financial interests;
  • Appointment of independent monitor(s) capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
  • Modification of the research plan;
  • Change of personnel or personnel responsibilities or disqualification of personnel from participation in all or a portion of the related project or research;
  • Reduction or elimination of the significant financial interest (e.g., sale of an equity interest); or
  • Severance of relationships that create actual or potential financial conflicts

Retrospective Review

Whenever an FCOI is not identified or managed in a timely manner including:

  • Investigator failure to disclose within 30 days an SFI that is determined to constitute an FCOI;
  • Cast’s failure to review or manage an FCOI within sixty days; or
  • Failure by the Investigator to comply with a FCOI Management Plan.

Cast shall, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the research project to determine whether any research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Cast shall document this retrospective review.

Such documentation shall include, but not necessarily be limited to, the following key elements:

  • Project number;
  • Project title;
  • PD/Pl;
  • Name of the Investigator with the FCOI;
  • Name of the entity with which the Investigator has a financial conflict of interest;
  • Reason(s) for the retrospective review;
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
  • Findings of the review; and
  • Conclusions of the review.

Based on the results of the retrospective review, if appropriate, Cast shall update the previously submitted FCOI report to the appropriate Agency, specifying the actions that will be taken to manage the financial conflict of interest going forward.

Reporting

Cast must report FCOIs to the federal funding agency.

Content: For all federally-funded research projects and prior to expenditure of any funds under the award, Cast is required to report to the Awarding Agency the existence of an FCOI and submit an FCOI report.

Timing: Cast is responsible for submitting FCOI reports to the Awarding Agency:

  • Initially (prior to expenditure of federally-funded research);
  • Within 60 days of any subsequently identified FCOI following the initial FCOI report during an ongoing federally-funded research project (e.g. upon the participation of an Investigator who is new to the federally-funded research project); and
  • Annually during the award period.

Annual FCOI Reports: For any FCOI previously reported by Cast with regard to an ongoing federally-funded research project, Cast shall provide to the Awarding Agency an annual FCOI report that addresses the status of the FCOI and any changes to the Management Plan for the duration of the funded research project. The annual FCOI report shall specify whether the FCOI is still being managed or explain why the FCOI no longer exists. Cast shall provide annual FCOI reports to the Awarding Agency for the duration of the project period (including extensions with or without funds) in the time and manner specifically specified by the Awarding Agency.

Public Accessibility of FCOI Policy and FCOI Information

Cast’s Financial Conflict of Interest Policy in federally-funded research is publicly available via this website: www.castla.org.

Cast will make information available concerning identified federally-funded FCOIs involving Senior/Key Personnel FCOIs via written response to any requestor within 5 business days of a
request made to info@castla.org.

Cast will update such information as specified by the federal funder requirements. This information will include:

  • Name of the Investigator,
  • Investigator’s title and role with respect to the research project,
  • Name of the entity in which the SFI is held,
  • The nature of the SFI, and Financial Conflict of Interest Policy in Research
  • 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 process or other reasonable measures of fair market value.

Subawards

Cast will take reasonable steps to ensure that subawardee Investigators comply with the FCOI regulation. For federally-funded research, Cast will incorporate in a written agreement with any subawardee terms that establish whether Cast’s FCOI Policy or the subawardee’s FCOI policy will apply. If the subawardee Investigator(s) must comply with the subawardee’s FCOI policy, the subawardee must certify as part of the agreement with Cast that its FCOI policy complies with the federal FCOI regulation. If the subawardee cannot provide such a certification, the agreement between Cast and the subawardee will state that subawardee Investigators are subject to Cast’s FCOI policy for disclosing significant financial interests that are directly related to the subawardee’s work for Cast.

Record Retention

Cast shall retain all records relating to Investigator disclosures of financial interests; the review of and response to such disclosures (whether or not a disclosure resulted in the determination of a FCOI); and all actions under this Policy or retrospective review, if applicable.

Such records shall be retained for at least seven (7) years from the date of submission of final expenditure reports to federal funders for each federally-funded research project (or where applicable from other dates specified in the federal Regulations for different situations).

Such records may be destroyed following the expiration of the retention period, unless there is relevant pending or active administrative or legal action or otherwise required by applicable law or Cast policy.