PURPOSE:
The purpose of this policy is to define the process for identifying, reporting, evaluating, and managing financial relationships that have or may have an impact on the objectivity and integrity of research conducted under the auspices of Memorial Health Services (“MemorialCare”) and its affiliated entities (“MemorialCare Entities”).

DEFINITION OF TERMS:

1. Conflict of Interest Official or COI Official means the institutional official designated by the MemorialCare Research Administration to oversee the implementation of, and compliance with, this policy.

2. Covered Individual means

  • (a) Any employee, contractor or medical staff member of a MemorialCare Entity who has the authority to make independent decisions related to the design, conduct, or reporting of a MemorialCare research project, but not including individuals who perform only incidental or isolated tasks related to the project. Examples of a Covered Individual include a principal investigator, co-investigator, research nurse, associate, personnel whose resume is provided to a sponsor, personnel listed on study budgets or on an FDA 1572 Form, or individuals who are likely to be authors on publications of research findings;
  • (b) Members of a MemorialCare research review-related committee; or
  • (c) Third parties who negotiate or execute research agreements on behalf of MemorialCare.

3. Covered Family Member means an individual who is the spouse or dependent child of a Covered Individual.

4. Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) (as defined below) that could directly and significantly affect the design, conduct, or reporting of research.

5. Financial Conflicts of Interest in Research Committee (FCOI-R Committee) means the persons appointed by the Conflict of Interest Official to provide an appropriate review of disclosed SFI(s), make a determination of the SFI relationship of the Covered Individual and the funded research (reasonable belief of a FCOI) and devise an appropriate management plan for all instances in which a Conflict of Interest has been determined to exist. The FCOI-R Committee is a subcommittee of the MHS Compliance Committee

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

7. Institutional Responsibilities means a Covered Individual’s professional responsibilities on behalf of a MemorialCare Entity including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee membership, and or service on panels such as the IRB or any other research related review committee or panel.

8. Investigator or Principal Investigator means an individual who is responsible for the design, conduct or reporting of research or proposals for research. This definition is not limited to those titled or budgeted as principal investigator or sub-investigator on a particular proposal.

9. Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of a Covered Individual or Covered Family Member that reasonably appears to be related to the Covered Individual’s Institutional Responsibilities:

  • Publicly Traded Entity
    • The value of stock or other equity interest in a publicly-traded company that, in aggregate, exceeds $5,000 as of the date of disclosure.
    • Income from a publicly-traded company that, in aggregate, exceeds $5,000 in the 12 months preceding disclosure (includes salary and payment for other services, e.g. consulting fees, honoraria, paid authorship).
  • Non Publicly Traded Entity
    • Any stock or other equity/ownership interest of any value.
    • Income from a private company that, when aggregated, exceeds $5,000 in the 12 months preceding disclosure (includes salary and payment for other services, e.g. consulting fees, honoraria, paid authorship).
  • Intellectual Property Rights and Interest
    • Income related to intellectual property rights or interests.
  • Travel
    • Reimbursed or sponsored travel (i.e., that which is paid on behalf of the Covered Individual and not reimbursed to the Covered Individual so that the exact monetary value may not be readily available) in the 12 months preceding disclosure.
  • Gifts
    • The value and source of a single gift that exceeds $250 in value, or multiple gifts from a single entity that in aggregate exceed $250 in value, received in the 12 months preceding disclosure.
  • Fiduciary Positions
    • A fiduciary position held in a for-profit or nonprofit entity in the 12 months preceding disclosure, for which the individual received any form of remuneration or reimbursement for expenses.
  • Other
    • Any other financial interest that the Covered Individual or the COI Official believes conflicts with the Covered Individual’s ability to protect research subjects.

Significant Financial Interest (SFI) does not include:

  • Salary, royalties, or other remuneration paid by a MemorialCare Entity to the Covered Individual if the Covered Individual is employed or otherwise appointed by the MemorialCare Entity, including intellectual property rights assigned to the MemorialCare Entity and agreements to share in royalties related to such rights.
  • The following income from a Federal, state or local government agency, or an institution of higher education (20.U.S.C.1001(a))
    • Income from seminars, lectures or teaching engagements sponsored by any of the above.
    • Income from service on advisory committees or review panels for any of the above.
    • Travel reimbursed or sponsored by any of the above.
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Individual does not directly control the investment decisions made in these vehicles

SCOPE AND RESPONSIBILITY:
This policy applies to Covered Individuals (as defined above). In cases where a MemorialCare Entity is the awardee Institution and carries out research through a sub-recipient (e.g., subcontractor or collaborator), the MemorialCare Entity will ensure that the written agreement with the sub-recipient establishes whether the sub-recipient will follow this policy or the sub-recipient’s own financial conflict of interest policy.

POLICY:
All research conducted at MemorialCare and all of its related entities shall be compliant with applicable laws, regulations and these policies and procedures, which includes the requirements that (a) all Covered Individuals disclose all significant financial interests in accordance with this policy, before research begins and immediately when a change in financial interest occurs, and (b) all Covered Individuals with conflicts address those conflicts as determined by the COI Official prior to beginning or resuming research activities.

PROCEDURE:

A. Submission of Research Financial Disclosure Information by Covered Individuals

  1. The COI Official or designee will provide each Covered Individual with a copy of this policy as well as instructions for utilizing MemorialCare’s research disclosure of financial interests program.
  2. All Covered Individuals must complete and submit MemorialCare’s online Research Financial Disclosure form as follows: (i) annually, (ii) within 30 days of acquiring or discovering a new SFI, and (iii) at the time of application for any new research project. A new Covered Individual is required to complete and submit the online form prior to involvement in any research-related activities. The financial interests of a Covered Individual, as well as those of a Covered Family Member, are subject to disclosure.
  3. In the case of a Covered Individual who has not previously completed the online disclosure form, the form must be completed and submitted prior to the Covered Individual’s involvement in any research-related activities.

B. Review of Financial Disclosure Information and Assessment of Potential FCOI

  1. The COI Official will review all disclosure forms that identify a Covered Individual with an SFI to determine if the SFI represents a FCOI that requires a management plan as described below.
  2. If a SFI is disclosed, the COI Official or designee will obtain any additional information needed to provide an assessment of whether a SFI may be related to research, and if so related, whether the SFI may be a Financial Conflict of Interest (FCOI).

C. Management of FCOIs

  1. If it is determined by the COI Official, in consultation with the FCOI-R Committee, that a SFI creates a FCOI, the COI Official, in consultation with the FCOI-R Committee, shall assess and determine if a management plan is necessary. If a financial conflict of interest exists that would reasonably appear to compromise objectivity of the research, a management plan will be proposed for ensuring research objectivity. Possible strategies include, but are not limited to:
    • Public disclosure of the FCOI when presenting or publishing the research
    • Disclosure of FCOI directly to potential research subjects
    • Monitoring of research by independent reviewers
    • Modification of the research plan
    • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
    • Reduction or elimination of the financial interest
    • Severance of relationships that create financial conflicts
  2. The proposed management plan will be shared with the MemorialCare IRB, which will have authority to add provisions to the management plan, if deemed necessary for the protection of human subjects.
  3. The COI Official grants final approval for the management plan.
  4. The management plan will be shared with funding agencies, as appropriate.
  5. For studies that are ongoing, when an existing Covered Individual discloses a new SFI, within 60 days the review process described above will be initiated. If a FCOI exists, a management plan will be implemented. If necessary, additional interim measures may be implemented to manage the FCOI between the date of disclosure and completion of the review.

D. Reporting of Financial Conflicts of Interest to Sponsoring Agency

  1. Prior to MemorialCare expenditure of any sponsor funds, a FCOI report will be sent to the relevant sponsoring agency. Any subsequent FCOI identified for an ongoing study will be reported to the relevant sponsoring agency within 60 days. Annual FCOI reports will be sent to update the sponsoring agency on the status of a previously reported FCOI and any changes to the management plan. FCOI reports will include information required by federal regulations (42 CFR 50.605(b)(3) & 45 CFR 94.5(b)(3).

E. Monitoring and Compliance

Each Covered Individual conducting research under a management plan is responsible for fully and promptly complying with the plan. The management plan will specify who is responsible for monitoring ongoing compliance with the plan.

F. Corrective Action

  1. If a Covered Individual, or a MemorialCare Entity, fails to comply with this policy, they will be referred to the COI Official, who may consult with the FCOI-R Committee and the applicable department director, if any, for noncompliance review.
  2. If the COI Official learns of a SFI that was not disclosed or reviewed in a timely manner, the above process for reviewing and managing financial conflicts will be completed within 60 days.
  3. If the COI Official learns that (a) a FCOI was not identified or managed in a timely manner or a Covered Individual failed to comply with a management plan, a retrospective review will be completed within 120 days to determine if the noncompliance caused bias in the design, conduct, or reporting of the research. Based on the results of the retrospective review, an updated FCOI report and/or mitigation report (if bias is found) may be sent to the relevant sponsoring agency.
  4. MemorialCare Research Administration may decline or withhold funding in all cases in which a Covered Individual does not comply with an established conflict of interest management plan. Other consequences may include a letter of reprimand or the removal of a Covered Individual from an ongoing project and, in the case of a MemorialCare employee, may include termination of employment.

G. Education

  1. All Covered Individuals must complete the MemorialCare approved and designated research conflict of interest training module prior to engaging in research at MemorialCare and every 3 years following the initial training. In addition, training may be required when there is a change in institutional policies or there is a case of noncompliance.

H. Public Accessibility

  1. This policy shall be publicly accessible on the MemorialCare Research page on the MemorialCare website.
  2. Information regarding current FCOIs related to PHS-funded research will also be publicly accessible. Please contact us. A written response including all the information required under the applicable federal regulation will be provided to the requestor within 5 business days. The required information includes: Investigator’s name; Investigator’s title and role with respect to the research project; Name of the entity in which the SFI is held; nature of SFI; and approximate dollar value of the SFI (ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,00 by increments of $50,000) 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.

I. Records

  1. All Financial Disclosure Forms, records of review and action under this policy, and management plans will be retained for the longer of at least 3 years following:
    • the date of creation, :
    • The date of termination or completion of a research award contract, or the submission of the final expenditures report, for research identified in a disclosure statement; or
    • The date of final resolution for any investigation, audit, or similar action involving the records.

This information is confidential and available only to pertinent MemorialCare personnel.

AUTHORITY

FDA: 21 CFR 54.1; 21 CFR 54.2; 21 CFR 54.4; 21 CFR 312.64(d); 21 CFR 812.110(d); HHS: 42 CFR 50, Subpart F; 45 CFR 94

1 42 CFR 50.605(a)(3); 45 CFR 94.5(a)(3).