Financial Conflict of Interest - Research Policy

Policy #: EHADM3009

Approval Body: Essentia Health Leadership Team Last Review Date: 5/28/2024

Review Cycle: Every 3 years

Scope: This policy applies to Essentia Health and its Affiliates.

Purpose:

I. 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, cooperative agreements or contracts will be free from bias resulting from Investigator financial conflicts of interest.

Definitions:

I. Affiliate means a wholly-owned subsidiary of Essentia Health.

II. Award means the provision of funds by PHS, based on an approved application and budget or progress report, to an organizational Entity or an individual to carry out a project or activity.

III. Contractor means an Entity that provides property or services under contract for the direct benefit or use of the Federal Government.

IV. Disclosure of Significant Financial Interests means an Investigator's disclosure of Significant Financial Interests to an Institution.

V. Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.

VI. Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded Research.

VII. FCOI Report means an Institution's report of a FCOI to a PHS Awarding Component.

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

IX. Institution means any domestic or foreign, public or private, Entity or organization (excluding a Federal agenda) that is applying for, or that receives, PHS Research funding. For the purposes of this policy, the Institution is Essentia Health.

X. Institutional Responsibilities means an Investigator's professional responsibilities on behalf of the Institution, 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.

XI. Institutional Official (IO) is the signatory on the Federal wide Assurance (FWA) filed with Office for Human Research Protections (OHRP) to ensure compliance with regulations governing protection of human subjects. OHRP requires the IO to be a high-level official who has the authority to represent the Institution named in the FWA.

XII. Investigator means the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of actual or proposed Research, or proposed funding for Research, which may include, for example, co-Investigators, collaborators, consultants, or other key Research personnel (includes nurses, coordinators, and statisticians).

XIII. Key Personnel includes the PD/PI and any other personnel considered to be essential to work performance in accordance with HHSAR subpart 352.242-70 and identified as Key Personnel in the contract proposal and contract.

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

XV. Project Director or Principal Investigator (PD/PI) a PHS-funded Research project; the PD/PI is included in the definitions of Senior/Key Personnel and Investigator under this subpart.

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

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

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

XIX. 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.

XX. 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.

XXI. Recipient means an organization that receives a Federal funding Award directly from a PHS Awarding Component. The term Recipient does not include Subrecipients of or consortiums benefiting from the Award.

XXII. Significant Financial Interest means:

A. 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, in excess of $5,000, related to such rights and interests.

B. Investigators also must disclose the occurrence of any reimbursed or sponsored travel in excess of $5,000 (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 located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a Research institute that is affiliated with a United States 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 IO(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.

C. 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 located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a Research institute that is affiliated with a United States Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a Research institute that is affiliated with a United States Institution of higher education.

XXIII. 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.

XXIV. Subrecipient means a third-party organization that receives funding from a Recipient or another Subrecipient to collaborate in carrying out externally funded Research or a program. May include subcontractors, subawardees, and cooperative/consortium members.

XXV. United States Department of Health and Human Services (HHS) includes any components of the Department to which the authority involved may be delegated.

Policy:

Essentia shall meet the regulatory requirements of 42 CFR Part 50 Subpart F and 45 CFR Part 94 for Public Health Service (PHS) funded Research through this policy, Essentia Health will:

I. Maintain this FCOI Policy

A. The Organizational Integrity and Compliance (OIC) department will maintain an up to date, written, enforced policy to identify and Manage financial conflicts of interest and make such policy available via the Essentia Health public website and submit copy to the NIH via eRA Commons.

II. Train and Inform Investigators

A. The OIC Research compliance team will inform each Investigator of this policy, the Investigator's responsibilities regarding Disclosure of Significant Financial Interests, and of these regulations.

B. Each Investigator who is new to Essentia Health (EH) is required to complete FCOI training prior to submitting a Research project for IRB approval or applying for Research funding.

C. At a minimum, Investigator(s) will complete the FCOI training every three (3) years and when Essentia Health significantly revises this Policy, or an Investigator is not in compliance with the Policy or applicable management plan.

D. The FCOI training module is available electronically, and Investigators will receive a notification when they are due to complete FCOI training. Alternative methods of training will be made available if necessary.

III. Ensure FCOIs are Disclosed When Engaging with Subrecipients or When Essentia Health Is a Subrecipient

A. When Essentia Health is a primary Recipient and engages another Subrecipient to assist in the funded Research, the written agreement between Essentia Health and the Subrecipient shall include terms that establish whether Essentia Health’s FCOI Policy or that of the Subrecipient will apply to the Subrecipient’s Investigators. This determination will be made on a case-by-case basis.

1. If a determination is made that the FCOI policy of the Subrecipient will be followed:

a. The Subrecipient shall certify as part of the agreement that its policy complies with the requirements of 42 CFR Part 50 Subpart F for grants and cooperative agreements and 45 CFR Part 94 for research contracts, and

b. The agreement shall specify time period(s) for the Subrecipient to report all identified FCOIs to Essentia Health in a timely manner.

2. If the agreement establishes that the Subrecipient Investigators will comply with the Essentia Health FCOI Policy or the Subrecipient is unable to provide certification of compliance with the requirements of 42 CFR Part 50 Subpart F and 45 CFR Part 94, the Subrecipient Investigators must report disclosures of Financial Interests relating to the Investigator’s work as defined in the agreement to Essentia Health within a timely manner.

3. The timing of the Subrecipient’s reporting must allow Essentia Health sufficient time to comply with reporting obligations as stated below.

4. The Chief Compliance Officer (or designee) will be responsible for providing FCOI Reports to the appropriate external agencies or primary Recipients regarding all Subrecipient Investigator FCOI in accordance with this Policy and other applicable standards.

B. Essentia Health as a Subrecipient

1. When Essentia Health is acting as a Subrecipient, the written agreement between Essentia Health and the prime/Subrecipient should include terms that establish whether Essentia Health’s FCOI policies or those of the other party will apply to Essentia Health’s Investigators.

2. If a determination is made that the FCOI policies of the other party will be followed, Essentia Health shall abide by those policies and contract requirements.

3. If a determination is made that the EH FCOI policies will be followed, the Chief Compliance Officer (CCO) (or designee) will be responsible for providing FCOI Reports to the Recipient/Subrecipient.

IV. Require Investigator Disclosure of Significant Financial Interests

A. Individuals who participate in the design, conduct, oversight and/or reporting of clinical Research are required to complete an initial and annual conflict of interest statement and disclosure. [See EHADM3005: Conflicts of Interest for additional information.]

B. In addition, each Investigator, who is planning to participate in PHS-funded Research must disclose to Essentia Health all foreign and domestic Significant Financial Interests (SFI) (and those of the Investigator's spouse and dependent children) no later than date of submission of the Institution's proposal for PHS-funded Research and/or annually during the period of the Award.

C. Each Investigator who is participating in the PHS-funded Research must submit an updated disclosure of Significant Financial Interests within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.

D. If an Investigator does not participate in the disclosure process (including timely participation and disclosure) or there is reason to believe that an Investigator has failed to disclose an SFI as required by this policy, the CCO will review the circumstances with the appropriate parties and take appropriate action as described below. Corrective actions will be based on the nature of the violation. Such action(s) may include but are not limited to the following: (1) removal from the Research project; (2) exclusion from current or future Research projects, or (3) disciplinary action for employees, up to and including termination.

V. Review & Determination of Significant Financial Interests When Disclosed

A. The review, analysis, and management of disclosures are the primary responsibility of the CCO, EH’s designated official, who will:

1. Prior to the expenditure of funds under a new award, determine whether an Investigator's Significant Financial Interest is related to PHS-funded Research and, if so related, whether the Significant Financial Interest is a FCOI.

a. An Investigator's Significant Financial Interest is related to PHS-funded Research when the CCO reasonably determines that the Significant Financial Interest:

1) Could be affected by the PHS-funded Research; or

2) Is in an Entity whose Financial Interest could be affected by the Research.

2. The CCO may involve the Investigator and the Institutional Official in the determination of whether a Significant Financial Interest is related to the PHS-funded Research.

a. A FCOI exists when the CCO reasonably determines that the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded Research.

3. The review and determination of whether an FCOI exists, and development of a management plan, when applicable, will be completed within sixty (60) days of the receipt of disclosure or discovery of the FCOI

VI. Manage Financial Conflicts of Interest (FCOI)

A. If the CCO (or designee) and the Institutional Official (IO) consider an Investigator’s disclosure to be a Significant Financial Conflict of Interest (SFCOI), they will develop and implement a management plan to specify the actions that have been and must be taken to Manage the specific SFCOI.

1. Examples of conditions or restrictions that might be imposed to Manage a SFCOI include, but are not limited to the following:

a. Public disclosure of the SFCOI (e.g., when presenting or publishing the Research or addendum to previously published presentations, provide written notification to staff members working on the project, to the Institution’s Institutional Review Board(s), and to the Grants and Contracts Supervisor, etc.);

b. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the SFCOI;

c. Modification of the Research plan;

d. For Research projects involving human subjects Research, disclosure of the SFCOI directly to the participants;

e. Change of personnel or personnel responsibilities or disqualification of personnel from participation in all or a portion of the Research;

f. Reduction or elimination of the Financial Interest(s) (e.g., sale of an equity interest);

g. Severance of relationships that create financial conflict(s); or

h. Withdrawal of IRB approval for a specific Research project.

B. The CCO (or designee) in collaboration with the IO will monitor the management plan for Investigator compliance on an ongoing basis until the completion of the Research project. Each monitoring plan will vary based upon the nature of the management plan.

VII. Conduct a Retrospective Review

A. A retrospective review will be completed by the CCO (or designee) within 120 days of the Institution’s determination of noncompliance when an SFI is not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner, including:

1. Failure of the Institution to disclose an SFI that is determined by the Institution to constitute a financial conflict of interest;

2. Failure by the Institution to review or Manage such a financial conflict of interest;

3. Failure by the Investigator to comply with the financial conflict of interest management plan.

B. The CCO and/or Essentia Health leadership may determine that interim measures are necessary with regard to the Investigator’s participation in the study or studies between the date that the FCOI or the Investigator’s noncompliance is determined and the completion of the retrospective review.

C. The CCO (or designee) will document the retrospective review to include at minimum the following key elements:

1. Project Number;

2. Project Title;

3. PD/PI or contact PD/PI if multiple PD/PI model is used;

4. Name of the Investigator with the FCOI;

5. Name of the Entity with which the Investigator has an FCOI;

6. Reasons for the retrospective review;

7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed);

8. Findings of the review (including an analysis of whether the Research project is salvageable);

9. Conclusions of the review;

10. How the management plan is designed to safeguard objectivity in the Research;

11. Confirmation of the Investigator’s agreement to the management plan;

12. How the management plan will be monitored to ensure Investigator compliance; and

13. Other information as needed.

D. The CCO (or designee) will update any previously submitted FCOI Reports made to external agencies or funding sources (e.g., primary Award Recipients), specifically addressing the identified noncompliance, actions to be taken to Manage the FCOI going forward, and if any bias was identified complete a Mitigation Report. (Refer to Section VIII. for reporting requirements.)

VIII. Report FCOIs to the Public Health Service

A. Prior to the expenditure of any funds under a PHS-funded Research project, the CCO (or designee) shall review all Investigator disclosures and either (1) notify the EIRH Grants Office that no FCOI exists or (2) if an FCOI exists, provide an FCOI Report of the Investigator and Subrecipient Investigator FCOIs including applicable management plans to the PHS Awarding Component. If the identified FCOI(s) has (have) been eliminated prior to the expenditure of PHS-Awarded funds, no report will be provided to the PHS Awarding Component.

B. Within 60 days of disclosure, the CCO will provide a FCOI Report to the PHS Awarding Component for any newly identified FCOI during an ongoing PHS-funded Research project, including the applicable management plan.

C. If a FCOI is discovered which has not been disclosed, identified, or Managed in a compliant and timely manner (i.e., noncompliance with this Policy), the CCO (or designee) shall complete a retrospective review (as described in Section VII. of this Policy) and file a report to the PHS Awarding Component within sixty (60) days of identifying the FCOI. See the Summary of FCOI Noncompliance and FCOI Reporting chart for reference.

1. If any bias is identified, the CCO (or designee) will promptly submit a Mitigation Report. If the FCOI was previously reported to the NIH, the Mitigation Report is submitted as a “Revised FCOI Report.” The Mitigation Report must include, at a minimum, the key elements documented in the retrospective review (outlined above) and a description of the impact of the bias on the Research project and the plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., the impact on the Research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the Research project is salvageable). Thereafter, Essentia Health will submit FCOI reports annually.

D. When a FCOI is disclosed for ongoing PHS-funded Research, including extensions with or without funding, the CCO (or designee) shall provide an annual FCOI Report to the PHS Awarding Component that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded Research project. The submission of the annual FCOI Report shall be completed at the same time as the annual progress report or multi-year progress report submitted by EIRH or other Essentia Health Entity to PHS.

E. For grants and cooperative agreements, COI reports submitted to the NIH agreements will be submitted to the NIH via the eRA Commons FCOI Module: Financial Conflict of Interest (FCOI) | eRA (nih.gov) and FCOI Module User Guide Financial Conflict of Interest User Guide (nih.gov). As a subrecipient of a grant or cooperative agreement, Essentia Health will submit FOCI report information to the prime awardee.

1. See the Required FCOI Reports to be Provided to NIH Through eRA Commons FCOI Module chart for reference.

F. For Research contracts, the FCOI Reports will be submitted to the NIH Contracting Officer. As subrecipient of a Research contract, Essentia Health will submit the FCOI Report information to the prime awardee.

IX. Ensure Public Accessibility Requirements

A. Prior to the expenditure of any PHS funding for a Research project, Essentia Health shall ensure public accessibility of information if a FCOI is identified and held by Senior/Key Personnel (grants and cooperative agreements) or Key Personnel (Research contracts). Requests for information must be submitted in writing to the Organizational Integrity & Compliance department and must specify the Investigator’s name and the title of the Research project. Essentia Health will respond to written requests within five (5) working days. Information provided will include:

1. The Investigator’s name, title and role in the specified Research project;

2. The name of the Entity in which the significant financial interest is held;

3. The nature of the Financial Interest (e.g., honorarium, travel reimbursement); and

4. The approximate dollar value or range of the significant financial interest, 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.

X. Maintenance of Records

A. Essentia Health will maintain all FCOI-related records relating to Investigator disclosures of Financial Interests and the Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of a FCOI), and all actions under the Institution's Policy or retrospective review, if applicable:

1. For at least three (3) years from the date of final expenditures report (Final Federal Financial Report) is submitted (for grants and cooperative agreements), or

2. From the date of the final payment (Research contracts), or

3. Where applicable, other dates specified in 45 CFR 75.361 (for grants and cooperative agreements) and 48 CFR part 4, subpart 4.7 (for Research contracts).

Procedure:

I. N/A

Attachments:

I. N/A

Associated Form Numbers:

I. N/A

Standard Work-Related Documents:

I. For a complete listing of all Essentia/Market Affiliates, see SW-EH-16141

References:

EHADM3005: Conflict of Interest Program

42 CFR 50 Subpart F

45 CFR 94

Retired Policy #: EHA3009; Mercy 5510.48; 5510.83