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Primary Author: Chief Compliance OfficerPolicy #: EHA3009Revision Date: 8/14/2018
I. To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from an Investigator financial conflict of interest.
II. To meet the regulatory requirements of 42 CFR Part 50 and 45 CFR Part 94 for Public Health Service (PHS) funded research.
I. Affiliate means entities owned or controlled by Essentia Health. For the purposes of this definition, “controlled” shall mean having power, directly or indirectly (through one or more intermediaries), to direct or cause the direction of the management and policies of an entity, whether through membership interest, ownership of stock, or acting as general partner thereof.
A. Direct subsidiary means an entity whose sole member is Essentia Health or for which Essentia health has the power to appoint/remove at least 80% of the governing body.B. Indirect subsidiary means an entity that is a wholly-owned subsidiary of an Essentia Health direct subsidiary or any of its wholly owned subsidiaries.C. An entity is wholly-owned by another entity if such other entity is the first entity’s sole member or has the power to appoint/remove at least 80% of the first entity’s governing body.
II. 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 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).
III. Family member means an individual who is related by blood, marriage/domestic relationship, or adoption.
IV. 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 institutional official to be a high-level official who has the authority to represent the institution named in the FWA.
V. Conflict of Interest means a situation in which an Investigator’s and his or her family members’ financial, professional, or other personal considerations may directly or indirectly affect, or appear to affect, the Investigator’s professional judgment in performing an Essentia Health-related duty or responsibility. A Conflict of Interest may be actual, apparent, or potential.
A. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. It may include, but is not limited to the following: (1) owning stock, holding debt, having any ownership interest in any entity or organization currently or potentially dealing with Essentia Health or its affiliate(s); (2) receiving compensation/remuneration of any kind from any person, entity, or organization which are related to a current or potential transaction involving Essentia Health or its affiliate(s); and (3) using Essentia Health or an affiliate’s time, personnel, equipment, supplies, or good will for competitive or personal activities carried on for financial gain.
B. Financial Conflict of Interest (FCOI) means a financial interest that could directly and significantly affect the design, conduct, or reporting of research.
VI. 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).
VII. PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50 and 45 CFR Part 94.
VIII. Subrecipient means a third-party organization that receives funding from a primary recipient or another subrecipient to collaborate in carrying out externally funded research or a program. May include subcontractors, subawardees, and cooperative/consortium members.
In accordance with EHA3005: “Conflict of Interest” and in addition to the requirements of EHA3008: “Conflicts of Interest—Employees and Contracted Medical Directors”:
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 EHA3005: Conflicts of Interest for additional information.] Each individual Investigator must disclose to Essentia Health any interest or situation that conflicts, may conflict, or appears to conflict with, Essentia Health’s interests, including the integrity of human subjects research activities and use of external research/grant funds.
B. When a research project is submitted for initial Institutional Review Board (“IRB”) approval or an application is submitted for external funding of research from any source, IRB or Essentia Institute of Rural Health (“EIRH”) staff will notify the Chief Compliance Officer (or designee). The Chief Compliance Officer (or designee) will review the funding source to determine if and what additional disclosures or information may be required from Investigators.
C. Investigators are required to disclose all financial interests and those of the Investigator’s family members. An Investigator’s complete disclosure of all relevant information is critical. Essentia Health will rely on the Investigator’s disclosure to make reasonable efforts to determine an Investigator’s potential conflict of interest.
D. Within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest, a potential conflict, or a change to any information that the Investigator previously reported, an Investigator must update his or her disclosure.
E. The review, analysis, and management of disclosures are the primary responsibility of the Chief Compliance Officer as outlined in the Procedure section below.
F. 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 actual, potential, or perceived conflict of interest as required by this policy, the Chief Compliance Officer 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.
Under this policy, potential financial conflicts of interest in research include, but are not limited to, the following as they relate to a specific research project, sponsor, or other related organization, company, or individual:
A. An arrangement between Essentia Health, the Investigator, or a company in which the Investigator has an interest that involves compensation, business courtesies/gifts, a transfer of property, or a right to use property, including, but not limited to:
1. Employment;2. Holding managerial positions or serving on advisory boards;3. Receiving honorarium for consulting, advising, or participating on speakers’ bureaus;4. Having a proprietary interest, e.g. patents, copyrights, royalties;5. Having an equity interest such as stocks, stock options, or ownership interest;6. Receiving any gifts, courtesies, or travel expenses paid on their behalf;
B. An Investigator’s financial interest in agencies, organizations, and associations that have the potential to influence or affect the applicable research project;C. A loan between the Investigator and a sponsor of a research project;D. A grant scholarship or other financial assistance between the Investigator and a sponsor of a research project; andE. An Investigator’s Family member or business relationship interest in any of the above.
The items described above are only examples of situations or relationships in which a conflict may arise. The examples are not meant to be exhaustive. Conflicts may arise in other situations or through other relationships. It is expected that Investigators will recognize such situations and relations by analogy. The Chief Compliance Officer, Chief Legal Officer, and their respective teams are available to discuss particular scenarios with Investigators when questions arise.
The mere disclosure of an interest or relationship does not necessarily mean that a conflict exists or that the conflict, if it exists, is material enough to be of practical importance, or if material, that upon full disclosure of all relevant facts and circumstances it is necessarily adverse to applicable regulatory requirements, research-related activities, or the interests of Essentia Health or its affiliate(s).
However, it is the requirement for all PHS-funded research and the policy of Essentia Health that the existence of any of these interests or relationships shall be disclosed before the IRB reviews any research or the researcher applies for or expends any research funding. It shall be the continuing responsibility of the Investigators to scrutinize their transactions, outside business interests, and relationships for potential conflicts and to immediately make such disclosures as described under Section I.
A. Each Investigator’s disclosure and other situations where a potential conflict is identified will be evaluated by the Chief Compliance Officer (or designee) to determine if an FCOI exists. This determination will be made according to the Procedures described below.
B. When the Chief Compliance Officer (or designee) and the Institutional Official (IO) consider an Investigator’s disclosure to be an FCOI, they will develop and implement a management plan to specify the actions that have been and shall be taken to manage the specific FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to the following:
1. Public disclosure of the FCOI (e.g., when presenting or publishing the research or addendum to previously published presentations);2. For research projects involving human subjects research, disclosure of the FCOI directly to the participants;3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;4. Modification of the research project;5. Change of personnel or personnel responsibilities or disqualification of personnel from participation in all or a portion of the research;6. Reduction or elimination of the financial interests (e.g., sale of an equity interest);7. Severance of relationships that create financial conflicts; or8. Withdrawal of IRB approval for a specific research project.
C. The review and determination of whether an FCOI exists, and development of a management plan, when applicable, shall be completed within sixty (60) days of the receipt of disclosure or discovery of the FCOI.
D. If an FCOI is not disclosed, identified, or managed in a compliant and timely manner, the Chief Compliance Officer will designate the appropriate parties to complete a documented retrospective review of any affected studies within 120 days of the discovery of noncompliance.
1. The Chief Compliance Officer 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.2. The retrospective review shall include the research project and the Investigator’s financial interests and actions to determine whether the study was biased in the design, conduct, or reporting of the research during the time of noncompliance. The Chief Compliance Officer (or designee) will document the retrospective review to include, but not limited to, the following elements:
a. Reasons for the retrospective review;b. Research project title, number, and Principal Investigator;c. Name of Investigator with the FCOI;d. Method for completing the review;e. Nature and value of the financial interest (e.g., equity, travel reimbursement, honorarium);f. Findings and conclusion of the review (including an analysis of whether the research project is salvageable); andg. Description of the key elements of the management plan including the following:
i. How the management plan is designed to safeguard objectivity in the research;ii. Confirmation of the Investigator’s agreement to the management plan;iii. How the management plan will be monitored to ensure Investigator compliance; andiv. Other information as needed.
3. The Chief Compliance Officer (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 non-compliance, actions to be taken to manage the FCOI going forward, and if any bias was identified. (Refer to Section VI. for reporting requirements.)
4. The Chief Compliance Officer (or designee) in collaboration with the Institutional Official will monitor management plans 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 and will be defined as part of the respective plan.
A. Subrecipients to Essentia Health
1. When Essentia Health is a primary/subrecipient and engages another subrecipient to assist in the funded research/program, 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.2. 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 and 45 CFR Part 94, andb. the agreement shall specify time period(s) for the subrecipient to report all identified FCOIs to Essentia Health in a timely manner.
3. 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 and 45 CFR Part 94, the subrecipient Investigators shall report disclosures of financial interests relating to the Investigator’s work as defined in the agreement to Essentia Health within a timely manner.4. The timing of the subrecipient’s reporting shall allow Essentia Health sufficient time to comply with reporting obligations as stated above in Section IV.5. The Chief Compliance Officer (or designee) will be responsible for providing FCOI reports to any applicable external agencies or primary recipients regarding all subrecipient Investigator’s FCOIs 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 Policy or that of the other party’s will apply to Essentia Health’s Investigators.
2. If a determination is made that the FCOI Policy of the other party will be followed, Essentia Health shall abide by the policy and contract requirements.
3. If a determination is made that the EH FCOI Policy will be followed, the Chief Compliance Officer (or designee) will be responsible for providing FCOI reports to the prime/subrecipient.
A. Prior to the expenditure of any funds under a PHS-funded research project, the Chief Compliance Officer or designee shall either (1) notify the EIRH Grants Office that no FCOI exists or (2) if an FCOI exists, provide an FCOI report for the Investigator’s and subrecipient’s Investigator’s FCOIs to include the applicable management plan to the PHS Awarding Component. If the identified FCOI has 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 Chief Compliance Officer will provide an 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 an FCOI is not disclosed, identified, or managed in a compliant and timely manner, the Chief Compliance Officer (or designee) shall complete a retrospective review and file a report to the PHS Awarding Component within 120 days of the discovery of noncompliance. This review will be completed as indicated in Section IV. D. of this Policy.
D. When an FCOI is disclosed for ongoing PHS-funded research, including extensions with or without funding, the Chief Compliance Officer 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.
A. Each Investigator who is new to Essentia Health is required to initially complete FCOI training prior to submitting a research project for IRB approval or applying for research funding for the first time.
B. At a minimum, Investigator(s) will complete the FCOI training every three (3) years and immediately if Essentia Health significantly revises this Policy or an Investigator is not in compliance with the Policy or applicable management plan.
C. 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 when deemed necessary.
A. Prior to the expenditure of any PHS funding for a research project, Essentia Health shall ensure public accessibility of information concerning any related FCOIs that have been identified and that are still held by the Investigator. Requests for information must be submitted in writing to the Organizational Integrity & Compliance office and must specify the Investigator’s name and the title of the research project. Essentia Health will respond to written requests within five working days. Information provided will include:
1. Investigator’s name, title and role with respect to the involved research project;
2. Name of the entity in which the financial interest is held;
3. Nature of the financial interest (e.g., honorarium, travel reimbursement); and
4. Approximate dollar value or range of the 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.
The website will include access to this Policy.
EHA3005: Conflict of Interest ProgramEHA3008: Conflicts of Interest—Employees and Contracted Medical Directors 42 CFR 50.601-50.60745 CFR 94.1-94.621 CFR 54 FDA Financial Disclosure by Clinical Investigators
***Previous Revision Dates: 2/11/2016
*Reviewed by Administrative Committee on 7/2/2018
©This P&P is copyright 2012 by Essentia Health. It is for internal use only and is not be shared outside of Essentia Health Facilities without permission from a member of the Essentia Health Leadership Team.
**Scope: Unless otherwise indicated above, this Policy, Standard Work /Procedure, or Protocol (collectively “P&P”) applies to Essentia Health and all Essentia Health Entities and their subsidiaries including, but not limited to, the following:
Brainerd Medical Center, dba Essentia Health Brainerd Specialty Clinic
St. Joseph’s Medical Center, dba Essentia Health St. Joseph’s Medical Center
Deer River Healthcare Center, Inc., dba Essentia Health Deer River
Essentia Health Virginia, LLC, dba Essentia Health Virginia
Northern Pines Medical Center, dba Essentia Health Northern Pines
Pine Medical Center, dba Essentia Health Sandstone
SMDC Medical Center, dba Essentia Health Duluth
St. Mary’s Hospital of Superior, dba Essentia Health St. Mary’s Hospital-Superior
St. Mary’s Medical Center, dba Essentia Health St. Mary’s Medical Center
Bridges Medical Center, dba Essentia Health Ada
First Care Medical Services, dba Essentia Health Fosston
Graceville Health Center, dba Essentia Health Holy Trinity Hospital
Innovis Health, LLC, dba Essentia Health Fargo
St. Mary’s Regional Health Center, dba Essentia Health St. Mary’s-Detroit Lakes
Clearwater Valley Hospital and Clinics
St. Mary’s Hospital
To learn more about research financial conflict interest, contact Essentia Health's Organizational Integrity & Compliance Department. Call 218-786-1172.
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