Calla Health Financial Conflict of Interest Policy

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Calla Health is committed to providing its employees with an open and constructive working environment in which to conduct good research and product development. Conflicts of interest arise when an employee’s actions or interests are divided between the business and a competitor or study patient, when there is the possibility of personal gain or when the employee’s interests conflict with the best interests of the company. Employees are encouraged to avoid potential conflicts of interest. If an employee is unsure whether their actions or relationships may put them in a potential conflict of interest, that employee is strongly encouraged to speak with a supervisor or the Board of Directors. Issues pertaining to conflicts of interest will be reviewed by the Board of Directors for Calla Health. Calla Health encourages its employees to maintain relationships with the FDA, universities, hospitals and experts in the field. Calla Health’s conflict of interest policy is as follows:

“Calla Health requires disclosure of any actual or perceived conflict of interest in order to protect the integrity of the company and its employees. 42 CFR 50.603 It is the responsibility of every employee to discuss with his or her supervisor or Human Resources representative and/or department head any activity that might result in a conflict of interest or conflict of commitment before participating in that activity. The employee will refrain from participation in the activity until it is determined that neither a conflict of interest nor commitment exists. Resolutions may include, for example, ceasing the activity, changing job duties, or changing hours or salary until the questionable activity is confirmed as non-compromising. All disclosures and their resolutions shall be documented and copies of the documentation will remain in the staff member’s department personnel file.”

Calla Health requires a mandatory consultation with an Executive Officer and the President if an employee “has a financial interest in a business, or has a right to receive, control or benefit from a business, under circumstances that significantly link the fortunes of the business to the member’s research.” Disclosures must be submitted at least annually and within 30 days of discovering or acquiring a new financial conflict of interest. The Conflicts of Interest Policy deems it “advisable to couple the formal presentation of research results with disclosure of the nature of the member’s interest.” Further, the policy states that “an employee may not participate in research involving technology that is owned by or contractually obligated to a business in which the employee has a financial interest, or with which the employee has a consulting relationship, unless the participation is approved by an Executive Officer and the President.” An employee is a “Participant” when “they are in a position to influence the study’s results or have privileged information as to its outcome.” They are not Participants “if they provide primarily technical support or they serve in a purely advisory capacity, such that they have no control over the collection or analysis of data, or if they lack direct access to trial participants.”

All Calla Health employees must comply with Federal regulations and complete Financial Conflict of Interest training prior to engaging in research related to PHS/NIH funded-grant 42 CFR 50.604(b). Training must be completed at least every four years. Training must be completed immediately, if Calla Health revises its FCOI policy that affects employees, an employ is new to Calla Health, or if an employee is not in compliance with the policy or management plan.

A Significant Financial Interest (SFI) is defined as follows:

• A financial interest consisting of one or more of the following interests of the employee (and those of the employee’s spouse and dependent children) that reasonably appears to be related to the employee’s institutional responsibilities:
  • 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;
  • 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 Employee (or the Employee’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
• Employees also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the employee and not reimbursed to the employee 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 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 institutional official(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.
• 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 employee if the employee 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 employee, 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 employee 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; or 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.

Each employee is required to disclose Significant Financial Interests (SFIs) (see FAQs D.8. and E.26) (and those of the employee’s spouse and dependent children) related to the employee’s institutional responsibilities that meet or exceed the regulatory definition of SFI:

• No later than at the time of application for PHS/NIH-funded research (see FAQ D.35)
• At least annually during the period of the award
• Within thirty (30) days of discovering or acquiring a new SFI

The Chief Executive Officer (CEO) is designated to solicit and review disclosures of SFIs of the employee (and those of the employee’s spouse and dependent children) related to an employee’s institutional responsibilities for a determination of FCOI. The CEO with the Board of Directors will:

• Review all employee SFI disclosures
• Determine if any SFIs relate to PHS/NIH-funded research
• Determine if an FCOI exists (e.g., the SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research)
• Develop and implement a management plan to manage the FCOI(s)

Calla Health will send initial, annual (i.e., ongoing) and revised FCOI reports, including all required information defined in the regulation and/or NIH’s FAQ H.5, to the NIH via the eRA Commons FCOI Module for the Institution and its subrecipients, if applicable, as required by the regulation and as stated below:

• Prior to the expenditure of funds
• Within sixty (60) days of identification for an employee who is newly participating in the project
• Within sixty (60) days for new, or newly identified, FCOIs for existing employees. At least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
• After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.

Calla Health will:

• Notify NIH promptly if bias is found with the design, conduct or reporting of PHS/NIH- funded research and include the requirement to submit a Mitigation Report to explain what action(s) have been or will be taken to mitigate the effects of the bias in accordance with the regulation. The policy and/or procedures includes all reporting elements (e.g., entity name, name of the employee with the FCOI, nature of SFI(s), value of the SFI(s), etc.) as required by the regulation.

• Notify NIH promptly if an employee fails to comply with the Institution’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research.
• Notify NIH promptly and take corrective action for noncompliance with the Institution’s policy or the management plan.
• Maintain all FCOI-related records relating to all employee 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 financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable,:
  • For at least three (3) years from the date the final expenditures report is submitted to the PHS (NIH).
  • Or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.
• Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure employee compliance (e.g., letters of reprimand, restriction on the use of funds, etc.).
• Complete a retrospective review (see FAQs in Section I) 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:
  • Failure by the employee to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest;
  • Failure by the Institution to review or manage such a financial conflict of interest;
  • Failure by the employee to comply with the financial conflict of interest management plan;
• Document the retrospective review which shall include at a minimum the following key elements:
  • Project Number
  • Project Title
  • PD/PI or contact PD/PI if multiple PD/PI model is used;
  • Name of the employee with the FCOI;
  • Name of the entity with which the employee has an FCOI;
  • Reasons for the retrospective review;
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed);
  • Findings of the review; and
  • Conclusions of the review
• Ensure that in any case in which the Department of Health and Human Services determines that a PHS/NIH-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an employee with an FCOI that was not managed or reported by the Institution as required by the regulation, the Institution shall require the employee involved to:
• Disclose the FCOI in each public presentation of the results of the research, and
• To request an addendum to previously published presentations.
• Address subrecipient requirements (See FAQ K.1).
• Where applicable, establish, via a written agreement, whether the subrecipient will follow the FCOI policy of the awardee Institution or the FCOI policy of the subrecipient.
  • If applicable, obtain a certification from the subrecipient that its FCOI policy complies with the regulation.
  • If applicable, include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Employees in a time frame that allows the awardee Institution to report identified FCOIs to the NIH as required by the regulation.
  • Alternatively, if applicable, include in the written agreement a requirement to solicit and review subrecipient Employee disclosures that enable the awardee Institution to identify, manage and report identified FCOIs to the NIH.

• Make the Institution’s FCOI policy publicly accessible:
  • Post the FCOI policy on the Institution’s public Web site
• Make available information concerning identified FCOIs held by senior/key personnel (as defined by the regulation, not the NIH Grants Policy Statement), publicly accessible prior to the expenditure of funds. See FAQs in Section G.1. The publicly accessible information will:
  • Include the minimum elements as provided in the regulation
  • Be posted on a Public Website or made available within five (5) business days of a written request (Determine which option will apply).
  • Be updated, at least annually (Web site only but any response to a written request should include the updated information)
  • Be updated, within sixty (60) days of a newly identified FCOI (Web site only but any response to a written request should include the updated information)
  • Remain available for three (3) years from the date the information was most recently updated.

Failure to comply with Calla Health Financial Conflict of Interest Policy may result in suspension or ultimately termination. Calla Health does not condone illegal or unethical activities.

CALLA HEALTH FOUNDATION

701 W. Main Street, Suite 410 Chesterfield  Building Durham, NC 27701

CALLA HEALTH SIGNIFICANT FINANCIAL INTEREST (SFI) DISCLOSURE FORM

The following is a list of all affiliations I (employee name) hold with other Boards, Corporations, Organizations and Employers in addition to Calla Health. Disclosure is required for all financial interests received from a foreign institution of higher education or the government of another country.

The following is a list of intellectual property rights and interests (e.g., patents, copyrights), I (employee name) have outside of Calla Health greater than $5,000

1.

2.

3.

By signing this agreement, I agree as an employee of Calla Health, to adhere to Calla Health Conflict of Interest Policy. I agree to avoid potential conflicts of interest. If a conflict of interest arises, I will disclose all relevant information regarding the conflict of interest to management or the Board of Directors of Calla Health. I acknowledge that as an employee of Calla Health I should avoid illegal and unethical activities.

Employee Signature:

Employee Name (please print):  

Witness Signature:

Witness Name (please print):