Conflicts of Interest Policy
Effective Date 12/17/2020
I. Purpose: To set forth the process pursuant to which Patient Advocate Foundation (“PAF”) ensure that officers, employees and, where applicable, subcontractors and agents disclose interests that could conflict with, or even appear to conflict with, the interests of PAF and how PAF manages and addresses such actual or potential conflicts of interest. This conflict of interest policy also sets forth the processes PAF officers and employees involved in conducting Research will use to disclose potential financial conflicts of interest related to Research conducted by PAF as described in more detail below. There is a separate conflict of interest policy and procedure for members of the PAF Board of Directors.
II. Definitions:
Conflict of Interest: A professional or personal interest, whether direct or indirect through an Immediate Family Member, which may compete with services provided to or on behalf of PAF or PAF’s interests. A Conflict of Interest can also arise when an individual’s position with PAF presents an opportunity for personal gain apart from the normal benefits of compensation by PAF.
PAF Representatives: Employees and officers of PAF. PAF Representatives also include subcontractors or agents when deemed appropriate by PAF senior management in consultation with the Compliance Counsel.
Donor: Any person or entity that donates to PAF, whether to a disease state fund operated under the Co-Pay Relief Program or otherwise.
Immediate Family Member: A spouse, child, sibling, parent, stepchild, stepparent, as well as a mother-, father-, son-, daughter-, brother-, or sister-in-law, and any other person living with you, except tenants and household employees.
Financial Conflict of Interest (“FCOI”): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of Public Health Services (“PHS”)–funded research or research that otherwise follows the conflict of interest reporting requirements set forth in 42 C.F.R. Part 50, Subpart F of the Public Health Services Regulations.
Financial interest: Anything of monetary value, whether or not the value is readily ascertainable.
PAF responsibilities: An investigator's professional responsibilities on behalf of PAF, which may include 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.
Investigator: 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 PHS (or other entities adopting the PHS regulations found in 42 C.F.R. Part 50, Subpart F), or proposed for such funding, which may include, for example, collaborators or consultants. The term “Investigator” will include only those PAF Representatives who are listed as research team members in grant applications or approved as team members on projects that receive grant funding.
Research: A systemic 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). Research includes any such activity for which research funding is available from the PHS or another source which follows PHS conflict of interest regulations set forth in 42 C.F.R. Part 50, Subpart F.
Significant Financial Interest: 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 PAF responsibilities:
(i) With regard to any remuneration received from a publicly traded entity, a significant financial interest exists if the value of the remuneration received by the Investigator 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. 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;
(ii) With regard to remuneration from any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received by the Investigator 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
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
Significant Financial Interests may also arise in connection with travel reimbursement received by Investigators.
The term significant financial interest does not include the following types of financial interests: (a) salary, royalties, or other remuneration paid by PAF to the Investigator if the Investigator is currently a PAF employee; (b) 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; (c) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or (d) income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
III. Policy: Each PAF Representative has a duty to avoid interests, both real and perceived, that may conflict with their employment by PAF and/or provision of services to PAF. Even if there is no evidence of improper actions, a Conflict of Interest can create an appearance of impropriety that can undermine confidence in the officer’s, employee’s or, where applicable, subcontractor’s or agent’s ability to act properly in his/her position or in the provision of services to PAF. Below are some common examples of potential Conflict of Interests:
• Having, or an Immediate Family Member, having a financial relationship with a Donor whether employment, investment, consulting or contractual (other than non-material stock interests in publicly-held companies);
• Having, or an Immediate Family Member having, a financial interest in a PAF vendor, potential vendor, customer or competitor (other than non-material stock interests in publicly-held companies);
• A PAF employee holding a second job or consulting arrangement that affects the employee’s job performance or conflicts with the employee’s obligations to PAF;
• Serving as a director on the board of a competitor company;
• Use of PAF proprietary information, trade secrets, and Company assets in connection with non-PAF activities or for personal gain or advantage;
• A PAF employee’s spouse being employed by a PAF competitor;
• Acquiring rights to property that PAF is interested in acquiring;
• Receiving, or an Immediate Family Member receiving, gifts and meals from a Company vendor, potential vendor, customer or competitor that are not in accordance with Company policy;
• Offering gifts and meals to a PAF vendor that are not in accordance with Company policy; and
• Taking part in a PAF business decision involving a company where your spouse or Immediate Family Member serves as an officer.
IV. Procedures:
Disclosure and Review of Conflicts of Interest
1. All PAF Representatives must disclose any actual or potential Conflicts of Interest to PAF in a timely manner. Conflicts of Interest may be reported to an employee’s supervisor, Talent Management or the Compliance Coordinator or Compliance Counsel.
2. Upon hire and on an annual basis, all PAF Representatives must review this Conflict of Interest Policy and Procedure and either certify that they have no Conflicts of Interest or disclose any potential conflicts to PAF.
3. Upon hire, the Talent Management department distributes this Conflict of Interest Policy and Procedure to newly hired employees. In addition, on an annual basis, the Talent Management department distributes this Conflict of Interest Policy and Procedure to all employees. All employees are required to complete the Conflict of Interest Disclosure Form, which is attached hereto, promptly following receipt. If no conflicts are revealed, the Disclosure Form is retained by the Talent Management department in the respective employee’s personnel file. If potential conflicts are revealed, the Disclosure Form is forwarded to the Compliance Counsel for review.
4. In the case of subcontractors or agents, PAF senior management in consultation with the Compliance Counsel will determine at the time of contracting with a new agent or subcontractor whether the Conflict of Interest Policy is applicable to the given subcontractor or agent based on the subcontractor or agent’s relationship with PAF. If PAF senior management concludes that the Conflict of Interest Policy is applicable, PAF will distribute the Conflicts of Interest Policy to the agent or subcontractor following contracting with the agent or subcontractor and annually thereafter. Corresponding subcontractors or agents are required to complete the Conflict of Interest Disclosure Form- Subcontractor or Agent, attached hereto for reference. Upon receipt of the completed Conflict of Interest Disclosure Form, if no potential Conflicts of Interest are revealed, the Disclosure Form is retained by PAF with subcontractor’s or agent’s contract file. If potential Conflicts of Interest are revealed, the Compliance Counsel will review, consider and manage/resolve the potential Conflicts of Interest through consultation with the Compliance Committee.
5. Compliance Counsel, in consultation with the Compliance Committee, is charged with resolving or managing Conflicts of Interest. Conflicts of Interest may be resolved in different ways, including, for instance, in the case of a gift, determining that the individual may accept or must reject the gift or, in the case of an association with an entity outside of PAF, determining that the individual may be restricted from certain activities involving the association or determining that PAF should not enter into a business relationship with the entity. The resolution of a Conflict of Interest is communicated to the PAF Representative in writing and the correspondence is maintained along with the applicable Disclosure Form in the locations specified above.
6. All Disclosure Forms and related documentation addressing implementation of the Conflict of Interest Policy and this Conflict of Interest Disclosure Procedure shall be maintained by PAF in accordance with its Record Retention Policy.
V. Research Policy:
Each Investigator has a duty to disclose Significant Financial Interests that may conflict with or appear to conflict with their work on Research projects. Even if there is no evidence of improper actions, a Significant Financial Interest can create an appearance of impropriety. Where the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Research, the Significant Financial Interest constitutes a FCOI, which must be managed and reported by PAF in accordance with the procedures described below. Each Investigator has a duty to work with PAF to address and manage any identified FCOIs to help ensure that all Research conducted by PAF is done in an ethical manner and to help ensure the Research conducted by PAF is free from bias.
VI. Research Procedure:
For purposes of Sections V and VI the term “manage” means taking action 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.
1. Disclosure of Significant Financial Interests:
Each Investigator will disclose to the Compliance Coordinator the Investigator’s Significant Financial Interests no later than the time a Research grant application is submitted.
Investigators who are involved in Research will also submit updated disclosures of their Significant Financial Interests to the Compliance Coordinator on an annual basis during the period of any Research award. The annual disclosure must include: (a) any updated information regarding previously disclosed Significant Financial Interests; and (b) any relevant information that was not disclosed in the Investigator’s initial or subsequent disclosures regarding Significant Financial Interests.
Each Investigator must submit an updated disclosure to the Compliance Coordinator within 30 days of discovering or acquiring a new Significant Financial Interest.
Disclosure of Travel Reimbursement. Because travel reimbursement may constitute a significant financial interest, Investigators also must disclose the occurrence of 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 PAF responsibilities, in accordance with this Section VI.1. Investigators are not required to disclose travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. An Investigator’s disclosure of reimbursed or sponsored travel must include: (a) the purpose of the trip; (b) the identity of the sponsor/organizer financially responsible for the trip; (c) the destination; and (d) the duration of the travel. Additionally, the Compliance Counsel or Compliance Committee may seek additional information, as necessary, to determine whether the travel constitutes an FCOI with the Research.
2. Assessing Significant Financial Interests. PAF’s Compliance Coordinator is responsible for soliciting conflict of interest disclosure forms from Investigators in order to assess any Significant Financial Interests. Reported Significant Financial Interests will be assessed in accordance with the procedures described in Sections IV and VI of this Policy. The Compliance Counsel and Compliance Committee will be responsible for assessing Significant Financial Interests, and managing and reporting any FCOIs. To determine whether a FCOI exists, the Compliance Counsel and Compliance Committee will consider whether the Investigator’s Significant Financial Interest could be affected by the Research or whether the Investigator’s Significant Financial Interest is in an entity that could be affected by the Research. A Significant Financial Interest will constitute a FCOI if the Compliance Counsel and Compliance Committee reasonable determine that the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Research.
Significant Financial Interests disclosed as part of the Research application process will be assessed and any FCOIs identified will be managed in accordance with this policy prior to the expenditure of any Research funds by PAF. Significant Financial Interests disclosed in subsequent disclosures, including annual disclosures, will, within 60 days of the disclosure, be assessed and any FCOIs identified will be managed in accordance with this policy.
The Compliance Counsel and Compliance Committee may consult with the Investigator in order to determine whether the Significant Financial Interest constitutes a FCOI.
Disclosure forms and other documents related to the management of FCOIs will be retained as described in Section IV.6 of this policy.
3. Managing FCOIs. If the Compliance Counsel and Compliance Committee determine that a Significant Financial Interest constitutes a FCOI, they will develop and implement a management plan specifying the actions that have and will be taken to manage the FCOI. The management plan may include one or more of the following strategies for managing a FCOI:
• Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
• For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
• 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 (e.g., sale of an equity interest); or
• Severance of relationships that create financial conflicts.
All management plans will be monitored for compliance by PAF until the completion of the relevant Research.
PAF will ensure public accessibility to information regarding FCOIs by responding to any requests regarding information about FCOIs in writing within 5 business days. When disclosing FCOIs to the public, PAF will include, at a minimum: (a) the Investigator’s name, title, and role with the Research; (b) the name of the entity in which the Significant Financial Interest is held; (c) the nature of the Significant Financial Interest; and (d) the approximate dollar amount of the Significant Financial Interest.
4. Reporting of FCOIs. Prior to the expenditure of any PHS-funded Research funds by PAF, PAF will provide to the PHS Awarding Component a FCOI report identifying any Investigator’s Significant Financial Interest that PAF determines is a FCOI in accordance with this policy, including information regarding any management plan implemented to manage the FCOI. For any subsequently identified FCOIs, PAF will submit the required report within 60 days of identification of the FCOI. Additional details regarding information required to be submitted as part of the FCOI report can be found in 42 C.F.R. § 50.605(b)(3). PAF will provide annual updated reports to the PHS Awarding Component for any FCOIs identified as part of on-going PHS-funded Research for the duration of the Research grant.
5. Training. Each Investigator will complete training on this policy prior to engaging in Research and at least every four years, thereafter. Investigators will also complete training when any of the following circumstances apply: (a) PAF revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators; (b) upon hire by PAF as an Investigator; or (c) if PAF determines that an Investigator is not in compliance with the PAF’s conflict of interest policy or a conflict management plan.
6. Applicability to Sub-recipients. To the extent PAF conducts any Research through sub-recipients (contracts with another entity conduct some portion(s) of the Research), PAF will ensure that any sub-recipient and the associated investigators are required to abide by a conflict of interest policy at least as stringent as this policy that complies with the requirements found in 42 C.F.R. Part 50, Subpart F, and will include a contractual requirement in the agreement with the sub-recipient reflecting the same.
VII. Enforcement
1. All PAF Representatives are expected to abide by this Conflict of Interest Policy and Procedure. PAF employees are subject to disciplinary action, up to and including termination, for violating this Policy and Procedure and/or for failing to report a potential violation of this Policy and Procedure whether by the employee or another employee or individual.
2. PAF’s relationship with a subcontractor or agent that is subject to this Policy and Procedure may be terminated by PAF if the agent or subcontractor has violated by this Policy and Procedure.
VIII. Annual Review of this Conflict of Interest Policy and Procedure
1. The Compliance Counsel, in consultation with the Compliance Committee, will review this policy and procedure on an annual basis and update it if and as needed.
IX. References:
1. Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers
2. Federal Anti-Kickback Statute- 42 U.S.C. § 1320a-7b
3. Independent Charitable Patient Assistance Program Code of Ethics
4. Public Health Services Regulations, Promoting Objectivity in Research, 42 C.F.R. Part 50, Subpart F
X. Related Policies:
1. Conflict of Interest Policy and Procedure for PAF Board of Directors
3. Record Retention Policy
Conflict of Interest Disclosure Form- Director, Officer or Employee
1. I have received a copy of the PAF Conflict of Interest Policy and Procedure, and have read, understand, and agree to abide by the Conflict of Interest Policy and Procedure.
2. I understand my ongoing responsibility to report all actual or potential Conflicts of Interests to my supervisor, Talent Management and/or the Compliance Coordinator or Compliance Counsel. I understand that I could be subject to disciplinary action, up to and including termination, for violating the Conflict of Interest Policy and Procedure and/or for failing to report a potential violation of the Conflict of Interest Policy and Procedure whether by me or another employee or individual promptly to my supervisor, Talent Management or the Compliance Coordinator or Compliance Counsel.
3. I further report the following:
_____ I have no actual or potential Conflicts of Interest.
_____ I have the following relationships, transactions, positions or circumstances that could represent or create a potential Conflict of Interest between my obligations to PAF and my personal interests, financial or otherwise:
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4. I understand that my adherence to the Conflict of Interest Policy and Procedure is not a guarantee of my employment with PAF, the terms and conditions of which remain governed by the PAF Employee Handbook, of which I have received a copy.
5. I completed this Disclosure Form truthfully and to the best of my knowledge and ability.
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