Legacy Conflict of Interest Policy
A significant public trust has been placed in Legacy. As a result, it is imperative that Legacy and its employees avoid even the appearance of conflicts of interest as they carry out their responsibilities. Legacy has long had in place Conflict of Interest policies for its Board and employees, including annual disclosure requirements, to ensure that Legacy’s high standards are maintained. Legacy periodically reviews and updates this policy to assure that it incorporates best practices and complies with relevant requirements. The current policy reflects changes in requirements applying to recipients of Public Health Service (PHS) research funding that are effective in 2012.
Overview of Policy
This policy provides guidance on what activities might conflict or appear to conflict with the work of Legacy. It applies to all Legacy employees. However, based on external requirements, some additional rules including more stringent reporting thresholds, apply to research investigators that do not apply to other Legacy employees. These differences are explained in this policy. In addition, we have instituted separate disclosure forms for research investigators and other reporting employees in order to facilitate compliance. For the purposes of this policy, a research investigator is (1) 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 or proposed research or (2) any other Legacy employee who has reported effort on a research grant or contract at any time during the reporting period .
Senior staff (Directors and above) and all research investigators must make annual written disclosures of information bearing on conflicts and potential conflicts and update the disclosures as appropriate throughout the year. Employees who are below the Director level and who are not research investigators do not have to file annual disclosures but must report conflicts or potential conflicts if they arise. The policy recognizes that some, although not all, conflicts can be satisfactorily addressed by full disclosure and prior approval and sets out other options for managing and eliminating conflicts. The updated policy applies to actions taken on or after the date it is issued; actions taken before that date are covered by the previous policy.
Conflicts of Interest Rules for All Employees
A conflict of interest may arise when an employee or a member of his or her immediate family (spouse, domestic partner, and dependent children): (1) takes or proposes an action that could reasonably be expected to result in an adverse effect on Legacy’s integrity or financial position; (2) takes or proposes a Legacy-related action which could reasonably be expected to result in financial gain to the employee or his or her immediate family; or (3) takes or proposes an action that could reasonably be expected to result in financial gain, other than through a specific Legacy-related business relationship, to a Legacy contractor, consultant, grantee or other business associate or to their immediate family. These categories are not necessarily mutually exclusive and may overlap.
Examples of where a conflict could arise or appear to arise include, by way of example, situations where a Legacy employee and/or a member of his or her immediate family, individually or together:
- Owns stock or holds debt or other proprietary interests, other than in pooled investment funds such as mutual funds or retirement investments where they do not directly control the investment decisions, in an outside entity in an amount that exceeds the thresholds set out in the relevant disclosure forms, or if the financial interests of the entity could otherwise reasonably appear to be affected by Legacy activities including but not limited to sponsored research;
- Owns intellectual property rights (e.g., patents, copyrights) or royalties from such rights the value of which could reasonably appear to be affected by Legacy activities including but not limited to sponsored research;
- Accepts a gift or loan of more than $100 in value from any individual or organization with which Legacy has, or reasonably may be expected to have, a business relationship, except that employees may originate loans from financial institutions with which Legacy has business dealings provided such loans incorporate the same terms available to other qualified borrowers;
- Holds office, serves on the board or advisory board, or assumes any other official role in connection with another entity that has or might have a relationship with Legacy;
- Receives a salary or other payments for services (e.g. consulting fees, honoraria, paid authorship) from any entity other than Legacy that has or may reasonably have a relationship with Legacy (see Employee Handbook Section 3.19 regarding receipt of honoraria and consulting fees);
- Uses Legacy’s time, personnel, equipment, supplies or good will (name, reputation, etc.) for the benefit of a non-Legacy individual or entity, other than for Legacy-approved activities, programs and purposes.
Additional Conflict of Interest Rules for All Legacy Research Investigators
In addition to the above standards, a financial conflict interest (FCOI) will also arise for a research investigator if the investigator or his or her immediate family member has a significant financial interest (SFI) that is related to externally funded research and could directly and significantly affect the design, conduct, or reporting of the funded research. An SFI is related to the research if it could be affected by the research or is in an entity whose financial interest could be affected by the research. The specific financial interests that must be disclosed are set out in the Conflict of Interest Disclosure Form for Research Investigators.
Responsibilities of Legacy
- Legacy will comply with all governing requirements regarding conflicts of interest, including but not limited to the Public Health Service regulations at 42 CFR Part 50 Subpart F.
- The General Counsel is responsible for administering the Employee Conflict of Interest Policy including providing necessary training and support to employees. The General Counsel, or his or her designee, shall annually inform employees of their responsibilities under this policy, assure that conflict of interest disclosure forms from all covered employees are timely filed, review within 60 days all disclosure forms including disclosure forms filed when employees are first hired or updated during the disclosure year, and review disclosures made to Department Heads by employees not required to submit a conflict of interest disclosure form. In addition, the General Counsel, or his or designee, will assure that all research investigators are trained on the changes to Legacy’s policy.
- In the event of a disclosure made pursuant to ¶ 3 under Responsibilities of Employees (below), the Department Head receiving the disclosure shall promptly inform the General Counsel of the disclosure.
- If the General Counsel determines that a conflict or potential conflict of interest as defined in this policy may exist including of a subrecipient investigator, she or he will, in consultation with the appropriate executive(s), assure that appropriate action is taken to manage, reduce or eliminate the identified conflict or potential conflict including the development and monitoring of a management plan. In the case of an FCOI in a PHS-funded project, the management plan shall extend through the end of the project. Examples of actions to manage, reduce or eliminate the conflict include, but are not limited to:
- Public disclosure of the financial interests;
- Monitoring of research by independent reviewers, including the Schroeder Institute’s External Board of Scientific Advisors;
- Modification of the research plan;
- Disqualification from participation in all or a portion of the funded research;
- Reduction or elimination of the financial interest; or
- Severance of relationship(s) that create actual or potential conflicts.
- Legacy will take appropriate action consistent with this policy and applicable regulations if employees fail to comply with this conflict of interest policy or a management plan issued pursuant to it.
- The General Counsel will maintain records of all disclosures and actions taken with respect to each conflicting or potentially conflicting interest for at least three years or, in the case of sponsored research, three years from the date of submission of the final expenditures report to the research sponsor, whichever is later.
- Prior to spending any funds under a research award from the PHS, the General Counsel, or his or her designee, will review all disclosures from research investigators on the project, determine whether any FCOI’s exist and, if so, develop and implement a management plan. Also prior to spending any such funds and within 60 days of identification of an FCOI for a research investigator who is newly participating in the project or of a newly identified FCOI of a research investigator on the project, Legacy will report to PHS the existence of any FCOI related to such research and how the FCOI has been managed, reduced, or eliminated, in accordance with PHS regulations. Legacy will provide annual updates of reported FCOI’s as required in the regulations.
- Legacy will respond to written requests regarding identified FCOI’s of senior/key personnel within 5 days and otherwise as required under the regulations.
- In the event that a research investigator’s FCOI is not identified or managed as required under this policy, Legacy shall, within 120 days of the determination of non-compliance, complete a retrospective review per PHS regulations to determine whether any PHS-funded research conducted during the period of the noncompliance was biased in its design, conduct or reporting. As appropriate, Legacy shall update any previously submitted FCOI report and, if bias is found, promptly notify PHS, take corrective action and submit a mitigation report.
- When Legacy conducts PHS sponsored research through subgrantees, contractors, subcontractors or collaborators (collectively subrecipients), Legacy will take reasonable steps to ensure that any subrecipient investigator, as defined in the regulations, complies with 42 CFR Part 50 Subpart F. Legacy may require that the subrecipient’s investigators comply with the subrecipient’s financial conflict of interest policy if the subrecipient certifies that its policy complies with the relevant requirements. In such event, Legacy will require that the subrecipient provide reports to Legacy of identified financial conflicts of interest in a timeframe that allows Legacy to make timely reports to PHS. Alternatively, Legacy may require that the subrecipient’s investigators comply with Legacy’s conflict of interest policy and that the subrecipient submits investigator disclosures of SFI’s to Legacy in a timeframe that allows Legacy to make timely reports to PHS. In either event, Legacy will report to PHS the existence of any FCOIs by its subrecipients and how the conflict has been managed, reduced, or eliminated, in accordance with PHS regulations.
- Legacy will post this policy on its website, https://www.americanlegacy.org/.
Responsibility of Employees
- All Legacy employees at the Director level or above, and all research investigators regardless of personnel level, must complete the appropriate conflict of interest disclosure form at the time of their hire and annually thereafter. In the event such employee discovers or acquires (i.e. through marriage or purchase) a new reportable interest during the course of the reporting year, he or she must submit an updated disclosure within thirty days of such discovery or acquisition.
- Research investigators must comply with the conflict of interest rule located at 42 CFR Part 50 Subpart F and when first hired and thereafter annually complete the NIH tutorial on conflicts of interest and present a certification of completion to the General Counsel as part of the annual disclosure form.
- Employees not required to submit annual disclosure forms (i.e. employees below the Director level and who are not research investigators) must promptly report any conflicts or potential conflicts of interest to their Department Head.
- All Legacy employees shall cooperate fully with management in addressing any conflict or potential conflict, including providing all additional information as requested. Employees shall refrain from taking any action which could constitute an actual or perceived conflict until such action is approved as provided in this policy. Failure to comply with this policy may result in disciplinary action, including termination.
- In the event that a research investigator has failed to comply with this policy resulting in a bias in the design, conduct, or reporting of PHS-funded research, Legacy will promptly notify PHS and take appropriate corrective action including, as appropriate, disciplinary action.
1Research 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...and product development.” 42 CFR § 50.603.
2For the purpose of compliance with requirements regarding sub-recipients of PHS sponsored research, see discussion below, the regulatory definition of a research investigator shall apply.