PHS Financial Conflict of Interest Policy

Public Health Service Financial Conflict of Interest Training and Disclosure Requirements

This policy details how RAND identifies and addresses potential Financial Conflicts of Interest relating to research funded by the U.S. Department of Health and Human Services Public Health Service agencies or by the Centers for Medicare and Medicaid Services to ensure RAND’s research is free from bias or the appearance of bias. It applies to all RAND Associates who participate in research funded by the Public Health Service agencies or Centers for Medicare and Medicaid Services and/or hold certain management positions.

1. Definitions

1.1 Associate means all Regular and Term Employees, Adjunct or Affiliated Adjunct staff, Pardee RAND Graduate School students, and Sponsored Fellows.

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

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

1.4 Healthcare-Related Entities include any organization or entity (including both publicly traded and private companies) that provides healthcare-related products or services, including but not limited to:

  1. Healthcare providers, including hospitals and clinics
  2. Healthcare insurance companies
  3. Healthcare research or service organizations
  4. Health information technology companies
  5. Medical device and equipment manufacturers and distributors
  6. Medical technology companies
  7. Pharmaceutical companies
  8. Other organizations that could be impacted by healthcare-related research, including alcohol, tobacco, or food products companies
  9. Any other entity, publicly-traded or private, that could be materially affected by the conduct or results of PHS or CMS-funded Research.

1.5 Institutional Responsibilities means an Investigator’s professional responsibilities relating to seeking (by submission of proposals for the award of contracts or grants) or conducting CMS or PHS-funded Research, including but not limited to: research; peer review; editing, publication, and dissemination of research; service on the RAND Human Subjects Protection Committee; and relevant work performed in administrative or support functions including the Office of the General Counsel, the Office of External Affairs, the Office of the Chief Financial Officer, and the Office of Research Services and Operations.

1.6 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 research funded by PHS or CMS, or proposed for such funding, which may include, for example, collaborators or consultants. For purposes of this policy, the following individuals at RAND are considered Investigators when they are responsible for the design, conduct, or reporting of research funded by the PHS or CMS:

  1. All research professionals, regardless of title (including Adjunct and Affiliated Adjunct researchers)
  2. Research Assistants
  3. Project Associates
  4. Survey Research Group
  5. Peer reviewers
  6. Research Programmers
  7. Pardee RAND Graduate School students
  8. Communications Analysts
  9. Human Subjects Protection Committee members
  10. Key members of the administrative staff, including the Operations Group and other senior administrative staff; Office of External Affairs staff responsible for the editing, publication, or dissemination of RAND Research; and management and professional staff in the Office of the General Counsel, Office of the Chief Financial Officer, and the Office of Research Services and Operations

1.7 PHS means the Public Health Service of the United States Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health. The PHS includes the agencies listed below:

  1. Agency for Healthcare Research and Quality (AHRQ)
  2. Agency for Toxic Substances and Disease Registry (ATSDR)
  3. Centers for Disease Control and Prevention (CDC)
  4. Food and Drug Administration (FDA)
  5. Health Resources and Services Administration (HRSA)
  6. Indian Health Service (IHS)
  7. National Institutes of Health (NIH)
  8. Office of the Assistant Secretary for Health (OASH)
  9. Office of the Assistant Secretary for Preparedness & Response (ASPR)
  10. Office of Global Affairs (OGA)
  11. Substance Abuse and Mental Health Services Administration (SAMHSA)

In addition to the PHS agencies listed above, RAND Investigators responsible for the design, conduct, or reporting of research funded by the Centers for Medicare and Medicaid Services (CMS) also must comply with this policy.

1.8 Research means a systematic investigation, study, or experiment designed to develop or contribute to the 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). The term includes any such activity for which research funding is available from PHS.

1.9 Significant Financial Interest (SFI) is described in Section 4.1 below.

2. Overview and Responsibilities

2.1 The United States Department of Health and Human Services has issued regulations pertaining to financial conflicts of interest. The regulations require that all individuals who participate in the design, conduct, or reporting of research funded by the Public Health Service (PHS) agencies complete training on financial conflicts and disclose personal financial interests that could give rise to an actual conflict of interest or the appearance of a conflict. See the full text of the regulations and the final rule implementing the regulations published in the Federal Register for more information. This policy also applies to research funded by the Centers for Medicare and Medicaid Services (CMS).

As detailed in this document, all RAND research professionals, including full-time, part-time, Adjunct staff, and Affiliated Adjunct Staff, will be required to complete training, submit an electronic financial conflict of interest screening form, and disclose relevant Financial Interests if they worked on a PHS or CMS-funded project in the preceding year, if they expect to work on a PHS or CMS-funded project in the upcoming year, or at any time they are named in a proposal for a PHS or CMS-funded project. Key members of management and certain administrative and support department staff also will be required to complete the training and the screening form and provide relevant disclosures, if they are responsible for the design, conduct, or reporting of research funded by the PHS or CMS.

The requirements of this Policy should be read in conjunction with RAND's Conflict of Interest Policy, which provides general instruction on preventing, recognizing, and mitigating conflicts of interest.

2.2 Responsibilities

  1. Investigators are responsible for completing all required training, disclosing all Financial Interests relating to PHS and CMS Research, for mitigating risks associated with Significant Financial Interests, and for assisting with the management of any identified FCOI.
  2. The Office of the General Counsel is responsible for reviewing all disclosed Financial Interests to identify any Significant Financial Interests to determine if they may represent an FCOI. All disclosed Financial Interests shall be reviewed by the OGC, and the OGC shall provide guidance to the Investigator and to RAND management with respect to Significant Financial Interests that may give rise to FCOI. Upon identification of potential FCOI related to a project funded by PHS or CMS, the Office of the General Counsel will work with the Investigator and the relevant research unit or corporate manager to manage the FCOI (Section 5.2 below).
  3. Unit/Corporate Management are responsible for identifying any potential FCOI related to an Investigator's participation in a Research project funded by PHS or CMS. This screening is performed using the "Lookup Conflicts" function within the Screening and Disclosure tool. Unit and Corporate management who identify such FCOI will contact OGC, request assistance in managing the FCOI, and assist in such efforts.
  4. Contracts & Grant Services is responsible for taking reasonable steps to ensure that subcontractors comply with the Department of Health and Human Services Financial Conflict of Interest regulations.
  5. All RAND Associates will comply with regulatory requirements relating to our Institutional Responsibilities, including certification of compliance, maintenance of records, responses to requests for information, and reporting requirements.

3. Reporting and Training Requirements

3.1 Requirements

As detailed in Section 3.2 below, all RAND Investigators must:

  1. Disclose all Financial Interests relating to RAND Research funded by PHS and CMS via the RAND online conflict of interest screening and disclosure tool (Section 3.2 below), and
  2. Complete the related conflict of interest training program at least every four years (Section 3.4 below).

Failure to accurately and timely complete the training and the disclosure and to provide updates as required by this policy could result in disciplinary action, up to and including termination.

3.2 Screening & Disclosure Form

The RAND online conflict of interest screening and disclosure tool is available on RAND's Intranet. All Investigators must fully and accurately complete the disclosure within the time allotted depending on the circumstances giving rise to the need for disclosure.

  1. Proposals & Projects. Investigators named in a proposal for a project funded by PHS or CMS must complete the training and the online disclosure before the proposal is submitted. Investigators who were not named in a proposal and who participate in the design, conduct, or reporting of PHS- or CMS-funded work must complete the training and the online disclosure before beginning any work on a project funded by PHS or CMS.
  2. Continuing Obligation to Update. All Investigators must update and certify the online disclosure form at least annually and within 30 days of receiving, acquiring, or discovering either a new Financial Interest or additional interests from an entity previously disclosed by the Investigator. For example, changes in a Financial Interest could include (but are not limited to) purchase or inheritance of stock or a change in a spouse/domestic partner's employment. All employees covered by the PHS regulations are expected to recognize their continuing obligation to timely disclose relevant Financial Interests to ensure RAND's compliance with the reporting and certification requirements of the PHS regulations.

3.3 Disclosure Thresholds

RAND is required to comply with different regulatory and contractual requirements relating to conflicts of interest that require different disclosure thresholds. Because of the variability among the regulatory schemes that apply to RAND, and because of the potential for enactment of changes in the disclosure thresholds, RAND has not set a minimum threshold for disclosure. This eliminates the need for staff to resubmit disclosures if thresholds are changed and reduces the potential for confusion about the threshold that applies in a particular situation. Investigators therefore are required to disclose the Financial Interests listed in Section 4.2 below, regardless of the value of such Financial Interests.

3.4 PHS Conflict of Interest Training

As part of completion of the online disclosure, Investigators are required to certify, at least every four years, completion of all training required by the Investigator's work on Department of Health and Human Services projects.

4. Identifying Significant Financial Interests

4.1 Significant Financial Interests

The Office of the General Counsel will review all disclosed Financial Interests and identify any Significant Financial Interests. Generally, a significant Financial Interest is a Financial Interest that is likely to have a material effect on the Research. In the context of PHS research, Significant Financial Interest means a Financial Interest of an Investigator (including the Investigator's spouse or domestic partner, dependent child, or other member of the Investigator's household) in any Healthcare-Related Entity consisting of one or more of the interests identified in Section 4.2 below (Relevant Financial Interests) if:

  1. the Financial Interest reasonably appears to be related to the Investigator's Institutional Responsibilities at RAND, and
  2. the aggregate value of all interests held in a particular Healthcare-Related Entity exceeds $5,000.

4.2 Relevant Financial Interests

The following Financial Interests may potentially qualify as Significant Financial Interests:

  1. Remuneration (including salary, wages, consulting fees, honoraria, and any other fee for services)
  2. Defined benefit pension payments or other post-employment payments
  3. Service in a management position such as a board member, director, officer, partner, or trustee of a Healthcare-Related Entity
  4. Ownership of an equity interest (including stock, stock options, bonds, or any other ownership interest)
  5. Holdings in a healthcare sector-oriented mutual fund
  6. Intellectual property rights (e.g., patents or copyrights) from which income is received
  7. Gifts of more than nominal value (more than $20) from clients, vendors, or Healthcare-Related Entities
  8. Reimbursed or sponsored travel related to an Investigator's Institutional Responsibilities
    1. Sponsored travel means travel expenses paid on behalf of an Investigator (or relevant family member) rather than paid by reimbursement
    2. Travel reimbursed or sponsored by the following is excluded: federal, state, or local government agencies; institutions of higher education; academic teaching hospitals; medical centers; and research institutes affiliated with institutions of higher education.
    3. Investigators will be required to provide the following information with respect to any reimbursed or sponsored travel: name of entity that sponsored or reimbursed any expenses associated with the trip; purpose of the trip; destination; date and duration of the trip; and amount of reimbursement received.

4.3 Excluded Financial Interests

The following Financial Interests do not give rise to Significant Financial Interests and therefore need not be disclosed:

  1. Salary, wages, and remuneration paid by RAND
  2. Travel expenses paid or reimbursed by RAND
  3. Income from mutual funds and retirement accounts (other than healthcare sector-oriented funds, see Section 4.2(e) above), as long as the Investigator does not directly control the investment decisions made by the funds
  4. 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
  5. 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

5. Review and Evaluation of Disclosed Financial Interests for FCOI

5.1 Identifying FCOI

A disclosure of a Financial Interest does not, by itself, create an impermissible conflict of interest. Each Financial Interest disclosure will be reviewed by the Office of the General Counsel. The Office of the General Counsel is responsible for determining when an actual or potential conflict of interest exists in a given situation - that is, when a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS- or CMS-funded research - and for taking action as necessary to address and manage such conflicts of interest, including development and implementation of a management plan (see Section 5.2 below). This responsibility will be exercised in cooperation with the relevant research unit or corporate manager and with full participation by the Investigator. A variety of criteria may be considered in determining whether a particular Financial Interest creates a conflict of interest with respect to a particular project funded by PHS or CMS.

5.2 Managing FCOI

RAND will take appropriate steps to address and manage FCOI to ensure that the design, conduct, and reporting of RAND's research is free from bias or the appearance of bias. As described in the PHS regulations, some examples of how financial conflicts of interest may be addressed and managed include:

  1. Public disclosure of an Investigator's Significant Financial Interests; disclosures will only occur after notice to and consultation with the Investigator
  2. Disclosure of FCOI directly to participants in Research projects involving human subjects
  3. Monitoring of Research projects by reviewers who do not have FCOI and who are capable of implementing measures to protect the design, conduct, or reporting of the Research against bias arising from identified FCOI
  4. Modification of the research plan, including, for example, change of personnel or personnel responsibilities with respect to particular tasks
  5. Disqualification of personnel from participation in all or a portion of a Research project funded by PHS or CMS
  6. Reduction or elimination of a Significant Financial Interest (e.g., sale of stock)
  7. Severance of relationships (e.g., consulting activities) that create actual or potential conflicts.

Questions regarding this policy and the Health and Human Services regulations should be directed to Brent Bradley, Interim Director for Legal Affairs.

Effective: August 11, 2017.