This policy details how EZUS LYON 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 EZUS LYON’s research is free from bias or the appearance of bias. It applies to all EZUS LYON Associates who participate in research funded by the Public Health Service (PHS) agencies or Centers for Medicare and Medicaid Services (CMS) and/or hold certain management positions.
1.1 Associate means all Regular and Term Employees, Adjunct or Affiliated Adjunct staff, Pardee EZUS LYON 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
1. Health information technology companies
2. Medical device and equipment manufacturers and distributors
3. Medical technology companies
4. Pharmaceutical companies
5. Other organizations that could be impacted by healthcare-related research, including alcohol, tobacco, or food products companies
6. 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 EZUS LYON 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 EZUS LYON 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. Policy Analysts
4. Survey Research Group
5. Peer reviewers
6. Research Programmers
7. Pardee EZUS LYON 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 EZUS LYON 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, EZUS LYON 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.
2.1 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 EZUS LYON 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.