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PHS Financial Conflict of Interest PolicyPublic Health Service Financial Conflict of Interest Training and Disclosure RequirementsThis 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 (PHS) agencies or Centers for Medicare and Medicaid Services (CMS) and/or hold certain management positions. Contents
1. Definitions1.1 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:
1.5 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:
1.7 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:
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 Responsibilities2.1 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
3. Reporting and Training Requirements3.1 Requirements As detailed in Section 3.2 below, all RAND Investigators must:
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.
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 Interests4.1 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:
4.2 Relevant Financial Interests The following Financial Interests may potentially qualify as Significant Financial Interests:
4.3 Excluded Financial Interests The following Financial Interests do not give rise to Significant Financial Interests and therefore need not be disclosed:
5. Review and Evaluation of Disclosed Financial Interests for FCOI5.1 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 division 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:
Questions regarding this policy and the Health and Human Services regulations should be directed to Robert Case, Vice President, General Counsel and Corporate Secretary. Effective: August 11, 2017. Menu
What triggers a COI disclosure to generate for an individual quizlet?An individual COI may arise when an individual has a personal or financial interest, which may affect or appear to affect the design, conduct, or reporting of the research.
What is an example of an institutional COI?An institutional conflict of interest occurs when a financial interest of the university (e.g., investments held by the university in a company) has the potential to bias research conducted by its employees or students, or creates an unacceptable risk to human subjects.
What is an example of an individual financial COI?An example of an individual financial COI is: A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study.
Which of the following studies would need IRB approval?Which of the following studies need IRB approval? Studies collecting data about living individuals. If a study intends to collect data or information about the living individual, an IRB review and approval must be obtained.
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What point he and his study team must submit COI disclosures to comply with the PHS regulation?
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