Policy identification number: SPON-007
File: Other Operational Policies / Sponsored Research & Federal Regulations
Promoting Objectivity in Research--Financial Conflicts of Interest in Research for Public Health Services (PHS) Investigators
This policy seeks to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under Public Health Services (PHS) grants or cooperative agreements will be free from bias resulting from an investigator’s financial conflicts of interest.
Provost and Vice President for Academic Affairs
January 27, 2016
January 27, 2016
pvpaa, objectivity, financial, conflicts, research, investigators
Scheduled for Review
Fort Lewis College (FLC or “The College”) and its employees are asked to assist in a broad range of economic development activities, to work on projects that involve support from the governmental and the commercial sectors, and to engage in consulting relationships and other outside economic activities. Generally, such outside activities enhance professional development, scholarship, and teaching and are strongly encouraged. Along with these benefits, the arrangements between external enterprises and the College, its employees, or students, can potentially create financial conflicts of interest.
A financial conflict of interest (FCOI) occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the College, such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal financial gain. A financial conflict of interest depends on actual situational conditions and the respective roles of the personnel who may be involved, but not on perceptions of the individual’s moral character.
Reason for Policy
This policy is intended to establish requirements to ensure that the College is in full compliance with all pertinent regulatory requirements in applying for or receiving PHS funding from a grant or cooperative agreement and is applicable to any PHS proposals submitted and/or awards received on or after August 24, 2012. This policy provides a detailed explanation of the FCOI requirements for Public Health Services (PHS)-funded investigators in accordance with 42 CFR 50, Subpart F, and 45 CFR 94.
For following policy: All PHS-funded Principal Investigators and Investigators must comply.
Principal Investigator Responsibilities
For enforcement of policy: The Director of Sponsored Research will serve as the Research Integrity Officer (RIO) responsible for compliance with Financial Conflict of Interest regulations. (50.604) (d)
For oversight of policy: Provost and Vice President for Academic Affairs
For notification: Policy Librarian
For procedures implementing policy: The Research Integrity Officer (RIO)
“Financial Conflict of Interest” means a significant financial interest that is related to a research program or project and could directly and significantly affect the design, conduct or reporting of that research.
“HHS” means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
“Institutional Responsibilities” means the Investigator’s professional responsibilities on behalf of the College including, but not limited to, activities such as research, consultation, teaching, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring boards.
“Investigator(s)” 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 the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
“Research Integrity Officer (RIO)” means the institutional official responsible for assessing allegations of research misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations. The Research Integrity Officer is also the institutional official who makes final determinations on allegations of research misconduct and any responsive institutional actions. The Director of the Office of Sponsored Research and Federal Relations, or his or her designee, will serve as the Research Integrity Officer.
“The U.S. Public Health Service (PHS)” means the Public Health Service of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH). Within the HHS, eight agencies are designated components of the U.S. Public Health Service (PHS): (1) the Agency for Healthcare Research and Quality (AHRQ), (2) the Agency for Toxic Substances and Disease Registry (ATSDR), (3) the Centers for Disease Control and Prevention (CDC), (4) the Food and Drug Administration (FDA), (5) the Health Resources and Services Administration (HRSA), (6) the Indian Health Service (IHS), (7) the National Institutes of Health (NIH), and (8) the Substance Abuse and Mental Health Services Administration (SAMHSA).
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
“PHS Awarding Component” means the organizational unit of the PHS that funds the research that is subject to 42 CFR 50 Subpart F.
“Research” 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 (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in 42 CFR 50 Subpart F, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
“Research Conflict of Interest Committee (RCIC)" refers to the college committee that advises the Provost and Vice President for Academic Affairs on conflict of interest matters in research. The Provost appoints the committee members and the following exofficio, non-voting members: The College General Legal Counsel; the Associate Vice President of Academic Affairs; the Vice President for Finance and Administration; the Controller; an IRB Chairperson, as a liaison to/from the IRB; and the Public Affairs Officer.
“Significant Financial Interest (SFI)" means, except as otherwise specified in this definition:
Designation of Institutional Official
The Research Integrity Officer will collect and perform an initial review of all disclosed SFIs from 1) Investigators who are planning to participate in, or are participating in, the PHS-funded research 2) Investigators who are newly participating in the research project, and 3) for existing Investigators who disclose a new SFI to determine if a FCOI exists. The signed original SFI disclosure form will be retained in the RIO office, and a copy will accompany the Project Data Sheet and be filed in the associated grant file in the Controller’s office. The RIO will develop and implement management plans, as needed to manage FCOIs. The RIO may submit an FCOI to the Research Conflict of Interest Committee (RCIC) for review in complex cases. (50.605) (a) (1)
If an investigator has a FCOI and is working on research involving human subjects the IRB must be notified of any management plan.
Annual updates are also required for the duration of the research project and must include:
Initial, annual, and revised FCOI reports will also be sent to the PHS component following a retrospective review to update a previously submitted report, if appropriate. (50.604 (h)); (50.605 (b))
Identification of untimely or any delayed disclosure of an SFI by an investigator requires FLC’s review within 60 days of determination: if it is related to PHS- funded research and if an FCOI exists. Determination that there is an unmanaged FCOI requires:
Mitigation Report (50.605 (a)(3)(iii)
As appropriate, FLC shall update the previously submitted FCOI report specifying the actions taken to manage the FCOI moving forward. If the institution determines there was bias it must notify the PHS awarding component promptly and submit a mitigation report to that component.
The mitigation report must include:
Depending on the nature of the FCOI, the institution may decide that additional interim measures are necessary regarding the Investigator’s participation in the PHS-funded research project between the date of the FCOI or the Investigator’s noncompliance is determined and the completion of the institution’s retrospective review.
If a FCOI is not identified or managed in a timely manner (i.e.: non-compliance to the disclosure requirements or management plan), FLC will complete a retrospective review of the Investigator’s activities and research project to determine whether the research was biased. If bias is found, FLC will notify PHS and submit a Mitigation Report. (50.605 (a)(3) and (i)-(iii)
that the value cannot be readily determined. This information will be updated at least annually. Newly identified FCOIs will be updated within 60 days of being identified. All information will remain available for three years from the date it was most recently updated. (50.604 (a) (5) (i)-(iv))
If any sub recipient does not have such a conflict of interest policy, then FLC shall require that the sub recipient follow the College’s policy, and Sub recipient’s failure to promptly do so upon request from FLC shall be considered to be grounds for immediate termination by FLC of any applicable subcontract or sub-award. Any written agreement terms required by the College shall contain the provision that Sub recipients will report to FLC as the awardee Institution, any identified FCOI in sufficient time to allow FLC to report the FCOI to meet its reporting obligations. (50.604 (c) and (1) (i) – (iii))
Consequences of Non-Compliance
When an investigator is found to have violated this policy or the terms of the management plan, the RIO may impose sanctions consistent with policy. Disciplinary action may vary from a warning to termination of employment. In cases of violation, the RIO (or designee) will notify the appropriate funding agency. (50.604 (j)) (50.606(a))