Current PHS regulations:

The U.S. Public Health Service (PHS) Conflict of Interest regulations, outlined in 42 CFR Part 50 Subpart F and 45 CFR Part 94, require institutions applying for or receiving PHS funding to identify, manage, and report financial conflicts of interest (FCOIs) related to sponsored research. Investigators must disclose significant financial interests (SFIs) that may reasonably appear to affect the design, conduct, or reporting of PHS-funded research. Institutions must review disclosures, determine related FCOIs, implement management plans, and submit required FCOI reports to the funding agency before funds are spent. Additional requirements include public accessibility of certain FCOI information, mandatory investigator training, and institutional oversight of subrecipients. These regulations promote research integrity, transparency, and public trust in federally funded research. The most recent revisions to the regulations were published in September 2024 and become effective on January 1, 2025.

NIH reminds investigators to disclose all financial interests.
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Who is covered by this regulation?

The regulation is applicable to each institution that applies for grants or cooperative agreements for research or submits a proposal for a research contract and all Investigators participating in that research with any of the following offices/agencies:

• NIH – National Institutes of Health
• FDA – Food & Drug Administration
• AHRQ – Agency for Healthcare Research and Quality
• ATSDR – Agency for Toxic Substances & Disease Registry
• ASPR – Office of the Assistant Secretary for Preparedness and Response
• CDC – Centers for Disease Control
• HRSA – Health Resources & Services Administration
• IHS – Indian Health Services
• OASH – Office of the Assistant Secretary for Health
• OGA – Office of Global Affairs
• SAMHSA – Substance Abuse & Mental Health Services

Other organizations may elect to adopt the PHS regulations or similar conflict of interest regulations. Some other sponsors that have conflict disclosure requirements are, but are not limited to:

• National Science Foundation
• American Heart Association
• American Cancer Society
• Arthritis Foundation
• Susan G. Komen Foundation
• Alliance for Lupus Research
• Juvenile Diabetes Research Foundation

What are the responsibilities of investigators under the PHS regulation?

PHS Investigators must disclose as directed under the policy of their institution. The revised PHS regulations are applicable to all Investigators who will participate in research funded under PHS grants or cooperative agreements.

• Disclosure of Significant Financial Interests (SFIs):
  • Investigators must disclose all SFIs that are related to their institutional responsibilities and may reasonably appear to affect PHS-funded research.
  • Disclosures must be made:
    • Before the submission of a proposal or expenditure of funds
    • Annually during the award period
    • Within 30 days of discovering or acquiring a new SFI
• Completion of Required Training:
  • Investigators must complete COI training:
  • Prior to engaging in PHS-funded research
  • At least every four years thereafter
  • Immediately if the institution revises its COI policy, if an investigator is new to the institution, or if an investigator is found to be noncompliant
• Cooperation with Institutional Review:
  • Investigators must cooperate with institutional officials in the review and management of disclosed SFIs, including the development and implementation of a Financial Conflict of Interest (FCOI) management plan, if required.
• Adherence to Management Plans:
  • If an FCOI is identified, investigators are responsible for complying fully with any management plan developed by the institution to mitigate or eliminate the conflict.
• Participation in Public Transparency Measures:
  • When applicable, investigators must consent to the public disclosure of certain information about managed FCOIs, as required by the regulation (e.g., name, nature of interest, and approximate value).

Will disclosures be publically available?

Consistent with the PHS regulations, for senior/key personnel only, the University of Missouri must ensure public accessibility of interests which are identified as a Financial Conflict of Interest (FCOI) by the Conflict of Interest Committee. An FCOI exists when the Committee determines that an Investigator’s financial interest is related to a PHS-funded research project and could directly and significantly affect the design, conduct or reporting of the PHS-funded research. The public must submit a written request to the University of Missouri System Custodian of Records before the information will be released. The University will respond to written requests within five business days. The Conflict of Interest Office will notify Investigators of any requests that involve their disclosure so they will know when and to whom that information was given.

Where can I find additional information?

The National Institutes of Health (NIH) has compiled answers to the most frequently asked questions regarding the implementation of the revised regulations for grants and cooperative agreements. The questions are arranged by topic and can be found on NIH’s website.