- PHS/ Promoting Objectivity in Research – 42 CFR 50, Subpart F (link)
- PHS/ Responsible Prospective Contractors — 45 CFR Part 94 (link)
Some of the key elements of the regulations are as follows:
- Additional disclosure requirements. The PHS regulation expands the requirements for disclosure. It requires that income related to all of an investigator’s “institutional responsibilities” be disclosed. In addition to reporting income from for-profit organizations, investigators must also report income from non-profit organizations. Investigators on PHS-supported grants or contracts must disclose each occurrence of sponsored or reimbursed travel that is related to their institutional responsibilities, regardless of the relationship of the travel to the PHS-funded project, when the amount of travel during the preceding 12 months reaches or exceeds $5,000 in the aggregate for a particular entity. (Note: This aggregate value includes travel for spouses, domestic partners and dependent children unless the travel occurs in the course of their employment by the entity.) Some exceptions apply. Click here for additional information on what you are required to disclose.
- Retrospective review. If a financial interest is disclosed “late” and is determined to be a financial conflict of interest (FCOI) with PHS-supported research, the institution must complete a retrospective review of the research project to determine whether the design, conduct or reporting of the research that was already conducted was biased.
- Training requirement. All investigators on PHS-supported grants and contracts are required to receive training on conflict of interest whenever the institution’s policy changes and every four years thereafter. In addition, training must be completed whenever the institution determines that an investigator is not in compliance with the university’s conflict of interest policy and/or has not adhered to the assigned management plan for his/her conflict.
- Public reporting of FCOIs. The institution must provide a written response within five business days of a request for information concerning any FCOI related to PHS-supported research if it involves the principal investigator/project director or any other person who has been identified by the institution as senior/key personnel. The written response must include: the investigator’s name, title and role with respect to the project; the name of the entity in which the investigator has the financial interest; the nature and approximate dollar value (in ranges), if fair market value can be reasonably determined.
What is “PHS”?
PHS is the Public Health Service of the U.S. Department of Health and Human Services. PHS agencies include
- Administration for Children and Families (ACF)
- Administration on Aging (AoA)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare & Medicaid Services (CMS)
- Federal Occupational Health (FOH)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
Who is covered by the PHS regulation? Must all institutions that receive PHS support adhere to the regulation?
Yes. The regulation is applicable to all institutions that apply for or receive PHS support by means of a grant, cooperative agreement, or contract and, through the implementation of the regulation by the institution, to all investigators on PHS-supported projects.