Tag Archives: PHS

Can I take the UW FCOI training even if my sponsor does not require it?

Yes, anyone with a UW NetID can take the training. However, the training content is mandatory only for investigators on an application to a sponsor that requires UW review of SFI. Other investigators may not find the contents of the training applicable to them.

Does an Investigator with a sponsor requiring UW SFI review need to disclose Sponsored or Reimbursed travel that is paid through a UW research budget?

No.  Travel disclosure is not required if the travel funding is paid through a UW budget (for example: sponsored award, gift, discretionary funds).

I was a speaker at a national meeting for pancreatic cancer and recently had travel reimbursed by the meeting’s sponsor, American Association of Cancer Researchers (AACR) which is a non-profit. What do I need to disclose under GIM 10?

The disclosure requirements will depend on the type of research in which you are engaged.

Funded Research that requires UW Review:  If you are an Investigator for Funded Research and the sponsor requires UW review, you will need to disclose the following:

  • Travel:  Professional societies and non-profit organizations are not excepted from the travel disclosure requirement.  The occurrence of this travel, including an estimate of the value of the travel, must be disclosed within thirty (30) days of the occurrence of the travel.
  • SFI: If the travel expenses and any compensation received for this activity total $5000 or more, you must disclose this SFI.  (This is in addition to the above travel disclosure.)

All Other Funded Research: If you are an Investigator who participated ONLY in Funded Research where UW review is not required, you will need to disclose the following:

  • SFI: If the travel expenses and any compensation received for this activity total $5000 or more AND relate to a proposed or ongoing research project, you must disclose this SFI.
When must an Investigator disclose SFI that is unrelated to their current research project?

Example: an Investigator receives PHS funding to perform quantitative imaging and also does outside consulting for Amgen and AstraZeneca. The Investigator receives more than $5000 from each Entity for the consulting work, but the work involves drug development, not quantitative imaging.   Does the $5000 from each Entity need to be disclosed if the work is not related to research?

Under GIM 10, Investigators participating in PHS-Funded Research must report SFIs as related to their Institutional Responsibilities.  This is a broader disclosure than was previously required.  GIM 10 defines “Institutional Responsibilities” as  “any professional activity carried out by an Investigator or Innovator for which the Investigator or Innovator is compensated by the University, including:  (i) sponsored activities (such as Research, training, and similar activities sponsored by external sources including federal, state and local governments and private businesses, corporations, foundations and organizations), (ii) non-sponsored activities (such as teaching, departmental or University supported Research, clinical work, and department and University administrative duties), and (iii) University-related public service.”

GIM 10 refers to “PHS Awarding Components” and research funded by these components. What is a PHS Awarding Component?

PHS is the primary division of the U.S. Department of Health and Human Services.  Agencies within PHS are:

  • Agency for Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA)
  • Health Resources and Services Administration (HRSA)
  • Indian Health Service (IHS)
  • National Institutes of Health (NIH) and all of the Institutes within the NIH
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
The new PHS regulation and GIM 10 list many reporting requirements, both to the PHS Awarding Component and to the public. What responsibility does an Investigator have to report a managed FCOI?

None.  The PHS Regulation requires that the Institution report certain information regarding managed FCOIs to the PHS Awarding Component and the public.  The Office of Research and the Office of Sponsored Programs will make all necessary reports to the PHS Awarding Component.  The Office of Research will maintain a publicly accessible website, in accordance with the PHS Regulation and GIM 10.

Am I considered an “Investigator” if I am funded by a Public Health Service (PHS) but my PHS-sponsored award is not for a specific research project?

No; however, the PHS definition of “research” includes funding mechanisms to which the regulation applies such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, Institutional training grant, program project, or research resources award. “Investigator” means any University personnel, regardless of title or position, including a University Research Employee who is responsible for the design, conduct or report of University Research.   If your PHS-sponsored award is not directly supporting a specific research project, then it is not subject to the University’s FCOI policy.  For example, if you are UW investigator receiving funds from the National Library of Medicine that is not identified with a specific research award, the recipient is not required to be an “investigator.”