Tag Archives: PHS

You can see all of your existing Significant Financial Interests (SFI) listed in this section. The information displayed is

  • Name of Entity
  • Interest Holder
  • Nature of Interest
  • Entity Type
  • Value

The following image shows an example list.

existing significant financial interests

You can add, edit, or delete SFI when you are creating a disclosure. Select Complete Disclosure or Create New Disclosure in the Action Items section to start this process.

If you are an investigator for an eGC1 with a Public Health Service (PHS) sponsor, you must disclose all Significant Financial Interests (SFI) related to your Institutional Duties, as defined by GIM 10: Financial Conflict of Interest Policy. FIDS will automatically link all of your SFI to any PHS-funded eGC1 disclosures.  An eGC1 is PHS-sponsored based on either the Sponsor or the Originating Sponsor. A list of PHS Sponsors is available.

If your eGC1’s sponsor is not PHS, you should only include those SFI related to the eGC1’s research. Specifically, SFI related to research means that the SFI either impacts, or could appear to impact, the design, conduct, or reporting of any current or proposed research projects.

Can I take the UW FCOI training if I’m not a PHS-Funded Investigator?

Yes, anyone with a UW NetID can take the training. However, the training content is mandatory only for PHS-Funded Investigators. Non-PHS Funded Investigators may not find the contents of the training applicable to them.

Does a PHS-Funded Investigator 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 via a UW budget (e.g., 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.

PHS Funded Research:  If you are an Investigator for PHS Funded Research 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.)

Non-PHS Funded Research: If you are an Investigator who participated ONLY in non-PHAS Funded Research, 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.”

When will the revised GIM 10 (including all of the new disclosure requirements) be implemented?

In accordance with the Public Health Services (PHS) regulation, all institutions receiving PHS Funding must implement the requirements under the regulation no later than August 24, 2012.  Investigators must be in compliance with the regulatory requirements prior to any expenditure of funds awarded on or after August 24, 2012.  While current awards (i.e., those existing prior to Aug. 24, 2012) are “grandfathered” from the new regulations, PHS-funded investigators must be in compliance with the revised disclosure requirements, for any new funding (including noncompeting continuation awards) received after August 24, 2012.

The Financial Interest Disclosure System (FIDS) is an online system that investigators use to disclose Significant Financial Interests (SFI) related to their research projects.

Access FIDS at http://www.washington.edu/research/tools/fids/

You will need to use FIDS to

  • disclose your SFI for each eGC1 for which you are an investigator.
  • disclose changes you make to your SFI, including updating information, adding new SFI,  or deleting SFI.
  • disclose your SFI for CoMotion technology transfer or Human Subjects Division (HSD).

For more information on

Parts of the Page

To help you navigate through FIDS, the following image shows the ten basic parts of the pages.

example page with the parts numbered

  1. Welcome with your name displays in the upper left of the window.
  2. Sign out link which will log you out of FIDS is to the right of your name.
  3. Help link which will open a new window and display the FIDS User Guide and other support pages. It’s to the right of the sign out link.
  4. Breadcrumb trail which you can click to return to your Profile page. Displays on the left, below the green FIDS banner.
  5. Page title which indicates the purpose of the page. Displays below the breadcrumb trail.
  6. Action Bar which will contain icons appropriate to the page. The Delete (trashcan) and Save icons appear in this image and appear on the right side of the bar, just below the page title.
  7. Section heading with a help icon to provide contextual help for this part of the page.
  8. Main section of the page, indicated by the pale colored background, where you might view information, enter or edit data, or click a link to add information in a new window.
  9. Page footer which contains buttons and/or links to complete this page and move to the next, or cancel out of this page and return to a prior state or page. Displays below the main section.
  10. System footer which contains links to Learning and Contact Us information.

Tip: Do not use your browser’s back button to navigate. Instead use the links and breadcrumb trail within FIDS.