Tag Archives: Disclosure

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The Disclosures section lists all of your pending and completed disclosures. The following image shows an example list.

disclosure section

The values listed for existing disclosures are:

  • Disclosure ID: automatically generated by FIDS. For completed disclosures, you may click the Disclosure IDs to see read-only views of your point-in-time disclosures. If your disclosure’s status is Review Complete or No Review Required, you may edit it. You will see an Edit this Disclosure button at the bottom of the page.
  • eGC1 Number: the primary eGC1 linked with this disclosure. Your disclosure status will appear on the PI, Personnel, & Organizations page of this eGC1. You will see “(not available)” displayed for disclosures that do not have a primary eGC1.
  • Date Disclosed: when you completed the disclosure.
  • Status
    • Disclosure Required: you need to complete this disclosure.
    • Disclosure Complete: you have completed this disclosure.
  • Review Status
    • Review Required: generally, this indicates the disclosure has related SFI, and the reviewer needs to review this disclosure now
    • Waiting for JIT (Just in Time):  the system will assess the need for review at the appropriate time
    • No Review Required: generally, this indicates no related SFI, and therefore no review is needed
    • Pending Answer: the reviewer needs information from the investigator; this status is set by the reviewers
    • Review Complete: the reviewer completed reviewing the disclosure

For more information, see the Disclosure Review Statuses section.

Notes:

  • If an investigator is removed from an eGC1, the system will delete the pending disclosure within 24 hours.
  • If a person’s investigator setting is changed from Yes to No, any completed disclosure will be disassociated from the eGC1, and as needed, the disclosure’s status will be reset to Waiting for JIT.
How do I complete an SFI disclosure for a tech transfer license agreement or unsponsored Human Subjects activity?

To create a disclosure:

  1. Go to http://www.washington.edu/research/tools/fids/, and click on Sign In to go to your FIDS profile page.
  2. Scroll down the Profile page to the Action Items section. Click on the Create New Disclosure button.
  3. On the Disclosure Type page, select the second choice “I need to make a disclosure for a CoMotion tech transfer agreement or IRB approval.”
  4. On the Enter Other Activity page, select either “CoMotion Technology Transfer Agreement” or “Human Subjects Activity” and complete the appropriate section.
  5. Click Next and then follow the instructions for disclosing any Significant Financial Interests, and completing the disclosure.

When your disclosure is complete, you will be able to see it listed on your Profile page.

If your disclosure was for a CoMotion technology transfer agreement, the system will send an email notification to license@uw.edu with the following information

  • Disclosure ID
  • Innovator Name
  • Department
  • CoMotion Agreement ID
  • Name of Party/Licensee
  • SFI indication (Yes/No)

It will also request that a copy of the license agreement be sent to the Office of Research at research@uw.edu for the Institutional Official as the disclosure is reviewed.

Can someone else enter details of my SFI for me?

No. All investigators are required to use their own UW NetID to log in to FIDS and complete their disclosures. It is not currently possible to create a disclosure for someone else and route it for approval.

What is FIDS?

GIM 10 disclosures are made using a web-based electronic system called the Financial Interest Disclosure System (FIDS) which is linked to the SAGE system. This system replaces the paper-based procedure.

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.
A listed exception to the Travel Disclosure requirement is travel that is sponsored or reimbursed by “a research institute that is affiliated with an Institution of Higher Education.” Is there a list of what research institutions will qualify?

At present, the UW has multiple affiliated research institutes, including FHCRC, Seattle Children’s SCRI, SIBCR and the Howard Hughes Medical Institute.  A list of eligible institutes affiliated with the UW will be published on the FCOI website as these relationships are clarified.

What travel must be disclosed? How will Investigators make the required travel disclosures?

PHS-funded Investigators must disclose all Reimbursed or Sponsored Travel that is related to their Institutional Responsibilities.  GIM 10 defines Sponsored Travel as “travel activity, the Travel Expenses for which are paid directly by an Entity on behalf of an Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available to the Investigator,” and Reimbursed Travel as “travel activity for which the Travel Expenses are paid directly by the Investigator, who is then reimbursed by an Entity for such Travel Expenses.”  Exceptions to the Travel Disclosures are Reimbursed or Sponsored Travel paid by the University, a federal, state or local government agency, an Institution of Higher Education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of Higher Education.

Travel Disclosures must be made within 30 days of the occurrence of travel and may be made up to twelve (12) months in advance.  The Travel Disclosures will be made through the Financial Interest Disclosure System (FIDS); in the same manner SFI will be disclosed.

When does an Investigator need to report stock ownership as an SFI?

GIM 10 defines Equity as “any interest in the profits of or other ownership interest in any commercial or nonprofit enterprise, including common stock and other equity securities, and any right to acquire any of the following such as an option, warrant or other security convertible into an equitable convertible.”   If Equity securities are publicly traded, they are an SFI if the value of the Equity is $5000 or greater.  For PHS-Funded Research, this SFI should be disclosed if the Equity interest is related to the Investigator’s Institutional Responsibilities.  For Non-PHS Funded Research, it should be reported if the SFI is related to a proposed or ongoing research project or Technology Transfer Transaction.

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.”

I am a member of the UW School of Medicine Faculty; however, all of my grants are managed at Seattle Children’s Research Institute (SCRI). My FCOI plan is presently managed by Children’s. Would changes in the UW’s GIM 10 impact my current arrangement?

Investigators are subject to the FCOI policy of the institution that manages the research funding.  Therefore, if SCRI manages the research funding, Investigators should disclose their SFIs in accordance with the SCRI’s FCOI policy.  Investigators conducting research at the UW would disclose SFI in accordance with GIM 10.