FAQ

Definitions

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)

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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.”

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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.

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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.”

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Disclosure System

C4C is now CoMotion

The Center for Commercialization (C4C) recently changed its name to CoMotion (comotion.uw.edu). We will reflect this change within FIDS in the near future. For now, all of the references are still to C4C.

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Do I need to disclose my SFI for every eGC1?

If you are an investigator on an eGC1 that is submitted to a sponsor or that receives funding after 8/16/2012, then you will be required to complete a new disclosure for that eGC1. Click the Complete Disclosure button on your profile page in FIDS and then select the appropriate option for SFI. You do not need to re-enter your SFI information if there have been no changes.

You can use the Create New Disclosure button to create a disclosure for a specific eGC1 before receiving the disclosure email notification.

All disclosures on new eGC1s must be completed before the application can be sent to the sponsor. Failure to complete a disclosure on time may result in sponsor deadlines being missed.

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Why isn’t my disclosure showing up on my eGC1?

There are two ways to link a disclosure to a specific eGC1.

  • Complete a pending disclosure for the eGC1 using the Complete Disclosure button in the Action Items section of your Profile page.
  • Use the Create New Disclosure button to create a disclosure for a selected eGC1. This button appears below the Action Items section.

For details on how to do either of these, see the Disclosures section of the FIDS User Guide.

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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.

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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://uw.edu/research/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 C4C tech transfer agreement or IRB approval.”
  4. On the Enter Other Activity page, select either “C4C 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 C4C technology transfer agreement, the system will send an email notification to c4ctl@uw.edu with the following information

  • Disclosure ID
  • Innovator Name
  • Department
  • C4C 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.

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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.

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Should mentors on T32 training grant proposals be designated as investigators?

Because all investigators must complete a disclosure before an eGC1 is ready to submit, we recommend that you complete the eGC1 with “No” selected in the Investigator column on the PI & Personnel page. As mentors are assigned a trainee, and become active, access the eGC1 for the T32 proposal and select “Yes” in the Investigator column.  SAGE will send an email to the now active mentor to disclose FCOI.

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What do I need to access FIDS?

All you need is your UW NetID and your password. You do not need any ASTRA authorizations.

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How can I certify to the sponsor that an investigator has completed a disclosure and/or the required training?

Currently, OSP is handling all certification, both for individuals and the institution. Ask your OSP administrator to help you with this.

To locate your Administrator, use the following link:  http://www.washington.edu/research/?page=ospContact

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Can I edit my completed disclosure?

A completed disclosure can be edited, if it has not yet reached the review status of Review Complete or No Review Required. See the Edit a Disclosure section of the User Guide for more information.

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General Policy

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.

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What is the process for disclosure and review of Significant Financial Interests (SFI)?

The Financial Interest Disclosure System (FIDS) which investigators use to electronically submit their SFI disclosures was released on August 16th, 2012.  FIDS replaces the current paper-based system.   The Investigator discloses SFI through FIDS and in accordance with GIM 10.  The Office of Research reviews the disclosed SFI and determines if an FCOI is present.  If a determination of FCOI is made, then a management plan will be produced and distributed to the Investigator, the Investigator’s Department and any other required parties.

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I am a graduate student/postdoc funded on my department’s PHS T32 training grant. Am I considered an investigator?

Yes, the SFI reporting requirements apply.

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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.

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I am a graduate student/postdoc funded on my own individual NIH F30/F31/F32/F33 award. Am I considered an investigator?

Yes, the SFI reporting requirements apply.

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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.

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Subrecipients

Are Investigators responsible for reporting the SFI of subcontractors?

In general, no.  Subrecipient institutions that meet the compliance requirements of the new PHS regulations will have their own reporting process; however, the subrecipient will need to provide the UW with the appropriate assurances as part of the subaward agreement. In the rare case where the UW might decide to manage a subrecipient’s SFI disclosures, the UW would be responsible for reporting the subrecipient’s disclosures to the sponsor.

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How will SFI disclosures be handled for PHS-funded projects which have “consultants” who are not UW faculty members? Does the PI need to obtain a temporary UW NetID for training and disclosures?

Most likely, consultants will not be considered investigators and will therefore not be affected.  If consultants (who are not UW employees) are investigators on a UW project, they will likely be contracted through their academic institution, rather than personally. The subawardee, whether through purchasing or a subcontract, will be required to have a compliant policy in order to get federal funding. To meet the mandatory training requirement, an investigator who is not UW personnel could take our training (via a sponsored UW NetID).

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Training

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.

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How can I determine if an investigator has completed the FCOI training?

Investigators who have completed the FCOI training should receive an email upon completion of the training that can be forwarded to anyone who needs the information.  Also, if Investigators have completed the training, they will see a confirmation banner displayed in the training.

If you have access to the eGC1, you can open it and view the training status and expiration date in the Compliance Details section of the PI & Personnel page.

There is a tool available to look up individual investigators at www.washington.edu/research/topics/fcoi/individual-training-verification

 Future enhancements will include providing a report with training completion information by organization code.

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How do I obtain a UW NetID if I’m not affiliated with the UW?

The following link has all the information as well as instructions on how to obtain a UW NetID:  http://www.washington.edu/itconnect/accounts/sponsored.html

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Travel

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.

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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.

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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).

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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.

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Since GIM-10 requires that I disclose my imputed SFI, does this mean that I have to disclose my spouse’s travel, even though s/he is not employed at the UW?

Most likely, the answer is “no”: as defined in GIM-10, imputed interests usually involve a partner/family member/spouse’s working for or equity in an outside entity whose business is related to your University research (e.g., ownership in a company that could profit based on the outcome of your University research project). The travel disclosure requirement is applicable to University personnel, since the new PHS regulations define travel paid for by an outside entity directly to the recipient to be SFI; this requirement does not apply to non-University personnel.

Travel expenses incurred by spouse/partner/family member are not a Financial Interest UNLESS they contribute to a University researcher’s SFI.  Therefore only if a spouse’s (or partner’s or other immediate family member’s) travel expenses, when combined with other financial interests of the same outside entity, create an imputed SFI do such things need to be disclosed.

There may be rare cases; e.g., where a spouse’s travel is paid for by an outside entity who also has a direct connection to your University research (e.g., your spouse works for the sponsor of your University research project), and her/his total amount of compensation or equity in the outside entity crosses the threshold for SFI that could appear to have a biasing effect on your University research. Since travel could be construed to be considered a form of compensation, it may be a judgment call as to whether such a situation becomes an imputed SFI. If there is any question about such examples, please contact the Office of Research for guidance.

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