PHS is the primary division of the U.S. Department of Health and Human Services. Agencies within PHS are:
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 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.
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.”
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.
There are two ways to link a disclosure to a specific eGC1.
For details on how to do either of these, see the Disclosures section of the FIDS User Guide.
GIM 10: Financial Conflict of Interest Policy 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.
To create a 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 email@example.com with the following information
It will also request that a copy of the license agreement be sent to the Office of Research at firstname.lastname@example.org for the Institutional Official as the disclosure is reviewed.
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. SFI is considered to be confidential information.
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, & Organizations 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.
All you need is your UW NetID and your password. You do not need any ASTRA authorizations.
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/contact-us/
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.
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.
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.
Yes, the SFI reporting requirements apply.
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.
Yes, the SFI reporting requirements apply.
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.
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.
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).
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.
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, & Organizations page.
You can also use MyResearch Training Transcript to look up individual investigators to see their training status.
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
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.
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:
Non-PHS Funded Research: If you are an Investigator who participated ONLY in non-PHAS Funded Research, you will need to disclose the following:
No. Travel disclosure is not required if the travel funding is paid via a UW budget (e.g., sponsored award, gift, discretionary funds).
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.
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.