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  • Revised GIM-10 and GIM-7 are final Aug 30, 2012 at 1pm

    Dear Colleagues:

    GIM-10 and GIM-7, http://www.washington.edu/research/osp/gim/gim10.html and http://www.washington.edu/research/osp/gim/gim7.html, respectively, are now revised to ensure compliance with the new Public Health Service (PHS) Financial Conflict Of Interest (FCOI) regulations. 

    Investigators are expected to be in full compliance of the revised GIM-10 as of August 24, 2012. Implementation systems and processes, such as the Financial Interest Disclosure System (FIDS) and FCOI training can be accessed through the FCOI Website:  http://www.washington.edu/research/topics/fcoi.  While the revision of UW policies and development of a new disclosure system were required for the UW to be compliance with PHS regulations, we recognize that we need feedback to best convey disclosure system and policy-related information effectively. We welcome your comments and questions to help us reach this goal through contacting the Office of Research: research@uw.edu.

    To stay apprised of system and process enhancements, please continue to periodically review the FCOI Website:  http://www.washington.edu/research/topics/fcoi

     

    Sincerely,

    Jeff Cheek, Ph.D.
    Associate Vice Provost for Research Compliance & Operations
    Office of Research

     

    cc:
    DDC (release date 8/30/2012)
    All Key Personnel (release date 8/30/2012)
    MRAM (release date 8/30/2012)

  • SFI disclosure policy information and new SFI disclosure tool Aug 21, 2012 at 10am
    Dear Colleagues: The main purpose of this email is to inform you of the Significant Financial Interest (SFI) disclosure policy and to announce the availability of the Financial Interest Disclosure System (FIDS). FIDS replaces the existing paper-based system (as described in the current version of GIM-10) to submit SFI disclosures. Investigators must now use FIDS to electronically submit their SFI and travel disclosures. Please note that eGC1s that are created on 8/17/2012 or later will automatically pull information from FIDS and the paper based process will no longer apply. * The definition of an “Investigator” includes the Principal Investigator (PI) and any other University person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research; changes to the eGC1 form in SAGE will permit the PI to identify which key personnel meet this definition on new proposals.

    Who should disclose and when?

    1. SFI Disclosures by Investigators
      1. Public Health Service (PHS)-funded Investigators are required to disclose all SFIs that are related to their institutional responsibilities, no later than submission of an application for PHS-funded research or, if during an ongoing research project, within thirty (30) days of acquiring the SFI.
      2. Non-PHS-funded Investigators are required to disclose only those SFIs that are related to their research, and no later than submission of an application for the related research; or if during an ongoing research project, within thirty (30) days of acquiring the SFI.
      3. For ongoing research projects –
        1. All Investigators shall submit SFI Disclosures within thirty (30) days of acquiring any new or increased SFI, and;
        2. When a new Investigator joins an ongoing research project, the new Investigator shall submit SFI Disclosures within thirty (30) days of joining the project.
        3. Investigators who haven’t submitted any new disclosures within twelve months of an initial disclosure will be prompted to update their disclosure status (i.e., an Annual Update is required unless an investigator’s record is otherwise refreshed).
      4. All Investigators who receive funding on or after August 24, 2012, even if they previously disclosed SFI through the paper process, will be required to re-disclose SFI through FIDS to ensure that their SFI is accurately reported to the Office of Research and OSP.
      5. Investigators with existing awards (i.e., awarded before August 24, 2012) will not need to re- disclose SFI through FIDS for their currently funded awards. However, they will be required to use FIDS to capture SFI disclosures on future proposals.
    2. Travel Disclosures
      1. PHS-Funded Investigators are required to disclose all travel that is either sponsored by or reimbursed directly to the investigator (i.e., paid by an outside entity), with some exceptions**. Note that travel disclosure does not apply to any travel paid via a University budget. The timing of Travel Disclosures shall be as follows:
        1. At the time of application for PHS-funded research, all sponsored travel and reimbursed travel paid directly to an individual by an outside entity occurring after August 24, 2012 must be disclosed, and;
        2. Thereafter, during the course of the Investigator’s participation in PHS-funded Research:
          1. No more than thirty (30) days after the occurrence of any sponsored travel or reimbursed travel.
          2. If a PHS Investigator is able to reasonably anticipate the occurrence of sponsored travel or reimbursed travel, the Investigator may elect to submit Travel Disclosures up to twelve (12) months in advance of the anticipated travel. Unless an advance Travel Disclosure becomes materially inaccurate, no further disclosure of such travel shall be required.
      2. ** Exceptions include: travel reimbursements from an institution of higher education, a federal/state/local government, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. Travel disclosures will be made using the electronic disclosure system. This disclosure requirement does NOT apply to funding provided to the investigator via the UW (e.g., as part of sponsored research projects; use of departmental discretionary or gift funds).
      3. Non PHS-funded Investigators shall submit Travel Disclosures through FIDS in accordance with the following:
        1. Non-PHS-funded Investigators shall disclose sponsored travel and reimbursed travel from an entity if:
          1. Either solely or when aggregated relative to the same outside entity, with the value of compensation, equity or intellectual property, the total value constitutes an SFI (for more details, see the Financial Conflict of Interest (FCOI) website), and;
          2. The SFI is related to their specific current or proposed research project.
        2. All Travel Disclosures that meet the threshold for SFI for Non-PHS-funded Investigators must include an estimate of the approximate value of the travel.
    3. Disclosures by Innovators
    4. When an Innovator has an SFI related to a technology transfer transaction, the innovator shall disclose the SFI prior to the conclusion of the technology transfer transaction. All SFI Disclosures related to technology transfer transactions shall be submitted by innovators. The University’s Center for Commercialization (C4C) will be responsible for identifying innovators and ensuring that innovators who have an SFI related to the proposed technology transfer transaction submit SFI Disclosures.

    How do I access FIDS?

    The FIDS website (http://uw.edu/research/tools/systems/fids) can be accessed by anyone with a UW NetID. The following information is available on the FIDS website:
    • The Financial Interest Disclosure System (FIDS)
    • Training on how to use FIDS
    • The FIDS User Guide
    • System and policy-related FAQs

    How do subrecipients comply?

    All subrecipients of PHS awards must have their own FCOI compliant policy in place and make an assurance in the subaward (or subcontract) to this regard. Reminders to the PI and eGC1 contacts regarding this requirement will be sent by OSP at proposal stage, JIT and award stage for PHS-funded projects in which subrecipients are proposed. An example of a PHS-compliant FCOI policy for potential adoption by subrecipients that do not yet have their own policy has been provided by the Federal Demonstration Partnership (FDP): http://sites.nationalacademies.org/PGA/fdp/PGA_061001

    When will the revised policy be available?

    GIM 10 and GIM 7 will be revised to ensure compliance with the new PHS FCOI regulations and will be posted on the FCOI website by August 24, 2012. We’ll keep you updated using email and the FCOI website: http://www.washington.edu/research/topics/fcoi. If you have any questions, please contact the Office of Research at: research@uw.edu. Sincerely, Jeff Cheek, Ph.D. Associate Vice Provost for Research Compliance & Operations Office of Research
  • 6/6 New Financial Conflicts of Interest Training Module is Available Aug 8, 2012 at 3pm
    Dear Colleagues: The online Financial Conflicts of Interest (FCOI) training, which will be mandatory for all PHS-funded investigators* as of August 24, 2012, is now available at: http://uw.edu/research/fcoi. *The definition of an “investigator” includes the Principal Investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research; upcoming changes to the eGC-1 form in SAGE will permit the PI to identify which key personnel meet this definition on new proposals. Who should take the training and when:
    • Public Health Service (PHS)-funded investigators (including those investigators anticipating receiving PHS awards after August 24, 2012) must complete online FCOI training prior to the expenditure of funds on any project awarded on or after August 24, 2012.
    • Current PHS awards are not subject to these new requirements until the next noncompeting continuation award is funded (i.e., if the continuation grant is awarded after August 24, 2012).
    • The mandatory training requirement applies only to PHS-funded investigators as of August 24, 2012.
    • This mandatory training must be re-taken at least every four years.
    How to access and track training:
    • Investigators log in to the FCOI training module (http://uw.edu/research/fcoi) using their UW NetIDs.
    • Training completions will be recorded automatically. Completion records will be made available to the Office for Sponsored Programs (OSP) for verification of Investigator compliance with the mandatory training requirement (which will be required before new awards can be released after August 24, 2012).
    • Training must be completed before new awards are processed.
    Further implementation processes to ensure compliance with the new regulations are still under development. We’ll keep you updated between now and August 24, 2012, using email and the FCOI website, http://uw.edu/research/fcoi. If you have any questions, please contact the Office of Research: research@uw.edu. Sincerely, Jeff Cheek, Ph.D. Associate Vice Provost for Research Compliance & Operations, Office of Research