Definitions Archives - FIDS

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

breona — Fri, 10 Aug 2012 22:11:31 +0000

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 Institutional Review Requited (IRR) Research, this SFI should be disclosed if the Equity interest is related to the Investigator’s Institutional Responsibilities.
For Non-IRR 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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When must an Investigator disclose SFI that is unrelated to their current research project?

breona — Fri, 10 Aug 2012 22:06:50 +0000

Example: an Investigator receives Institutional Review Required (IRR) 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 , Investigators participating in IRR-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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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?

breona — Fri, 10 Aug 2012 21:55:39 +0000

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 91̽��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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