Transcript WSU Financial Conflict of Interest (FCOI) Training

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Why are you reading this?
Both the Public Health Service and the National Science Foundation require WSU
to provide all investigators training related to Financial Conflict of Interests.
The University must be able to provide evidence that such training programs
exist and be able to document that investigators have completed the required
programs.
For more detail on the federal regulations, please see:
NIH – 42 CFR Part 50 Subpart F – Promoting Objectivity in Research
NSF - Award and Administration Guide: Chapter IV – Grantee Standards
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How has WSU implemented these regulations?
WSU’s Regulation on Financial Conflict of Interests (WSU Regulation 3-28) has
been revised to meet the PHS disclosure requirements.
Investigators need to review this brief information module and:
Investigators applying to Public Health Service agencies such as the National
Institutes of Health, Health Resources and Service Administration, etc., and certain
private sponsors that use PHS Regulations such as the American Heart Association,
American Cancer Society, etc. are also required to complete the more comprehensive
NIH FCOI Tutorial and submit a certificate of completion to the Grants & Sponsored
Projects Office.
Investigators applying to the National Science Foundation are also required to
complete a training module on the Responsible Conduct of Research. That module
is available at the University of Illinois Ethics Resource Center. WSU can confirm
completion by accessing their data base.
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Who is covered by this regulation?
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An “investigator” at WSU is defined as:
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Project Director
Principal Investigator
Any person responsible for the design, conduct, or reporting of research
Subgrantees, consortium participants, collaborators, or consultants (Note that
individuals employed by institutions of higher education should complete the training
programs offered at their home institutions.)
“Research” at WSU involves:
◦ Basic and applied research
◦ Product development
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What is covered?
“Significant financial interests” exist if -- from entities related to the research
-- you (and your family members) have received (in the last 12 months):
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Income and equity from a publicly-traded entity over $5,000
Any income or equity from a private (non-publicly-traded) entity
Payments for intellectual property rights over $5,000
Travel reimbursements from any entity (not including WSU)
“Significant financial interests” are NOT:
◦ Any payments from WSU
◦ Any income from seminars, lectures, teaching engagements, service on advisory
committees, service on review panels or travel reimbursements supported by any
government agency, institution of higher education, or medical center
◦ Income from pension funds or investments in which the investigator makes no
investment decisions
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When?
◦ At the time a proposal is submitted
◦ Annually when progress reports are filed
◦ Within 30 days of acquiring of discovering a new COI
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How?
◦ 1. Review this education module and complete the appropriate
◦ 2. For Public Health Service grants, complete the NIH FCOI Tutorial and
submit a certificate of completion to the Grants & Sponsored Projects
Office; OR
For National Science Foundation grants, complete the module available
at the University of Illinois Ethics Resource Center.
◦ 3. Submit a WSU Disclosure Form to the Grants & Sponsored Projects
Office
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Why?
◦ If you have no potential conflicts of interest, the disclosure form will
simply be kept on file in the Office of Grants & Sponsored Projects.
◦ If there are any significant financial conflict of interests, the institution
will work with you to determine the best method for managing those
conflicts to ensure that the conduct of research will be free from bias.
A management plan will be developed which may include:
 Public disclosure when presenting or publishing the research,
 Disclosure to participants for research projects involving human
subjects,
 Appointment of an independent monitor,
 Modification of the research plan,
 Change of personnel or personnel responsibilities
 Reduction or elimination of the financial interest.
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Contact
Brett Ayers
Conflict of Interest Point of Contact
Grants & Sponsored Projects Office
Maxwell 155 - Winona Campus
507-457-5519
[email protected]