WSU Financial Conflict of Interests FCOI Module FCOI

WSU Financial Conflict of Interests (FCOI) Module

FCOI Federal Requirements � 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

WSU Requirements � 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.

WSU Definitions � Who � An “investigator” at WSU is defined as: ◦ ◦ � is covered by this regulation? 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

Financial Conflict of Interest (FCOI) � What � “Significant financial interests” exist if -- from entities related to the research -- you (and your family members) have received (in the last 12 months): ◦ ◦ � is covered? 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

Disclosure Requirements � When? ◦ At the time a proposal is submitted ◦ Annually when progress reports are filed ◦ Within 30 days of acquiring of discovering a new COI � 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

Managing a COI � 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 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.

Questions? � Contact Nancy Kay Peterson Conflict of Interest Point of Contact Grants & Sponsored Projects Office Maxwell 155 - Winona Campus 507 -457 -5519 npeterson@winona. edu