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Human Subjects Division (HSD)

Announcements

UW IRB policy about significant financial interest

Dec 6, 2010 at 1:47pm

Implementation date:  12-2-10

A new policy and procedure is being implemented to address significant financial interests in research, as defined by UW Policy GIM 10,  and other possible types of research conflicts of interest.  The policy and procedure are posted on the HSD website, as a document entitled "Researcher Conflict of Interest."

The policy statement is:

Researchers are required to disclose to the IRB any potential conflict of interest with respect to a human subjects research activity, including any significant financial interest.  A significant financial interest of any member of the research team shall be disclosed to the subjects through the consent process, unless consent is not required (exempt research) or has been waived by the IRB.  For research that uses a consent form, the disclosure requirement is fulfilled by the Financial Interest section of the consent form (for all consent forms approved after December 31, 2010).

The requirements of a Significant Financial Interest (SFI) Management Plan from the UW Office of Research shall be incorporated into the research before the IRB can grant full unconditional approval or HSD can grant exempt status for the research.  The IRB or HSD may impose additional requirements to mitigate or manage financial or other potential conflict of interest if it feels that the researcher's plans and the SFI Management Plan are not sufficient.  This policy applies to all human subjects research activities, regardless of level of IRB review, type of research, or source of funding.