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Human Subjects Division (HSD)

Announcements

New section in consent form

Dec 6, 2010 at 1:52pm

Implementation date:  1-1-11

Purpose.

The purpose of the new section is to implement the new policy about significant financial interest (see announcement on SFI Policy).

Description.

A new section called Financial Interest has been added to the UW Consent Form Template.  It is required when any member of the research team has a significant financial interest, as defined by UW Policy GIM 10.  If no one has a significant financial interest, the section may be omitted.   The consent form must disclose of the existence of a significant financial interest but not the monetary value of the financial interest.  The consent template provides short descriptive language to use for specific types of financial interest.

New research.

All consent forms approved after December 31, 2010 must have this new section, if applicable.

Existing research.

The Financial Interest section must be added to the already-approved consent forms of ongoing research, if applicable.  This may be done at any time (such as when a Modification is being submitted for another purpose) but will be required at the time of the next Status Report if the issue has not already been addressed.   In some cases, the IRB may contact the research team and require the consent form revision before the next Status Report.   Though this revision will generally not require re-consenting of already-enrolled subjects who are still actively participating in a study, the IRB will use its judgment to determine whether the financial interest information should be communicated to such subjects. 

Questions?  Consult hsdinfo@uw.edu or one of HSD's IRB Administrators.