SFI Review for Unsponsored Research that Requires IRB Approval
What research requires IRB approval?
- Internally funded or unfunded research activities with an IRB component.
- Collaborative or multi-site research activities relying on an external (non-UW) IRB.
Who needs to disclose?
Any “Investigator” on the study with a related Significant Financial Interest requiring review by the Office of Research.
How do I disclose?
For SFI Review of human subjects research not associated with external funding (no associated eGC1) Investigators will need to submit “IRB Only” FIDS disclosures. These may be created and submitted by following these steps:
- Log in to the Financial Interest Disclosure System (FIDS).
- Click the “Create New Disclosure” button located on the Investigator Profile page, at bottom of the ‘Investigator Details’ box.
- Select the option “I need to make a disclosure for a CoMotion tech transfer agreement or IRB approval.” Click “Next” button.
- Select the option “Human Subjects Activity.” The screen will expand and prompt the Investigator to add: Title, Human Subjects Application Number, and Which IRB(s) will be reviewing your application (if applicable). When complete, click “Next” button.
- Select the option “Yes” for “Does your SFI pertain to this research activity?” (If it is not related, and this research is not PHS-sponsored, disclosure is not required).
- For the question “Do you need to add new SFI or change existing SFI?”
- If an entity needs to be added or edited select the option “Yes” for “Do you need to add new SFI or change existing SFI?”
- To edit an SFI, click the corresponding hyperlink under “Name of Entity” column, make appropriate changes, and click the “Next” button.
- Click “Next” button, skip to step #8.
- Complete Disclosure” page, check boxes next to any related SFI entities, add or edit your Narrative as needed, and click the “Submit Disclosure” button.
- To expedite the review please submit a notification to firstname.lastname@example.org that a disclosure has been submitted and include, when available, the Disclosure ID and Human Subjects Activity Number (e.g. Zipline Study ID).
How do I request review?
Please submit notification to email@example.com that a disclosure has been submitted and include, when available, the Disclosure ID and Human Subjects Activity Number (e.g. Zipline Study ID).
More guidance about FCOI at the University here.