Obtaining Regulatory Approvals
Significant Financial Interest (SFI)
Prior to submitting a proposal, PIs are required to determine whether any participants on their projects have Significant Financial Interest (SFI), or stand to profit from the project aside from UW salary. If financial interest exists, and it’s significant, complete the GIM 10, Exhibit 1 form and process.
Is it Financial Interest?
Put simply, financial interest is the potential for any project participants or their immediate families to profit from the following as a result of the project:
- Non-UW Compensation within the past 12 months, the coming 12 months, or during research.
- Equity in a related enterprise (For example from ownership interest such as stocks.)
- Intellectual Property interest within the past 12 months, the coming 12 months, or during research.
Is it Significant?
UW requires the submission of an SFI form only when certain thresholds are met, making the financial interest significant. In the GIM10, these thresholds are described as:
- For a Clinical Trial, ANY Financial Interest.
- For Human Subjects Research other than a Clinical Trial (i) any Financial Interest exceeding $5,000 in value, (ii) any Equity Interest; or (iii) any Intellectual Property Interest.
- For all Research other than Human Subjects Research and all Technology Transfer Transactions, (i) any Financial Interest (including a Compensation Interest, an Equity Interest and an Intellectual Property Interest) exceeding $10,000 in value, or (ii) any Equity Interest representing more than a 5% ownership in any single entity.
Source: GIM 10
Steps to Take:
If SFI exists, send the following to RGA:
- The completed, signed GIM 10, Exhibit 1 form, and
- A sealed letter describing the work you've performed and the amount / types of compensation you've received.
We'll oversee subsequent signatures and include this documentation in the proposal package that goes to the Dean, School of Medicine. The fully approved package will then be forwarded to OSP.
Other Considerations
Human Subjects Division
Guidelines on obtaining Human Subjects approval via the Institutional Review Board (IRB)
IACUCGuidelines on obtaining approval for use of animal subjects
EHSGuildelines on research involving environmental hazards
Grants Information MemosComprehensive list of UW policies and procedures pertaining to grants and contracts
