Human subjects research or educational activities involving the physical interaction of human beings, other than exclusively faculty or enrolled students, with manufactured devices (a) that have not been commercially obtained by the university or (b) that have been modified by university personnel or students for use are subject to the device safety review process as guided by UPP 2-3.
When is Device Safety Review required?
Device safety review is required if Marquette University personnel (faculty, staff, or students) are:
i. are manufacturing or fabricating a new device; or
ii. modifying a commercially available device
i. transferring the device to non-Marquette personnel; or
ii. testing the device on non-Marquette personnel; or
Access the decision tree and definition of human subject and research for additional guidance.
I've determined that I need Device Safety Review. Now what?
- NOTE: Approval is required prior to any testing or transferring of devices.
- Complete the Device Safety Advisory Board Review Form (DSAB)
- The faculty advisor must submit the DSAB form to Ben Kennedy at firstname.lastname@example.org. The “submitter” should be cc’d in that email.
- Subject line must read “DSAB for [submitter’s name]”
- If available/applicable, attach the following:
- Project Definition Document (for Senior Design students)
- Detailed device information including photographs or drawings
- Manufacturer’s device electrical/mechanical safety documentation (for devices being modified)
- Electrical Safety Testing documentation
- Any other documentation that would assist the Device Safety Advisory Board to determine the level of risk posed by the device
- If review/inspection by the Device Safety Advisory Board is required, the Office of Research Compliance (ORC) will contact the Submitter to coordinate an inspection time and date.
- After inspection/review, you may be required to make modifications to your device prior to final approval for testing/transfer.
- If you plan to transfer your device to an individual external to MU, you may be required to complete the Release and Indemnity Form.
- Click here for the Appendix A template. The template should be used in conjunction with the Release and Indemnity Form.
- The recipient should receive a copy of Appendix A.
- Once the form has been notarized forward the original to: Ms. Melody Baker, on behalf of Dr. Jeanne Hossenlopp.
Holthusen Hall, room 305
Milwaukee, WI 53233
- If you need a Notary Public, contact Dr. Dean Jeutter (email@example.com)
Who do I contact if I have questions?
Contact Ben Kennedy, firstname.lastname@example.org, at (414) 288-1479 if you have questions.