Manufactured & Fabricated Devices

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 糖心传媒 personnel (faculty, staff or students) are:

1.manufacturing or fabricating a new device; or
modifying a commercially available device

AND

2. transferring the device to non-Marquette personnel.

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?

  1. NOTE: Approval is required prior to the transfer of devices.
  2. Complete the Device Safety Advisory Board Review Form (DSAB)
  3. The faculty adviser must submit the DSAB form to Ben Kennedy at benjamin.kennedy@mu.edu. The 鈥渟ubmitter鈥� should be cc鈥檇 in that email.
  4. Subject line must read 鈥淒SAB for [submitter鈥檚 name]鈥�
  5. If available/applicable, attach the following:
  • Project Definition Document (for senior design students)
  • Detailed device information, including photographs or drawings
  • Manufacturer鈥檚 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
  1. 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.
  2. After inspection/review, you may be required to make modifications to your device prior to final approval for transfer.
  3. If you plan to transfer your device to an individual external to Marquette, you are 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.
    Zilber Hall, 435
    Milwaukee, WI 53233
    Phone: (414) 288-1532

Whom do I contact if I have questions?

Contact Ben Kennedy, benjamin.kennedy@mu.edu, at (414) 288-1479 if you have questions.