Campus

 

 

Introduction

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.pdf

When is Device Safety Review required?

Device safety review is required if Marquette University personnel (faculty, staff, or students) are:

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

AND

2. i. transferring the device to non-Marquette personnel; or
ii. testing the device on non-Marquette personnel; or

Access the decision treeWord Icon and definition of human subject and researchWord Icon for additional guidance.

I've determined that I need Device Safety Review. Now what?

  1. NOTE: Approval is required prior to any testing or transferring of devices.
  2. Complete the Device Safety Advisory Board Review Form (DSAB)Word Icon
  3. The faculty advisor must submit the DSAB form to Ben Kennedy at benjamin.kennedy@mu.edu. The “submitter” should be cc’d in that email.
  4. Subject line must read “DSAB for [submitter’s name]”
  5. If available/applicable, attach the following:
  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 testing/transfer.
  3. If you plan to transfer your device to an individual external to MU, you may be required to complete the Release and Indemnity Form.

Who do I contact if I have questions?

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



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Schroeder Complex

Mission Statement

The mission of the Office of Research Compliance, in cooperation with and in support of the Institutional Review Board, Institutional Animal Care and Use Committee, Radiation Safety Committee, and Institutional Biosafety Committee, is to facilitate safe and ethical research conducted by Marquette faculty, staff and students in the areas of human subjects, animal subjects, radiation safety and biosafety.