IRB Protocol Submission Requirements
No research project can start until written approval by
the Marquette University IRB is received from the Office of Research
Compliance. There are three different types of IRB review based on risk to participants:
The type of review depends on the research project being proposed.
These guidelines will assist Principal Investigators
(PIs
) in selecting the appropriate type
of review. Ultimately, the IRB must decide which type of review
a protocol will require.
If the research project involves collecting data with identifiers
that can be linked directly to individual research subjects (Name,
Social Security Number, Hospital Admission Number, Subject Number,
Address, Phone Number, etc.), then the research project does
not
qualify for Exemption and the investigator must submit the project
for Expedited or Full Board review.
Definition of Human Subject
"Living Individual(s) about whom an investigator (whether
professional or student) conducting research obtains (1) data
through intervention or interaction with the individual, or (2)
identifiable private information." Federal Policy 46.102
(f)
Definition of Research
"A systematic investigation, including research development,
testing, and evaluation, designed to develop or contribute to
generalizable knowledge." Federal Policy 46.102 (d)
