Protocol Submission Forms
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Request for Determination of Human Subjects Research
The Request for Determination of Human Subject
Research Form is in Word. However, all protocol
submission forms are in pdf format and must be
completed using Adobe Acrobat. Researchers should
always download forms from this website to ensure
that they have the most current version. Prior
versions will not be accepted.
Request for Determination of Human Subjects Research:
Stem Cell Research
A request for determination as to
whether a project is "research" or involves "human subjects" can be
made to the IRB by completing and submitting this form. All official
IRB determinations of "human subjects research" must be submitted
and reviewed in this manner. This process is not required if the
Researcher has already determined that their project is human
subject research which requires IRB approval.
An IRB shall conduct continuing review of research
covered by this policy at intervals appropriate to the degree of risk,
but not less than once per year, and shall have authority to observe or
have a third party observe the consent process and the research. 45 CFR
Request for Modification
modification to the recruitment, consent process, or procedures must
undergo IRB review prior to implementation into the study. Changes
to procedures may change the risk or benefits to the participants.
Researchers must file a final report after all
research data from the project has been collected and analyzed.
Note: Renewals should be filed as long as the researcher maintains
identifiable data. After identifiable data is destroyed and all
data is anonymous, a final report can be filed. Limited exceptions