Auburn University
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Protocol Submission Forms

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Protocol Form
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.
Request for Renewal
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 46.109(e)
Request for Modification

Any 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.

 
Final Report Form

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 apply.