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IRB Submission Process
Anyone affiliated with AUM who is using AUM resources (participant pool, facilities, academic process, etc) conducting any phase of human subject research must submit their proposal for research to the Institutional Review Board (IRB). The proposal for research must be submitted on the IRB Protocol form. This form is a fillable word.doc with expandable response boxes. The protocol must be submitted with all necessary attachments (survey instruments, CITI completion reports, Informed Consent documents, signatures, etc).
CITI Training
All members of the research team and faculty/department personnel signing the protocol must complete CITI training prior to submission and these CITI completion reports must be attached to the protocol.
CITI Training FAQ
Collaborative Institutional Training Initiative is an online training program for principal investigators and their research teams. Over 18,000 institutions are subscribed to CITI. Human Subjects Research from CITI provides foundational training in human subjects research and includes the historical development to human subjects protections, ethical issues, and current regulatory and guidance information.
The Researcher or Principal Investigator, Co-Investigators, all research team members, and anyone else handling the data or interacting with research participants.
Compliance is one reason for this training, however, it is important that all research be conducted in an ethical manner and that students of all levels should learn ethical research principles. It is a part of the institutional mission to educate students (and faculty). Graduates should understand research ethics because they might one day be a participant in a study, or conduct studies themselves.
Finally, AUM has Federalwide Assurance from the Office of Human Projections in Research (under Health and Human Services). A requirement of Federalwide Assurance is to train our researchers. CITI is an approved training provider under OHPR’s regulations.
Without Federalwide Assurance AUM cannot qualify for funded research.
CITI certification is valid for 5 years at AUM. Each institution can set their own parameters. At the end of 5 years researchers must retake the course.
CITI training is transferable to other universities.
Yes. The option to CITI’s human subjects in research training is NIH training.
The university pays for the annual subscription. There is no charge to students, faculty, or staff of AUM to take the courses.
Yes, as long as the date is valid. You must provide the IRB with a copy of the completion report from CITI or NIH.
IRB Submission
IRB Protocol Form
All researchers conducting research with human subjects, or their data, must complete this document and submit to the IRB Administrator. The researcher (PI :Principal Investigator) submits 3 hard copies. Documents must be typed. All questions answered in complete sentences, include all necessary attachments, and obtain all signatures.
Additional Researchers
This form maybe be used as an attachment to the IRB Protocol Form when the project includes more research team members than can be listed on the IRB Protocol Form.
Request for Exemption
The “exempt” category does not mean that a project is exempt from IRB review. The AUM IRB will review the project and determine if it fits in this category (or expedited or full board review). The PI may request exemption through use of this form. Survey instruments and any other instruments will still need to be included as attachments. See Policies and Procedures for definition of Exempt research. Submit a single hard copy to the IRB Administrator.
Request for Modification
Any modification to the project must be requested prior to implementation in the study. These changes may effect the risk or benefits to the participants. Modifications include, but are not limited to recruitment, consent process, targeted population, scope of study, change of team members. Send by email or hard copy to the IRB Administrator.
Request for Continuing Review
The IRB will conduct continuing review of projects that last longer than 12 months. The PI will need to complete a Request for Renewal and document all progress and any changes. Submit at least 2 weeks prior to scheduled end of project. Send by email or hard copy to the IRB Administrator.
Guidance & Resources
Templates & Sample Forms
Sample IRB Protocols
Examples of previously submitted approved protocols
