Use this form to submit a research proposal to the IRB for the Exempt, Expedited, or Full risk levels.
Before submitting, each investigator must have completed CITI training (a copy of the certificate will be uploaded as part of the proposal process). See proposal for more information. After receiving the proposal, a preliminary review is completed by the chair with request for edits back to researcher if required. Once they are received and reviewed again by the chair for completeness, the proposal is assigned to committee members to evaluate if it meets the guidelines set forth by the Department of Health and Human Services for ethical treatment of human subjects.
Please allow at least 1 week for the IRB Chair to provide initial feedback on your proposal (time may vary based on the volume of proposals received in the timeframe) and at least 4 weeks for Committee approval. Committee approval is based upon completeness of proposal submission and revisons, readiness of investigator(s) to respond to edit requests, and level of risk.
While there is no "standard" time frame, as all research proposals are unique, the Committee works expeditiously to move all proposals forward in a timely manner. Requests related to urgency of approvals (deadlines/due dates for grants/funding) and delays responding to IRB requests for revisions are not given priority. All proposals are afforded the same review procedures. Please plan ahead accordingly to meet your external deadlines. Guidance can be found on the SpartanIRB Human Subjects Research Portal on Canvas.
A Non-Human Subjects Research (NHSR) form is an application to formally document that a project does not meet the federal definition of human subjects research and therefore does not require full IRB oversight.
You will be required to submit the following for determination:
Project Title and Personnel: Basic contact information and roles for the research team.
Project Description: A clear summary of the background, objectives, and operational methods.
Data Source Details: Information detailing where the data originates and proof that it lacks personal identifiers.
Intervention/Interaction Check: Confirmation that no physical procedures, surveys, interviews, or private tracking will occur with living humans
Guidance can be found on the SpartanIRB Human Subjects Research Portal on Canvas.
Use this form to update or modify an already approved project. Updates must be limited in scope (e.g., adding a research assistant, modifying the wording of a questionnaire item, or widening your sample). Changes that are larger than that will need to submitted as a new proposal.
An IRB update form (amendment or modification request) cannot be used if the changes fundamentally alter the nature of the research or if the original study approval has expired.
Guidance can be found on the SpartanIRB Human Subjects Research Portal on Canvas.
Many courses include a class project that your students will conduct that involves interaction with humans. These projects allow your students to experience data collection on their own. Some of these class projects may involve IRB approval, but many will not. This form allows you to inform the IRB about projects that do not require the IRB's committee's oversight of the individual projects.
*Do not use this form if you as a researcher are conducting research into a pedagogical technique; you will probably need to fill out the exempt research form for that.
*Use this form only if you are assigning an assignment to your students for them to do their own research, and you need to alert the IRB of that fact.
You only need to submit one form per course assignment per semester. If there are multiple projects being done by different student groups under this same assignment, either describe them more generically (see the example provided on the form), or you may describe the individual projects if that seems more convenient to you. There is a question on the form to indicate how many total projects are being done within the class.
The Office for Human Research Protections (OHRP) does not have a standalone "classroom project policy"; instead, classroom projects are governed by how they fit into the federal definitions of "research"and "human subjects" under the Common Rule (45 CFR 46).
If a class assignment is exclusively designed for educational or teaching purposes, it is generally not considered human subjects research.
Intent: To teach students research methods, survey design, or interview techniques.
Dissemination: Results are restricted to the classroom (e.g., presentations to peers or the instructor) and are never published, presented at conferences, or archived publicly.
Risk Profile: The activity must involve minimal risk, no vulnerable populations, and no sensitive data collection
Guidance can be found on the SpartanIRB Human Subjects Research Portal on Canvas.
Attention: IACUC Chair
Dr. Bridgette Froeschke
Box U
401 W. Kennedy Blvd.
Tampa, FL 33606
iacuc@ut.edu
*Please note if you are submitting this as an "Emergency Submission," i.e. not during the normal cycle. Please send an email to IACUC@ut.edu to explain why the proposal needs to be reviewed out of cycle and when the proposal needs to be reviewd by.
Please use this form to make an amendment to a previously approved IACUC. Please note, this form is not for a completely new project or research experiment, instead it is for a change to an already approved protocol.