Office of Research Integrity
Institutional Review Board
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Not all research involving humans qualifies as human subjects research according to federal regulations. Questions about what does and does not require IRB review hinge on two key terms--what counts as research involving human subjects and what counts as research.
Federal regulations define a human subject as "a living individual about whom an investigator conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." [28CFR 46.102(e)(1)].
Research is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." [28CFR 46.102(l)].
Refer to the document available here and to the following Decision Trees for further guidance:
Data collected before formal IRB approval is received may not be used under any circumstances. Non-compliance by faculty may result in censure, suspension of research privileges at the University, removal from graduate faculty status, and/or termination of employment; students will not be allowed to use any data towards fulfillment of degree requirements (Human Subjects Research Policy).
If you are unsure of whether or not your project requires IRB review, contact irbFREEMississippi.
The IRB has the authority to review, approve, disapprove, and request modifications to all human subjects research performed under the aegis of the University.
All investigators must have active (non-expired) human subjects research training certificates, which include the CITI Common Course and the CITI Human Subjects Research Course.
All USM faculty, staff, postdoctoral fellows, and students (undergraduate & graduate) who conduct human subjects research reviewed by the Institutional Review Board (IRB) are required to complete an additional CITI course, Research Security Training (Combined). The course is now available through CITI and must be completed by September 30, 2025.
IRB applications must be submitted through Cayuse. After a PI submits a protocol, all co-PIs will need to approve the application. For student protocols, it will then go to their Research Advisor for approval; faculty or staff protocols will be sent to the Unit Director for approval. After all required approvals have been made, it will be submitted to the IRB for pre-review.
IRB reviewers are USM faculty who volunteer their time in addition to their teaching, research, and other service commitments to the university. Review time varies depending on reviewer availability, the volume of submissions, the type of review needed, and the quality of the application, but expect approximately 3-4 weeks for approval from the time the form is submitted to the IRB. Submissions received close to winter break or during the summer may take somewhat longer. If research procedures will occur in a country of concern, USM's Office of Research Security & Export Control may also need to conduct an ancillary review. It is highly recommended that you obtain IRB approval at least one semester before you plan to begin collecting data.
You will be contacted by the IRB if revisions to the application need to be made. If a submission is sent back, the PI must address all comments and resubmit.
Upon approval, Principal Investigators (PIs) will receive an electronic approval letter from the IRB Chair.
If you are trying to figure out where your IRB protocol is in the IRB process, click here for help.
USM's Federalwide Assurance (FWA) with OHRP is FWA00002393 (expires 10/25/2025), IORG is IORG0001657 (expires 05/30/2028), and IRB Number is IRB00002123.
The Office of Research Integrity is pleased to announce that Cayuse has gone to production and will be live on January 1, 2026. Investigators may start submitting protocols in Cayuse at that time; however, consistent with the university calendar, ORI will be closed until January 5th, so anyone who decides to submit before then who runs into issues or has questions will have to wait a few days.
Additional information on Cayuse is available here.
The following are sample forms which will need to be modified appropriately for your study and attached to your IRB submission in Cayuse. The use of these templates is not required -- they are meant to serve as a reference for what information needs to be included on each document. The templates are updated periodically--please ensure that you are using the most recent version.
- Standard Informed Consent Templates
- Parental Consent and Minor Assent Templates
- Assessment of Consent Capacity in Adults with Decisional Impairment
- Foreign Language Templates
- Oral Presentation of Informed Consent Templates
- HIPAA-related Templates
- External Permission Letter Template
- Data Sharing Template
Federalwide Assurance (FWA) 00002393
Institutional Organizations (IORG) 0001657
IRB Number IRB00002123
As a Federalwide Assurance (FWA) holder, The University of Southern Mississippi is obligated to ensure proper oversight and reporting of incidents related to nonexempt human subjects research approved by the Institutional Review Board (IRB).
The following information must be reported to the IRB:
- any unanticipated problems involving risks to subjects or others;
- any serious or continuing noncompliance with 45 CFR part 46;
- any serious or continuing noncompliance with determinations of the IRB; and
- any suspension or termination of IRB approval.
The IRB will review the reported incident to make sure that appropriate actions are taken to address the incident and generate a report to share with OHRP.
Incidents are to be reported by submitting an Incident form in Cayuse.
Human Subjects Research at USM: Getting Started Handout
Presentations & Workshops
- If you would like for someone from the Office of Research Integrity to provide a presentation or workshop, please use this link to submit an outreach request. Please allow at least two weeks prior to the presentation date to ensure that we are able to cover your request.
Responsible Use of AI Guidelines
USM Policies
Links
For additional Institutional Review Board (IRB) information not found on these pages, or for any questions involving the application process, please call (601) 266-5997 or email irbhelpFREEMississippi.
For questions or concerns about your rights as a study participant, the IRB may be contacted at IRBFREEMississippi%2C (601) 266-5997, or:
Chair of the Institutional Review Board The University of Southern Mississippi 118 College Dr. #5116 Hattiesburg, MS 39406