Institutional Review Board

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:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. 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: 

• Decision Tree 1
• Decision Tree 2

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 student researchers named as a PI or co-PI on a submission must complete the InfoEd training program.

IRB applications must be submitted through the InfoEd system. After a PI submits a protocol through InfoEd, 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. 

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.

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) and IORG is IORG0001657 (expires 6/30/2025). 

InfoEd can be accessed at https://usm.infoedglobal.com/. Your user name is your "w" number @usm.edu (w123456@usm.edu and the "w" must be lowercase) and your USM SOAR password. Researchers not affiliated with USM will not have access to InfoEd. 

If you are unable to access InfoEd, your user information may not be in the InfoEd system. To be added, please fill out the InfoEd Registration Form and at least 3 days for access. If, after 3 days, you do not have access to InfoEd, please contact RISGAFREEMississippi.  

Prior to submitting an application, all student PIs or co-PIs are REQUIRED to complete the InfoEd Training Course. After completing the course, students will receive an email message to convert and upload as a PDF in InfoEd. The InfoEd Training Course is available here. 

Please refer to the following documents for submitting your IRB protocol through InfoEd: 

• InfoEd Training Document - This document corresponds with the InfoEd Training Course and will walk you through how to navigate InfoEd, as well as how to submit/revise an application. 
• InfoEd Quick Start Manual - This provides a basic introduction to InfoEd, including how to access InfoEd and how to create an Initial Application. 
• InfoEd Frequently Asked Questions - This document outlines FAQs about InfoEd. Refer to this document before reaching out for additional help. 
• Approving a Submission in InfoEd - After reviewing an application as a co-PI, Research Advisor, or School Director, you will need to either approve or request revisions to the application. Refer to this guide for instructions. 
• Making Revisions in InfoEd - After submitting your Initial Application, you may receive reviewer comments requesting edits. To address these comments, you will revise your Initial Application. Use this guide to help--do not create a Modification to your protocol. 
• Submitting a Modification in InfoEd - If you would like to make a modification to a previously approved protocol, refer to this guide. 
• InfoEd Training Session Video - The IRB office frequently holds training sessions to walk new students and/or faculty through the IRB process; this video was recorded in September 2022. 
• Reviewing an InfoEd Submission - If you are an IRB reviewer, refer to this guide for instructions. 

The following are sample forms which will need to be modified appropriately for your study and attached to your IRB submission in InfoEd. 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 
  • Online Informed Consent
  • Signed Informed Consent
• Parental Consent and Minor Assent Templates
  • Parental Consent
  • Minor Assent
• Assessment of Consent Capacity in Adults with Decisional Impairment
  • Assessment of Consent Capacity
• Foreign Language Templates
  • Signed Consent Form for Translation
  • Translation Verification Form
• Oral Presentation of Informed Consent Templates
  • Oral Presentation of Informed Consent
  • Witness Verification Form
  • Signed Consent Form for Oral Presentation
• HIPAA-related Templates 
  • Authorization for HIPAA
  • Authorization Waiver or Alteration for HIPAA
• External Permission Letter Template
  • Sample External Permission Letter
• Data Sharing Template
  • Data Sharing Agreement

Federalwide Assurance (FWA) 00002393

Institutional Organizations (IORG) 0001657

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. 
• Faculty First Week 2023: Applying for IRB Approval via InfoEd at USM

USM Policies

• Human Subjects Research 
• Integrity Assurance 
• Scholarly Misconduct

Links

• The Belmont Report
• 28 CFR 46 
• Office for Human Research Protections (OHRP)

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 (601) 266-5997 or: 

Chair of the Institutional Review Board

The University of Southern Mississippi

118 College Dr. #5116

Hattiesburg, MS 39406