Researchers, whether faculty or students, must protect the rights of their subjects as described in Ethical Research.
Steps
- Determine if your research activities meet the definition of Human Subjects Research as defined by 45 CFR 46.
- If your research activities meet the definition of Human Subjects Research, please complete the CITI Human Subjects training prior to submission (it will help you complete the applications that follow).
- To apply, first determine if your research is eligible for Exemption as defined by 45 CFR 46. Detailed definitions of allowable exempt research activities can be found here.
- If your research activities qualify for exemption fill out the Exempt Research Activities IRB Protocol Application. If your research activities do not qualify for exemption fill out the Non-Exempt Research Activities IRB Protocol Application.
- Attach additional documents required to complete the IRB Protocol Application by following the checklist in the next tab. Additional documents can be found on the Forms and Templates page.
- Submit one electronic copy of the complete IRB Protocol Application package to IRBoard@sou.edu that includes signatures from all investigators listed on the protocol.
Checklist
Include these items with your proposal packet:
- Training certificate from CITI Human Subjects Basic/Refresher within last 3 years (IRB administrator can check CITI training status as long as registered with sou.edu email) for each principal investigator and co-investigator. See Training and Resources.
- Investigator Information Sheet and Additional Investigator Information Sheet as needed.
- Application for IRB Review. Use either the Exempt Research Application OR the Non-Exempt Research Application.
- Any Exempt Category Worksheets that apply (for Exempt Research only).
- Research Plan Narrative (for Non-Exempt Research only).
- Forms that will be used to document informed consent and assent if research activities enroll minors.
- Cover letter and/or script to be used to inform subjects about the nature of the research.
- Copies of surveys, instruments or measures, questionnaires, interview schedules, focus group questions, and/or other materials used to collect data.
Submission
Submit Electronic Copy of Protocol and all checklist items that apply to your research to IRBoard@sou.edu.
Review Timeline
For Exempt applications, please allow 2 weeks for the review and confirmation of exemption.For Non-Exempt applications, please allow 4 weeks for review and determination.
Why would review of my IRB Protocol Application take longer than the times stated above?
- IRB protocol is incomplete. You didn't answer the questions in the application, or you are missing required documents. Revisions will be requested.
- Your IRB protocol lacked sufficient detail and you need to provide more information so the board can assess the research activities and the benefits of the research compared to the risks to the subjects. Revisions will be requested.
- You are still waiting to obtain permission from an organization or insititution to use their employees, staff, students, patients, etc. as the subject population. The IRB cannot approve research activities when permission has not been granted.
- The level of risk to the research subject is greater than minimal and requires more time to review.
- Research activities requiring Full-Board Review will be reviewed when the board can be convened.
Contact Anne Sebanc, Associate Director, Faculty Scholarship Development and Research Compliance for more information.
