Institutional Review Board (IRB)

Tips for Submitting a Successful Protocol:

We strive to ensure every researcher has a good experience with the IRB. We want your application to be successful from the start and have developed the tips below to assist you in writing and submitting a successful IRB application.

1. Start early and submit early. Refer to the timetable below and the IRB Checklist to get started.
   1. Each research team member must electronically sign the protocol before it can be submitted for review.
   2. Before review, all protocols require approval from the department/division chair or dean.
2. All forms and templates can be found below under the IRB Forms header. Please use only SU-provided forms to avoid delay.
3. All PIs, Co-PIs, and faculty advisors must complete Collaborative Institutional Training Initiative (CITI) Program training before the Institutional Review Board will approve any protocol. CITI training should be completed before submitting a protocol for review. CITI Training is valid for three years following successful completion of required modules. 
4. Clearly describe the informed consent (and/or minor assent) process. A copy of the informed consent form (and/or minor assent form) must be included in your submission. If informed consent will not be obtained, clearly document the procedures that will be used to protect human subjects and request a waiver of informed consent (note: approval of an informed consent waiver is rare).
5. The informed consent form must be written in language that the subject population can easily read, and the use of jargon or technical language should be avoided. It is suggested that the informed consent form should be written at no higher than an 8th-grade reading level and in the second person (e.g. you, your, yours).
6. The completed protocol application must include anything being used to gather data from participants, such as:
   1. surveys,
   2. questionnaires,
   3. assessments,
   4. assignments,
   5. interview questions,
   6. focus group questions,
   7. electronic safety check memos, 
   8. and other relevant documentation 
7. Submissions will be considered incomplete if all documentation is not included in the initial submission, which will delay the review process.
8. The protocol must include all recruitment materials, such as:
   1. advertisements,
   2. flyers,
   3. email invitations,
   4. letter invitations, 
   5. and other relevant recruitment materials
9. If you are conducting research at a non-SU site, permission is required from each site on their letterhead and signed by the site facilitator, school principal, school superintendent, etc. before approval will be granted.
10. Only electronic submissions in Sitero Mentor will be accepted. All other paper or emailed versions will automatically be returned to PIs to submit electronically.
11. Student protocols will not be reviewed until the faculty advisor has approved the submission in Sitero Mentor. Advisors will be electronically notified of the submission and are responsible for timely acceptance/denial.
12. Do not begin your research until you receive approval from the IRB. In most cases, an official stamped and approved copy of the informed consent form will be emailed to the PI. The stamped and approved copy of the informed consent form should be the only copy provided to potential subjects and participants.

All primary investigators (PIs), Co-PIs, faculty advisors, and department/approving chairs of PIs planning to conduct studies are required to attain Collaborative Institutional Training Initiative (CITI) certification in Human Subject Research. Certification information is kept on file per compliance regulations and accessed when a protocol is submitted. Certification needs to be renewed every 3 years. A Help File for registering and enrolling in CITI courses is available through the Center for Teaching, Learning, and Technology (ctlt@su.edu). 

To complete CITI Certification:

1.     See the Completing CITI Certification or CITI Certification Renewal help file to start.
2.     Visit www.citiprogram.org.
3.     Be sure to save your CITI registration information for future reference.
4.     To complete your certification, click the Main Menu and follow the instructions.
5.     When you complete the course, save your certification for your records.
6.     Your certification information will be accessed automatically by Sitero when you submit a research protocol.

A help file is available from the Center for Teaching, Learning, and Technology at ctlt@su.edu.

Please use the forms below when submitting your documentation to the Axiom Mentor system.

• IRB Checklist 2018
• IRB Decision Charts
  • The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. 
• Application for Use of Human Subjects in Research SAMPLE (example; questions must be answered online in Sitero Mentor) 
• Informed Consent Revised July 2022
• Minor Assent Template Revised July 2022
• Survey Consent Template July 2022
• Electrical Equipment Safety Check Memo July 2022
• Request for Amendment Form C July 2022
  To request an amendment/modification to previously approved protocols, complete this form and upload it to the Amendments tab of Sitero Mentor.

If you have any questions about whether or not your project needs to be evaluated or how to go about IRB submission, please contact your IRB representative below:

Administration: Karen Abraham, Beth Rogers (Compliance Coordinator)

Arts and Sciences: Scott King, Kim Newberry, Kim Orrell

Education & Leadership: Sarah Daniel, Karen Huff

Business: Clifford Thies

Conservatory: Anthony Meadows

Community: Polly Porter, PA-C

Nursing:  Melissa Dixon

Pharmacy: Sean Kim, Katerina Petrov

Health Professions: Lindsay Carroll, Morgan Luck, Kim Pritchard (Interim IRB Co-Chair), Morghen Sikes (Interim IRB Co-Chair)

IRB Timetable

The expected turnaround times for the IRB committee to process applications are as follows**:

• Exempt – 2-4 weeks
• Expedited – 3-6 weeks
• Full review – 6-8 weeks

**Assuming that the proposals are complete and no major revisions are requested. Please allow enough time for review.

IRB Related Links

• U.S. Department of Health & Human Services (HHS) Office for Human Research Protections

• DHHS Federal Regulations–45 CFR 46 – Protection of Human Subjects

• HHS: Expedited Review Categories

• Guidelines on the Inclusion of Women and Minorities in Research

• Inclusion of Children in Research

• Research Involving Individuals with Questionable Capacity to Consent

• Office of Civil Rights (OCR)

• HIPAA-Health Information Privacy for Research

• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research 

2023 IRB Manual