Human Subjects Research (IRB)
Human Subjects Research includes any data collected on humans for scientific purposes. Data collections for administrative or pedagogical purposes are not included.Review of Human Subjects Research is mandated by the National Research Act (PL 93-348) and implemented by Federal Regulations (45 CFR 46). The research of faculty, staff, and students involving human subjects requires review. A university that is not in compliance with the law could lose federal funding of its programs.
The Institutional Review Board (IRB) reviews Human Subjects Research. Members of the committee come from a variety of disciplines including one member whose primary concerns are nonscientific and one member who is not affiliated with the University.
Required Human Subjects Training
All Investigators engaging in human subjects research are required to have current CITI Human Studies Training. If your training has expired, you will need to complete the refresher training via CITI. The CITI training is good for 3 years and once that time is up, Investigators will be required to take the refresher training. To access the CITI training:
- Log into eCompliance using your SSO and password.
- Select the Institutional Review Board module.
- Under the Prerequisites column, click on "Take IRB training".
- Sign into the CITI Program using your SSO and password.
- The instructions for how to select the correct training in CITI are provided here and eCompliance. eCompliance is synced with the CITI program and CITI updates eCompliance within 24 hours with your training course and dates. Your training date will auto-populate within the eCompliance system.
eCompliance Templates
Protocol Templates - Only for Expedited and Full Board Projects
Exempt Projects only
Expedited and Full Board Consent and Assent Templates
- Social Behavioral Educational Consent
- Social Behavioral Educational Consent with Waiver of Documentation
- Biomedical Consent
- Supplemental Consent Language for Social Behavioral Educational Consent
- Assent
HIPAA Templates
eCompliance Submission Help
eCompliance Quick Reference Tool - This guide gives you a detailed view of the eCompliance IRB submission system. It explains how to log in, the features of the system, and explains the various form choices in detail.
UMSL IRB Submitter Training - If you missed the training that was offered for your department on the transition to eCompliance, view the slides here. This training provides information on the new IRB submission system, the forms, how to begin a new IRB application, and how to transition your project.
Guidance Documents
- Additional Protections for International and Non-English Speaking Participants
- Benign Behavioral Interventions Guidance
- External Researcher Guidance
- IRB Definition Guidance
- Quality Improvement Guidance
- Student Research and Class Projects
IRB Meetings
The UMSL IRB meets the 3rd Thursday of each month. Applications for FULL Committee review must be received by the IRB 10 days before the scheduled meeting of the respective month (no exceptions). All submissions must be made electronically through eCompliance. Only research requiring Full IRB review will be reviewed at the IRB Committee Meetings. Research meeting the qualifications for Exempt and Expedited review are reviewed on an ongoing basis in the office.
2024 Full Board Meeting Dates and Deadlines
2025 Full Board Meeting Dates and Deadlines
UMSL IRB Registrations & Approvals
You can search the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) Database for Registered IORGs and IRBs and Approved FWAs by IORG number, FWA number or IRB registration number (see below):
- Institutional Review Boards (IRBs) are operated IRB Organizations (IORGs). An initial registration with OHRP registers both the IORG and its IRB or IRBs. UMSL's IORG number is "0000445."
- Federalwide Assurance (FWA) for the Protection of Human Subjects ( more info on OHRP rules and regulations). UMSL's FWA number is "00000011."
- UMSL's IRB Registration number is "00000756."
More Information & Resources
- FAQs
- DHHS Office for Human Research Protections (OHRP)
- DHHS booklet: " Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule"
- Federal Regulations on the Protection of Human Subjects (45CFR46)
- NIH Statement on Required Education on the Protection of Human Research Participants
- PHS Office of Research Integrity