Types of IRB Review
Whether you are begining a new Full Board Study or preparing for continuing review, the following guidance will aid you in submitting your application to the IRB.
Not Human Subjects Research (NHSR) Guidance
Research that does not meet the federal definition of “human subjects” or “research” is referred to as “Not Human Subjects Research” or “NHSR”
Exempt Study Guidance
Study must meet one of the federal exemption categories and present no more than minimal risk.
- The Exemption Categories: 45 CFR 46.101, Categories (b)(1) thru (b)(6)
- Expedited vs Exempt Studies…perspective of an IRB reviewer
Note: “Exempt” DOES NOT MEAN THE STUDY IS EXEMPT FROM IRB REVIEW.
Expedited Study Guidance
Study must meet one of the federal expedited review categories.
- The Expedited Categories: 45 CFR 46.110, Categories #1-9
- Expedited vs Exempt Studies…perspective of an IRB reviewer
Continuing Review Guidance
The IRB determines the period of approval and frequency of review for all studies involving human subjects research. If an investigator intends to continue the study beyond the period for which it was approved, then the investigator must complete a Continuing Review application.
Full Board Study Guidance
Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to subjects will receive Full Board Review.
Other Guidance
- Research Coordinator Guidance
- Biomedical Regulatory Binder: Table of Contents
- Biomedical Subject File
- Social Behavioral Study Binder: Table of Contents
- IRB Guidebook (Guidebook for researchers and IRB members)
- Certificates of Confidentiality
- Human Subjects Regulations Decision Charts
- Research Related Professional Ethics Codes and Guidelines(Word Doc)
- Tips for IRB Submissions
- Keeping Out of Legal Trouble -Academic Senate Faculty Guide (PDF)
If you need additional guidance contact the IRB to which you will be submitting your application:
HSIRB Contact Page
UPIRB Contact Page