Start with the Six Steps to Completing an IRB Application
Investigators START HERE
STEP 1: Determine Level of Review and Type of Application
STEP 2: Complete Human Subjects Training
STEP 3: Familiarize Yourself with eProtocol
STEP 4: Gather the Necessary Materials for Submission
STEP 5: Consult IRB (if necessary)
STEP 6: Submit Your Application
What is HIPAA? HIPAA is the Health Insurance Portability and Accountability Act of 1996. In the IRB context, HIPAA refers to the part of that law dealing with privacy of health and mental health care information and the regulations that the Department of Health and Human Services has issued to implement the law.
Please review the HIPAA Policies, Procedures, and Forms Manual for additional information.
a. IRB Manual
b. New Common Rule
c. Sample IRB application
Exempt Categories New Common Rule Handout
Expedited Categories New common Rule Handout
Minimal Risk vs. Greater than Minimal Risk
Confidentiality vs. Anonymity
Establishing Inclusion and Exclusion Criteria
Guidance on the Storage of Sensitive Data
Principal Investigator (PI) Checklist
All PIs should use this to check off necessary steps before IRB application submission.
Faculty Chair Checklist
All Faculty Chairs and Sponsors should use this to check off chair responsibilities before IRB application submission.
MSOD One-Page Template
MSOD investigators should submit this page as an attachment in the eProtocol application
f. Video tutorials
Purpose of the IRB and the application timeline
IRB application process and eProtocol (part 1 and part 2)
g. Training Presentations
GSBM IRB Presentation
GSEP IRB Presentation
SPP IRB Presentation
SOL IRB Presentation