Investigator Resources
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
eProtocol Step-By-Step
HIPAA
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.
Resources
a. IRB Manual
b. New Common Rule
c. Sample IRB applications
Expedited Sample IRB Application
d. Handouts
Guidance on Data Collection via Zoom
Exempt Categories New Common Rule Handout
Expedited Categories New Common Rule Handout
Minimal Risk vs. Greater than Minimal Risk
Establishing Inclusion and Exclusion Criteria
Guidance on the Storage of Sensitive Data
e. Checklists
Principal Investigator (PI) Checklist
All PIs should use this to check off necessary steps before IRB application submission.
All Faculty Chairs and Sponsors should use this to check off chair responsibilities before IRB application submission.
f. Video tutorials
Purpose of the IRB and the application timeline
IRB application process and eProtocol (part 1 and part 2)