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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

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 application

d. Handouts

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

Password Etiquette

Data Encryption 

e. Checklists

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  

h. Frequently Asked Questions

i. Additional IRB forms