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Institutional Review Board

HIPAA Applicability & Forms

HIPAA Applicability: Does HIPAA apply to your study?

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.

If HIPAA applies to your study you will need to:

1. Familiarize yourself with the HIPAA material in the Policies and Procedures Manual,
2. Complete a tutorial certifying your knowledge of HIPAA material, and
3. Include a HIPAA Authorization Form or the Application for use or disclosure of PHI without HIPAA Authorization form in your IRB application.

HIPAA Guidance from the Policies and Procedures Manual

HIPAA policies and procedures also are printed in the Protection of Human Particpants in Research: Policies & Procedures Manual.  The entire Manual may be obtained at http://www.pepperdine.edu/irb/policies/.

• What is HIPAA?
• HIPAA Authorization
• Use and Disclosure of PHI without HIPAA Authorization

HIPAA Forms

• HIPAA Authorization Form #1
• HIPAA Authorization Form #2
• Revocation of HIPAA Authorization Form
• Application for use or disclosure of PHI without HIPAA authorization