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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH

HIPAA AND HUMAN RESEARCH


Background

The Health Insurance Portability and Accountability Act (HIPAA), also known as “The Privacy Rule,” set new standards and regulations to protect patients from inappropriate disclosures of their “protected health information” (PHI) that could cause harm to their insurability, employability and/or their privacy. PHI is information that can be used to identify an individual which is created, used, or disclosed in the course of providing a health care service, such as diagnosis or treatment. HIPAA does allow for researchers to access and use PHI when necessary to conduct research. The Committee for Human Research will act as the HIPAA-required Privacy Board to review the use/disclosure of PHI for research.

Effective Compliance Date: As of April 14, 2003, all human subjects research must be in compliance with the Privacy Rule.

  HIPAA Guidance
  •  UCSF Privacy Office
    UCSF HIPAA Policies and Procedures
  •  Data Security
  UCSF CHR HIPAA Decision Tree
  One-Page Guide to HIPAA
  PHI: List of 18 Identifiers and Definition of PHI
  Authorization: Required Elements
  Frequently Asked Questions (FAQs)
  Email and Fax Restrictions for Using PHI
  Abbreviated Recruitment Guidelines
  HIPAA Consent Form Guidance
    Standard Consent Forms Formats and Samples
  Definitions
  HIPAA Forms
    UCSF Forms
  UCSF Subject Authorization for Release of PHI for Research - If submitted in iRIS, attach it under Other Study Documents
   
The UCSF authorization form is available in many different languages. If the language you need is not listed, download the English version and follow these instructions. Click here for more info on obtaining consent and authorization from non-English speakers.
English Polish
Arabic Portuguese - Brazilian
Armenian - Eastern Portuguese - Continential
Armenian -Western Romanian
Burmese Russian
Chinese Spanish
Farsi Tagalog
Hindi Turkish
Korean Urdu
Japanese Vietnamese
   
  Cancellation of Permission to Use Personal Health Information for Research
  Data Use Agreement
     
    SF VAMC Forms
  SF VAMC Authorization for Release of PHI for Research (Updated 11/13) - Submit as an Other Study Document or VA Form in iRIS
  SF VAMC Revocation of Authorization for Release of PHI
   
   

The CHR Application in iRIS includes questions to determine whether HIPAA authorization is needed, or if a waiver of authorization can be granted for the entire study or for recruitment purposes only. Review your approval letter to determine whether or not subjects must sign a HIPAA authorization form.

Authorizations to Be Used at Other Hospitals or Institutions

Other hospitals, medical centers, institutions or clinics will likely have their own versions of the Subject Authorization for access to their own medical records. For example, Kaiser and CPMC and Stanford have their own forms. Those forms will have to be used at their sites, just as the UCSF form must be used at UCSF and the VAMC form must be used at the VAMC.

  HIPAA Research Training (Revised February 2004)
   
  Other HIPAA Links
 

Questions

HIPAA Questions: Call the CHR Front Desk at 415-476-1814 and your questions will be answered or your call will be redirected appropriately. You can also contact us.