Human Research News, v4, n2: New Revised HIPAA Research Authorization Form

NEW HIPAA RESEARCH AUTHORIZATION


SUMMARY

The University of California Office of the President released the attached new final revised HIPAA research authorization form. The new revised form replaces previously released forms and should be used when requesting Protected Health Information (PHI) from research subjects consistent with the Federal HIPAA rule. Authorizations obtained to date using the previously approved HIPAA research authorization form are grandfathered.

The new revised FINAL HIPAA RESEARCH AUTHORIZATION has undergone extensive review by various stakeholders, including privacy officers, research administrators, legal counsel, IRB directors, and clinical trial sponsors. It coordinates applicable federal and state law and represents hundreds of hours of consultation among the stakeholders.

PLEASE IMMEDIATELY DISCONTINUE THE USE OF PREVIOUSLY APPROVED FORMS AND ONLY USE THE ATTACHED FORM.

OUTLINE OF CHANGES
  1. Readability - The revised authorization has an improved readability score based on two web-based reading level calculators.


  2. 14 point type - The authorization is in 14 point type as required by state legislation, AB 715, enacted in 2003.


  3. Section B, Health Information to be Released - The IRB authorizied individual completes Section B by:

    1. Filling in the name of the campus or entity that is releasing the medical records; and


    2. Checking off the specific medical records to be released. Investigators and research staff should be instructed to check only those records that are minimally necessary, and should NOT routinely check "entire medical record" unless absolutely necessary and only when approved by the IRB. Please see the HIPAA IRB review form HS-1a.


  4. Section C, Specific Authorizations - The research subject must initial the provisions of Section C that apply, as required under federal and state law (42 C.F.R. §§2.34 and 2.35, California Health and Safety Code §§120980(g) and 124980(j), California Welfare and Institutions Code §§5328).


  5. Section D, Use of Personal Health Information - This section includes language designed to meet the requirements of the California Confidentiality of Medical Information Act (CMIA), which allows personal health information to be diclosed without the subject's authorization so long as the disclosure is allowed by law. Without this language, we would have to include an expiration date and meet other CMIA requirements in order to have a legal authorization.


  6. Section E, Case Reports - This section advises the subject of the potential further use of research data in case reports and limits the types of identifiable information that may be released to sponsors and to other investigators to the information that is found in case reports. Under the CMIA, certain information may be disclosed without the subject's authorization; this section meets the CMIA's disclosure limitations. The specific language allows subjects to authorize the use of the information without an expiration date and ensures compliance with other CMIA requirements.


  7. Section F, Expiration - CMIA provisions require the expiration section to include the specific content. "Required study monitoring" includes all activities required by domestic and foreign regulatory agencies to monitor the quality, safety and effectiveness of the study.


  8. Section H, Signature Blocks - There are three signature blocks, (i) for the subject who can sign on his/her own behalf, (ii) for the subject who is represented by a surrogate or is a minor, and (iii) for the subject for whom the authorization must be translated.