OFFICE FOR PROTECTION OF HUMAN SUBJECTS


This is samplet template from which a HIPAA Authorization form can be developed. THE AUTHORIZATION FORM IS A STAND-ALONE DOCUMENT MEANT TO ACCOMPANY YOUR STANDARD CONSENT FORM. As in the case with all of our templates, you may alter the format, but keep in mind that much of the language is required by HIPAA. Information provided in bold italics needs to be filled in and the bold italics deleted.

A sentence referencing the HIPAA Authorization form needs to be added to your consent form. For example, the form could state: "In order to do this research, you must also authorize us to access and use some of your personal health information. An authorization form is attached for you to review and sign and is an addendum to this consent form."

There are six required elements of an authorization for research disclosure of protected health information (PHI)

  1. A specific and meaningful description of the information to be used or disclosed;
  2. Specific identification of persons or class of persons authorized to make the requested use or disclosure;
  3. Specific identification of persons or class of persons to whom the requested use or disclosure may be made;
  4. A description of each purpose of the requested use or disclosure;
  5. An expiration date or event (can be no expiration if for research); and
  6. The individual's signature and date the document is signed.
There are also two required statements, one on the right of the participant to revoke the authorization and a second explaining the potential for re-disclosure to others not required to comply with the privacy rule. In addition, the research participant must sign and date the authorization document.

SAMPLE AUTHORIZATION FORM: Disclosure of Personal Health Information (PHI)


By my signature below, I authorize ______________________________ [Insert - name of person or class of persons who may make the disclosure, generally, the health care provider] to release to ____________________________________________ [Insert - name of Principal Investigator and research staff, department, University of Oregon] the following medical records:

[Note, this list should be tailored specifically to your research and state precisely which records are being requested. Delete what does not apply and include additional records as needed.]

___ Demographic information, including your name, address, phone number . . .

___ Information in your medical records related to . . .

___ X-rays/laboratory results obtained by ____ laboratory.

___ Information from mental health records.

___ Other:________________________________

We will use the medical records containing your personal health information to . . . [Insert purpose statement from the Informed Consent form and describe each use of the information.]

[Choose one of the following sentences that best describes your time frame and delete the other two]
This authorization will expire on (date).
This authorization will expire at the end of the research study.
This authorization will not have an expiration date.

This authorization can be revoked at any time by delivering a revocation in writing to the Health Care Provider named above and that the revocation will be effective except to the extent (1) research has already been conducted in reliance on my previous authorization or (2) if necessary to protect the integrity of the research (e.g., to account for a person's withdrawal from the research).

I realize that __________________________ [name of Principal Investigator] may not be bound by the Privacy Rule and therefore may not be required by that Rule to maintain the confidentiality of my personal health information.[This is language that is required because the University is not bound by the Privacy Rule.]

[You must also include a statement explaining what protections the University will provide for the PHI it receives. Sample language follows that may be used.] The researchers can only use or disclose your health information for purposes approved by the Institutional Review Board at the University of Oregon or as required by law or regulations and will continue to protect your personally identifiable health information as described in the attached Informed Consent Form.

I understand what this document says and authorize release of my personal health information as stated above. I understand I will be given a signed copy of this Authorization for my records.

Signature of research participant:________________________________ Date:______________

Print Name:__________________________________________________________________

For Minor Subjects:

Name of Minor:_______________________________________________________________

Signature of Legally Authorized Rep.:______________________________________ Date:___________________

Print Name:________________________________ Relationship of Representative to Subject:__________________________


HIPAA Form - 8/2007