A significantly revised HIPAA Authorization Form is now posted and implemented.  The purpose of the revisions is to:

• Ensure that all required elements of HIPAA Authorization are present and clearly stated.
• Clarify that the form may be used by parents or other legally-authorized representatives for health information of children subjects or other subjects who are not capable of providing authorization.
• Allow for some customization of the form, to better fit a wide variety of research.

All new IRB applications submitted on or after December 1, 2009 must use this revised version, if HIPAA Authorization is being obtained as part of the research.

For already-approved studies that are still enrolling subjects:   the HIPAA Authorization form must be replaced with this revised version at the time of the next Modification or Status Report, beginning on December 1, 2009.  However, researchers do not need to wait until this time, if they wish to replace their current HIPAA Authorization forms more quickly. Previously enrolled subjects do not need to sign a new HIPAA Authorization Form.