Starting January 9, 2006, the HIPAA authorization language should be included in the INSPIR consent form for all new studies. You will then be able to alter the templated HIPAA authorization language in the consent form to fit your study.
The HIPAA authorization language gives the investigator formal permission to collect protected health information directly from the subject or from wherever that information is stored. The authorization also should, if applicable, indicate any other non-BUMC research groups, institutions, or agencies with whom the investigators plan to share this data.
Existing studies that already have an approved separate HIPAA Authorization Form, have the option to include the HIPAA authorization language in the INSPIR consent form at the time of their progress report submission only, but are not required to do so. The separate HIPAA Authorization Form is approved once and then remains active for the remainder of a study. There is no expiration of approval for separate HIPAA Authorization Forms. Thus, the PI may choose to continue using the approved HIPAA Authorization Form and/or the separate INSPIR consent form.
For more information, please see the December 2005 Clinical Research Times feature article, or contact the IRB Office.
- Click here to download the HIPAA Authorization Form (only to be used for studies approved before January 9, 2006)