Starting January 9, 2006, the HIPAA authorization language will be inserted into the INSPIR consent form for all new studies. You will then be able to alter the templated HIPAA authorization language to fit your study, as per the instructions in Section Q of INSPIR.
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.
Any studies submitted to the IRB before January 9, 2006 will NOT have the combined consent form, and will need to have the HIPAA Authorization Form attached separately in Section S of INSPIR. The approved HIPAA Authorization Form will then be externally attached in INSPIR by the IRB Coordinator. At the time of the next submission of the protocol (either for an amendment or progress report), please delete the unapproved HIPAA Authorization Form from Section S.
Existing studies 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 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 the separate INSPIR consent form.
For more information, please see the December 2005 Clinical Research Times feature article, or contact the IRB Office.