Office of Research Integrity
Institutional Review Board for Human Research (IRB) Front Page
ANNOUNCEMENT REGARDING HIPAA REVISION
Did you see the announcement about the revisions to the research HIPAA Authorization?
The MUSC University Compliance Office, IRB and Legal Counsel have worked together to revise the research HIPAA Authorization form. Beginning November 1, 2014, all new initial protocols submitted to the IRB will be required to include the new HIPAA Authorization unless the study qualifies for a waiver of HIPAA of Authorization. The form is easier to use and now only requires minimal study details to be added to the template. These revisions allow for minimal study details to be added to the template. When using the revised template, the PI will only need to enter the following information:
• Study title
• A sentence about the purpose of the study
• The PI’s name and contact information.
Of note, the form now includes the Notice of Privacy Practice (NPP) which is to be given to all participants per HIPAA requirements. Also, research subjects will no longer be required to initial the HIPAA Authorization indicating that they have received the NPP. This change makes it easier for researchers to comply with this component of the HIPAA regulations.
Where can the new form be found?
You can find the newly revised HIPAA Authorization on the forms page of the IRB website: http://academicdepartments.musc.edu/research/ori/irb/forms.html
What happens to the currently approved HIPAA authorizations that are part of a currently approved study?
For those studies that are currently IRB approved, with a currently approved HIPAA Authorization, there is no requirement to submit an amendment to the IRB to revise the HIPAA.
Why was the HIPAA Authorization revised?
The current HIPAA Authorization was created twelve years ago and has not undergone any substantial changes since its creation. With NIH recently supplying a new sample HIPAA template, the MUSC Privacy Officer drafted the revision to streamline the MUSC template and then worked with a small committee to bring the MUSC HIPAA Authorization more in line with the smaller NIH sample template. The hope is that the newly revised HIPAA is easier to use and requires less time for researchers.
Are there any exceptions?
The new HIPAA revisions only apply to the MUSC HIPAA Authorization.
If you have any questions regarding the newly revised HIPAA, please contact either the MUSC IRB or MUSC University Compliance.