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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.

Questions?

If you have any questions regarding the newly revised HIPAA, please contact either the MUSC IRB or MUSC University Compliance.

  • Before a study is submitted to the IRB, departmental approvals must be obtained. The eIRB system automatically routes the study to the approving individuals along with a notification email...
  • Expedited Review-Retrospective Studies...
  • From the FAQ Page

    Q9.1 Why am I not able to log into the eIRB?

    A9.1.

    • Please make sure when entering your username you are entering your MUSC NetID name. Then enter your password.
    • If you continue to have log in issues, you may need to be registered in the eIRB system. This may be the case for someone who has just been assigned a NetID and has not yet been added into the eIRB system. If this is the case, the 1st time a new user logs into the system, a registration screen will be displayed. Fully complete the requested information. Note: Non-faculty member study PIs will require a mentor to be able to be listed in eIRB with PI rights. To ensure this, check the box that indicates you are a student, as this is the mechanism to grant you this PI access right. After the registration form is complete and the user clicks ok, an email is sent to the MUSC eIRB administrator. The site administrator will complete the registration (about a 24 hour turn-around timeframe), assign the user roles appropriate to the user’s research activities and activate the account. The user will receive an email notification of account activation. This process can take up to 24 hours; however, if registration is required sooner, contact the eIRB systems administrator.
    • If you continue to have log in issues, you may need to contact OCIO at 792-9700 to ensure your Net ID is working properly.

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