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Office of Research Integrity

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Changes and Updates

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.

DID YOU KNOW?

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.

If required approvals are incomplete, the current “State” of the study under the study’s main page will be "Department Review.” In this case, the department reviewers may not have issued approval for the study.

The IRB does not have your application until all of the necessary prior approvals have been completed. The state will then change to “IRB staff review”. An application is not complete and deemed received by the IRB until the state changes to “IRB staff Review.”

Please remember to leave time for Department Review when trying to make the deadlines for meeting submissions.

Research & Guidance Pages:

Expedited Review - Retrospective studies: A New Path (PPT)

Community-Engaged Research Guidance
 Guidance and Regulations for Federal Departments

MUSC Policy on Reporting Unanticipated Problems and Adverse Events to the IRB - October 1, 2010 Letter from Kathryn Magruder, Ph.D., Director of the Office of Research Integrity to university Researchers and Sponsors

MUSC IRB Newsletters

Volume 1, Issue 1, November 2010
Volume 2, Issue 1, February 2011
Volume 2, Issue 2, May 2011
Volume 2, Issue 3, November 2011
Volume 3, Issue 1, February 2012

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