IRB change - Initial application only (reminder)

IRB change - Initial application only (reminder)

The following changes to the Human Research Review Application (HRRA) went into effect at MUSC on Aug. 12, 2005: (1) The Principal Investigator's Statement of Assurance became a separate form. (2) The following statement was added: "I am responsible for all changes made to this study and for all reports submitted to the IRB by all members of my study team."

By signing this statement, the PI will no longer be required to sign other IRB forms with two exceptions – the Change in Personnel form and the Conflict of Interest form. These exceptions continue to require the Principal Investigator's signature.

The Institutional Review Board (IRB) is accepting the revised PI Statement of Assurance for existing studies. The most practical way to prepare this form is to open the electronic version of the study and print out the PI Statement, which will include the HR#, study title, etc. The signed form can be mailed or faxed (792-7457) to the IRB. A blank form will also be available on the IRB web site, IRB Forms page: http://research.musc.edu/ori/irb/forms.htm.

A signed, revised PI Statement of Assurance must be submitted for every HR# under a PI's name. The revised PI Statement of Assurance can be submitted at the time of the next amendment or when a Continuing Review Application is submitted.

The revised PI Statement is an early step in preparing for electronic submission of amendments and other reports. If this signed form is not on file at the IRB, items submitted without the PI's signature in the future cannot be processed, nor can they be submitted electronically.

For additional information please contact Lillie Brinson in the IRB office at MUSC by email to brinson@musc.edu or phone call to 792-4764.

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