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Scientific Review Questions Added to IRBIS to Support Scientific Review Committee Review (9/16/2016)

As previously announced, beginning September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented. All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must undergo scientific review. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. To facilitate this process, a new Scientific Review section has been added to the Initial IRB application. Read more...

New Scientific Review Process at UNC

Date new process begins: Monday, September 19, 2016 All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must be submitted for review to the UNC Scientific Review Committee. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. Beginning Monday, September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented prior to the review. Investigators should anticipate at least 7 business days for this review. Read More...

How to Request a Reliance Agreement updated 8-12-16

The IRB guidance titled “How to Request a Reliance Agreement” has been updated August 12, 2016, as follows: Page 4 and 5 – Previously the IRB has only required a CV or resume for investigators; this requirement has been extended to all external collaborators regardless of role.

Updated Statement of Compliance

The IRB has posted an updated Statement of Compliance.

How to Request a Reliance Agreement updated 7-1-16

The IRB guidance titled “How to Request a Reliance Agreement” has been updated July 1, 2016, as follows: Page 5 – Previously the IRB has only required a CV or resume for individual investigators; this requirement has been extended to all individual collaborators