The form below documents NRDR's exemption from the Common Rule's provisions regarding protection of human subjects. The phrase, “approved for use through 11/28/2008”, applies to the blank form used to document IRB assurance status or exemption, not to the exemption itself. All assurances and exemptions documented between the expiration date of the previous form and 11/28/2008 have this phrase. The exemption itself does not have an expiration date.

Because NRDR data are being collected for the purpose of quality assurance and peer review, it is not required that participating facilities obtain IRB approval. Nevertheless, individual institutions may choose to request an exemption from their IRB.

Version: October, 2007