FDA 483 - BRI Institutional Review Board, Inc. - October 28, 2010

From October 12 to October 28, 2010, the FDA inspected the Burzynski Research Institute / IRB, an Institutional Review Board located at 9432 Katy Freeway #105, Houston, TX 77055-6349. The inspection revealed four observations.

Observation 1 notes the IRB lacks written procedures for initial and continuing review of research. Specifically, during the March 26, 2010 meeting, the IRB did not request or obtain current Informed Consent (IC) copies for studies approved for continuation. For Protocols [redacted] and [redacted], the investigator provided an IC approval date of 12/05/02, but no corresponding consent forms were found in IRB records; forms found were dated 12/11/2001 and 10/22/2002, respectively. Additionally, the IRB's Standard Operating Procedures (both Approved Version-Rev H and Draft) lack procedures for reviewing device studies to determine significant risk per 21 CFR 812.66.

Observation 2 states the IRB has no written procedure for determining which projects require review more often than annually.

Observation 3 indicates that copies of all approved sample consent documents and progress reports submitted by investigators have not been maintained.

Observation 4 highlights that the IRB did not determine, at initial or continuing review for an ongoing