Johns Hopkins University School of Medicine IRB – FDA 483, Sep 7, 2001

The FDA Form 483 documents observations from an inspection, citing failures in maintaining adequate documentation and following written procedures for an Institutional Review Board (IRB).

**Facility and Operation Details:** The observations pertain to an IRB's operations, specifically regarding the review and approval of research protocols.

**Violations and Observations:** 1. **Inadequate Meeting Minutes:** The facility failed to prepare and maintain adequate documentation of minutes for six out of 21 fully convened IRB meetings on 1/9/00, 1/23/00, 2/13/00, 3/13/00, 3/27/00, and 4/10/00. 2. **Conflict of Interest Documentation:** IRB minutes lacked sufficient detail to determine if an IRB member with a conflicting interest in project RPN #00-11-07-02 (approved 12/12/00) participated in its initial review or voting, despite being present. 3. **Failure to Follow Written Procedures for Initial Review:** The IRB failed to follow its written procedure (Guideline IV. A. Full Board/Committee Review) requiring significant issues, comments, or questions regarding protocols to be sent to the subcommittee and then forwarded to the investigator in writing for a response prior to the fully convened meeting. * **Study RPN #00-1