Johns Hopkins Bayview Medical Center, Human Subjects Committee – FDA 483, Sep 7, 2001

The FDA Form 483 documents observations from an inspection, citing failures to follow written procedures for the initial review of research and issues with informed consent.

**Violations and Observations:**

1. **Failure to follow written procedures for initial research review:** The IRB guideline IV. A. Full Board/Committee Review states that the protocol application packet, including the proposed consent document, should be distributed to all IRB members for review. The Executive Subcommittee is to conduct initial review after receiving written comments from a majority of IRB members. If significant issues arise, the Chair (or designee) should contact the investigator for a response before the fully convened IRB meeting. * **Specific Instances:** * Six IRB members did not receive the proposed consent document for review before the 9/18/00 meeting. * Written questions from two IRB members regarding hexamethonium's IND status were not sent to the investigator. * A subcommittee member's written questions about hexamethonium's manufacturing date and potency determination were not sent to the investigator. * An IRB member's written questions about the standard dose of hexamethonium and the protocol's dosage choice were not sent to the investigator. * Written questions from two IRB members about the Phase I vs. Phase II study dose rationale were not sent to the investigator. * Written questions from two subcommittee members about animal studies were not sent to