Approved-By: NiemoelL@OD.NIH.GOV
Date: Fri, 15 Jun 2001 06:27:26 -0400
Reply-To: "Niemoeller, Larry (OD)" <NiemoelL@OD.NIH.GOV>
Sender: "Office for Human Research Protections (OHRP)"
<OHRP-L@LIST.NIH.GOV>
From: "Niemoeller, Larry (OD)" <NiemoelL@OD.NIH.GOV>
Subject: ALERT FOR IRBs THAT REVIEW BIOMEDICAL RESEARCH:
To: OHRP-L@LIST.NIH.GOV
The Office for Human Research Protections would like to alert Institutions and their Institutional Review Boards (IRBs) to a death of a healthy research subject following the inhalation of hexamethonium as part of a research protocol. Please note that at the present time the death of the subject has not been directly linked to the inhalation of the test agent. IRBs should re-assess protocols involving inhalation of hexamethonium and, if necessary, consider temporarily suspending the research in light of this event.