Officials from Johns Hopkins and the NIH Office for Human Research Protections (OHRP) worked together intensively over the weekend to address OHRP's concerns and enable Hopkins' valuable research studies to continue as soon as possible.
OHRP approved a corrective action plan formulated by Johns Hopkins, a plan consistent with the approach Hopkins suggested as a result of its own internal investigation into the tragic death last month of a healthy subject enrolled in an NIH-funded research study.
OHRP's action was triggered by the death of Ellen Roche, 24, of Reisterstown, Md., who died of lung damage and multiple organ failure after inhaling hexamethonium, which had earlier been linked to cases of fatal lung disease.
OHRP also imposed certain conditions on the resumption of research.
The Johns Hopkins' corrective action plan is online at this URL.
The OHRP response is at this URL.
The Johns Hopkins statement to faculty and staff re OHRP new procedures is at this URL.