June 15, 2001
MEDIA CONTACT: Joann Rodgers
After notifying a representative of the family of the volunteer who died at Johns Hopkins Bayview Medical Center following participation in a research study, Hopkins officials are releasing copies of the application sent to the Bayview Institutional Review Board for review, the approval notice to the faculty investigator and the approved version of the consent document for the hexamethonium study.
The documents can be found, along with the institutionís original statement, on the Hopkins website at www.hopkinsmedicine.org or via email request to Beth Simpkins at firstname.lastname@example.org.
Johns Hopkins researchers participate in numerous studies involving human subjects. In order to do so, Hopkins must have in place certain processes and protections, as required by federal regulations. For this study, Hopkins secured the required Institutional Review Board approval of the research protocol and an approved consent document for the study. We, along with the federal agencies, are eager to understand how this tragic event occurred.
Hopkins promptly notified all agencies after the volunteer became ill, again when the volunteer died of unknown causes and subsequently disclosed the information more broadly to the scientific community and the public on Wednesday. Hopkins officials emphasize that our public communication has been limited out of respect for the familyís wishes.