Source documents and reaction

Full text of the correspondence between Johns Hopkins Medicine and the Office for Human Research Protections over the death of an asthma study volunteer

July 23, 2001

Johns Hopkins' corrective action plan

July 21, 2001 Michael A. Carome, M.D. Director, Division of Compliance Oversight Office for Human Research Protections 6100 Executive Boulevard, Suite 3B01 National Institutes of Health (MSC 7507) Rockville, Maryland 20852-7507

OHRP letter reinstating JHU MPA with restrictions

Office for Human Research Protections 6100 Executive Boulevard, Suite 3B01 National Institutes of Health (MSC 7507) Rockville, Maryland 20892-7507

OHRP letter to Hopkins on decision to suspend funding

FOR US POSTAL SERVICE DELIVERY:

Hopkins responds to OHRP suspension of research

In what Johns Hopkins believes to be an unwarranted, unnecessary, paralyzing and precipitous action, the Office of Human Research Protection (OHRP) has today suspended all federally supported medical research projects involving human subjects at almost all of our institutions. We strongly believe that this action was taken in utter disregard of patients health and potentially of life. Even a temporary interruption in therapeutic clinical trials, such as those involving cancer patients, could be devastating. In addition, the OHRP letter forbids us from enrolling new, sick patients in these trials.