Hopkins Reaches Agreement With Federal Regulators to Resume Research on Human Subjects -- July 23, 2001

[Wise Young]

Human Research Issues
Hopkins Reaches Agreement With Federal Regulators to Resume Research on Human Subjects -- July 23, 2001, The Associated Press
Johns Hopkins University said [July 23] it has reached an agreement with the government allowing research on human subjects to resume. Regulators had halted the research last week because of the death of a volunteer. The federal Office of Human Research Protection approved a plan reached with the university to correct deficiencies found after the June 2 death of a healthy 24-year-old during an asthma experiment, the university announced. Hopkins, however, said the federal office has also "imposed certain conditions on the resumption of research." The conditions were not immediately released. The federal office last week put almost all of Hopkins' federally funded research involving human subjects on hold. ...Johns Hopkins receives more federal research funding than any other institution in the United States - more than $300 million last year.
For additional context, see "Death Halts Human Tests at University" (July 20, 2001, The Los Angeles Times) and "Johns Hopkins Admits Fault in Fatal Experiment" (July 17, 2001, The New York Times)

[pecla]

The federal Office for Human Research Protections approved a plan reached with the university to correct deficiencies found after the June 2 death of a healthy 24-year-old during an asthma experiment.

Research in which there is "no more than a minimal risk to the volunteers" may resume, OHRP spokesman Bill Hall said. That includes studies applying "noninvasive" means of collecting information, such as conducting surveys and taking blood, urine or saliva samples, ultrasounds and MRIs.

However, the majority of studies in which there is "greater than a minimal risk" remain suspended until they are "re-reviewed" by a Hopkins review board and approved by the federal office, Hall said.

If these studies meet OHRP requirements, they will be reinstated one at a time -- a process that could "take more than a few weeks," Hall said.