Johns Hopkins Can Resume Some Human Trials
But government will scrutinize other tests in aftermath of volunteer's death
Federal officials have given Johns Hopkins University the go-ahead to resume some of its medical research on humans. The government had halted most federally funded clinical trials at the university four days ago, as a result of the death last month of an otherwise healthy trial volunteer.
According to an article on MSNBC, the June 2 death of Ellen Roche, 24, came shortly after she began participating in a trial of the drug hexamethonium, which restricts airways. The study was designed to examine how healthy lungs fight asthma-like conditions, the article says.
While hexamethonium was approved for use as a tablet in the 1940s and '50s to treat hypertension, the U.S. Food and Drug Administration later withdrew its approval. And it was never approved for use as an inhalant, which is what the Johns Hopkins study involved.
The order by the federal Office for Human Research Protection (OHRP) suspending the university's work affected at least 15,000 patients and volunteers, according to the article.
The prestigious Baltimore-based medical institute -- which receives more federal research money than any other U.S. institution, $300 million last year -- says it will improve the protection of people who participate in its experiments, the story says.
Research involving "minimal risk" to volunteers may resume immediately, an OHRP spokesman says. Studies in which there is a "greater than minimal risk" remain on hold, pending review by a university panel and OHRP approval.
How safe is it to be a research subject? Some say not safe enough. To find out more, you can read this article from ABCNews. To find out more about what Johns Hopkins is going to do to change its procedures, you can read this from The Baltimore Sun.