The Federal Government dealt a blow to Johns Hopkins University last week when it suspended human-research trials there following the death of Ellen Roche, a volunteer in a Hopkins asthma study. While the move had dramatic public-relations value, it left many in the medical community confused over how the government is regulating such research.
Roche volunteered for a trial in which she took hexamethonium, a compound not currently approved by the FDA for use in humans. In these cases, the FDA requires that researchers obtain the agency's approval before administering such compounds. But because of the huge number of academic trials...
To continue reading:
or
Log-In
