Johns Hopkins has become the latest in a line of American universities forced to suspend clinical trials because of its failure to comply with federal oversight rules. Last month it placed 22 trials on hold following the death of a healthy volunteer in a study that government inspectors say failed to follow proper patient protection measures.

In a trial designed to assess lung function in asthma, healthy volunteers were asked to inhale substances that irritate the airways. The participant who died had inhaled hexamethonium as part of the study one month previously. Hexamethonium is a ganglion-blocking drug that can temporarily paralyze some nerves in the airways. It was initially approved in the 1950s by the Food and Drug Administration (FDA) for its vasodilatory properties to treat hypertension and was therefore being used for a different indication—so-called 'off-label' use—in the Hopkins trial.

The case has alerted many researchers to the fact that they may need FDA approval for clinical trials that use a drug already approved for another indication. The FDA virtually ignores doctors when they engage in the common practice of prescribing drugs for conditions that are not officially sanctioned by the agency. But in this case, the FDA said that the researchers should have obtained investigational new drug (IND) approval before using a medicine for another purpose.

The National Heart, Lung and Blood Institute (NHLBI) was funding the trial, led by two prominent pulmonary researchers, Solbert Permutt and Alkis Togias, under a four-year, $400,000 grant. However, the NHLBI has now frozen the funding and has notified all of its lung researchers of the death and asked them to “reassess” and “consider suspending research with hexamethonium in light of this event until more information is available.” No researchers have yet reported using the drug, according to an NHLBI spokesperson.

In a statement released by Johns Hopkins, school officials say that both the investigators and the school's institutional review board felt the IND was unnecessary for the use of hexamethonium because it was already approved by the FDA. However, the trials suspended by the school cover all studies that use FDA-approved agents that do not have an IND for that indication.