U.S. Suspends Human Research at Johns Hopkins After a Death. This draconian step, effectively shutting down federally financed medical research involving human subjects (at the university that receives the most federal research funds bar none) is virtually unprecedented. In June, a healthy volunteer died in an asthma study after inhaling a non-FDA-approved drug; federal overseers found Hopkins negligent with respect to precautions to protect subjects in the study. The FDA has been ambivalent about whether it ought to review and approve applications to do basic research with human subjects, and used to discourage academics who inquired. Now the FDA says scientists should seek its approval for any study, such as the one in question, involving new or unusual uses of drugs, but it does not enforce compliance, and the human investigations board at Johns Hopkins was free to approve the study without FDA approval. Officials of the university reacted with outrage to the funding suspension despite the fact that a university committee investigating the death found that the researcher had ignored or missed reports in the medical literature indicating that the drug had the potential to cause severe lung injury of the type that killed the research subject. New York Times