The controversy surrounding a study of whether moderate drinking might prevent cardiovascular disease isn’t over: If one interpretation of federal regulations is correct, the study may be in violation of Food and Drug Administration requirements meant to protect the health of research volunteers.
STAT has learned that the study’s leaders failed to seek a form of regulatory approval intended to protect study participants and ensure they understand the possible health risks of the research. By not seeking approval from the FDA, said public health researcher Dr. Michael Siegel of Boston University, the study “is in violation of federal law.”
But the hospital whose physician designed the trial said he asked the FDA whether the investigational new drug (IND) application was required and was told no. Other experts said the requirement for an IND in this case is not crystal clear. Of seven additional researchers or regulatory consultants interviewed by STAT, four agreed with Siegel that FDA approval via an IND was required and the others weren’t sure.
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