Alcohol study failed to seek FDA approval, possibly violating federal rules
A controversial study of whether moderate drinking reduces the risk of heart disease may be in violation of FDA rules meant to protect the health of research volunteers.
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
