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.”
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Derek…..my comment was intended to be somewhat “tongue-in-cheek”! The fact that you responded is telling. The real point I sought to make is that too much clinical science today is being hijacked by specious processes, much of it driven by consultants under the name of ethical concerns. All processes slow down medicine’s ability to provide society with answers to critical health-related questions. Therefore, it is important that we as a society get these processes right. If, as appears to be the case with the current study, that the need to subject the investigation to a very complicated IND process was borderline, what investigator in their right mind would do it! In conclusion, where is the real story/scandal in this article??
It is no surprise that the experts who were consulted and deemed an IND to be required all make a living off the complexity of clinical trials. Perhaps these experts should be required to file conflict of interest statements before being allowed to render such opinions in a public news article like this? After all the purpose of these regulation is to serve the public and not the bureaucracy.
Not all who interpreted policy as requiring an IND were in the clinical trial consulting business. Requiring a conflict of interest statement seems like a stretch when their affiliations were made clear for the reader to scrutinize. What I would have liked to have seen is more study details to evaluate from the clinicians involved. In that respect, this article came across as a little shallow.