This has strong whiffs of grudge-grinding and ass-covering. My take is that the IRB was miffed at the end-run using an ethics committee instead of the IRB. How

This has strong whiffs of grudge-grinding and ass-covering. My take is that the IRB was miffed at the end-run using an ethics committee instead of the IRB. However, this is neither unprecedented nor illegal. Ethics committees are widely used to oversee investigational or quasi-elective procedures (ie "elective" off-label procedures for non-life-threatening but massively debilitating conditions). It is quite telling that both surgeons still have privileges, and indeed one remains the department chair. The Sac Bee article and the FDA notification letter contain no mention of medical licensure investigations. There is a massive gray area between clinical judgement and IRB or FDA purview. Drs. can and do use drugs and devices far, far off-label all the time - and there is essentially nothing the FDA can do to the Dr. (however they can come down hard on manufacturers for promoting unapproved uses) The FDA and IRB do not regulate the practice of medicine and "medical judgement"; those are constrained by medical boards, tort, and in extreme cases prosecution for criminal negligence. This was research misconduct only to the extent that they made the mistake of involving the IRB in the first place. background: http://www.ncbi.nlm.nih.gov/pubmed/21552172 http://www.ncbi.nlm.nih.gov/pubmed/21552172 study pro: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2039978/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2039978/ study con: http://www.ncbi.nlm.nih.gov/pubmed/19404146 http://www.ncbi.nlm.nih.gov/pubmed/19404146