CHAPTER 17
COMPLIANCE TRAINING
Why is the healthcare industry so heavily regulated? Because people’s lives depend on it! Let’s consider the case of Jesse Gelsinger, an 18-year-old who died in September 1999 during a research experiment involving a gene transfer at the University of Pennsylvania School of Medicine. His death raised concerns and debate about the protection of human subjects in medical research, financial conflicts of interest, the appropriate reporting of adverse events, informed consent of participants, and properly following research protocols. Of course, this was an extreme example, but it drives home the point. These areas were all well-known to compliance professionals who provide training in many of these regulatory ...
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