Despite the fundamental, core importance of Informed Consent for research, concern for adherence to this sacrosanct process continues to be a concern, especially with studies involving vulnerable patients. The phrase involves one of the major principles of medical ethics stating, “A person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care.” Informed Consent, a cornerstone of medical ethics, derives from the Helsinki Declaration a standard created in response to the horrific human experimentation done by the Nazis in World War II. The Helsinki Declaration is a statement of ethical principles for researchers involving human participants. But now that Big Pharma has emerged as perhaps one of the most powerful corporate interests in America, what happens to those ethical principles? Are they at risk? At least in some cases, it appears, those principles are sidestepped, and another principle comes into play. This principle used to be associated with the auto and banking industries, but now seems to apply to Big Pharma and it’s called “Too Big to Fail”. This term was used in a recent article in The New York Times regarding drug trials involving an Alzheimer’s medication.
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