Some Avoid Details For CRO’s

Some physician-researchers have been accused of not having respected the proper conduct during any experimentation on human subjects. In fact, the CRO’s research protocols in question violated in several respects the code of conduct established in 1947 during the Nuremberg trials, which was inspired, among other things, by a less well-known code of ethics adopted by the American Medical Association (ama ) in 1946: Principles of Ethics Concerning Experimentation with Human Beings.

The course of the various trials has shown that the 1947 code was not precise enough to constitute an effective ethical reference in a context where therapeutic research was in full development. A new version of these principles, the Declaration of Helsinki, was developed in 1964 as part of the work of the World Medical Association. This version has since gone through six revisions; the last date of October 2008.

Thus, the desire to better control research activities in the hospital environment led to the creation of new bodies whose objective was to evaluate CRO’s protocols, thereby seeking to prevent slippages and limit any recourse to judiciary.

Therefore, how is it that a debate on human experimentation has resurfaced in the United States, when draconian measures were taken very quickly, with real follow-up, by local and federal control authorities? ? This is because new revelations were made from 1999, notably on the occasion of the death in September of that year of an 18-year-old young man.

The most recent case dates from May 2005, and concerns trials on children placed in foster families, a status that allowed researchers to circumvent procedures for seeking consent from the parent or representative. legal.

Some denounce the breach of the rule of consent, but others retort that the impossibility of obtaining the agreement of the CRO’s parents prevents children from receiving the most innovative treatments, accessible only within the framework of experimental protocols. The norm of protection in the name of the principle of respect for the person, which took precedence in the debate on human experimentation in the 1970s, tends today to be transformed into a debate on equitable access to treatment for all. peak.

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