Clinical Research and the Law by Patricia M. Tereskerz

By Patricia M. Tereskerz

This e-book presents a finished source for doctors at the a number of criminal features taken with accomplishing medical study. It encompasses criminal and moral matters reminiscent of accountability of care, learn malpractice and negligence, criteria of care, knowledgeable consent, legal responsibility matters for Institutional assessment forums (IRB), conflicts of curiosity, insider buying and selling and the disclosure and withholding of scientific trial effects. it's going to additionally supply criminal assistance on learn contracts, establishing scientific trials and customary felony pitfalls encountered in clinical study.

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24 Daum v. , 52 Cal App 4th 1285, 51 Cal Rptr 2d 260 (1997). 44 Clinical research and the law Mr Daum testified that he would not have consented to participate in the clinical trial if he had seen the Wiltse II consent form prior to surgery. Mr Daum requested jury instructions covering a number of California statutes and federal regulations regarding clinical trials of investigational devices. He requested an instruction on negligence per se, which means there is negligence because there was a violation of a public duty under a law or regulation.

3 In research malpractice actions thus far, federal regulations have only been used to establish standard practice in informed consent cases. This is because regulations do not impose requirements on researchers, other than obtaining informed consent and approval of the IRB to conduct the research, with the burden of risk assessment placed primarily on IRBs. The use of federal regulations to establish the standard of care related to IRBs is discussed in Chapter 5. The current chapter describes how expert 1 Pederson v.

5 Clinical trials and pediatric patients Clinical trials involving children present unique challenges. 30 For example, some diseases are specific only to children. In addition, children are physiologically different from adults and metabolize drugs differently, meaning safety and efficacy data emerging from adult clinical trials cannot reliably be extrapolated to children. There are many instances where children unexpectedly have very different side-effect profiles from adults. Complicating factors involved when children participate in clinical trials include the fact that children are minors who do not have legal capacity to consent to participate in research, and they are a particularly vulnerable population.

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