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Abstract

Part II of this Comment will examine the history of human experimentation and how the current regime of experimenting developed then explore the gap between experimentation approved by an Institutional Review Board (“IRB”) and FDA oversight. Part III will consider the competing interests of individual patient protection and medical innovation in general and whether informed consent appropriately balances those interests. Part IV will evaluate the inadequacies of current reliance on informed consent by using two case studies, both involving novel microbial procedures, and discuss how codification of the reasonable innovation rule would address those inadequacies. Ultimately, this Comment will argue that the common law reasonable innovation rule must be codified to protect vulnerable patients who are willing to try anything. Current oversight and regulation of physicians who implement novel treatments on a regular basis do not offer enough protection to the desperate patient. It is time for the FDA to intervene in our current “wild west” system where physicians are free to deviate from common practice and implement novel and even dangerous procedures as long as they obtain patients’ informed consent.

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