Different Mistakes in the Law and the Difference They Make
There are various sorts of mistakes one might make regarding the law. For instance, one might incorrectly believe that there is a law when there isn’t one or that there is no law when there is. One might also know the law but incorrectly appraise the facts covered by the law. The former mistake is traditionally classified as a legal mistake while the latter is generally referred to as a factual mistake. Both those under the law and those charged with enforcing the law are capable of making both sorts of mistakes. As might well be expected, however, the consequences of a citizen’s legal or factual mistake might be quite distinct from those of the executive officer. Perhaps contrary to common belief concerning the protections afforded the accused, it is more likely for the government to forgive empirical and legal mistakes made by governmental officers than it is for the government to forgive those same mistakes made by private parties in the role of the criminally accused. Mistakes made by the former group may have no effect upon their endeavors, if certain conditions obtain. Mistakes by the latter group, with two exceptions, will generally have significant legal effects. To investigate the varied ramifications in light of two recent United States Supreme Court cases shall be the goal of this paper. More...
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Data and Safety Monitoring Board and the Ratio Decidendi of the Trial
Current decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct is intricate, largely limited by cases and rules, and essentially secretive. Decision-making by court of law, by contrast, although also intricate and largely constrained by cases and rules, is essentially public. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my central analog will lead us to an analogy for much more systematic documentation and transparency of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use reported DSMB experiences of the Women’s Health Initiative Clinical Trials to illustrate my analogical argument. More...
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