Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obama's administration left out these troubling changes, and there was a collective sigh of relief. (...) Relief is appropriate, but celebration premature: researchers have little reason to avail themselves of the new broad consent option offered in the Final Rule, and the question of whether biospecimens ought to be treated as inherently identifiable has merely been postponed. (shrink)
Using mobile health research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that the Common Rule does or does not “apply,” the extent to which these different meanings of “apply” matter, and, when the Common Rule does apply, how it applies.
Chaïm Perelman and Lucie Olbrechts-Tyteca founded the Brussels school of argumentation in 1958, when they published their famous Traité de l'argumentation. Even if, in Brussels, Eugène Dupréel had already set out to rehabilitate the Sophists, the intellectual atmosphere in the French-speaking world was not very propitious for rhetoric. Most French intellectuals were plunged into ideological debates linked to the intellectual monopoly of the French communist party on societal issues. Free discussion was certainly not very topical. It was only after the (...) fall of the Berlin wall in 1989, five years after Perelman's death, that rhetoric began to draw increasing attention. His ideas then gained momentum in France, as .. (shrink)
For the passions represent a force of excess and lawlessness in humanity that produces troubling, confusing paradoxes.In this book, noted European philosopher Michel Meyer offers a wide-ranging exegesis, the first of its kind, that ...
Many feel the Common Rule treats an unwieldy range of activities identically under the monolithic label "human subjects research." Past objections centering on the conflation of biomedical and behavioral research have gained new currency with the increase in biobanking and Internet-based research. A more nuanced approach to research is overdue. Regulation will no doubt remain a major component of any new approach. But in some research contexts, investigators and subjects should be permitted to reach voluntary, informed agreements about certain aspects (...) of their relationship.Consider the National Institutes of Health's new "Guidelines for Human Stem Cell Research."1 The guidelines owe their existence to the NIH's .. (shrink)
Contemporary or postmodern thought is based on the lack of foundation. The impossibility of having a principle for philosophy has become a position of principle. As a result, rhetoric has taken over. Content has given way to the priority of form. Michel Meyer's book aims at showing that philosophy as foundational is possible and necessary, and that rhetoric can flourish alongside, but the conception of reason must be changed. Questioning rather than answering must be considered as the guiding principle. What (...) the author calls "problematology" is not only the study of questioning but also the analysis of the reasons why it has been repressed throughout the history of philosophy. Since Socrates, philosophers and scientists have reasoned by asking questions and by trying to solve them. Questioning has been the unthematized foundation of philosophy and thought at large. Philosophers, however, have preferred another norm, granting privilege to the answers and thereby repressing the questions into the realm of the preliminary and unessential. They have not considered their discursive practice as being based upon some question-answer complex, but exclusively on the results they call propositions. Meyer argues that propositions ensue from corresponding questions, and not the other way around. Anthropology, ontology, reasoning, and language thus receive a new interpretation in the problematological conception of philosophy, a conception in which questions and problems are thematized afresh. The theory of language in everyday use, in argumentation, or in literary analysis receives a full and decisive treatment here, making Meyer's question-view one of the leading theories in contemporary thought, alongside his rhetoric for which he is already well known. (shrink)