Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond (...) its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials. (shrink)

Organic chemists have been able to develop a robust, theoretical understanding of the phenomena they study; however, the primary theoretical devices employed in this field are not mathematical equations or laws, as is the case in most other physical sciences. Instead it is diagrams, and in particular structural formulas and potential energy diagrams, that carry the explanatory weight in the discipline. To understand how this is so, it is necessary to investigate both the nature of the diagrams employed in organic (...) chemistry and how these diagrams are used in the explanations of the discipline. I will begin this paper by characterizing some of the major ways that structural formulas used in organic chemistry. Next I will present a model of the explanations in organic chemistry and describe how both structural formulas and potential energy diagrams contribute to these explanations. This will be followed by several examples that support my abstract account of the role of diagrams in the explanations of organic chemistry. In particular, I will consider both the appeal to ‘hyperconjugation’ in the explanation of alkene stability and how the idea of ‘ring strain’ was developed to explain the relative stability of cyclic compounds. (shrink)

The death of Jesse Gelsinger in 1999 during a gene therapy trial raised many questions about the ethical review of medical research. Here, the author argues that the principle of justice is interpreted too narrowly and receives insufficient emphasis and that what we permit in terms of bodily invasion affects the value we place on individuals. Medical research is a societally supported activity. As such, the author contends that justice requires that invasive medical research demonstrates sufficiently compelling societal benefit. Many (...) consider this societal benefit to be self evident. However, medical research is a complex activity; it yields new treatments but also creates financial rewards and affects health resource allocation. As research evolves into a multibillion pound, multinational enterprise, justice requires a much broader analysis of societal benefit. Without such evaluation we risk undermining the value of bodily integrity and of research participants. (shrink)

The United States Court of Appeals for the Seventh Circuit held, in Murrey v. United States ), that claims for a physician's failure to obtain a patient's informed consent are not barred by the Federal Tort Claims Act as a species of misrepresentation. The court further held that the claim was not barred by the failure to include the issue of informed consent in the administrative claim. This decision reduces the burden on plaintiffs to state every cognizable claim consistent with (...) the facts in an administrative proceeding; the failure to do so would prevent them from raising the claim in court.The patient, Thomas Murrey, a sixty-eight-year-old U.S. veteran, sought treatment at a Veteran's Administration hospital in North Chicago, Illinois. VA doctors diagnosed him with prostate cancer, and advised him to undergo surgery to remove his entire prostate. (shrink)

“A New Budget of Paradoxes” will be a section of our Journal devoted to the pathological. It is not mere amusement. The old “Budget of Paradoxes,” edited by Augustus De Morgan is our model both for choice of material and for humaneness toward the Don Quixotes of Thought.