Background: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. (...) Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges. (shrink)

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Essay Review of two books of A.N. Maxwell, last of the Neo-Popperians: The Comprehensibility of the Universe (1998) and The Human World in the Physical Universe (2001).

Rapid developments in Artificial Intelligence are leading to an increasing human reliance on machine decision making. Even in collaborative efforts with Decision Support Systems (DSSs), where a human expert is expected to make the final decisions, it can be hard to keep the expert actively involved throughout the decision process. DSSs suggest their own solutions and thus invite passive decision making. To keep humans actively ‘on’ the decision-making loop and counter overreliance on machines, we propose a ‘reflection machine’ (RM). This (...) system asks users questions about their decision strategy and thereby prompts them to evaluate their own decisions critically. We discuss what forms RMs can take and present a proof-of-concept implementation of a RM that can produce feedback on users’ decisions in the medical and law domains. We show that the prototype requires very little domain knowledge to create reasonably intelligent critiquing questions. With this prototype, we demonstrate the technical feasibility to develop RMs and hope to pave the way for future research into their effectiveness and value. (shrink)

The general context of this paper is the locality problem in quantum theory. In a recent issue of this journal, Redei (1991) offered a proof of the proposition that algebraic Lorentz-covariant quantum field theory is past stochastic Einstein local. We show that Redei's proof is either spurious or circular, and that it contains two deductive fallacies. Furthermore, we prove that the mentioned theory meets the stronger condition of stochastic Haag locality.