Publications by authors named "Dave Wendler"

Background: A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.

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Background: High-quality oncology care is marked by skillful communication, yet little is known about patient and family communication perceptions or content preferences. Our study sought to elicit pediatric oncology patient and parent perceptions of early cancer communication to establish whether informational needs were met and identify opportunities for enhanced communication throughout cancer care.

Method: An original survey instrument was developed, pretested, and administered to 129 patients, age 10-18 years, and their parents at 3 cancer centers between 2011 and 2015.

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Completion of the human genome project is expected to lead to an increase in the number of individuals who participate in genetics research. The current informed consent process-developed prior to widespread genetics research-may not be sufficient to minimize the research risks that these individuals face. The current consent process focuses on informing individuals of the risks of research participation prior to their research enrollment.

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Background: The debate over informed consent for research on stored biological samples has enormous scientific implications. Unfortunately, there are no data on individuals' attitudes regarding when their consent should be obtained for such research.

Methods: Data were gathered using a telephone survey of 504 individuals living in the United States.

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Objective: The authors' goal was to assess healthy individuals' attitudes toward five of the most prominent proposed safeguards regarding the consent process for research with adults unable to consent.

Method: Telephone interviews were conducted with 246 individuals with a family history of Alzheimer's disease who had participated in clinical research.

Results: The majority of respondents said that they were willing to participate in research if they lost the ability to consent.

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The exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulation is addressed by a specific account of a "condition on inclusion risks" (CIR), a condition under which potential subjects should be excluded from research on the basis of increased risks.

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