Volume 20, Issue 9, September 2020, Page 62-65.

There are approximately one million cases oftype 1 diabetes in the US, and the incidenceis increasing worldwide. Given that two-thirdsof cases present in childhood, it is criticalthat prediction and prevention research involvechildren. In this article, I examine whethercurrent research methodologies conform to theethical guidelines enumerated by the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research, andadopted into the federal regulations thatprotect research subjects. I then offer twopolicy recommendations to help researchersdesign studies that conform to these ethicalrequirements.

November 2009’s announcement of the USPSTF’s recommendations for screening for breast cancer raised a firestorm of objections. Chief among them were that the panel had insufficiently valued patients’ lives or allowed cost considerations to influence recommendations. The publicity about the recommendations, however, often either simplified the actual content of the recommendations or bypassed significant methodological issues, which a philosophical examination of both the science behind screening recommendations and their import reveals. In this article, I discuss two of the leading ethical (...) considerations at issue in screening recommendations: respect for patient autonomy and beneficence and then turn to the most significant methodological issues raised by cancer screening: the potential biases that may infect a trial of screening effectiveness, the problem of base rates in communicating risk, and the trade-offs involved in a judgment of screening effectiveness. These issues reach more broadly, into the use of “evidence-based” medicine generally, and have important implications for informed consent. (shrink)

Volume 20, Issue 9, September 2020, Page 60-62.

Individual autonomy is a concept highly appreciated in modern Western societies. Its significance is reflected by the central importance and broad use of the model of informed consent in all fields of medicine. In predictive genetic testing, individual autonomy gains particular importance, for what is in focus here is not so much a concrete medical treatment but rather options for taking preventive measures and the influence that the test results have on long-term lifestyle and preferences. Based on an analysis of (...) autonomy-related issues in predictive genetic diagnosis and genetic screening programmes, this contribution stresses the central relevance of a broad notion of autonomy for the discussion of ethical issues raised in connection with predictive genetic testing and genetic screening programmes. Only against the background of such a broad notion of autonomy, which stresses not only free and informed decision-making but also the relevance of long-term prospects for leading a self-determined life in familial and social contexts, can the manifold autonomy-related issues linked to predictive genetic testing be given adequate consideration. (shrink)

During the past decade, screening tests using computed tomography have disseminated into practice and been marketed to patients despite neither conclusive evidence nor professional agreement about their efficacy and cost-effectiveness at the population level. This phenomenon raises questions about physicians' professional roles and responsibilities within the setting of medical innovation, as well as the appropriate scope of patient autonomy and access to unproven screening technology. This article explores how physicians ought to respond when new screening examinations that lack conclusive evidence (...) of overall population benefit emerge in the marketplace and are requested by individual patients. To this end, the article considers the nature of evidence and how it influences decision-making for screening at both the public policy and individual patient levels. We distinguish medical and ethical differences between screening recommended for a population and screening considered on an individual patient basis. Finally, we discuss specific cases to explore how evidence, patient risk factors and preferences, and physician judgment ought to balance when making individual patient screening decisions. (shrink)