Bioethics
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This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government regulations and even the research enterprise. ⋯ When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research.
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The application of genetic editing techniques for the prevention or cure of disease is a highly promising tool for the future of humanity. However, its implementation contains a number of ethical and legal challenges that should not be underestimated. On this basis, some sectors have already asked for a veto on any intervention that modifies the human germ line, while supporting somatic line editing. ⋯ While doing so, I will provide some examples of the different approaches to germ line editing adopted by different regulations so as to demonstrate that, contrary to what is sometimes stated, a general ban on this practice is not the rule, but the exception. Additionally, I will show how alternative options which currently exist, such as a selective ban based on criteria different to the germ line/somatic line distinction, match better with the need to conciliate research needs and legitimate ethical concerns. Finally, I will introduce some further suggestions to this same purpose.
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Most proponents of conscientious objection accommodation in medicine acknowledge that not all conscientious beliefs can justify refusing service to a patient. Accordingly, they admit that constraints must be placed on the practice of conscientious objection. I argue that one such constraint must be an assessment of the reasonability of the conscientious claim in question, and that this requires normative justification of the claim. ⋯ This generally involves a claim along the lines that conscientious refusals should be permitted to the extent that they do not cause unwarranted harm to the patient. I argue that explaining what would constitute warranted harm requires an explanation of what it is about the conscientious claim that makes the harm warranted. 'Warranted' is a normative operator, and providing this explanation is the same as providing normative justification for the conscientious claim. This shows that resorting to facts about the patient's condition does not avoid the problem of providing normative justification, and that the onus remains on advocates of conscientious objection to provide normative justification for the practice in the context of medical care.