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This chapter addresses ethical issues for informed consent when recruiting autistic participants for research. The process of informed consent for participation in research involves some abilities, such as dialogue and understanding the intentions of the researchers, that can be especially challenging when autistic individuals are being asked to participate. This chapter reviews these abilities, and suggests ways to provide meaningful support to promote autonomy and help researchers meet their responsibilities. Beyond these more general challenges, it explores Hans Jonas’s suggestion that (...) |
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Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) |
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Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...) |
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ABSTRACT Clear guidelines addressing the ethically appropriate use of anti‐infectives in the setting of hospice care do not exist. There is lack of understanding about key treatment decisions related to infection treatment for patients who are eligible for hospice care. Ethical concerns about anti‐infective use at the end of life include: (1) delaying transition to hospice, (2) prolonging a dying process, (3) prescribing regimens incongruent with a short life expectancy and goals of care, (4) increasing the reservoir of potential resistant (...) |
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Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they (...) |
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The American Journal of Bioethics, Volume 12, Issue 1, Page 42-44, January 2012. |
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Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) |
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BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) |
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In an earlier Dissecting Bioethics contribution, Debra J. H. Mathews, Joseph J. Fins, and Eric Racine challenge standard ways of thinking about the therapeutic misconception in the context of consent for research participation. They propose that instead of demanding “rational congruence” between how researchers and participants conceive of a given protocol, we should accept a less stringent standard of “reasonable coherence.” While Mathews, Fins, and Racine (MFR) provide some important insights, their proposal needs refinement. There is room for a wide (...) |
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The American Journal of Bioethics, Volume 12, Issue 1, Page 44-46, January 2012. |
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Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...) |
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Clear guidelines addressing the ethically appropriate use of anti-infectives in the setting of hospice care do not exist. There is lack of understanding about key treatment decisions related to infection treatment for patients who are eligible for hospice care. Ethical concerns about anti-infective use at the end of life include: (1) delaying transition to hospice, (2) prolonging a dying process, (3) prescribing regimens incongruent with a short life expectancy and goals of care, (4) increasing the reservoir of potential resistant pathogens, (...) |
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Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) |
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BackgroundStudies have shown that research participants fail to appreciate the difference between research and medical care, labeling such phenomenon as a "therapeutic misconception" (TM). Since research activity involving human participants is increasing in the Middle East, qualitative research investigating aspects of TM is warranted. Our objective was to assess for the existence of therapeutic misconception amongst Egyptians.MethodsStudy Tool: We developed a semi-structured interview guide to elicit the knowledge, attitudes, and perspectives of Egyptians regarding medical research.Setting: We recruited individuals from the (...) |
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This article draws on ethnographic field data collected during an investigation of the informed consent process and AIDS clinical trials. It describes the involvement of care providers (physicians, nurse practitioners, physician assistants) during the enlistment, or recruitment, phase of the informed consent process. It shows that sometimes care providers are involved in the receipt, evaluation and distribution of information on clinical trials through their interactions with research professionals and patients. It suggests that the involvement of care providers has the potential (...) |
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Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal (...) |
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The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how (...) |
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abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent and parental permission for research, (...) |
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Twenty-five years after the term "therapeutic misconception’ (TM) first entered the literature, most commentators agree that it remains widespread. However, the majority of scholarly attention has focused on the reasons why a patient cum human subject might confuse the goals of research with the goals of therapy. Although this paper addresses the social and cultural factors that seem to animate the TM among subjects, it also fills a niche in the literature by examining why investigators too might operate under a (...) |
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The paper reviews some of the transformations of cancer clinical trial protocols made necessary by the emergence of molecularly targeted agents. These changes include the creation of a new phase of clinical trials and the alteration of the parameters governing the other three phases. The situation remains unstable: repeated attempts to speed up the development of new drugs have not yet led to a consensus on how to best do so. The new targeted agents raise issues that go beyond the (...) |
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