“Consent Forms and the Therapeutic Misconception: The Example of Gene Transfer Research,”
University of North Carolina at Chapel Hill, USA.IRB Ethics and Human Research 01/2005; 27(1):1-8. DOI: 10.2307/3563865
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- "That physicians/investigators themselves incorrectly conceive clinical trials from a therapeutic perspective also exacerbates the therapeutic misconception . Although the therapeutic misconception matters ethically for a variety of reasons , failure to distinguish the aims of research participation from those of medical treatment can seriously undermine informed consent  . If subjects misunderstand the goal of research, they are likely to underestimate risks or overestimate benefits. "
ABSTRACT: First-in-human clinical trials of innovative medical procedures, such as cell transplantation for Parkinson's disease, present a variety of ethical challenges. In an era of rapidly developing stem cell technologies likely to be translated into clinical trials over the next few years, it is critical that ethical concerns be fully considered. One important undertaking is ensuring that research participants give free and truly informed consent. This will necessitate adequate disclosure of risks and benefits at a time when these are incompletely defined; ensuring understanding of a complex research protocol when there is significant possibility of therapeutic misconception; and careful determination of capacity for informed consent in patients with a neurodegenerative disorder that is known to affect cognition. Here we call attention to the ethical issues that researchers conducting these types of trials will face when trying to obtain a genuinely informed consent, and we suggest possible solutions. Copyright © 2015. Published by Elsevier Ltd.Parkinsonism & Related Disorders 05/2015; 21(8). DOI:10.1016/j.parkreldis.2015.05.011 · 3.97 Impact Factor
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- "The significance of the King et al. (2005) study is heightened by the reality that the participants all suffered from diseases such as cancer and HIV. King and her colleagues found that individuals struggling with these incurable diseases were often misled about the difference between research, which is intended to produce knowledge, and therapeutic treatment, which is intended to produce a cure or alleviate symptoms. "
ABSTRACT: The mapping of the human genome and scientific discoveries regarding genetic contribu - tions to disease hold great promise for the prevention and treatment of an array of conditions. Social workers and other professionals must keep abreast of these developments and the ethi - cal dimensions of such progress. Familiar ethical provisions such as confidentiality, informed consent, self-determination, and social justice take on new meaning in light of innovations in genetic science. This article reviews ethical issues and practice implications emerging from advances in genetics knowledge, and it suggests mechanisms for continuing professional devel - opment and involvement in this important area. ETHICSFamilies in society: the journal of contemporary human services 10/2008; 89(4). DOI:10.1606/1044-3894.3820 · 0.29 Impact Factor
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ABSTRACT: Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines are derived. Informed consent for phase I clinical trials of hESC transplantation also raises ethical concerns. In previous phase I trials of highly innovative interventions, allegations that trial participants had not really understood the risk and benefits caused delays in subsequent trials. Thus, researchers should consider what information needs to be discussed during the consent process for hESC clinical trials and how to verify that participants have a realistic understanding of the study. Lack of attention to the special ethical concerns raised by clinical trials of hESC transplantation and their implications for the derivation of new hESC lines may undermine or delay progress toward stem cell therapies.Stem Cells 23(10):1454-9. · 6.52 Impact Factor
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