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1.
Familial determination, replete with its frequent usurping of patient autonomy, propagation of collusion, and circumnavigation of direct patient involvement in their own care deliberations, continues to impact clinical practice in many Asian nations. Suggestions that underpinning this practice, in Confucian‐inspired societies, is the adherence of the populace to the familial centric ideas of personhood espoused by Confucian ethics, provide a novel means of understanding and improving patient‐centred care at the end of life. Clinical experience in Confucian‐inspired Singapore, however, suggests that personhood is conceived in broader terms. This diverging view inspired a study of local conceptions of personhood and scrutiny of the influence of the family upon it. From the data gathered, a culturally appropriate, clinically relevant and ethically sensitive concept of personhood was proposed: the Ring Theory of Personhood (Ring Theory) that better captures the nuances of local conceptions of personhood. The Ring Theory highlights the fact that, far from being solely dependent upon familial centric ideals, local conceptions of personhood are dynamic, context dependent, evolving ideas delineated by four dimensions. Using the Ring Theory, the nature of familial influences upon the four dimensions of personhood – the Innate, Individual, Relational and Societal – are examined to reveal that, contrary to perceived knowledge, conceptions of personhood within Confucian societies are not the prime reason for the continued presence of this decision‐making model but remain present within local thinking and practices as a sociocultural residue and primarily because of inertia in updating ideas. 相似文献
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Sonia Mannan Jobair Alam K. M. Ashbarul Bari S. M. A. A. Mamun Rehnuma Mehzabin Orin 《Developing world bioethics》2023,23(3):252-259
Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care. 相似文献
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Phoebe Friesen 《Bioethics》2018,32(5):298-307
It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of unauthorized pelvic examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible. 相似文献
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Varelius J 《Bioethics》2012,26(4):207-214
In contemporary Western biomedical ethics, informed consent practices are commonly justified in terms of the intrinsic value of patient autonomy. James Stacey Taylor maintains that this conception of the moral grounding of medical informed consent is mistaken. On the basis of his reasoning to that effect, Taylor argues that medical informed consent is justified by the instrumental value of personal autonomy. In this article, I examine whether Taylor's justification of medical informed consent is plausible. 相似文献
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S. Rebers E. Vermeulen A. P. Brandenburg T. J. Stoof B. Zupan-Kajcovski W. J. W. Bos M. J. Jonker C. J. Bax W. J. van Driel V. J. Verwaal M. W. van den Brekel J. C. Grutters R. A. Tupker L. Plusjé R. de Bree J. H. Schagen van Leeuwen E. G. J. Vermeulen R. A. de Leeuw R. M. Brohet N. K. Aaronson F. E. Van Leeuwen M. K. Schmidt 《PloS one》2016,11(3)
Background
Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness.Methods
We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded.Results
We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus.Conclusion
We conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals.Trial Registration
Dutch Trial Register NTR2982 相似文献7.
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从知情同意产生和发展的历史、知情同意的含义和模式方面来说明产生于一定历史背景下的知情同意,在临床和研究领域,以及生物信息库的建设中,具有一定的局限性,也面临着挑战。面对这样的挑战,不应该拘泥于对知情同意概念本身如何准确表述、模式如何创新,而更应该从知情同意所要达到的目的——保护患者、受试者和样本提供者的权益来考虑。 相似文献
9.
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. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. 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. 相似文献
10.
Aasim I. Padela Aisha Y. Malik Farr Curlin Raymond De Vries 《Developing world bioethics》2015,15(2):98-106
Contemporary clinical ethics was founded on principlism, and the four principles: respect for autonomy, nonmaleficence, beneficence and justice, remain dominant in medical ethics discourse and practice. These principles are held to be expansive enough to provide the basis for the ethical practice of medicine across cultures. Although principlism remains subject to critique and revision, the four‐principle model continues to be taught and applied across the world. As the practice of medicine globalizes, it remains critical to examine the extent to which both the four‐principle framework, and individual principles among the four, suffice patients and practitioners in different social and cultural contexts. Using the four‐principle model we analyze two accounts of surrogate decision making – one from the developed and one from the developing world – in which the clinician undertakes medical decision‐making with apparently little input from the patient and/or family. The purpose of this analysis is to highlight challenges in assessing ethical behaviour according to the principlist model. We next describe cultural expectations and mores that inform both patient and clinician behaviors in these scenarios in order to argue that the principle of respect for persons informed by culture‐specific ideas of personhood may offer an improved ethical construct for analyzing and guiding medical practice in a globalized and plural world. 相似文献
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Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal
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Pramod R. Regmi Nirmal Aryal Om Kurmi Puspa Raj Pant Edwin van Teijlingen Sharada P. Wasti 《Developing world bioethics》2017,17(2):84-89
Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low‐and middle‐income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. 相似文献
13.
Background
The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information.Methods and Findings
We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%). In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization) was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias.Conclusions
For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully described (namely, whether participants were informed of the allocation group before being recruited) for a better appraisal of the risk of selection bias. 相似文献14.
Christopher F. C. Jordens Kathleen Montgomery Rowena Forsyth 《Journal of bioethical inquiry》2013,10(1):67-77
Concerns are frequently raised about the extent to which formal consent procedures actually lead to “informed” consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation is largely implicit, however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness. 相似文献
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TOM WALKER 《Bioethics》2013,27(7):388-394
There is widespread agreement that it would be both morally and legally wrong to treat a competent patient, or to carry out research with a competent participant, without the voluntary consent of that patient or research participant. Furthermore, in medical ethics it is generally taken that that consent must be informed. The most widely given reason for this has been that informed consent is needed to respect the patient's or research participant's autonomy. In this article I set out to challenge this claim by considering in detail each of the three most prominent ways in which ‘autonomy’ has been conceptualized in the medical ethics literature. I will argue that whilst these accounts support the claim that consent is needed if the treatment of competent patients, or research on competent individuals, is to respect their autonomy, they do not support the claim that informed consent is needed for this purpose. 相似文献
16.
Onora O'Neill 《Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences》2001,32(4):689-704
In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent. 相似文献
17.
This paper is an analysis of the limits of family authority to refuse life saving treatment for a family member (in the Chinese medical context). Family consent has long been praised and practiced in many non-Western cultural settings such as China and Japan. In contrast, the controversy of family refusal remains less examined despite its prevalence in low-income and middle-income countries. In this paper, we investigate family refusal in medical emergencies through a combination of legal, empirical and ethical approaches, which is highly relevant to the ongoing discussion about the place of informed consent in non-Western cultures. We first provide an overview of the Chinese legislation concerning informed consent to show the significance of family values in the context of medical decision-making and demonstrate the lack of legal support to override family refusal. Next, we present the findings of a vignette question that investigated how 11,771 medical professionals and 2,944 patients in China responded to the family refusal of emergency treatment for an unconscious patient. In our analysis of these results, we employ ethical reasoning to question the legitimacy of family refusal of life-sustaining emergency treatment for temporarily incompetent patients. Last, we examine some practical obstacles encountered by medical professionals wishing to override family refusal to give context to the discussion. 相似文献
18.
Griffiths J 《Tijdschrift voor gerontologie en geriatrie》2002,33(5):219-223
The right of a competent patient to stipulate in advance of possible non-competence, medical treatment he does not want, is based on the fundamental legal principle that a person cannot be medically treated without his informed consent. It is in Dutch law a strong and almost unqualified right. There are indications in the international literature, however, that advance directives in many cases may not have much influence on medical treatment at the end of life. Very little is known about the social practice of advance directives in the Netherlands. 相似文献
19.
Informed consent requires surgeons to provide information about all available alternatives and their associated risks and tradeoffs to every prospective breast augmentation patient. The informed patient and surgeon then make decisions based on the information the patient has received, clinical parameters that may affect those decisions, and the patient's willingness to accept specific risks and tradeoffs. During the authors' 22 years of clinical practice, substantial changes have occurred in the requirements for adequate informed consent and the methods of ensuring that patients receive it.The numbers of alternatives for augmentation and the relative benefits and risks of each method have changed substantially over the past two decades. Four specific areas of postoperative issues stimulated major changes in the authors' approach to patient education and informed consent: 1) questions or dissatisfaction with implant size postoperatively, 2) questions about financial responsibility for costs associated with untoward events requiring reoperation postoperatively including capsular contracture or other problems, 3) spouses or other concerned parties rendering opinions postoperatively when they had not been involved in the informed consent process, and 4) criteria for whether reoperations were indicated, how many were indicated, and when implant removal without replacement might be most logical.This paper describes an approach that integrates patient education and informed consent in stages by 1) providing detailed, highly specific written and verbal information, 2) utilizing a staged approach to education and informed consent that provides information and requires simultaneous, informed consent in stages, 3) repeating each critical topic at least two or three times during the process, requiring repetitive written documentation by the patient on at least three different occasions, 4) emphasizing patient accountability for choices selected, and 5) organizing the education and informed consent process so that it is clinically practical and also increases thoroughness and documentation while conserving surgeon time.This staged, integrated system of patient education and informed consent uses a comprehensive set of informed consent documents that are available for downloading from the Plastic and Reconstructive Surgery Web site (www.plasreconsurg.org).Before incorporating any of the informed consent documents or statements reported in this paper, each surgeon should seek review by the surgeon's malpractice insurance carrier and by appropriate legal counsel to ensure compliance with state and federal laws applicable to the surgeon's practice. These documents have evolved to prospectively address patient management issues that have occurred over the authors' 22-year experience in augmentation. The documents are not endorsed by ASPS and do not necessarily represent the views of ASPS. 相似文献
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Chabot C Shoveller JA Spencer G Johnson JL 《Journal of empirical research on human research ethics》2012,7(2):20-33
Debates over how to determine age of consent for youth to participate in research feature prominently in the practice of researchers, research ethics boards (REBs), and community decision makers working with youth. In particular, tensions can arise over how the ethical principles of beneficence, autonomy, and justice are interpreted and applied in research involving young people. We discuss our experiences obtaining ethical approval to conduct a participatory action research project involving youth and the differences of opinion we encountered regarding underage youth's capability to make informed consent. We suggest that researchers, REBs, and community decision makers all share a responsibility to conduct proactive outreach to youth participants, so that they are adequately informed of their rights related to research. 相似文献