Consent In Medicine Research Articles

Geneza świadomej zgody w medycynie krajów anglojęzycznych. Od narkozy do świadomości i od kontraktu do praw

Origins of informed consent in medicine in English-speaking countries. From narcosis to consciousness and from contract to rights The text presents the origins of informed consent in medical practice and research, with a special focus on English-speaking countries. The introduction of anesthesia into medical practice resulted in the emergence of a new group of injured patients who operated in the unconscious state, have no control over medical intervention, and complain that they were subjected to procedures to which they did not agree. The second impulse is experimenting involving humans in the 18th and 19th centuries, some cases gain considerable publicity (e.g. infection with pathogens) and led to high-profi le trials in which the argument of patients’ consent to participate in a non-therapeutic experiment appeared. In the case of therapeutic experiments, the principle of the patient’s benefi t prevails over his autonomy. The third factor is a gradual transition from the individual approach of the doctor to the patient, based on virtue ethics, to understanding the relationship between the doctor and the patient in terms of a contract. Then, the transition from the contract to general rights and the formulation of general patient rights.

Transformative experience and the principle of informed consent in medicine

This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and information handle transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these.

Informed Decision-Making and Capabilities in Population-based Cancer Screening.

Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy-as a right and as an ideal-we describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so.

Consent in organ transplantation: putting legal obligations and guidelines into practice

Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first out the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel ‘multi-factor approach’ to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine.

Informed consent for whole blood donation.

It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non-remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established. This review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis. A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre-donation transfusion-transmissible infection (TTI) screening, potential non-transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non-disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information. Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid.

Informed consent with a focus on islamic views.

For at least 50 years informed consent in medicine has focused on the principle of autonomy. Recently, attention has been given to informed consent being a shared decision. A primary mandate to do what is in the best interest of the patient still remains. The shared view looks to expand beyond the dyadic image of doctor and patient, to acknowledge the essential contribution to be made to informed consent from the cultural, religious, and personal values. This paper explores some of the cultural aspects of Islam that should influence informed consent.

The Varieties of Consent

we really need another book on informed consent? Frank Miller and Alan Wertheimer, who edited The Ethics of Consent, have two good answers to this question. First, they write, despite a considerable literature on consent in different contexts, there is surprisingly little systematic analysis of the concept of consent and the moral and legal work that it performs (p. x). Second, they point out (correctly, I believe) that bioethicists sometimes write as if the concept and principle of (informed) consent was first developed for their purposes and [as if] there was no need to reflect on the way in which consent operates in other contexts in order to provide an adequate account of consent in medicine and

Una riflessione sul trattamento sanitario obbligatorio coattivo e sul Codice deontologico

Introduction In psychiatry informed consent is an uttermost complex topic, especially when considering the 2006 Code of Medical Ethics/Medical Ethics Code (articles 33 and 35). Informed consent is the foundation of every possible therapeutic choice, although there are some notable exceptions, such as compulsory treatment for psychiatric reasons. Materials and methods The current mental health law system has been evaluated. It is noted that informed consent is not the central issue in the reasons for the involuntary admission. The problem of informed consent is subordinated to an ill-defined medical condition such as “psychic alterations that request an urgent intervention”. This ill defined condition leaves a wide array of difficulties open, when the psychiatrist has to propose the compulsory treatment. Results We consider that the stratification of different laws about freedom/mental illness interface is not rationally harmonized with the centrality of informed consent in medicine. Conclusions It would be appropriate to develop an evaluation of compulsory admission based on the centrality of informed consent (that is, the lack of informed consent). Consent can be viewed as an initial recovery of responsibility for the patient.

Bioética y buen gobierno en la Union Europea

RESUMENLa Carta de Derechos Fundamentales de la Unión Europea contribuye a desarrollar la ciudadanía europea, basada en valores comunes, como la justicia y la dignidad. La Carta se refiere al consentimiento libre e informado en Medicina y Biología, prohibiendo la clonación reproductiva y las prácticas eugenesicas. El artículo considera el papel de los temas de Bioética en la expansión de los derechos de los ciudadanos; los debates recientes han demostrado que los derechos han de estar garantizados y, además, que las buenas practicas profesionales sólo pueden desarrollarse dentro de buenas instituciones. El artículo analiza el papel de los principios de gobernanza (transparencia, eficiencia, participación, rendición de cuentas), así como la relación interna entre éstos y la integración de las políticas publicas: las cuestiones de Bioética ejemplifican el proceso de «europeanización».PALABRAS CLAVEBIOÉTICA, UNIÓN EUROPEA, GOBERNANZA, BUENAS PRACTICAS, EUROPEANIZACIÓNABSTRACTThe Charter of Fundamental Rights of the European Union contributes to develop European citizenship based on common values like justice and dignity. The Charter refers to free and informed consent in Medicine and Biology, and prohibits reproductive cloning and eugenic practices. This article considers the role of bioethical topics in the expansion of citizens’ rights; in fact, recent debates not only have proved that rights have to be guaranteed but that good professional practice could only develop within good institutions. The article also analyzes the role of the principles of governance (transparency, efficiency, participation, accountability), and the internal relationship between these principles and the integration of social policies; bioethical issues could exemplify the process of Europeanization.KEY WORDSBIOETHICS, EUROPEAN UNION, GOVERNANCE, GOOD PRACTICES, EUROPEANIZATION

Aufklärung und Einwilligung in Psychiatrie und Psychotherapie

The number of medical liability court cases in Germany has more than trebled over the past 30 years. In almost every case of a therapeutic failure, the accusation is one of insufficient medical information. It was investigated which requirements information for patients has to meet in the field of psychiatry and psychotherapy. The supreme court jurisdiction relating to patient information and consent in medicine was analysed. Legal and medical documents on the topic were also evaluated. Doctors' legal duty to provide information includes the areas of therapeutic information, enabling information for the patient, and information relating to costs. The burden of proof is always on the doctor, and the documentation needs to be legally safe. The legal basis relating to patient information and consent is consistent with the objectives of patient oriented psychiatry and psychotherapy. However, many legal requirements are exaggerated and far removed from medical practice. The specialist societies are called on to develop guidelines on how to provide information during the medical consultation.

Informed consent without bureaucracy

A comparison is drawn between informed consent in medicine and consenting practices in other areas of human activity, and an underlying conceptual unity is detected in all of these consenting practices. We insist on obtaining consent, in medicine and elsewhere, because of the value we place on personal autonomy. The conceptual unity of informed consent and consenting practices outside of medicine is defended against a series of objections. On the basis of the comparison with consenting practices in other areas of human activity, it is argued that bureaucratic informed consent processes in medicine are both unnecessary and unwarranted.

Inalienable Rights: The Limits of Consent in Medicine and the Law

Book Review| April 01 2002 Inalienable Rights: The Limits of Consent in Medicine and the Law Terrance McConnell, Inalienable Rights: The Limits of Consent in Medicine and the Law. New York: Oxford, 2000. Pp. ix, 172. Scott Kim Scott Kim Search for other works by this author on: This Site Google The Philosophical Review (2002) 111 (2): 275–278. https://doi.org/10.1215/00318108-111-2-275 Cite Icon Cite Share Icon Share Twitter Permissions Search Site Citation Scott Kim; Inalienable Rights: The Limits of Consent in Medicine and the Law. The Philosophical Review 1 April 2002; 111 (2): 275–278. doi: https://doi.org/10.1215/00318108-111-2-275 Download citation file: Zotero Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search Books & JournalsAll JournalsThe Philosophical Review Search Advanced Search The text of this article is only available as a PDF. Cornell University2002 Article PDF first page preview Close Modal You do not currently have access to this content.

Inalienable Rights: The Limits of Consent in Medicine and the Law

McConnell presents the unusual and distinctive argument that inalienable rights differ from other types of rights in that, rather than restraining the behaviour of others, inalienable rights seem to put limits on the possessors themselves, because even the possessor's consent does not justify others in encroaching on them. He offers a full account of what it means for a right to be inalienable, distinguishing them from other kinds of rights in the contexts of moral and political issues in medicine and law: for example, the right to life, the right of conscience, and, in particular, the right of informed consent. McConnell's book is intended as a distinctive conception and persuasive defence of inalienable rights, which ties into current discussions of informed consent. It should appeal to applied ethicists and philosophers of law among others.

"Doctor, are you trying to kill me?": ambivalence about the patient package insert for estrogen.

In 1976, the U.S. Food and Drug Administration proposed new requirements for patient labeling for estrogens prescribed for menopausal and postmenopausal women. This paper explores the variety of responses to this proposal from women and their husbands, feminist and consumer activists, physicians, pharmacists, and pharmaceutical manufacturers, as represented in letters written to the FDA. The drug industry and the medical profession opposed patient labeling on the grounds of cost and a resentment of governmental intrusion. Feminists and consumer advocates were in favor of the idea, but the response from current estrogen users was mixed: most women wished to be better informed, but many expressed concern that estrogen would be removed from the market. This ambivalence suggests unresolved tensions regarding conceptions of female aging, the medical management of menopause and aging, informed consent in medicine, and governmental regulation of medical practice. The debate thus represents an important moment in the history of women's health care.

Informed Consent in Medicine in Comparison with Consent in Other Areas of Human Activity

The Southern Journal of PhilosophyVolume 39, Issue 2 p. 169-187 Informed Consent in Medicine in Comparison with Consent in Other Areas of Human Activity Steve Clarke, Steve Clarke Centre for Applied Philosophy and Public Ethics Charles Sturt University Steve Clarke is a Research Fellow in the Centre for Applied Philosophy and Public Ethics and a Lecturer in Philosophy in the School of Humanities and Social Sciences at Charles Stuart University in Australia. He is the author of Metaphysics and the Disunity of Scientific Knowledge (Aldershot: Ashgate, 1998) as well as recent and forthcoming articles in the American Philosophical Quarterly, the British Journal for the Philosophy of Science, the Journal of Applied Philosophy, and Philosophy of the Social Sciences.Search for more papers by this author Steve Clarke, Steve Clarke Centre for Applied Philosophy and Public Ethics Charles Sturt University Steve Clarke is a Research Fellow in the Centre for Applied Philosophy and Public Ethics and a Lecturer in Philosophy in the School of Humanities and Social Sciences at Charles Stuart University in Australia. He is the author of Metaphysics and the Disunity of Scientific Knowledge (Aldershot: Ashgate, 1998) as well as recent and forthcoming articles in the American Philosophical Quarterly, the British Journal for the Philosophy of Science, the Journal of Applied Philosophy, and Philosophy of the Social Sciences.Search for more papers by this author First published: 26 March 2010 https://doi.org/10.1111/j.2041-6962.2001.tb01812.xCitations: 12 AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Citing Literature Volume39, Issue2Summer 2001Pages 169-187 RelatedInformation

Is consent in medicine a concept only of modern times?

Although the issue of consent in medical practice has grown immensely in recent years, and it is generally believed that historical cases are unknown, our research amongst original ancient Greek...

Assault and Battery, or Legitimate Treatment?

In response to cases of high-handed medical interventions and treatments, a debate on the legal justification of operations and the relevance of patients' consent developed among German-speaking jurists in the 1890s. The view that surgery was objectively physical injury or battery, which went merely unpunished through the patient's consent, was highly contested among legal experts and firmly rejected by doctors. Various proposals to justify indicated medical treatment without consent were discussed. German jurisdiction, however, endorsed the battery theory of medical interventions and thus prepared the way for the concept of informed consent in medicine.

Informed consent: ideal or reality?

Is it ever possible to give informed consent to treatment or research? Are the standards of consent set by ethicists and lawyers too high for ordinary people to reach? Should these standards be abandoned or modified? These questions are discussed in this paper mainly in relation to the extensive literature on consent in medicine, with examples about consent to children's treatment and research which raise extra dilemmas. Paradoxical meanings are considered: consent as an informed correct choice or a courageous best guess, and autonomy as isolated, uncompromised freedom or reasonably uncoerced self-realisation. Beyond being informed, consent involves evaluating, making and signifying a decision. It is better understood as a process than an event, in which reasoned understandings can be complemented by emotional insights. Ethical and legal standards of voluntary consent, although partly an unrealistic ideal, provide important guidelines for people who request and give consent to research.

Truce on the Battlefield: A Proposal for a Different Approach to Medical Informed Consent

What is informed consent in medicine? For more than a generation, this deceptively simple question has vexed the law, discomfited medicine, and generated much inspired, provocative, and even contentious commentary.The question has also spawned several lawsuits. On one side stand patients who claim that, at the time of consent, they were ignorant of a particular risk; who state that, with more or different information, they would have chosen a different treatment; and who argue that, because of an adverse outcome, they now deserve remuneration. On the other side, doctors uneasily watch the lengthening list of suits. Some, troubled by the law's expectations, have reacted by variously describing informed consent as a myth, a fiction, an unattainable goal, or a snare to entrap physicians. They point to the legal commentary condemning informed consent law as ill-defined, diffuse, and fraught with inconsistency, hazy at its best and virtually indecipherable to physicians at its worst: and lacking a fair standard to determine when a patient has sufficient knowledge to give effective consent.

Informed consent in medicine: one physician's perspective

The American physician is today besieged by economic and societal forces which conspire to weaken whatever equanimity he or she could once bring to the practice of medicine. In the latter realm, the threat of malpractice actions is ever-present. In this regard, negligence has long been the theory whereupon plaintiffs' attorneys seek to recover damages for patients' misfortunes in the medical system. However, when no physician negligence can be shown to be the cause of bad medical outcomes, lack of informed consent has become an alternative theory for attorneys to use in pursuing legal action. This development in the law balances a laudable effort to protect patients' autonomy rights against an often intolerable burden for physicians. What to tell patients is thus a matter of paramount concern in the era of risk management. The issue of informed consent is a relatively recent development in the history of medicine. Traditionally the doctor-patient relationship has been paternalistic. In ancient Greece, Hippocrates advised physicians to