Bioethics is a subject far removed from the Chinese, even from many Chinese medical students and medical professionals. In-depth interviews with eighteen physicians, patients, and family members provided a deeper understanding of bioethical practices in contemporary China, especially with regard to the doctor-patient relationship (DPR) and informed consent. The Chinese model of doctor-family-patient relationship (DFPR), instead of DPR, is taken to reflect Chinese Confucian cultural commitments. An examination of the history of Chinese culture and (...) the profession of medicine in China is used to disclose the deep roots of these commitments. The author predicts that the DFPR model will further develop in China but that it will maintain its Chinese character. (shrink)

Background Informed consent is a process in which a healthcare provider obtains permission from an individual prior to surgery. Patient satisfaction with the informed consent process is one of the main indicators of healthcare service quality. This study aimed to assess patient satisfaction with surgical informed consent at Jimma Medical Center, Ethiopia, in 2020. Methods A facility-based cross-sectional study was conducted from April 1 to June 30, 2020, at Jimma Medical Center. Face-to-face (...) interviews were conducted using structured questionnaires. A systematic sampling technique was used to select the study participants. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between patient satisfaction and socio-demographic and facility-related factors. In multivariate regression, predictors with a P-value of < 0.05 were considered statistically significant. Results Totally 372 study participants were interviewed with a response rate of 97.8%. Nearly two-fifths (43%) of patients were satisfied with surgical informed consent. Living in an urban area (AOR: 2.279, 95% CI 1.257–4.131), having current referred history (AOR: 1.856, 95% CI 1.033–3.337), consent form version (AOR: 2.076, 95% CI 1.143–3.773), time spent on the provision of informed consent (AOR: 5.227, 95% CI 2.499–10.936) and having better patient-health providers relationship (AOR: 5.419, 95% CI 3.103–9.464) predictors were positively associated with patient satisfaction. Conclusion Patient satisfaction with the surgical informed consent process was relatively low. Therefore, Health care professionals need to emphasize a way of delivering informed consent, patients' needs and obey a standard informed consent to improve patient satisfaction. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the (...) most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical (...) assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the (...) most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

The biblical healings by Jesus and the primitive Church, the liturgical development of the Roman Rite of Exorcism, and the current practice of exorcists reflect a relationship between exorcism and the medical healing arts. Since mutuality characterizes all healer–sufferer interactions, informed consent is a central concept in physician–patient and exorcist–energumen relationships. Informed consent requires adequate information, decision-maker competence, and freedom from coercion. The determination of freedom from coercion is a particular challenge in exorcism, and (...) guidelines for its assess­ment are discussed. While proxy decision making in medical care is generally driven by concerns over competence, foreseeable periods of demonic coercion will necessitate establishing proxies in exorcism. This places a moral duty on the exorcist to establish a substitute decision maker even in cases where the energumen would be considered competent. Discussion of this need through the process of informed consent builds the trust necessary for mutual decision making. (shrink)

This chapter contains sections titled: The Moral Foundation The Legal Requirement for Consent in Therapeutic Settings The Exceptions References.

An obstacle to abortion exists in the form of abortion ‘counselling’ that discourages women from terminating their pregnancies. This counselling involves providing information about the procedure that tends to create feelings of guilt, anxiety and strong emotional reactions to the recognizable form of a human fetus. Instances of such counselling that involve false or misleading information are clearly unethical and do not prompt much philosophical reflection, but the prospect of truthful abortion counselling draws attention to a delicate issue for healthcare (...) professionals seeking to respect patient autonomy. This is the fact that even accurate information about abortion procedures can have intimidating effects on women seeking to terminate a pregnancy. Consequently, a dilemma arises regarding the information that one ought to provide to patients considering an abortion: on the one hand, the mere offering of certain types of information can lead to intimidation; on the other hand, withholding information that some patients would consider relevant to their decision-making is objectionably paternalistic on any standard account of the physician-patient relationship. This is an unsettling conclusion for the possibility of setting fixed professional guidelines regarding the counselling offered to women who are considering abortion. Thus, abortion ought to be viewed as an illuminating example of a procedure for which the process of securing informed consent ought to be highly context-sensitive and responsive to the needs of each individual patient. This result underscores the need for health care professionals to cultivate trusting relationships with patients and to develop finely tuned powers of practical judgment. (shrink)

Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow (...) research to proceed without patient consent. This article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients’ perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment. (shrink)

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK’s National Health Service. We explore two aspects of (...) consent: first, how healthcare professionals consider the act of ‘consenting’ patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients’ understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients’ decision-making. Rather, decision-making is socially contextualised – also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed. (shrink)

The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing (...) of the patient towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship. (shrink)

The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing (...) of the patient towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship. (shrink)

In December 2017, Law 219/2017, ‘Provisions for informed consent and advance directives’, was approved in Italy. The law is the culmination of a year-long process and the subject of heated debate throughout Italian society. Contentious issues are addressed in the law. What emerges clearly are concepts such as quality of life, autonomy, and the right to accept or refuse any medical treatment – concepts that should be part of an optimal relationship between the patient and healthcare (...) professionals. The law maximizes the value of the patient’s time to decide. Every patient is allowed to make choices for the present as well as for the future, conceived as a continuation of the present, and to decide what comes next, based on what he/she already knows. The law identifies three distinct but converging paths towards the affirmation of a care relationship based on reciprocal trust and respect: the possibility to consent to or refuse treatment, the shared care planning, and advance directives. The fundamental point to emerge from the new Italian law is that consensus is an essential connotation of the treatment relationship. Consensus is not limited to the acceptance/rejection of medical treatment but is ongoing. It is projected into the future through shared care planning and advance directives which act as tools for self-determination and the manifestation of the beliefs and preferences of persons unable to express their will. These principles are in line with the idea of appropriate care as evaluated from two different perspectives, one of scientific adequacy and the other commensurate with the individual’s resources, fragility, values, and beliefs. Surely, however, the new law is not the end of the matter on issues such as conscientious objection, which is deeply rooted within the Italian cultural and political debate. In this regard, healthcare institutions and policymakers will be called upon to develop and implement organizational policies aimed at the management of foreseeable conscientious objection in this field. (shrink)

Background: The law and literature about children’s consent generally assume that patients aged under-18 cannot consent until around 12 years, and cannot refuse recommended surgery. Children deemed pre-competent do not have automatic rights to information or to protection from unwanted interventions. However, the observed practitioners tend to inform young children s, respect their consent or refusal, and help them to “want” to have the surgery. Refusal of heart transplantation by 6-year-olds is accepted. Research question: What are possible (...) reasons to explain the differences between theories and practices about the ages when children begin to be informed about elective heart surgery, and when their consent or refusal begins to be respected? Research design, participants and context: Research methods included reviews of related healthcare, law and ethics literature; observations and conversations with staff and families in two London hospitals; audio-recorded semi-structured interviews with a purposive sample of 45 healthcare professionals and related experts; interviews and a survey with parents and children aged 6- to 15-years having elective surgery (not reported in this paper); meetings with an interdisciplinary advisory group; thematic analysis of qualitative data and co-authorship of papers with participants. Ethical considerations: Approval was granted by four research ethics committees/authorities. All interviewees gave their informed written consent. Findings: Interviewees explained their views and experiences about children’s ages of competence to understand and consent or refuse, analysed by their differing emphases on informed, signified or voluntary consent. Discussion: Differing views about children’s competence to understand and consent are associated with emphases on consent as an intellectual, practical and/or emotional process. Conclusion: Greater respect for children’s practical signified, emotional voluntary and intellectual informed consent can increase respectful understanding of children’s consent. Nurses play a vital part in children's practitioner-patient relationships and physical care and therefore in all three elements of consent. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent (...) in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

Argumentation theory has much to offer our understanding of the doctor-patient relationship as it plays out in the context of seeking and obtaining consent to treatment. In order to harness the power of argumentation theory in this regard, I argue, it is necessary to take into account insights from the legal and bioethical dimensions of informed consent, and in particular to account for features of the interaction that make it psychologically complex: that there is a (...) fundamental asymmetry of authority, power and expertise between doctor and patient; that, given the potential for coercion, it is a challenge to preserve the interactive balance presumed by the requirement of informed consent; and finally that the necessary condition that patients be ‘competent to consent’ may undermine the requirement of respecting patient autonomy. I argue argumentation theory has the resources to deal with these challenges and expand our knowledge, and appreciation, of the informed consent interaction in health care. Keywords: argumentation theory, informed consent, doctor-patient interaction, competency to consent, autonomy, medical paternalism. (shrink)

Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent (...) has, at best, been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better. (shrink)

As policy makers place great hope in health information technology as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven environment can reasonably be expected to affect (...) the relationship between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Living Organ Donors’ Stories: (Unmet) Expectations about Informed Consent, Outcomes, and CareElisa J. Gordon, Symposium EditorKeywordsEthics, informed consent, kidney, liver, living donor, narrative, transplantationLiving donor organ transplantation has become standard treatment for patients with end-stage kidney or end-stage liver disease. Live donors comprised approximately 5,769 (34%) and 247 (4%) of all kidney and liver transplants in 2011, respectively (OPTN/UNOS). The reasons why people donate, the (...) perception that donating does not entail a decision per se, and the attendant fears and anxieties living donors feel about donating, have all been previously well investigated (Lennerling, Forsberg, Meyer, & Nyberg, 2004; Papachristou, Walter, Frommer, & Klapp, 2010). But much less is known about how donors experienced the overall donation process including the donor evaluation, preparation, appreciation of risks, decision-making, informed consent, post-operative, recovery processes, and the impact of donating on all aspects of their life, from their point of view. Thus, a narrative approach is essential for gaining insights into these less well known phenomena.There is good reason to remain concerned about the safety and ethical basis of living donation considering that living donors undergo serious health risks for no direct medical benefit to themselves (Ethics Committee of the Transplantation Society, 2004; Laird, 2012; Neergaard, 2011; Ratner & Sandoval, 2010; Shelton, 2011). The situation raises serious ethical questions specifically about nonmaleficence and informed consent, and more broadly about using people as a means to an end. The absence of long-term information may not undermine a willing donor’s commitment to save a loved one’s life, but is certainly cause for concern among transplant clinicians who want to be sure to disclose information that may be material for donors in order to provide adequate informed consent. In other words, the disjuncture between what transplant clinicians find important to disclose to donors and what prospective donors need to know—which follows along the lines of what Elliot Mishler referred to as the ‘voice of medicine’ versus the ‘voice of the lifeworld’(1984)—seems to complicate donors’ preparation for donation. Donors’ stories are important for addressing these concerns by identifying risks that typically do not get reported in the scientific literature—perhaps owing to a different [End Page 1] conceptualization of what should be construed as noteworthy risks—as well as by demonstrating how personal situations can enhance or detract from the experience overall.This issue of Narrative Inquiry in Bioethics (NIB) affords a unique entrée into both the often heard and unheard stories of living organ donors. A set of topical areas were presented for the authors’ consideration that relate to the donation process in general and the informed consent process more specifically: whether donors were prepared to donate; comprehended what they were told; could have understood the process better, as well as, the impact of donation on health, employment, finances, and personal relationships (Table 1). When soliciting donors’ stories, every effort was made to include a full range of experiences—both good and bad—from a variety of donors: kidney donation, liver donation, adult-to-adult and adult-to-child donation, related, unrelated, directed and anonymous (also known as ‘altruistic’ or ‘good Samaritan’ donors), paired chain exchange, and list exchange (Table 2)—in order to present a balanced perspective on live donation. Additionally, this issue includes a full breadth of stories about the donor experience, ranging from positive to mixed to negative (Table 3). While donors were given tremendous leeway in what stories they told, they were asked to focus their narratives on the lesser known dimensions of donation—the experience of it. While additional stories from liver donors would have helped to underscore common concerns among liver donors, we only received a few. Some of the donors are themselves health care professionals, active in the United Network for Organ Sharing (UNOS) or their local OPO, or have leveraged their experiences to help others by becoming a donor buddy or donor advocate. Given that we received more stories than Click for larger view View full resolutionTable 1.Topical areas to address[End Page 2] Click for larger view View full resolutionTable 2.Forms of Living Donation Click for larger view View... (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent (...) in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

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. (shrink)

Background: Biological products are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature.Aims: This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents.Methods: The religious groups that make up about 75% of the United Kingdom population were (...) identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products was sent to 100 healthcare professionals working in seven specialist units in the UK.Results: All religious leaders replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals surveyed knew the constituents of all the products correctly.Conclusion: Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients. (shrink)

Definition of the problems: The physician-patient-relationship is influenced by economically driven decisions. This study explores the ethical consensus in explaining economical backgrounds of therapeutic and diagnostic interventions to patients, and the clinical practices of patient information.Method: A combination of questionnaire send to members of relevant health care organisations (n=132) and interviews with physicians working in different clinical resorts (n=15).Results and conclusion: In general there is a consensus in truth-telling about the economical background, however this ethical principle in (...) many cases is neglected. Whenever possible physicians try to translate economically driven decisions into medical terms. There is a broad disagreement and a wide range of individual ethical preferences regarding patient information, that can not be controlled by patients in any way. (shrink)

Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent (...) has, at best, been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better. (shrink)

Treatment informed consent aims to preserve the autonomy of patients in the clinician – patient relationship so as to ensure valid consent. An acceptable method of evaluating understanding of consent information is by assessing the extent of recall by patients of the pieces information believed to have been passed across. When concerns are not satisfactorily addressed from the patients’ perspective, recall of consent information may be low. This study is a questionnaire – based (...) cross – sectional interview of consecutive adult surgical patients who could give their respective medical histories and who were booked for elective major surgical procedures over a period of 7 months in a tertiary health institution in southeastern Nigeria. Four to five days after a formal consent session, during ward admission, extent of recall of information on the nature of the disease condition or diagnosis, the nature of the planned procedure and the risks involved in the planned procedure were assessed and analyzed on the background of how satisfying the consent sessions were from individual patient’s perspective. Generally, the recall of nature of disease condition and nature of planned procedure is better than recall of risks involved in the planned procedure. More specifically however, recall in these 3 domains is significantly better among the patients that affirmed that their concerns were satisfactorily addressed. The findings from this study support that no effort should be spared in ensuring that the consent information are satisfying to the patients from the patients’ viewpoint. (shrink)

This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often-cited assertion that the patient–physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients’ decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician’s role (...) on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients’ risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials. (shrink)

BackgroundPrecision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review.MethodsWe used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided 665 (...) different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine.ResultsMany patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceive some risks. Commonly perceived risks include: lack of evidence for accuracy of tests and efficacy of treatments; limited knowledge of patients, which makes informed consent more difficult; possible unavailability of access to precision medicine for underprivileged people and ethnic minorities; misuse of data by insurance companies and employers, potential of racial stigmatization due to genetic information; unwanted communication of incidental findings; changes in doctor-patient-relationship through focusing on data; and the problem that patients could feel under pressure to optimize their health.ConclusionsNational legislation and guidelines already minimize many risks associated with precision medicine. However, from our perspective some problems require more attention. Should hopes for precision medicine’s benefits be fulfilled, then the ethical principle of justice would require an unlimited access to precision medicine for all people. The potential for autonomous patients’ decisions must be greatly enhanced by improvements in patient education. Harm from test results must be avoided in any case by the highest possible data security level and communication guidelines. Changes in the doctor-patient relationship and the impact of precision medicine on the quality of life should be further investigated. Additionally, the cost-effectiveness of precision medicine should be further examined, in order to avoid malinvestment. (shrink)

The informed consent process is the legal embodiment of the fundamental right of the individual to make decisions affecting his or her health., and the patient’s permission is a crucial form of respect of freedom and dignity, it becomes extremely important to enhance the patient’s understanding and recall of the information given by the physician. This statement acquires additional weight when the medical treatment proposed can potentially be detrimental or even fatal. This is the case of (...) thalassemia patients pertaining to class 3 of the Pesaro classification where Allogenic hematopoietic stem cell transplantation remains the only potentially curative treatment. Unfortunately, this kind of intervention is burdened by an elevated transplantation-related mortality risk , equal to 30% according to published reports. In thalassemia, the role of the patient in the informed consent process leading up to HSCT has not been fully investigated. This study investigated the hypothesis that information provided by physicians in the medical scenario of HSCT is not fully understood by patients and that misunderstanding and communication biases may affect the clinical decision-making process. (shrink)

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be (...) difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice. (shrink)

Informed consent, decision-making styles and the role of patient-physician relationships are imperative aspects of clinical medicine worldwide. We present the case of a 74-year-old woman afflicted with advanced liver cancer whose attending physician, per request of the family, did not inform her of her true diagnosis. In our analysis, we explore the differences in informed-consent styles between patients who hold an "independent" and "interdependent" construal of the self and then highlight the possible implications maintained by (...) this position in the context of international clinical ethics. Finally, we discuss the need to reassess informed-consent styles suitable to the needs of each patient regardless of whether he or she resides in the United States or in Japan. (shrink)

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it (...) creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent. (shrink)

Physician assistants (PAs), nurse practitioners (NPs), and medical residents constitute an increasingly significant part of the American health care workforce, yet patient assent to be seen by nonphysicians is only presumed and seldom sought. In order to assess the willingness of patients to receive medical care provided by nonphysicians, we administered provider preference surveys to a random sample of patients attending three emergency departments (EDs). Concurrently, a survey was sent to a random selection of ED residents and PAs. All (...) respondents were to assume the role of patient when presented with hypothetical clinical scenarios and standardized provider definitions. Despite presumptions to the contrary, ED patients are generally unwilling to be seen by PAs, NPs, and residents. While seldom asked in practice, 79.5% of patients fully expect to see a physician regardless of acuity or potential for cost savings by seeing another provider. Patients are more willing to see residents than nonphysicians. (shrink)

Background Informed consent prior to nursing care procedures is an established principle which acknowledges the right of the patient to authorise what is done to him or her; consent prior to nursing care should not be assumed. Nursing care procedures have the potential to be unwanted by the patient and hence require an appropriate form of authorisation that takes into consideration the relationship between the nurse and patient and the ongoing nature of care (...) delivery. Research question How do nurses obtain consent from patients prior to nursing care?. Design Critical incident technique and the collection of critical happenings. Participants 17 participants who were all qualified nurses took part in in-depth interviews Ethical considerations Ethical approval was obtained from the university ethics committee. Findings Information giving is a key component prior to nursing care procedures. Nurses provide information to patients as a routine aspect of care delivery, and do so even when the patient is unable to communicate themselves. Whilst some participants described how information giving might be rushed or overlooked at times, it is clearly an established part of nursing care and is provided to ensure the patient knows what to expect when care is delivered. What is less clear is the extent to which information is given in order to seek the consent – rather than merely inform the patient – about nursing care. Conclusion Implied consent is often an appropriate way in which consent is obtained prior to nursing care procedures. It takes into account the ongoing care provision and the relationship that exists between the nurse and patient. However implied consent should not be assumed. Nurses need to ensure that information is given not only to inform the patient about a procedure but to enable the patient to give his or her consent and to find an alternative way forward if the patient withholds their consent. (shrink)

Green bioethics is an area of research and scholarship that examines the impact of healthcare practices and policies on the environment and emphasises environmental values, such as ecological sustainability and stewardship. Some green bioethicists have argued that healthcare providers should inform patients about the environmental impacts of treatments and advocate for options that minimise adverse impacts. While disclosure of information pertaining to the environmental impacts of treatments could facilitate autonomous decision-making and strengthen the patient–provider relationship in situations where (...) patients have clearly expressed environmental concerns, it may have the opposite effect in other situations if makes patients feel like they are being judged or manipulated. We argue, therefore, that there is not a generalisable duty to disclose environmental impact information to all patients during the consent process. Providers who practice green bioethics should focus on advocating for system-level changes in healthcare financing, organisation and delivery and use discretion when bringing up environmental concerns in their encounters with patients. (shrink)

The carbon emissions of global health care activities make up 4–5% of total world emissions, placing it on par with the food sector. Carbon emissions are particularly relevant for health care because of climate change health hazards. Doctors and health care professionals must connect their health care delivery with carbon emissions and minimize resource use when possible as a part of their obligation to do no harm. Given that reducing carbon is a global ethical priority, the informed consent (...) process in health care delivery must change. I argue that the expanded role of bioethicists in this climate crisis is to promote and support “green informed consent:” the sharing of climate information with patients, offering options for lower-carbon health care, and accepting the patient’s right to decline treatments which are deemed too carbon intensive for their values. (shrink)

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and (...) many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure. (shrink)

This contribution deals with the issue of the professional autonomy ofthe medical doctor. Worldwide, the physician's autonomy is guaranteedand limited, first of all, by Codes of Medical Ethics. InItaly, the latest version of the national Code of MedicalEthics (Code 1998) was published in 1998 by the Federation ofprovincial Medical Associations (FnomCeO). The Code 1998acknowledges the physician's autonomy regarding the scheduling, thechoice and application of diagnostic and therapeutic means, within theprinciples of professional responsibility. This responsibility has tomake reference to (...) the following fundamental ethical principles:(1) the protection of human life; (2) the protection of thephysical and psychological health of the human being; (3) therelief from pain; (4) the respect for the freedom and the dignityof the human person, without discrimination; (5) an up-to-datescientific qualification (Art. 5). The authors underline that autonomyis an anthropological – and consequently ethical –characteristic of the human person. Different positions on autonomy inbioethics (individualistic, evolutionistic, utilitarian andpersonalistic models) are explained. The relation between theprofessional autonomy of the physician and the autonomy of the patientand of colleagues is discussed. In fact, the medical doctor isobliged: (1) to respect the fundamental rights of the person,first of all his/her life; (2) to ensure the continuity of thecare, even if he can only relieve the patient's suffering; (3) tomaintain, except under certain circumstances, professional secrecy andconfidentiality regarding patients and their medical records. Moreover,the physician cannot deny the patient correct and appropriateinformation. He/she should not perform any diagnostic or therapeuticactivity without the informed consent of the patient and the medicaldoctor must give up medical treatment in case of documented refusal ofthe individual. Furthermore, the medical doctor has the right to raiseconscientious objections if he/she is requested to perform medicalactions that are contrary to his/her conscience or medical opinion,unless this attitude would seriously and immediately harm the patient.Regarding the relationships with colleagues, the physician is obliged tosolidarity, mutual respect, and care of sick colleagues. Finally, theauthors discuss the Italian legislation affecting the physician'sprofessional autonomy: (1) the SSN health care Acts; (2) theso-called Charter for Public Health Care Services; (3) the Acts onprivacy; (4) Good Clinical Practice. (shrink)

This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of (...) IVF treatment, and the tendency for patients to overestimate their chances of success prior to the experience of treatment. Once in active treatment, however, patients identify their oöcytes as both precious and precarious. We argue that it is necessary to formally include embodied experience as a source of knowledge in informed consent procedures, both for gratuitous donation and for egg-sharing regimes. We recommend that at least one full cycle of IVF be completed before approaching women to divert eggs away from their own fertility treatment. (shrink)

In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.

Subjective rights enjoy limited import in Kelsenian theory for whereas the concept of duty underlies every legal norm, that of rights is merely possible and only emerges when the imposition of the sanction attached to the breach of the duty is made dependent upon a subject's will to bring legal action. The presence of secondary norms establishing certain duties of medical professionals on informed consent displays the existence of correlative reflex rights of patients. Yet, together with secondary norms, (...) Western legal systems typically institute norms of competence enabling patients to take legal action when those duties correlative to their reflex right to informed consent have been infringed. Thus, informed consent constitutes a set of subjective legal positions of patients and medical professionals. Despite its excessive formalism and questionable neutrality, the Kelsenian approach permits to define and clearly distinguish patients' genuine rights from mere aspirations devoid of legal basis. (shrink)

Patient autonomy, as exercised in the informed consent process, is a central concern in bioethics. The typical bioethicist's analysis of autonomy centers on decisional capacity—finding the line between autonomy and its absence. This approach leaves unexplored the structure of reasoning behind patient treatment decisions. To counter that approach, we present a microeconomic theory of patient decision-making regarding the acceptable level of medical treatment from the patient's perspective. We show that a rational patient's desired (...) treatment level typically departs from the level yielding an absence of symptoms, the level we call ideal. This microeconomic theory demonstrates why patients have good reason not to pursue treatment to the point of absence of physical symptoms. We defend our view against possible objections that it is unrealistic and that it fails to adequately consider harm a patient may suffer by curtailing treatment. Our analysis is fruitful in various ways. It shows why decisions often considered unreasonable might be fully reasonable. It offers a theoretical account of how physician misinformation may adversely affect a patient's decision. It shows how billing costs influence patient decision-making. It indicates that health care professionals' beliefs about the ‘unreasonable’ attitudes of patients might often be wrong. It provides a better understanding of patient rationality that should help to ensure fuller information as well as increased respect for patient decision-making. (shrink)

Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern (...) of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for (...) risk–benefit assessment and informed consent. (shrink)

In the present contribution, we argue that all health care professionals and particularly psychotherapists should provide a plausible rationale for their treatment including an etiological model and a model of unique and common change mechanisms. The provision of a plausible rationale has two goals: (1) meet the ethical challenge of informed consent, and (2) to improve treatment outcome by fostering the meaning response. In the course of the ethical and a legal obligation of psychotherapists to obtain patients’ (...) class='Hi'>informed consent before initiating psychotherapy, patients have the right to receive maximally comprehensive information for providing their consent, which - among other information about the treatment (such as general psychotherapeutic approach, setting, and procedures) – should include a plausible treatment rationale. A useful concept in conceptualizing and communicating a treatment rationale as part of the informed consent procedure is Moerman’s general notion of the meaning response as the physiological or psychological effects of meaning in the course and treatment of an illness. The more compelling the rational explanation of the targeted treatment effects, the stronger the meaning response is expected to be. As the mechanisms of change in psychotherapy are known to be quite abstract and considered common to all approaches to a large extent, it seems especially important to provide a convincing treatment rationale to strengthen trust in the therapist and potentially foster positive expectations of process and outcome. To that extent, strengthening a patient`s meaning response to information provided at the beginning of psychotherapy may be central to activating common therapeutic factors. (shrink)

The author of this paper discusses why the issue of financial conflicts of interest in psychiatry has important public health implications for women and why FCOI complicate the informed consent process. For example, when psychiatric diagnostic and treatment guidelines are unduly influenced by industry, informed consent becomes a critical issue, because women may be assigned diagnostic labels that are not valid and may also be receiving imbalanced or even inaccurate information about their mental health treatment options. (...) However, mere disclosure of industry relationships is an insufficient solution. Following Ells, the author offers a more robust account of autonomy, inspired by Foucault, to strengthen informed consent practices. In addition to addressing power relations, this Foucauldian account of autonomy emphasizes the relational and dialogical aspect of the physician–patient relationship. (shrink)

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed (...) class='Hi'>consent and a survey of patient subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)