Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher (...) has the responsibility to inform the participant thoroughly about the purpose of the research, the risks and benefits of participation, and any alternatives to research available, as well as the .. (shrink)

Many believe that the ethical problems of donation after cardiocirculatory death (DCD) have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: (...) irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD. (shrink)

This article discusses nurses’ and elderly patients’ perceptions of the realization of autonomy, privacy and informed consent in five European countries. Comparisons between the concepts and the countries indicated that both nurses and patients gave the highest ratings to privacy and the lowest to informed consent. There were differences between countries. According to the patient data, autonomy is best realized in Spain, privacy in the UK (Scotland), and informed consent in Finland. For the staff (...) data, the best results tended to concentrate in the UK. The conceptual and methodological limitations of the study are identified and discussed. Implications of the results are divided into three areas: nursing practice, education and research. In practice, the analysis of patients’ values and the ethical sensitivity of nurses are important as part of ethically good care. In nurse education, students should learn to recognize ethical problems, generally and particularly, among vulnerable groups of patients. Multicultural international research is needed in this area. This is the last of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented. (shrink)

While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because they differ (...) so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized. (shrink)

Ethical issues in the care of elderly people have been identified in many countries. We report the findings of a comparative research project funded by the European Commission, which took place between 1998 and 2001. The project explored the issues of autonomy (part I), privacy (part II) and informed consent (part III) in nursing practice. Data were collected from elderly residents/patients (n = 573) and nursing staff (n = 887) in five European countries: Finland, Spain, Greece, Germany and (...) the UK (Scotland). Questionnaires were used as the data collection tool (self-completion questionnaires for staff, structured interviews for the elderly participants). Four basic nursing interventions in the care of elderly people were targeted: hygiene, fluid intake and nutrition, medication, and elimination. The data were analysed statistically. The results indicated differences within all five countries between staff and patient perceptions of autonomy, privacy and informed consent. There were also similar differences between individual countries. Conclusions were reached concerning practice, education and research. This is the first of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented. (shrink)

Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of (...) knowledge they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected. (shrink)

The right to informed consent, as established in the Supreme Court judgment in Montgomery v Lanarkshire Health Board [2015] UKSC 11, I claim involves a ‘journey of love’ between clinicians and...

In their target article, Millum and Bromwich situate their article against a backdrop of well-documented empirical research demonstrating that many participants have variable and often poor...

Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability (...) to give valid informed consent.Design: 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

Aim Genetic research representative of the population is crucial to understanding the underlying causes of many diseases. In a prospective evaluation of informed consent we assessed the willingness of individuals of different ethnicities, gender and drug dependence history to participate in genetic studies in which their genetic sample could be shared with a repository at the National Institutes of Health. Methods Potential subjects were recruited from the general population through the use of flyers and referrals from previous participants (...) and clinicians with knowledge of our study. They could consent to 11 separate choices so that they could specify how and with whom their genetic sample could be shared. Rates of affirmative consent were then analysed by gender, ethnicity and drug dependence history. Results Of 1416 volunteers enrolled, 99.7% gave affirmative informed consent for studies of addiction conducted in our laboratory. No significant difference was found for participation in genetic studies conducted in our laboratory by gender, ethnicity or drug dependence history. Over all 11 questions, individuals with a history of drug use were more likely to agree to consent to participate in our study than were healthy volunteers. Conclusion A high percentage of each category of gender, ethnicity and drug history, gave affirmative consent at all levels. The level of detail in and the amount of time spent reviewing the informed consent, and a relationship of trust with the clinical investigator may contribute to this outcome. (shrink)

on the part of physicians are most welcome and not to be disputed. If widely implemented, they should substantially improve the atmosphere of relations between patients and physicians. So, what, if anything, is to be said about his diagnoses and prescriptions, other than "Right on!?".

This narrative symposium examines the relationship of bioethics practice to personal experiences of illness. A call for stories was developed by Tod Chambers, the symposium editor, and editorial staff and was sent to several commonly used bioethics listservs and posted on the Narrative Inquiry in Bioethics website. The call asked authors to relate a personal story of being ill or caring for a person who is ill, and to describe how this affected how they think about bioethical questions and the (...) practice of medicine. Eighteen individuals were invited to submit full stories based on review of their proposals. Twelve stories are published in this symposium, and six supplemental stories are published online only through Project MUSE. Authors explore themes of vulnerability, suffering, communication, voluntariness, cultural barriers, and flaws in local healthcare systems through stories about their own illnesses or about caring for children, partners, parents and grandparents. Commentary articles by Arthur Frank, Bradley Lewis, and Carol Taylor follow the collection of personal narratives. (shrink)

In this paper we argue that ‘informed’ consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In (...) addition, and using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance‐theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants’ decision to consent. We do not prescribe a standard, formal approach to decision‐making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front‐line of genomic science. (shrink)

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They (...) argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients’ well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA’s cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer (...) patients in a large, public, west-coast clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice. (shrink)

Nursing research in China is at an early stage of development and little is known about the practices of Chinese nurse researchers. This interview study carried out at a university in central China explores the informed consent practices of Chinese nurse researchers and the cultural considerations of using a western technique. Nine semistructured interviews were conducted in English with assistance and simultaneous translation from a Chinese nurse with research experience. The interviews were analyzed by one western and two (...) Chinese researchers and major themes were identified. All participants endorsed informed consent as ethically required. Differences were noted between some of the informed consent practices typically recommended in the USA and those identified in this study, such as: recruitment using local and government officials, recruiting directly from medical records without special permission, family consultation in consent and consent control, and not revealing randomization to intervention groups receiving different treatments. (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)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; (...) and third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

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 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. (shrink)

Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus (...) pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way. (shrink)

Informed consent is the single most important concept for understanding decision-making capacity. There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. This is a classic example of medicalization. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to normalize capacity assessment.Returning the locus of capacity assessment to the attending, the primary care (...) doctor, and even to ethics consultation in today's environment will require a substantial effort to undo a strong but illusory impression of capacity assessment. Hospital attorneys as well as clinical ethicists with a sophisticated understanding of health law can be in the vanguard of this reorientation. (shrink)

Background: In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Objectives: Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses’ roles therein and whether there is a difference between ideal and experienced practice (...) (reality), and whether this differs across hospitals. Methods: A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: ‘nurses’ roles’, ‘barriers in informed consent’, and ‘adequacy of information’. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Participants and research context: Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. Ethical consideration: The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Findings: Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses’ roles varied across professions, while barriers in informed consent differed between hospitals. Discussion: The differences between ideal and reality indicated that improvement in the informed consent process and nurses’ roles therein is called for. Varying views between physicians and nurses on nurses’ roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Conclusion: Views on nurses’ roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent practice should be tailored to the hospital context. (shrink)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally (...) children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

Informed consent is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions. Adult postsurgical patients in nine general hospitals of Italy’s Campania Region were (...) interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire. The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients and patients with higher levels of education were more likely to read the written IC form. The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients’ needs. To improve the quality of communication we suggest enhancing physicians’ communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures. (shrink)

Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices (...) of surgeons at University teaching Hospitals in a low resource setting. (shrink)

Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and (...) rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts. (shrink)

This manuscript describes the responses and correlates of outpatients with schizophrenia spectrum disorders to a tool designed to measure comprehension before obtaining informed consent for research participation. We used the Evaluation to Sign Consent form to document comprehension in 100 outpatients as part of their consent to participate in an ongoing study of an exercise intervention. The findings suggest that using this form is a feasible and acceptable approach to documenting comprehension of research procedures prior to (...) obtaining informed consent. Age 49 years and older and the receipt of intramuscular antipsychotic medication predicted the need for additional assistance to complete the Evaluation to Sign Consent form successfully (χ2 = 8.29, P = 0.016). Nurse researchers should consider documenting comprehension with this tool owing to its availability, time efficiency and utility. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer (...) of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

This Element examines three related topics in the field of bioethics that arise frequently both in clinical care and in medico-legal settings: capacity, informed consent, and third-party decision-making. All three of these subjects have been shaped significantly by the shift from the paternalistic models of care that dominated medicine in the United States, Canada, and Great Britain prior to the 1960s to the present models that privilege patient autonomy. Each section traces the history of one of these topics (...) and then explores the major ethics issues that arise as these issues are addressed in contemporary clinical practice, paying particular attention to the role that structural factors such as bias and social capital play in their use. In addition, the volume also discusses recent innovations and proposals for reform that may shape these subjects in the future in response both to technological advances and changes in societal priorities. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for (...) research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

This article argues that the study conducted by Facebook in conjunction with Cornell University did not have sufficient ethical oversight, and neglected in particular to obtain necessary informed consent from the participants in the study. It establishes the importance of informed consent in Internet research ethics and suggests that in Facebook’s case (and other, similar cases), a reasonable shift could be made from traditional medical ethics ‘effective consent’ to a ‘waiver of normative expectations’, although this (...) would require much-needed change to the company’s standard practice. Finally, it gives some practical recommendations for how to implement such consent strategies, and how the ethical oversight gap between university-led research and industry-led research can be bridged, potentially using emerging Responsible Research and Innovation frameworks which are currently gathering momentum in Europe. (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)

Cancer susceptibility testing is likely to become routine in medical practice, despite many limitations and unanswered questions. These uncertainties greatly complicate the process of informed consent, creating an excellent opportunity to reconsider exactly how it should be conducted. Research with women's reactions to the availability of genetic susceptibility testing for breast cancer dramatically underscores that informed consent ought to be highly individualized, taking care to discern what patients believe about the disease and its causes and what (...) role they want their physician to play. (shrink)

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination (...) of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

Informed consent is thought to exist as a well-defined entity. Altered concepts of patient autonomy, differential cultural understanding of the entity, and the failure of clients to distinguish between research and clinical ethics, and various hierarchical cultural views of informed consent all suggest that alterations may be needed in the traditional concept. By using the methodology outlined by Gasking in which he defines the idea of “cluster concepts,” one may be able to enlarge the definition and (...) augment the understanding of the informed consent and include the time and culture-specific variants which exist. (shrink)

BackgroundThis essay provides an ethical and conceptual argument for the use of informed consent prior to the diagnosis of brain death. It is meant to enable the family to make critical end-of-life decisions, particularly withdrawal of life support system and organ donation, before brain death is diagnosed, as opposed to the current practice of making such decisions after the diagnosis of death. The recent tragic case of a 13-year-old brain-dead patient in California who was maintained on a ventilator (...) for over 2 years illustrates how such a consent would have made a crucial difference.MethodsConceptual, philosophical, and ethical analysis.ResultsI first consider a conceptual justification for the use of consent for certain non-beneficial and unwanted medical diagnoses. I suggest that the diagnosis of brain death falls into this category for some patients. Because the diagnostic process of brain death lacks the transparency of traditional death determination, has a unique epistemic structure and a complex risk-benefit profile which differs markedly from case to case, and presents conflicts of interest for physicians and society, I argue that pre-diagnostic counseling and informed consent should be part of the diagnostic process. This approach can be termed as “allow cardiac death”, whose parallel logic with “allow natural death” is discussed. I also discuss potential negative impacts on organ donation and health care cost from this proposal and offer possible mitigation. I show that the pre-diagnostic counseling can improve the possibility for well-thought-out decisions regarding organ donation and terminating life-support system in cases of hopeless prognosis. This approach differs conceptually from the pluralism of the definition of death, such as those in New Jersey and Japan, and it upholds the Uniform Determination of Death Act.ConclusionsMy intention is not to provide an instant panacea for the ongoing impasse of the brain death debate, but to point to a novel conceptual ground for a more pragmatic, and more patient- and family-centered approach. By enabling the family to consent to or decline the diagnostic process of brain death, but not to choose the definition of death, it upholds the current legal definition of death. (shrink)

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is (...) evolving along a purely Western model.Empirical studies show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences.Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians’ behaviors. (shrink)

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and (...) the impact of socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. (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)

Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...

Ten years ago, Megan Shinal sought the care of neurosurgeon Steven Toms for the surgical treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. In their twenty-minute meeting, Shinal did not make a final decision about which surgical approach she wished to pursue. Subsequently, she spoke with Tom's physician assistant once by phone and once in person, when she signed the consent form, which did not appear to designate which surgical approach she had chosen. During (...) the operation—a total resection—Toms perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. The jury found that Toms had fulfilled his informed-consent obligations prior to performing the resection; however, in June 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania Medical Care Availability and Reduction of Error Act. The court found that the language of the act is unambiguous in its requirement that “a physician's duty to provide information to a patient sufficient to obtain her informed consent is non-delegable.” Presumably, this rule of nondelegation applies beyond the surgical theater to other major treatment decisions. And it is unclear whether it applies to other professionals in a subordinate position to the treating physician, such as residents and fellows. (shrink)

Background: Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature. Research objectives: This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale. Research design: Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional (...) survey was administered, after which an exploratory factor analysis was conducted. Participants: We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan. Ethical considerations: This study was approved by two Institutional Review Boards and the autonomy of the participants was respected. Findings: The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 – ‘Understanding of the research’, Factor 2 – ‘Trust and confidence’ and Factor 3 – ‘Doubt and uncertainty’. The three factors accounted for is 52.954 of the total variance with Cronbach’s α of.917. Discussion and conclusion: The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application. (shrink)