In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses (...) a major problem to informed consent. The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Informed consent is the legal instrument that purports to protect an individual's autonomy and defends against medical arbitrariness. Informed Consent and Health highlights that possession of complete information about all relevant aspects of a proposed treatment is integral to the ability of a patient to make an informed choice. With patient choice at both legislative and judicial levels rising to greater levels of prominence, this timely book examines how the tensions between the rights of patients (...) to make choices and the duties of doctors to provide health care are managed.This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.Containing an in-depth discussion on this fundamental right, this thought-provoking book will be of value to academics and practitioners alike. Providing fascinating insight into new solutions and interpretations, this book will also prove a key resource for clinicians and health care workers. (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)

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)

Informed consent, a cornerstone of research ethics, ensures participant protection and informed participation, particularly in online settings. Despite its significance, engagement with online consent forms remains low, underscoring the need for improved presentation strategies. This study investigates the impact of interactive elements and diverse presentation formats on the comprehension and engagement of online informed consent documents among a broad demographic beyond the commonly studied student populations. Employing a between-subjects experimental design, we explored six versions (...) of online consent forms varying in interactivity, readability, and visual formatting to identify optimal strategies for enhancing participant comprehension and engagement. Our findings reveal that interactive formats significantly improve comprehension and perceived readability, highlighting the pivotal role of design in facilitating informed consent. The study also examines the influence of individual differences, such as self-efficacy and trust in science, on the effectiveness of consent forms, providing insights into the nuanced dynamics between participant characteristics and consent form engagement. These results advocate for integrating interactive elements and thoughtful design in consent forms to foster a more informed and engaged participant base. Implications for research ethics, best practices in consent form development, and future research directions are also discussed, emphasizing the need for ongoing innovation in the consent process to adapt to the evolving landscape of online research. This study contributes to the body of knowledge on research ethics by offering evidence-based recommendations for enhancing the informed consent process, ultimately promoting participant-centered research practices. (shrink)

Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, (...) data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

In Amerika wie auch in Deutschland wird die Verletzung der ärztlichen Aufklärungspflicht im Arzthaftungsprozess als Alternativklagegrund angeführt für den Fall, dass der Nachweis eines Behandlungsfehlers (malpractice) nicht gelingt. Gegenstand dieser Arbeit ist es, die zahlreichen amerikanischen Gerichtsentscheidungen sowie die juristische Literatur im Vergleich mit dem deutschen Recht darzustellen und zu untersuchen, ob sich Fallgruppen bilden und Regeln ableiten lassen, denen in beiden Rechtsordnungen Gültigkeit zukommt.

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)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby (...) adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

The process of seeking the consent of a patient to a medical procedure is, arguably, one of the most important skills a doctor, or indeed any clinician, should learn. In fact, the very idea that doctors may institute diagnostic or treatment processes of any sort without a patient's consent is utterly counter-intuitive to the modern practice of medicine. It was not always thus, and even now it can be reliably assumed that consent is still not sought and (...) gained appropriately in every clinical encounter. To say that it should be sought and gained in this manner elevates the value of consent to a high level. It can be instructive to ask oneself why such a value might be held to be the case. The answer to this question lies in the philosophical underpinning of clinical consent, which sits within a notion of personal autonomy, and respect for autonomous decision making. (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)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

Several attempts have been made to transfer the concept of informed consent from medical and research ethics to dealing with affected groups in other areas such as engineering, land use planning, and business management. It is argued that these attempts are unsuccessful since the concept of informed consent is inadequate for situations in which groups of affected persons are dealt with collectively (rather than individually, as in clinical medicine). There are several reasons for this. The affected (...) groups from which informed consent is sought cannot be identified with sufficient precision. Informed consent is associated with individual veto power, but it does not appear realistic to give veto power to all individuals who are affected for instance by an engineering project. Most importantly, the concept of informed consent puts focus on the public’s acceptance of ready-made proposals rather than on its participation in the decision-making process as a whole, which includes the development of alternatives for the decision. Therefore, the concept of informed consent is not applicable to a company’s relations with groups and collectives. It may, however, be applicable to a company’s relations with individual persons such as customers and employees. (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)

Implantable brain–computer interface technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, (...) and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants. (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform (...) patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (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 a central concept for empirical and theoretical research concerning pregnancy management decisions and is often taken to be one of the more fundamental goals of the profession of genetic counseling. Tellingly, this concept has been seen by disability communities as salutary, despite longstanding critiques made by disability activists, advocates, and scholars concerning practices involved in genetic counseling more generally. In this chapter, we show that the widespread faith in informed consent is misleading and (...) can be detrimental to the practice of genetic counseling as guided by concerns of justice and equity. We proceed in two steps. First, we explain how informed consent is flawed as a practical concept. Second, we show how the inadequacy of informed consent illuminates the animating core of disability critiques of genetic counseling: the issue of ableism. We argue that the problem of ableism cannot be solved with informed consent because it is not merely a problem of information, but also of epistemic schemas. We suggest that what we call critically informed consent is better suited to move genetic counseling from being aware of the problem of ableism to becoming actively anti-ableist. (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)

Since its advent in the 20th century, informed consent has become a cornerstone of ethical healthcare, and obtaining it a core obligation in medical contexts. In my dissertation, I aim to examine the theoretical underpinnings of informed consent and identify what values it is taken to protect. I will suggest that the fundamental motivation behind informed consent rests in something I’ll call bodily self-sovereignty, which I argue involves a coupling of two groups of values: (...) autonomy and non-domination on the one hand, and self-ownership and personal integrity on the other. I will then go on to consider two 'case studies' I take to shed light on what is at stake in securing informed consent - consent in psychiatrically ill populations, and consent to interventions that involve the modification of the genetic germline. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss (...) it with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

The received view in medical contexts is that informed consent is both necessary and sufficient for patient autonomy. This paper argues that informed consent is not sufficient for patient autonomy, at least when autonomy is understood as a "relational" concept. Relational conceptions of autonomy, which have become prominent in the contemporary literature, draw on themes in the thought of Charles Taylor. I first identify four themes in Taylor's work that together constitute a picture of human agency (...) corresponding to the notion of agency implicit in relational accounts of autonomy. Drawing on these themes, I sketch two arguments against the position that informed consent secures autonomy. The first is that informed consent is an "opportunity" concept whereas autonomy is an "exercise" concept; the second is that informed consent requires merely weak evaluation and not strong evaluation. On Taylor's analysis of agency, strong evaluation is required for agency and for autonomy. (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)

This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the (...) exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent on the character of the information exchanged, and we uncover a range of causes of routinisation. Finally, the article discusses possible ways of countering the problem of routinisation of informed 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...

Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions. This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example, people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of (...) standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some commonsense intuitions about informed consent. We should revise the argument, commonsense morality, or both. (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)

(2013). Informed Consent, Big Data, and the Oxymoron of Research That Is Not Research. The American Journal of Bioethics: Vol. 13, No. 4, pp. 40-42. doi: 10.1080/15265161.2013.768864.

This paper attempts to establish the epistemological import and limits of informed consent in clinical research. It points out that informed consent is a necessary requirement in clinical research because it ensures adequate participation of care receivers in issues relating to their health. Besides ensuring that care receivers have knowledge of whatever medical intervention they are consenting to, informed consent, as an ideal, provides assurance that care receivers and others are neither coerced nor deceived. (...) While the question of the value of informed consent in health care delivery is not so much controverted, in contest is the question of whether or not complete and wholly specifically informed consent can indeed be realized in medical intervention. Two orientations are identified in this debate. One insists that an individual will be able to make an informed decision and make reasonable choices amongst alternatives when fully informed. The other orientation sees as an epistemic illusion, achieving full informed consent, and rather opts for informed request. This paper examines this debate by clarifying the notion of informed consent, its components and its nexus with knowledge. The position of the paper is that informed consent is not only an ethical ideal in clinical research and health care; it is also an epistemic virtue that must be continuously strived towards. This paper establishes that health care receivers can only have an epistemic claim of their medical situation if all requirements of informed consent in health care delivery such as provision of adequate information, the risk and benefits of treatment, avoidance of vague/ambiguous statements, voluntariness, etc. are met. (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)

Current legal standards of informed consent send the wrong message to physicians about their moral and legal expectations. A “transparency” model that sees consent as a conversation process can enhance good medical practice and patient autonomy without foreclosing appropriate judicial review.

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)

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue (...) that current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

ABSTRACT Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country (...) researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in‐depth interviews and 78 responses to open‐ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research. (shrink)

The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the (...) roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as “qualified relatives” who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families. (shrink)

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to (...) a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (shrink)

In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say “no.” I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that (...) are known to the patient prior to treatment. Yet, for many patients, knowledge of the price is relevant to whether they would give consent. If informed consent requires that patients know all information about their treatment that is relevant to their decision, then consent to a medical intervention in the absence of the price is not informed consent. (shrink)

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed (...) class='Hi'>consent, while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically. (shrink)