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In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic., Author(s): Rieke van der Graaf [sup.1] , Marie-Astrid Hoogerwerf [sup.2] [sup.3] , Martine C. de Vries [sup.4] Author Affiliations: (1) Department of Medical Humanities, Julius Center for Health Sciences and [...]

Given Kant's exceptionless moral prohibition on lying, one might suspect that he is committed to a similar prohibition on withholding diagnostic and prognostic information from patients. I confirm this suspicion by adapting arguments against therapeutic privilege from his arguments against lying. However, I show that all these arguments are importantly flawed and submit that they should be rejected. A more compelling Kantian take on informed consent and therapeutic privilege is achievable, I argue, by focusing on Kant's duty of beneficence, which requires us to aim at furthering others' ends. But I show that there are some cases in which furthering a patient's ends requires withholding material medical information from her. Although I concede that these cases are probably quite rare, I conclude that the best Kantian thinking agrees with that of therapeutic privilege's advocates. Keywords: informed consent, Kant, lying, therapeutic privilege

This paper discusses interpretations and practical requirements for fulfilling informed consent on social surveys, particularly in the health field, in order to achieve a balance between two competing principles: the public good of carrying out high-quality survey research which requires unbiased representative participation; and respect for individuals' rights to refuse to participate. It examines the appropriateness of different practical procedures aimed at getting agreement to voluntary participation consistent with the requirements of informed consent. It seeks to raise awareness of the principles and practicalities of carrying out social surveys in the health field, which can inform judgements of what is appropriate ethical practice, which in turn can inform judgements of ethical review committees. Keywords: Informed consent; Ethical approval; Survey research; UK

The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation. Keywords: Research ethics; Informed consent; Social research; Autonomy; Research relationships

This paper concentrates on controversies about children's consent, and reviews how children's changing status as competent decision makers about healthcare and research has gradually gained greater respect. Criteria for competence have moved from age towards individual children's experience and understanding. Uncertain and shifting concepts of competence and its identification with adulthood and childhood are examined, together with levels of decision-making and models for assessing children's competence. Risks and uncertainties, methods of calculating the frequency and severity of risks, the concept of 'therapeutic research' and problems of expanding consent beyond its remit are considered. The paper ends by considering how strengths and limitations in children's status and capacities to consent can be mirrored in researchers' and practitioners' own status and capacities. Examples are drawn from empirical research studies about decision-making in healthcare and research involving children in the UK. Keywords: Minors' consent; Informed consent; Voluntary consent; Assessing competence; Valid consent; Therapeutic research; Children; UK

This paper situates discussion of the ethics of ethnographic research against the background of a theoretical and methodological debate about the relationship between ethics and method, and about the relationships between research methods and their objects. In particular, the paper investigates the implications of folding together the ethical and the empirical in research and argues that this requires the development of new ethico-ethnographic methods for the investigation of ethico-moral objects. The paper falls into three main parts. The first considers calls for what has come to be known as empirical ethics, that is, for a more empirically informed bioethics, by way of an exploration of the integration of ethnographic methods in bioethics, and concludes that approaches which see the ethical and the empirical as 'complementary' do not do justice to the methodological implications of enfolding the ethical and the ethnographic. The second part juxtaposes this with calls for the integration of ethics in ethnography and, similarly, argues that the enfolding of the ethical and the empirical in ethnography calls for the development of new methods. The paper goes on to problematise the 'negotiational' approaches to informed consent preferred by many ethnographers, arguing that the concept of negotiation, rather than offering a solution to the problem of consent, is itself ethically complex and in need of analysis. The paper argues that, in the context of ethnographic research, the possibility of negotiational forms of consent depends upon engagement between researchers and researched, with unavoidably 'ethical' concepts such as 'respect', 'recognition', 'dignity', 'justice' and so on, and that this poses methodological challenges to ethnography. The paper's third section explores the implications of these arguments for research practice, using The Genethics Club as an example. Keywords: Ethics; Ethnography; Methodology; Informed consent; Genetics; Bioethies; Empirical

Conducting anthropological research into situations where public health interventions are ongoing raises a number of complex ethical issues. This paper addresses this by focusing on recent debate around questions of informed consent in research situations into health care in the 'developing' world. Two issues are developed: firstly, that of anthropological engagement with medical research trials; and secondly, how medical ethics debates have impinged upon and influenced anthropological ideas of ethics. Drawing on personal anthropological research into the implementation of the WHO prescribed tuberculosis control programme (DOTS) in the context of Nepal, I outline a number of ethical dilemmas and issues that arose. This research context included other ongoing research into DOTS implementation, as well as the local culture of health care provision. It involved moving between a number of sites and subject positions while interacting with heath professionals and patients. In conclusion, rather than prescribing ethical norms for researchers in such situations, I argue that we need more ethnographic examples and case studies as a means of thinking through the issues. I suggest that we need to reflect on both the ethical issues that arise when undertaking research into multifaceted public health interventions and into the situations where ethical guidelines and stipulations are formulated. The best place for this may be the Internet, where we increasingly see the conditions emerging for open dialogue. Keywords: Ethics; Informed consent; Public health; Anthropology; Nepal

In this paper we examine the application of informed consent to ethnographic research in health care settings. We do not quarrel with either the principle of informed consent or its translation into the requirement that research should only be carried out with consenting participants. However, we do challenge the identification of informed consent with the particular set of bureaucratic practices of ethical review which currently operate in Canada, the US and elsewhere. We argue that these anticipatory regulatory regimes threaten the significant contribution of ethnographic research to the creation of more efficient, more effective, more equitable and more humane health care systems. Informed consent in ethnographic research is neither achievable nor demonstrable in the terms set by anticipatory regulatory regimes that take clinical research or biomedical experimentation as their paradigm cases. This is because of differences in the practices of ethnographic and biomedical research which we discuss. These include the extended periods of time ethnographers spend in the research setting, the emergent nature of ethnographic research focus and design, the nature and positioning of risk in ethnographic research, the power relationships between researchers and participants, and the public and semi-public nature of the settings normally studied. Anticipatory regulatory regimes are inimical to ethnographic research and risk undermining the contribution of systematic inquiry to understanding whether institutions do what they claim to do, fairly and civilly and with an appropriate mobilisation of resources. We do not suggest that we should simply ignore ethics or leave matters to the individual consciences of researchers. Rather, we need to develop and strengthen professional models of regulation which emphasise education, training and mutual accountability. We conclude the paper with a number of suggestions about how such professional models might be implemented. Keywords: Ethics; Informed consent; Ethnography; Research; Regulation; Ethical review

It is now widely accepted that experiments using human subjects without their informed consent is unethical. However, in certain kinds of experiment, such as placebo trials, informing participants about what will happen will invalidate research results. Some authors have suggested that the principle of informed consent has to be modified, others claim that ethical concerns can be set aside in the interest of advancing medical research. I argue that these attempts at justifying withholding information from participants are inadequate. Drawing from a debate in epistemology between so-called internalists and externalists, I claim that we can know on a different level that we are not to know certain details about an experiment, and argue that consent given on the basis of such knowledge is informed consent and is ethically sufficient.

The experience of conducting ethnographic research in the oncology department of a large Italian hospital is compared with the experiences of different American ethnographers in order to study the features of research ethics. Problems like the influence of the cultural context on the ethnographer's moral choices or the value of informed consent and ethical committees are examined.

Informed consent is an essential aspect of the establishment of every professional relationship in which psychologists participate. When done effectively, it helps promote other individuals' autonomy, engages them in a collaborative process, and helps to reduce the likelihood of exploitation or harm, among a number of potential benefits. Yet, a number of challenges and dilemmas relevant to informed consent exist for psychologists. Three invited experts provide commentaries on issues raised, questions asked, and dilemmas posed that will, the authors hope, fully stimulate further consideration and discussion of these important issues. The commentaries also broaden the discussion of informed consent in all roles in which psychologists serve. Specific recommendations are made for practicing psychologists for the ethical and effective application of informed consent in their work. Keywords: ethics, ethical practice, informed consent, professional roles

In this paper I problematise quite a simple assertion: that the two major frameworks used in assessing consent to post-mortem organ donation, presumed consent and informed consent, are procedurally similar in that both are 'default rules.' Because of their procedural common characteristic, both rules do exclude marginalized groups from consent schemes. Yet this connection is often overlooked. Contract theory on default rules, better than bioethical arguments, can assist in choosing between these two rules. Applying contract theory to the question of post-mortem organ donation suggests that the default rule should be one that goes against the wishes of the stronger party in consent decisions.

It is often claimed that the autonomy of heroin addicts is compromised when they are choosing between taking their drug of addiction and abstaining. This is the basis of claims that they are incompetent to give consent to be prescribed heroin. We reject these claims on a number of empirical and theoretical grounds. First we argue that addicts are likely to be sober, and thus capable of rational thought, when approaching researchers to participate in research. We reject behavioural evidence purported to establish that addicts lack autonomy. We present an argument that extrinsic forces must be irresistible in order to make a choice non-autonomous. We argue that heroin does not present such an irresistible force. We make a case that drug-oriented desires are strong regular appetitive desires, which do not compromise consent. Finally we argue that an addict's apparent desire to engage in a harmful act cannot be construed as evidence of irrational or compulsive thought. On these arguments, a sober heroin addict must be considered competent, autonomous and capable of giving consent. More generally, any argument against legalisation of drugs or supporting infringement of the liberty of those desiring to take drugs of addiction must be based on considerations of harm and paternalism, and not on false claims that addicts lack freedom of the will.

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. KEY WORDS: informed consent, stakeholder, veto, engineering ethics, planning, democracy, participation

There is growing concern about the reuse and exportation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.

In this article, we first document the virtually complete absence of infectious disease examples and concerns at the time bioethics emerged as a field. We then argue that this oversight was not benign by considering two central issues in the field, informed consent and distributive justice, and showing how they might have been framed differently had infectiousness been at the forefront of concern. The solution to this omission might be to apply standard approaches in liberal bioethics, such as autonomy and the harm principle, to infectious examples. We argue that this is insufficient, however. Taking infectious disease into account requires understanding the patient as victim and as vector. Infectiousness reminds us that as autonomous agents we are both embodied and vulnerable in our relationships with others. We conclude by applying this reunderstanding of agency to the examples of informed consent and distributive justice in health care.

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research. Keywords: Community participation; Informed consent; Developing countries; Kenya

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute 'right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to 'push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to 'screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account.

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.

Numerous benefits for patients have been predicted if prescribing decisions were routinely accompanied by pharmacogenetic testing. So far, little attention has been paid to the possibility that the routine application of this new technology could result in considerable harm to patients. This article emphasises that pharmacogenetic testing shares both the opportunities and the pitfalls with 'conventional' disease-genetic testing. It demonstrates that performing pharmacogenetic tests as well as interpreting the results are extraordinarily complex issues requiring a high level of expertise. It further argues that pharmacogenetic testing can have a huge impact on clinical decisions and may influence the therapeutic strategy as well as the clinical monitoring of a patient. This view challenges the predominant paradigm that pharmacogenetic testing will predict patients' responses to medicines, but that it will not provide any other significant disease-specific predictive information about the patient or family members. The article also questions published proposals to reduce the consent procedure for pharmacogenetic testing to a simple statement that the physician wishes to test a sample of the patient's DNA to see if a drug will be safe or whether it will work, and presents an alternative model that is better suited to protect patients' interests and to obtain meaningful informed consent. The paper concludes by outlining conditions for the application of pharmacogenetic testing in clinical practice in a way that can make full use of its potential benefits while minimising possible harm to patients and their families.

A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue that this demand for informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research.

INTRODUCTION The role of psychology and related mental health disciplines in the informed consent process has gradually evolved from an essentially non-existent role into a central and important one. The [...]

INTRODUCTION It is virtually impossible to state the Protestant position on any bioethical problem or issue. As a result, interpreters must focus on one Protestant position or, at most, identify [...]

Recruiting patients into clinical research is essential for the advancement of medical knowledge. However, when the physician undertaking the care of the patient is also responsible for recruitment into clinical research, a situation arises of an inter-role breach of confidentiality which is distinguishable from other conflicts of interest. Such discord arises as the physician utilizes confidential information obtained within the therapeutic relationship beyond its primary objective, and safeguards ought to be observed in order to avert this important, and generally overlooked, problem. The moral worth of the pledge of confidentiality is based not on its innate value but on its being a promise on which subsequent interactions and disclosures are founded. Within the patient-doctor interaction, confidentiality is an important facet of the promised fidelity and, as such, a loose interpretation of the notion threatens the essence of the relationship, and any violation thereof requires compelling moral justification. To avoid conflict, patients' confidential information ought not be used for the purpose of recruitment, which needs to be undertaken through general education and non-directed appeals, and a preliminary consent to be approached for research should be obtained from the patient prior to her being identified as a suitable research subject. Securing this prior consent would avoid one source of potential, albeit unintended, coercion. Keywords: clinical research, confidentiality, consent

Does respect for autonomy imply respect for precedent autonomy? The principle of respect for autonomy requires us to respect a competent patient's treatment preference, but not everyone agrees that it requires us to respect preferences formed earlier by a now-incapacitated patient, such as those expressed in an advance directive. The concept of precedent autonomy, which concerns just such preferences, is problematic because it is not clear that we can still attribute to a now-incapacitated patient a preference which that patient never disaffirmed but can no longer understand. If we cannot make that attribution, then perhaps we should not respect precedent autonomy -- after all, how can you respect patient autonomy by giving patients what they no longer want, even if they never disaffirmed those wants? I argue that whether an earlier preference can still be attributed to a now-incapacitated patient depends on the reasons behind the preference, for a preference includes (and is not merely supported by) the reasons behind it. When the considerations that served as reasons no longer exist, neither does the preference which included those reasons. In particular, if the considerations that served as reasons for the patient exist only under conditions where the patient retains full mental capacity, then once that capacity is lost, so are those reasons and the preference based upon them. I use this analysis of precedent autonomy to ascertain the merits of various approaches to advance medical decisionmaking; including Nancy Rhoden's approach, approaches based on a Parfitian personal identity analysis, approaches based on soft paternalism, and approaches based on the stability and longevity of preferences. Despite the apparent absurdity of respecting patient autonomy by giving patients what they no longer prefer but have never disaffirmed, I conclude with some programmatic remarks on when and why respect for (precedent) autonomy nonetheless requires us to respect former preferences.

In examining the doctrine of informed consent in the context of pathology practice, it is useful to begin by examining the conceptual underpinnings of the doctrine generally. Why must a [...]

Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devastating conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions.

This study examines the process and consequences of an increasingly important element of the dying experience in American hospitals: the writing of a Do-Not-Resuscitate (DNR) order. The focus of the study is on the decision-making process and timing of the DNR decision, the impact of the DNR order on the dying experience, and the consequences of the DNR order for length of hospital stay and accrued medical charges. Patients with a DNR order are compared to those who were unsuccessfully coded. Data are obtained from a review and analysis of the medical charts and death monitor sheets of a sample of 249 persons who died in 1994 in a single teaching hospital. The study found that physicians routinely discuss the DNR decision with patients and/or their surrogates (though patients are involved in the decision in only about one-third of cases) and that the decision is often made relatively early in the hospital stay. The dying experience of patients with a written DNR was different in significant ways from the experience of unsuccessfully-coded patients. Those with a DNR were more likely to remain in a single unit in the hospital and less likely to die in an intensive care unit or while connected to a ventilator. Consistent with other studies, however, average length of hospital stay and average medical charges were actually higher for the DNR patients. Implications of these differences between DNR and unsuccessfully-coded patients are discussed.

Alcohol and drag abusers present issues that complicate the informed consent process. The present study examined the practices of federally funded clinical investigators in obtaining informed consent from alcohol and drug abusers. Ninety-one (51%) researchers completed a 27-item survey on informed consent issues. The majority of investigators (57%) recruited participants susceptible to coercion; most used procedures to minimize coercion. Two thirds of researchers used objective means to determine competence to give consent and comprehension of consent forms. Virtually all investigators had policies to deal with suicidality, homicidality, or reports of child abuse; less than 1/2 informed participants of these limits to confidentiality. Almost 50% of investigators had dealt with intoxicated or suicidal participants; 12% had encountered homicidal participants; and 23% had encountered child abuse or neglect. Half of the sample used collateral data sources; about 1/2 of these obtained written informed consent from collaterals. Guidelines for informed consent with substance abusers are suggested.

A group of doctors argues against using informed consent in clinical trials. The use of informed consent when carrying out medical research on humans arose after the Nuremberg trials. However, studies have shown that many patients do not understand the consent forms. A good institutional review board can ensure that patients are not being exposed to questionable treatments. In 1996, the FDA and the Department of Health and Human Services said doctors did not need to get informed consent when treating emergency conditions. Most doctors can use experimental treatments on individual patients without getting informed consent.

This paper tells the story of events that led up to a septoplasty and the consequences that followed it. The patient is a medical ethicist. After scratching the inside of a nostril in 1976, he suffered with occasional bleeding and irritation for almost two decades. He tried topical treatment. As this failed, he sought help from an ENT specialist. The paper relates the conduct of the patient and others (friends in the medical field, the patient's spouse, nurses and anesthesiologists) vis-a-vis informed consent. Key words: anesthesia, friend, informed consent, nurses, septoplasty.

The physician in Erde's clinical case study performed poorly in a number of aspects of informed consent and good physician-patient communication. However, the patient also failed to perform some of his own duties to participate in effective communication and so shares at least some responsibility for the bad outcome. Key words: abandonment, communication, informed consent, patients' duties.