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)

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of (...) the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create. (shrink)

Mitochondrial replacement therapy requires oocytes of women whose mitochondrial DNA will be transmitted to resultant children. These techniques are scientifically, ethically and socially controversial; it is likely that some women who donate their oocytes for general in vitro fertilisation usage would nevertheless oppose their genetic material being used in MRT. The possibility of oocytes being used in MRT is therefore relevant to oocyte donation and should be included in the consent process when applicable. In present circumstances, specific consent should be (...) obtained. However, once MRT becomes more routine, such consent could be incorporated into the general consent process for oocyte donation. The reported lack of proper consent for MRT from the oocyte donor in the first baby born via the technique is an ethical failing and should be corrected in any future practice of MRT. (shrink)

In this article we examine the effectiveness of consent in data protection legislation. We argue that the current legal framework for consent, which has its basis in the idea of autonomous authorisation, does not work in practice. In practice the legal requirements for consent lead to ‘consent desensitisation’, undermining privacy protection and trust in data processing. In particular we argue that stricter legal requirements for giving and obtaining consent as proposed in the European Data protection regulation will further weaken the (...) effectiveness of the consent mechanism. Building on Miller and Wertheimer’s ‘Fair Transaction’ model of consent we will examine alternatives to explicit consent. (shrink)

The focus of this article is on elderly patients’ and nursing staff perceptions of informed consent in the care of elderly patients/residents in five European countries. The results suggest that patients and nurses differ in their views on how informed consent is implemented. Among elderly patients the highest frequency for securing informed consent was reported in Finland; the lowest was in Germany. In contrast, among nurses, the highest frequency was reported in the UK (Scotland) and the lowest in Finland. In (...) a comparison of patients’ and nurses’ perceptions, nurses had more positive views than patients in all countries except Finland. Patients with less need for nursing interventions in Greece and Spain gave their consent less often. The German and Greek patients were older, and the results also point to an association between this and their lower frequency of giving consent. In Spain, patients who were married or who had a family member or friend to look after their personal affairs were more likely to be included in the group whose consent was sought less often. This is the fourth 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)

In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical profession as (...) well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial’s conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)

Medical school curricula and postgraduate education programmes expend considerable resources teaching medical ethics. Simultaneously, whistleblowers’ agitation continues, at great personal cost, to prompt major intrainstitutional and public inquiries that reveal problems with the application of medical ethics at particular clinical “coalfaces”.Virtue ethics, emphasising techniques promoting an agent’s character and instructing their conscience, has become a significant mode of discourse in modern medical ethics. Healthcare whistleblowers, whose complaints are reasonable, made in good faith, in the public interest, and not vexatious, we (...) argue, are practising those obligations of professional conscience foundational to virtue based medical ethics. Yet, little extant virtue ethics scholarship seriously considers the theoretical foundations of healthcare whistleblowing.The authors examine whether healthcare whistleblowing should be considered central to any medical ethics emphasising professional virtues and conscience. They consider possible causes for the paucity of professional or academic interest in this area and examine the counterinfluence of a continuing historical tradition of guild mentality professionalism that routinely places relationships with colleagues ahead of patient safety.Finally, it is proposed that a virtue based ethos of medical professionalism, exhibiting transparency and sincerity with regard to achieving uniform quality and safety of health care, may be facilitated by introducing a technological imperative using portable computing devices. Their use by trainees, focused on ethical competence, provides the practical face of virtue ethics in medical education and practice. Indeed, it assists in transforming the professional conscience of whistleblowing into a practical, virtue based culture of self reporting and personal development. (shrink)

In patient centred care, shared decision making is a central feature and widely referred to as a norm for patient centred medical consultation. However, it is far from clear how to distinguish SDM from standard models and ideals for medical decision making, such as paternalism and patient choice, and e.g., whether paternalism and patient choice can involve a greater degree of the sort of sharing involved in SDM and still retain their essential features. In the article, different versions of SDM (...) are explored, versions compatible with paternalism and patient choice as well as versions that go beyond these traditional decision making models. Whenever SDM is discussed or introduced it is of importance to be clear over which of these different versions are being pursued, since they connect to basic values and ideals of health care in different ways. It is further argued that we have reason to pursue versions of SDM involving, what is called, a high level dynamics in medical decision-making. This leaves four alternative models to choose between depending on how we balance between the values of patient best interest, patient autonomy, and an effective decision in terms of patient compliance or adherence: Shared Rational Deliberative Patient Choice, Shared Rational Deliberative Paternalism, Shared Rational Deliberative Joint Decision, and Professionally Driven Best Interest Compromise. In relation to these models it is argued that we ideally should use the Shared Rational Deliberative Joint Decision model. However, when the patient and professional fail to reach consensus we will have reason to pursue the Professionally Driven Best Interest Compromise model since this will best harmonise between the different values at stake: patient best interest, patient autonomy, patient adherence and a continued care relationship. (shrink)

Hospize verstehen sich als Orte einer ganzheitlichen Sterbebegleitung, welche nicht allein die Behandlung körperlicher und psychischer Symptome, sondern auch die soziale und spirituelle Betreuung der Sterbenden beinhaltet. Eine zentrale Bedeutung innerhalb dieser umfassenden Begleitung am Lebensende hat die Idee der Selbstbestimmung. Dem Hospizgast soll ermöglicht werden, im Sinne einer größtmöglichen Autonomie über die eigenen Belange bis zuletzt selbst entscheiden zu können. Diese zentrale Zielsetzung der Hospizarbeit wurde in der Literatur bisher überwiegend in theoretisch-programmatischer Weise thematisiert, es liegen jedoch kaum Untersuchungen (...) zu der Frage vor, wie die Idee der „Selbstbestimmung bis zuletzt“ im Alltag der Hospize praktisch umgesetzt wird. Über die besonderen Umstände der Pflege in stationären Hospizen hinaus ist der hier zugrunde gelegte Begriff von Autonomie auch von grundsätzlichem medizinethischen Interesse. Das ganzheitlich-palliative Konzept von Behandlung und Pflege, welches bereits im Hospiz als Institution fest verankert ist, legt nahe, dass die Idee der Selbstbestimmung in diesem Umfeld anders konzeptualisiert wird als im Bereich der „klassischen“, zumeist kurativ orientierten Medizin. Die qualitative Interviewstudie mit haupt- und ehrenamtlichen Mitarbeiterinnen und Mitarbeitern konnte zeigen, dass in stationären Hospizen ein Konzept von Selbstbestimmung vertreten wird, welches über rein medizinische Entscheidungen weit hinausgeht. Zugleich konnte aber auch herausgearbeitet werden, wo nach Ansicht der Mitarbeiterinnen und Mitarbeiter mögliche Grenzen der Selbstbestimmung des Gastes im Hospiz liegen. (shrink)

In recent years, ‘nudge’ theory has gained increasing attention for the design of population-wide health interventions. The concept of nudge puts a label on efficacious influences that preserve freedom of choice without engaging the influencees’ deliberative capacities. Given disagreements over what it takes genuinely to preserve freedom of choice, the question is whether health influences relying on automatic cognitive processes may preserve freedom of choice in a sufficiently robust sense to be serviceable for the moral evaluation of actions and policies. (...) In this article, I offer an argument to this effect, explicating preservation of freedom of choice in terms of choice-set preservation and noncontrol. I also briefly explore the healthcare contexts in which nudges may have priority over more controlling influences. (shrink)

Respect for Autonomy has been a mainstay of medical ethics since its enshrinement as one of the four principles of biomedical ethics by Beauchamp and Childress’ in the late 1970s. This paper traces the development of this modern concept from Antiquity to the present day, paying attention to its Enlightenment origins in Kant and Rousseau. The rapid C20th developments of bioethics and RFA are then considered in the context of the post-war period and American socio-political thought. The validity and utility (...) of the RFA are discussed in light of this philosophical-historical account. It is concluded that it is not necessary to embrace an ethic of autonomy in order to guard patients from coercion or paternalism, and that, on the contrary, the dominance of autonomy threatens to undermine those very things which have helped doctors come to view and respect their patients as persons. (shrink)

This essay argues that individual-oriented informed consent is inadequate to protect human research subjects in mainland China. The practice of family-oriented decision-making is better suited to guide moral research conduct. The family’s role in medical decision-making originates from the mutual benevolence that exists among family members, and is in accordance with family harmony, which is the aim of Confucian society. I argue that the practice of informed consent for medical research on human subjects ought to remain family-oriented in mainland China. (...) This essay explores the main features of this model of informed consent and demonstrates the proper authority of the family. The family’s participation in decision-making as a whole does not negate or deny the importance of the individual who is the subject of the choice, but rather acts more fully to protect research subjects. (shrink)

This paper throws some light on the nature of argumentation, its use and advantages, within the setting of doctor–patient interaction. It claims that argumentation can be used by doctors to offer patients reasons that work as ontological conditions for enhancing the decision making process, as well as to preserve the institutional nature of their relationship with patients. In support of these claims, selected arguments from real-life interactions are presented in the second part of the paper, and analysed by means of (...) a model of argumentation borrowed from classical rhetoric, and refined according to the modern orientation of the pragma-dialectic approach. (shrink)

Autonomy and valuing are two significant practical phenomena that have been analysed in terms of higher-order wanting. I argue that reference to higher-order capacities is indeed required to make sense of both concepts, but also that such analyses need a more differentiated understanding of "wanting to want" than has hitherto been proposed. Central for autonomy is the instantiation of four types of optative relationship by an accountable agent under conditions of rationality. Valuing requires the disposition to instantiate only one of (...) the relevant structures. Clarity on this allows an analysis of the precise relationships between the two phenomena. (shrink)

Patient and family demands for the initiation or continuation of life-sustaining medically non-beneficial treatments continues to be a major issue. This is especially relevant in intensive care units, but is also a challenge in other settings, most notably with cardiopulmonary resuscitation. Differences of opinion between physicians and patients/families about what are appropriate interventions in specific clinical situations are often fraught with highly strained emotions, and perhaps none more so when the family bases their desires on religious belief. In this essay, (...) I discuss non-beneficial treatments in light of these sorts of disputes, when there is a clash between the nominally secular world of fact- and evidence-based medicine and the faith-based world of hope for a miraculous cure. I ask the question whether religious belief can justify providing treatment that has either no or a vanishly small chance of restoring meaningful function. I conclude that non-beneficial therapy by its very definition cannot be helpful, and indeed is often harmful, to patients and hence cannot be justified no matter what the source or kind of reasons used to support its use. Therefore, doctors may legitimately refuse to provide such treatments, so long as they do so for acceptable clinical reasons. They must also offer alternatives, including second opinions, as well the option of transferring the care of the patient to a more accommodating physician or institution. (shrink)

Abstract:The number of patients with organ failure who could potentially benefit from transplantation continues to exceed the available supply of organs. Despite numerous efforts to increase the number of donors, there remains an enormous mismatch between demand and supply. Large numbers of people still die with potentially transplantable organs remaining in situ, most frequently as a result of family objections. I argue that there are no persuasive moral arguments against mandated organ retrieval from all dead individuals who meet clinical criteria. (...) However, because of continuing endemic prejudice in United States society and its healthcare system and the distrust this engenders, I conclude that proceeding with a policy of compulsory organ retrieval, even if morally unobjectionable, would not be warranted. (shrink)

The proliferation of social media and web 2.0 applications (Facebook, MySpace, Twitter, blogs, etc.) in the previous 5 years has created a new social research opportunity, with over an estimated 552 million active daily users on Facebook (Facebook Press 2012). As with all research, boundaries must be set out to create valid and accurate data, keeping ethical practices at the forefront of the data gathering process. The lack of standardized practices requires an in-depth look into the use of such methods, (...) with focus on four major areas: 1) security for the individual, 2) anonymity, 3) safety and 4) use of mined data and information gathered by either passive or active means. (shrink)

The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent (...) process. Too often, the sharing of information has been replaced by the mere acquisition of agreement with the authority ostensibly offering a choice.Scholars of informed consent agree that its salience and its legitimacy derive from a fiduciary duty to inform, in order to respect, protect, and promote autonomous decision making by those to whom the duty is owed. (shrink)

In light of the variety of uses of the term autonomy in recent bioethics literature, in this paper, I suggest that competence, not being as contested, is better placed to play the anti-paternalistic role currently assigned to autonomy. The demonstration of competence, I will argue, can provide individuals with robust spheres of non-interference in which they can pursue their lives in accordance with their own values. This protection from paternalism is achieved by granting individuals rights to non-interference upon demonstration of (...) competence. In this paper, I present a risk-sensitive account of competence as a means of grounding rights to non-interference. On a risk-sensitive account of competence individuals demonstrate their competence by exercising three capacities to the extent necessary to meet a threshold determined by the riskiness of the decision. These three capacities are the capacity to acquire knowledge, use instrumental rationality, and form and revise a life plan. (shrink)

In interprofessional clinical teams, the patients have interpersonal relationships with several practitioners. The aim of this study was to explore patients’ and practitioners’ perceptions of how such relationships may contribute to promote the whole team’s respect for the patient’s autonomy, as interpersonal patient–provider relationships may contribute to enhance patient autonomy. Sixteen qualitative in-depth interviews were conducted with 12 informants, including patients, nurses, physiotherapists, and physicians from three rehabilitation teams. Data were analysed according to Grounded Theory procedures. The informants discussed interpersonal (...) relationships as an integral and significant part of the team work. The practitioners tried to adjust their professional approach to the patients’ genuine opinions and let patients decide the teams’ goals. Close relationships with patients could be important to accomplish this, particularly described by nurses and physiotherapists, who could facilitate the communication with the rest of the team. (shrink)

Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician''s responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient''s decisions and a surrogate''s and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional (...) capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate''s decision. They have to assess the surrogate''s decisional capacity and attitude toward the patient as well as the reasons that support the surrogate''s decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Informed choice is increasingly recognised as important in supporting patient autonomy and ensuring that people are neither deceived nor coerced. In cancer screening the emphasis has shifted away from just promoting the benefits of screening to providing comprehensive information to enable people to make an informed choice. Cancer screening programmes in the UK now have policies in place which state that it is their responsibility to ensure that individuals are making an individual informed choice. There is a need to evaluate (...) whether such policies mean that those people invited for screening are making informed choices, and how comprehensive information affects other variables such as uptake, cost effectiveness, and satisfaction. At the present time, there is no validated measure of informed choice in cancer screening. Such a measure could be used to evaluate the effectiveness of interventions to increase informed choice and levels of informed choice in a population invited for screening. It could encourage health professionals to be accountable. Factors important when measuring informed choice in cancer screening include an individual’s understanding of the limitations of screening, the ability to make an autonomous choice, and the difference between choice and behaviour. (shrink)

A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the (...) crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process. (shrink)

The field of nanotechnology and nanoscience is growing rapidly in many areas of research, from electronics to biomedicine to material science. Carbon nanotubes are receiving a lot of attention in the research due to their unique properties and many possible applications. This new material is a good example of how nanotechnology provides us with new opportunities, but at the same time leaves us a lot of unknowns to deal with. In order to deal with the unknowns we need to consider (...) both the science and the ethics of the different applications of this novel material. Nanoethics is the study of the ethical issues in nanotechnology. It is a relatively new field of study and a lot of different methods have been suggested in this area. In this article a method is suggested combining an existing ethical theory with a practical approach in order to do a case study of the ethical considerations of using carbon nanotubes in biomedicine. For the case study to be of practical significance the scientific characteristics and properties of carbon nanotubes are reviewed to give the reader an overview of the research field. (shrink)

Although Chinese law imposes informed consent for medical treatments, the Chinese understanding of this requirement is very different from the European one, mostly due to the influence of Confucianism. Chinese doctors and relatives are primarily interested in protecting the patient, even from the truth; thus, patients are commonly uninformed of their medical conditions, often at the family’s request. The family plays an important role in health care decisions, even substituting their decisions for the patient’s. Accordingly, instead of personal informed consent, (...) what actually exists is ‘family informed consent’. From a Western perspective, these features of Chinese law and Chinese culture might seem strange, contradicting our understanding of doctor-patient relationship and even the very essence of self-determination and fundamental rights. However, we cannot forget the huge influence of cultural factors in these domains, and that ‘Western’ informed consent is grounded on the individualistic nature of Western culture. This article will underline the differences between the Western and the Chinese perspectives, clarifying how each of them must be understood in its own cultural environment. But, while still respecting Chinese particularities, this paper advocates that China adopt patient individual informed consent because this is the only solution compatible with human dignity and human rights. (shrink)

Although employed throughout health-related rhetoric and research today, prevention it is an ambiguous and complicated category when applied to mental and behavioral health. It is analyzed here, along with four ethical issues arising when public health preventative methods and goals involve mental health: age of intervention; resource priorities between prevention and treatment; substantive issues in preventive pedagogies and trade-offs framed by differences of approach. Illustrations include some of the most widespread and ambitious recent preventive models: those aiming to avert subsequent (...) mood disorders of depression and anxiety; those that would curb self-harming behavior, and efforts to anticipate and avoid or delay psychosis. To suppose that public mental health can be entirely modeled on other public health programs is mistaken. Instead, it must proceed with awareness of the particular features typifying many mental disorders. These include features of the disorders themselves; the preliminary nature of scientific knowledge about them; the contested applicability of traditional disease models to them; the dearth of established research data available about preventive interventions currently in place or proposed; and the effects of stigma and discrimination on any such interventions. (shrink)

Alzheimer’s disease is the most common form of dementia which is estimated to impact 350,000 people over 65 years of age in Canada. The lack of effective treatment and the growing number of people who are expected to be diagnosed with Alzheimer’s disease in the near future are compelling reasons why continued research is in this area is necessary. With additional research, there needs to be greater recognition of the complexity of seeking ongoing informed consent from those with Alzheimer’s disease. (...) This complexity is because the impairment of memory and cognitive ability does not diminish in a linear manner, but rather fluctuates between periods of impairment and relatively normal cognitive lucidness. There is limited discussion in the guidelines of those progressing from early stages of Alzheimer’s disease who have intermittent cognitive function. Guidelines to research and Research Ethics Boards require further development to facilitate researcher including those with Alzheimer’s disease while protecting this growing pool of potential participants. (shrink)

A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details the (...) curriculum topics developed that incorporate ethical principles, particularly for group protections/benefits within the field practices of environmental/engineering researchers. (shrink)

Research ethics principles and regulations typically have been applied to the protection of individual human subjects. Yet, new paradigms of research that include the place-based community and cultural groups as partners or participants of environmental research interventions, in particular, require attention to place-based identities and geographical contexts. This paper argues the importance of respecting “place” within human subjects protections applied to communities and cultural groups as part of a critical need for research ethics and cultural competence training for graduate research (...) students. These protections and benefits are extensions of the Belmont Principles and have been included in recent recommendations from research regulatory committees. (shrink)

The opaque use of data collection methods on the WWW has given rise to privacy concerns among Internet users. Privacy policies on websites may ease these concerns, if they communicate clearly and unequivocally when, how and for what purpose data are collected, used or shared. This paper examines privacy policies from a linguistic angle to determine whether the language of these documents is adequate for communicating data-handling practices in a manner that enables informed consent on the part of the user. (...) The findings highlight that corporate privacy policies obfuscate, enhance and mitigate unethical data handling practices and use persuasive appeals to increase companies’ trustworthiness. The communicative strategies identified provide starting points for redesigning existing privacy statements with a view to communicating data handling practices in a more transparent and responsible manner, laying the groundwork for informed consent. (shrink)

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and (...) Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. (shrink)

In his recent article ‘Nudging, Informed Consent and Bullshit’, William Simkulet1 convincingly argues that certain types of nudging satisfy Frankfurt’s criteria of bullshit. As a prelude to this argument, Simkulet considers whether recommendations and framing are types of nudging and whether they satisfy the requirement of adequate disclosure essential for a valid informed consent. He defines nudging as the systematic attempt at altering behaviour by non-rational means, and describes adequate disclosure as providing the patient with true information that enables an (...) understanding of treatment options and their risks and benefits. Simkulet argues that recommendations and framing are types of rational persuasion in that they potentially enhance patients’ understanding of treatment options and their risks and benefits. Therefore, not only do they not qualify as nudging, but they may be required in order to secure adequate disclosure. In this brief comment, I focus on Simkulet’s considerations of framing and show that framing may be nudging and that it may violate the requirements of informed consent. The framing of medical information may influence patients’ preferences for treatment. It has been shown that framing information about a risky medical intervention in chance of survival rather than risk of death increases patients’ preferences for the intervention.2 3 In his exploration of framing, Simkulet contends that the fact that people respond differently to …. (shrink)

In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

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)