Unequal treatment of human research subjects is a significant ethical concern, because justice requires that equals be treated equally. If two research subjects are the same in the relevant respects, they should be treated equally. However, not all human subjects are the same in relevant respects: people differ with respect to age, health, gender, race, mental abilities, socioeconomic status, and other characteristics. Disputes sometimes arise concerning the issue of whether subjects are the same in relevant respects and should therefore be treated equally. Allegedly unequal treatment occurs when subjects are treated differently and there is a serious dispute about whether subjects are the same in relevant respects. Patently unequal treatment occurs when there is no significant dispute about whether subjects are the same in relevant respects and they are treated unequally. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, institutional review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Additional guidance may be necessary to minimize patently unequal treatment of research subjects.
human subjects research; justice; equal treatment; ethics; regulation
The field of bioethics continues to struggle with the problem of cultural diversity: can universal principles guide ethical decision making, regardless of the culture in which those decisions take place? Or should bioethical principles be derived from the moral traditions of local cultures? Ten Have and Gordijn (2011) and Bracanovic (2011) defend the universalist position, arguing that respect for cultural diversity in matters ethical will lead to a dangerous cultural relativity where vulnerable patients and research subjects will be harmed. We challenge the premises of moral universalism, showing how this approach imports and imposes moral notions of Western society and leads to harm in non-western cultures.
Bioethics; cross-cultural bioethics; culture; cultural diversity; ethics; ethical relativism; morality; moral universalism; moral imperialism; multiculturalism; Western bioethics
Rapid Tissue Donation (RTD) is an advancing oncology research procedure for collecting tumors, metastases, and unaffected tissue 2 to 6 hours after death. Researchers can better determine rates of progression, response to treatment, and polymorphic differences among patients. Cancer patients may inquire about posthumous body donation for research to offer a personal contribution to research; however, there are barriers to recruiting for an RTD program. Physicians must reassure the patient that their treatment options and quality of care will not be compromised due to participating in RTD. In this commentary we discuss how theories of altruism may explain cancer patients’ desire to participate in an RTD program, the ethical concerns of health care professionals and patients and the use of altruism as a recruitment strategy. We offer recommendations for examining the cultural and ethical climate of the institution prior to initiating such a program such as examining the relationship of healthcare professionals and patients, identifying ethical concerns, and examining ways to promote acceptance and buy-in across professionals, patients, and families.
Tissue donation; cancer; altruism; ethics; health care professionals
Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects.
Best interests standard; Children; Non-therapeutic research; Pediatric research; Precedence of individual interests; Research ethics
In the paper we are analyzing the Polish ART market. It can be noticed that the lack of legal regulation has resulted in many discrepancies among the policies adopted by various ART agencies. The social acceptance of ART procedures available mostly in private clinics led to growing commercialization of the Polish ART market. Additionally, the language of gift and altruistic rhetoric that are overwhelmingly employed by ART agencies reveals hypocrisy of the Polish ART market.
ART market; Poland; Commercialization; Altruism
Since the revolutionary mood of the 1960s, patient-centered mental health care and a research emphasis on service users as experts by experience have emerged hand in hand with a view of service users as consumers. What happens to knowledge derived from firsthand experience when mental health users become experts and actively choose care? What kind of perspective do service users pursue on psychological distress? These are important questions in a field where psychiatric expertise on mental illness is socially structured and constrained as an intra-personal disturbance of the mind. We argue that experience experts have lost a coherent perspective on care and health. We illustrate this by rationally reconstructing how the interpersonal view of mental health first gained and then lost coherence between the conception of mental health, the practice of mental health care, and the user experience. Harry Stack Sullivan’s interpersonal theory was a paradigm case for such coherence. The inclusion of mental health consumers as ‘experts by experience’ in the mental health field took place at the cost of Sullivan’s coherent interpersonal theory. Service users who interact side by side with medical experts as experience experts are constrained by the evidence-based imperative and consumerism. Service users are caught up in a race among experts to gain knowledge about mental problems from a third-person perspective instead of from first-person experience. To make a contribution service users have more to gain from a research approach that appreciates that they are persons among persons rather than experts among experts.
Anti-psychiatry; Consumers; R.D. Laing; Logic of care; Relational health; Service users; H.S. Sullivan; Survivors; T. Szasz
The world population aged significantly over the twentieth century, leading to an increase in the number of individuals presenting progressive, incapacitating, incurable chronic-degenerative diseases. Advances in medicine to prolong life prompted the establishment of instruments to ensure their self-determination, namely the living will, which allows for an informed person to refuse a type of treatment considered unacceptable according to their set of values. From the knowledge on the progression of Alzheimer disease, it is possible to plan the medical care, even though there is still no treatment available. Irreversible cognitive incapacity underlines the unrelenting loss of autonomy of the demented individual. Such a loss requires the provision of specific and permanent care. Major ethical issues are at stake in the physician–patient–family relationship, even when dementia is still at an early stage. The authors suggest that for an adequate health care planning in Alzheimer disease the living will can be presented to the patient in the early days of their geriatric care, as soon as the clinical, metabolic or even genetic diagnosis is accomplished. They also suggest that the appointment of a health care proxy should be done when the person is still in full enjoyment of his cognitive ability, and that the existence and scope of advance directives should be conveyed to any patient in the early stages of the disease. It follows that ethical guidelines should exist so that neurologists as well as other physicians that deal with these patients should discuss these issues as soon as possible after a diagnosis is reached.
Advance directives; Alzheimer’s disease; Durable power of attorney; Genetics; Living will
This paper presents the results of a qualitative interview study exploring English and French physicians’ moral perspectives and attitudes towards end-of-life decisions when patients lack capacity to make decisions for themselves. The paper aims to examine the importance physicians from different contexts accord to patient preferences and to explore the (potential) role of advance directives (ADs) in each context. The interviews focus on (1) problems that emerge when deciding to withdraw/-hold life-sustaining treatment from both conscious and unconscious patients; (2) decision-making procedures and the participation of proxies/relatives; (3) previous experience with ADs and views on their usefulness; and (4) perspectives on ways in which the decision-making processes in question might be improved. The analysis reveals differences in the way patient preferences are taken into consideration and shows how these differences influence the reasons physicians in each country invoke to justify their reluctance to adhering to ADs. Identifying cultural differences that complicate efforts to develop the practical implementation of ADs can help to inform national policies governing ADs and to better adapt them to practice.
Decision-making for incompetent patients; Advance directives; Patient preferences at the end-of-life; England, France; Qualitative study; Comparative approach
This article explores the phenomenon of “phantom pain.” The analysis is based on personal experiences elicited from individuals who have lost a limb or live with a paralyzed body part. Our study reveals that the ways in which these individuals express their pain experience is an integral aspect of that experience. The material consists of interviews undertaken with men who are living with phantom pain resulting from a traumatic injury. The phenomenological analysis is inspired by Zahavi (J Conscious Stud 8(5–7):151–167, 2001) and Merleau-Ponty (Phenomenology of perception. Routledge and Kegan Paul, London, 1962/2000). On a descriptive level the metaphors these patients invoke to describe their condition reveal immense suffering, such as a feeling of being invaded by insects or of their skin being scorched and stripped from their body. Such metaphors express a dimension of experience concerning the self that is in pain and others whom the sufferer relates to through this pain, as well as the agony that this pain inflicts in the world of lived experience. This pain has had a profound impact on their lives and altered their relationship with self (body), others and the world. Their phantom pain has become a reminder of their formerly intact and functioning body; they describe the contrast between their past and present body as an ambiguous and disturbing experience. We conclude that these sensitive and personalized experiences of phantom pain illuminates how acts of expression—spoken pain—constitute a fundamental dimension of a first-person perspective which contribute to the field of knowledge about “phantom pain”.
Pain; Body; Phantom pain; Metaphors; Phenomenology
Some brain injured patients are left in a permanent vegetative state, i.e., they have irreversibly lost their capacity for consciousness but retained some autonomic physiological functions, such as breathing unaided. Having discussed the controversial nature of the permanent vegetative state as a diagnostic category, we turn to the question of the patients’ ontological status. Are the permanently vegetative alive, dead, or in some other state? We present empirical data from interviews with relatives of patients, and with experts, to support the view that the ontological state of permanently vegetative patients is unclear: such patients are neither straightforwardly alive nor simply dead. Having defended this view from counter-arguments we turn to the practical question as to how these patients ought to be treated. Some relatives and experts believe it is right for patients to be shifted from their currently unclear ontological state to that of being straightforwardly dead, but many are concerned or even horrified by the only legally sanctioned method guaranteed to achieve this, namely withdrawal of clinically assisted nutrition and hydration. A way of addressing this distress would be to allow active euthanasia for these patients. This is highly controversial; but we argue that standard objections to allowing active euthanasia for this particular class of permanently vegetative patients are weakened by these patients’ distinctive ontological status.
Defining death; End-of-life; Euthanasia; Nutrition and hydration
The spectacular progress in assisted reproduction technology that has been witnessed for the past thirty years resulted in emerging new ethical dilemmas as well as the revision of some perennial ones. The paper aims at a feminist approach to oocyte and spare embryo donation for research. First, referring to different concepts of autonomy and informed consent, we discuss whether the decision to donate oocyte/embryo can truly be an autonomous choice of a female patient. Secondly, we argue the commonly adopted language of gift is misleading and that calling for altruism could put female patients at risk of exploitation. Finally, we point out that the presence of gender stereotypes in the procreative area casts doubt whether even a more robust notion of informed consent manages to overcome this risk.
Gender stereotype; Exploitation; Oocyte and spare embryo donation for research; Autonomy and internalized oppression; Informed consent
‘DU bist Radio’ (DBR) is an award winning [DBR has been awarded with the “Catholic Media Award of the German Bishops Conference, Prädikat WERTvoll” (2011), the Suisse “Media Prize Aargau/Solothurn” (2010), the German “Alternative Media Award” (2009) and was nominated for the “Prix Europa” (2009)] monthly radio format that goes on air on three Swiss radio stations. The purpose of this program which was first broadcast in 2009 is the development of a new media format which—without applying any journalistic (or other) filter and influence—conveys authenticity of expression amongst society’s most vulnerable fellow citizens such as patients, clients and the socially deprived. So-called marginal groups are encouraged to speak for themselves, as a possible paradigm case for encouraging the inclusion of patients’ and relatives’ “unfiltered” voices in general and in clinical ethics as well. Before handing over the microphone to the groups in focus, a team of journalists, educated in medical ethics, over a period of 4 days, teaches them on-site radio skills and craft. Once this task is completed and the actual production of the broadcast begins, the media crew does not exert any influence whatsoever on the content of the 1-h program. Thus, the final product is solely created and accounted for by the media-inexperienced participants, leading to unforeseen and often surprising results. It is discussed that the DBR approach of fostering authenticity of expression can serve as an enhancement to today’s respect and autonomy oriented field of medical ethics.
Medical ethics; Media ethics; DU bist Radio; DBR; Patient participation; Vulnerable groups; Aidōs; Patient rights; Patient discrimination
The present article considers conflicts and conflict regulation in hospices. The authors carried out a qualitative study in three hospices in North Rhine-Westphalia, Germany, to explore how conflicts arise and how conflict regulation proceeds. Hospice nurses should act according to a set of ethical codes, to mission statements of the institution and to professional standards of care. In practice the subjective interpretations of codes and/or models concerning questions of care are causes of conflicts among nurses, with doctors, patients and family members. The management has two choices to react to these conflicts. It can either tolerate the conflicts, as long as they do not disturb the daily routine. Or it can increase the degree of organisation by integrating the different viewpoints into its own program and/or by restructuring its organisational units.
Conflict regulation; End-of-life decision making; Ethics of care; Hospice; Palliative care; Terminal care
The right not to know is often defended on the basis of the principle of respect for personal autonomy. If I choose not to acquire personal information that impacts on my future prospects, such a choice should be respected, because I should be able to decide whether to access information about myself and how to use it. But, according to the incoherence objection to the right not to know in the context of genetic testing, the choice not to acquire genetic information undermines the capacity for autonomous decision making. The claim is that it is incoherent to defend a choice that is inimical to autonomy by appealing to autonomy. In this paper, I suggest that the choice not to know in the context of genetic testing does not undermine self-authorship, which is a key aspect of autonomous decision making. In the light of this, the incoherence objection to the right not to know seems less compelling.
Right not to know; Genetic testing; Personal narratives; Autonomy; Open future; Self-authorship; Self-knowledge
Today, the frequency and the rate of success resulting from advances in medicine have made organ transplantations an everyday occurrence. Still, organ transplantations and donations modify the subjective experience of human beings as regards the image they have of themselves, of body, of life and of death. If the concern of the quality of life and the survival of the patients is a completely human phenomenon, the fact remains that the possibility of organ transplantation and its justification depend a great deal on the culture in which we live. The exploration of the philosophical tradition allows for a reconsideration of organ transplantation. If we listen to people who have experienced the decline of one of their organs and their own rebirth through the organ of someone else, we arrive at the conclusion that they went through an extreme experience in which nothing appeared as before. All those experiences intensify philosophical questionings on the meaning of life with respect to self fulfilment. The concept of nature as the experience of others can be an authentic source from which to nourish our thoughts about organ transplantation. However, and this is our hypothesis, we need something more if we are to decide something about our own life. We need a hermeneutical stance in relation to ourselves and to our world. Philosophical counselling, as a long established tradition originating with Pythagoras and later reframed by the German philosopher Achenbach could be useful in inspiring a reflection on the good life, chiefly as it takes the form of a Socratic dialogue.
Nature; Naturalism; Phenomenology; Hermeneutics; Aristotle; Descartes; Meaning; Wisdom; Organ transplantation
One of the key roles of the English National Institute for Health and Clinical Excellence (NICE) is technology appraisal. This essentially involves evaluating the cost effectiveness of pharmaceutical products and other technologies for use within the National Health Service. Based on a content analysis of key documents which shed light on the nature of appraisals, this paper draws attention to the multiple layers of uncertainty and complexity which are latent within the appraisal process, and the often socially constructed mechanisms for tackling these. Epistemic assumptions, bounded rationality and more explicitly relational forms of managing knowledge are applied to this end. These findings are discussed in the context of the literature highlighting the inherently social process of regulation. A framework is developed which posits the various forms of uncertainty, and responses to these, as potential conduits of regulatory bias—in need of further research. That NICE’s authority is itself regulated by other actors within the regulatory regime, particularly the pharmaceutical industry, exposes it to the threat of regulatory capture. Following Lehoux, it is concluded that a more transparent and reflexive format for technological appraisals is necessary. This would enable a more robust, defensible form of decision-making and moreover enable NICE to preserve its legitimacy in the midst of pressures which threaten this.
Alzheimer’s; Complexity; Hope; Polycentric regimes; Regulation; Uncertainty
In this paper phenomenological descriptions of the experiential structures of suicidality and of self-determined behaviour are given; an understanding of the possible scopes and forms of lived self-determination in suicidal mental life is offered. Two possible limits of lived self-determination are described: suicide is always experienced as minimally self-determined, because it is the last active and effective behaviour, even in blackest despair; suicide can never be experienced as fully self-determined, even if valued as the authentic thing to do, because no retrospective re-evaluation from some future vantage is possible. The phenomenological descriptions of the possible scope of lived self-determination in suicidality, presented in this paper, should prove to be extremely helpful in three different fields of interest: (a) ethical debates regarding the pros and cons of autonomous or heteronomous suicide; (b) clinical day-to-day practice with respect to treating suicidal people; (c) people who suffered a suicidal crisis, attempted suicide or lost loved ones through suicides. (155 words).
Agency; Autonomy; Conduct of life; Experience of being rescued; Minimal sense of self-determination; Phenomenology; Self-effectivity; Suicide
Great hope has been placed on biobank research as a strategy to improve diagnostics, therapeutics and prevention. It seems to be a common opinion that these goals cannot be reached without the participation of commercial actors. However, commercial use of biobanks is considered morally problematic and the commercialisation of human biological materials is regulated internationally by policy documents, conventions and laws. For instance, the Council of Europe recommends that: “Biological materials should not, as such, give rise to financial gain”. Similarly, Norwegian legislation reads: “Commercial exploitation of research participants, human biological material and personal health data in general is prohibited”. Both articles represent kinds of common moral intuitions. A problem, however, is that legislative documents are too vague and provide room for ample speculation. Through the use of focus group interviews with Norwegian biobank donors, we have tried to identify lay intuitions and morals regarding the commercial use of biobanks. Our findings indicate that the act of donation and the subsequent uses of the samples belong to two different spheres. While concerns around dignity and commodification were present in the first, injustice and unfairness were our informants’ major moral concerns in the latter. Although some opposition towards commercial actors was voiced, these intuitions show that it is possible to render commercial use of biobanks ethically acceptable based on frameworks and regulations which hinder commodification of the human body and promote communal benefit sharing.
Benefit sharing; Biobanking; Commercialisation; Commodification; Focus group research; Lay perspective
This article analyzes the religio-ethical discussions of Muslim religious scholars, which took place in Europe specifically in the UK and the Netherlands, on organ donation. After introductory notes on fatwas (Islamic religious guidelines) relevant to biomedical ethics and the socio-political context in which discussions on organ donation took place, the article studies three specific fatwas issued in Europe whose analysis has escaped the attention of modern academic researchers. In 2000 the European Council for Fatwa and Research (ECFR) issued a fatwa on organ donation. Besides this “European” fatwa, two other fatwas were issued respectively in the UK by the Muslim Law (Shariah) Council in 1995 and in the Netherlands by the Moroccan religious scholar Muṣṭafā Ben Ḥamza during a conference on “Islam and Organ Donation” held in March 2006. The three fatwas show that a great number of Muslim religious scholars permit organ donation and this holds true for donating organs to non-Muslims as well. Further, they demonstrate that transnationalism is one of the main characteristics of contemporary Islamic bioethics. In a bid to develop their own standpoints towards organ donation, Muslims living in the West rely heavily on fatwas imported from the Muslim world.
Islam; Fatwas; Organ donation; Islamic bioethics; Interplay of Islam and the West; Muslims in Europe
In various documents the view emerges that contemporary biotechnosciences are currently experiencing a scientific revolution: a massive increase of pace, scale and scope. A significant part of the research endeavours involved in this scientific upheaval is devoted to understanding and, if possible, ameliorating humankind: from our genomes up to our bodies and brains. New developments in contemporary technosciences, such as synthetic biology and other genomics and “post-genomics” fields, tend to blur the distinctions between prevention, therapy and enhancement. An important dimension of this development is “biomimesis”: i.e. the tendency of novel technologies and materials to mimic or plagiarize nature on a molecular and microscopic level in order to optimise prospects for the embedding of technological artefacts in natural systems such as human bodies and brains. In this paper, these developments are read and assessed from a psychoanalytical perspective. Three key concepts from psychoanalysis are used to come to terms with what is happening in research laboratories today. After assessing the general profile of the current revolution in this manner, I will focus on a particular case study, a line of research that may serve as exemplification of the vicissitudes of contemporary technosciences, namely viral biomaterials. Viral life forms can be genetically modified (their genomes can be rewritten) in such a manner that they may be inserted in human bodies in order to produce substances at specific sites such as hormones (testosterone), neurotransmitters (dopamine), enzymes (insulin) or bone and muscle tissue. Notably, certain target groups such as top athletes, soldiers or patients suffering from degenerative diseases may become the pioneers serving as research subjects for novel applications. The same technologies can be used for various purposes ranging from therapy up to prevention and enhancement.
Psychoanalysis of science; Genomics; Synthetic biology; Biomimesis; Viral biomaterials
After having received little attention over the past decades, one of the least known human rights—the right to enjoy the benefits of scientific progress and its applications—has had its dust blown off. Although included in the Universal Declaration of Human Rights (UDHR) and in the International Covenant on Economic, Social and Cultural Rights (ICESCR)—be it at the very end of both instruments -this right hardly received any attention from States, UN bodies and programmes and academics. The role of science in societies and its benefits and potential danger were discussed in various international fora, but hardly ever in a human rights context. Nowadays, within a world that is increasingly turning to science and technology for solutions to persistent socio-economic and development problems, the human dimension of science also receives increased attention, including the human right to enjoy the benefits of scientific progress and its applications. This contribution analyses the possible legal obligations of States in relation to the right to enjoy the benefits of scientific progress and its applications, in particular as regards health.
Human Rights; International Human Rights Law; Universal Declaration of Human Rights; International Covenant on Economic, Social and Cultural Rights; Right to Enjoy the Benefits of Scientific Progress; Right to Health; Scientific Progress; Health
Terminal kidney patients are faced with lower quality of life, restricted diets and higher morbidity and mortality rates while waiting for deceased donor kidney transplantation. Fortunately, living kidney donation has proven to be a better treatment alternative (e.g. in terms of waiting time and graft survival rates). We observed an inequality in the number of living kidney transplantations performed between the non-European and the European patients in our center. Such inequality has been also observed elsewhere in this field and it has been suggested that this inequality relates to, among other things, attitude differences towards donation based on religious beliefs. In this qualitative research we investigated whether religion might indeed (partly) be the explanation of the inequalities in living donor kidney transplants (LDKT) among non-European patients. Fifty patients participated in focus group discussions and in-depth interviews. The interviews were conducted following the focus group method and analyzed in line with Grounded Theory. The qualitative data analyses were performed in Atlas.ti. We found that religion is not perceived as an obstacle to living donation and that religion actually promotes helping and saving the life of a person. Issues such as integrity of the body were not seen as barriers to LDKT. We observed also that there are still uncertainties and a lack of awareness about the position of religion regarding living organ donation within communities, confusion due to varying interpretations of Holy Scriptures and misconceptions regarding the process of donation. Faith leaders play an important educational role and their opinion is influential. This study has identified modifiable factors which may contribute to the ethnic disparity in our living donation program. We argue that we need to strive for more clarity and awareness regarding the stance of religion on the issue of living donation in the local community. Faith leaders could be key figures in increasing awareness and alleviating uncertainty regarding living donation and transplantation.
Attitudes; Communication; Ethnicity; Kidney transplantation; Organ donation; Religion