Background Informed consent confers upon participants the right to decline or accept participation in a study in equal measure. Consent declines can be used as a potential metric to assess the adequacy of the informed consent process. Limited literature is available on the reporting of consent declines in Clinical Research. We evaluated randomized controlled trials published in three high-impact factor journals for consent declines (four-year period) to assess the extent of exertion of autonomy by (...) research participants. Methods CONSORT flow charts in RCTs published in New England Journal of Medicine (NEJM), The Lancet and Journal of the American Medical Association (JAMA) between 2012 and 2015 were evaluated. The total and per journal proportion of RCTs reporting consent declines was calculated. Percentage of consent declines was also compared based on number of centers (single centric vs. multicentric) and type of setting (developed vs. developing). Between-groups analysis was done using Chi Square, Chi Square for trend and a Crude odds ratio [95% C.I] (cOR) were calculated. Results Only 3.7% (1103/29,825) of the published articles were RCTs. Of the 1103 RCTs, only 532 (48.2%) reported consent declines. JAMA had the highest RCTs reporting consent declines (171/267.64%), the Lancet [129,150/781,924, 16.5%] had the most participants declining consent. Difference was significant using Chi square for linear trend [ p < 0.00001]. Consent decline rate was higher in developed countries relative to developing countries [cOR(95% C.I): 2.27(2.23,2.32), p < 0.000001] and in single centric versus multicentric studies [cOR (95% C.I): 3.63(3.56,3.71), p < 0.0000001]. Conclusion Both authors and journal editors need to ensure better reporting of consent declines. (shrink)

This paper focuses on the position of consent in prevailing models of hegemony. It is argued that the commonly invoked consent assumption is a weakness in the hegemony construct that demands review. Consent is purportedly a crucial element of the hegemony dynamic, yet is often overlooked in favour of dominance and resistance. To illustrate this, the paper provides a genealogical account of the consent premise as it is formulated in notable models of political hegemony. This reveals (...) a declining interest in the purportedly crucial consent element of the hegemony construct, accompanied by a reductive view of language and discourse. Next, the paper contrasts the collective consent premise with modern notions of individual sexual consent. This highlights the connection between the consent assumption and hegemonic masculinity. It is observed that if hegemony is based on modes of control and the lack of meaningful choice, it is not founded on consensus. Rather, it is postulated that such conditions might aptly be described as a form of tolerance. This concept is outlined here as a means of departure towards theorizing how hegemonic domination might be actualized discursively without the requirement of consent. In this respect, the paper responds to proponents of post-hegemony by arguing that it is not the concept of hegemony that is outmoded, but rather how it is secured. (shrink)

Se realiza la investigación con el objetivo de perfeccionar la obtención del consentimiento informado en las amputaciones mayores de causa vascular en el Servicio de Angiología del Hospital Universitario Manuel Ascunce Domenech. Se constató debilidades en la institucionalización del consentimiento informado y específicamente en el caso de tales amputaciones. Se utilizaron métodos y técnicas del nivel empírico: encuestas a 30 pacientes con riesgo inminente de amputación. El 64% eran mayores de 65 años, 73 % femeninos, todos escolarizados y 73% residentes (...) urbanos. Los resultados más relevantes fueron: que el 54% de los pacientes manifestaron debe existir consentimiento en la aceptación de la amputación, aunque un grupo no despreciable el 37% declinó este derecho a favor de sus familiares. A los médicos se les realizó una entrevista y aunque no hubo unanimidad de criterios, todos coincidieron en que debía legislarse este consentimiento, como parte del perfeccionamiento de los servicios de salud. Research is conducted to improve the process of obtaining informed consent for major amputations due to vascular causes in the Angiology Service of the Manuel Ascunce Domenech Teaching Hospital. Deficiencies were identified in the institutionalization of informed consent protocols, most specifically as they relate to major lower limb amputations. Empirical methods and techniques were used. Thirty patients at imminent risk of amputation were surveyed by questionnaire methods; 64% of those surveyed were of 65 years of age, 73% were female, all of them had an average educational level, and 73% were urban residents. The results indicated that 54% of patients recognized the importance of informed consent in cases of amputation, although a rather considerable group declined this right for their families. Physicians were also interviewed and, although there was no unanimity of criteria, all of them considered that this consent should be legislated as part of the improvement of health services. (shrink)

Background Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? -/- Methods In a systematic search, we identified 30 (...) studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. -/- Results Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. -/- Conclusions In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Declining Circumcision for My Premature NewbornDionne DeschenneIn 1993, I was pregnant with my first of three sons and was busy preparing for his arrival. Unlike most parents, who focus much of their time on decorating the nursery and buying supplies, I was researching the medical decisions that I would need to make in the moments and weeks following his birth. Having worked in a hospital while a pre-medicine student, (...) I had heard the cries of babies undergoing tests and procedures shortly after birth and knew I needed to be clear on the necessity of those tests and procedures if I was going to consent to them for my baby.My husband was in the Navy and out to sea for six months, so I took a few college courses to pass the time. One was a philosophy course on ethics, and I chose the bioethics of infant male circumcision as the focal point of my coursework that quarter. This allowed me to work through my findings in a racially, religiously, and age-diverse classroom under the guidance of a skilled professor. I was shocked to learn that even the American Academy of Pediatrics (AAP) at that time acknowledged that there were no known medical benefits that resulted from circumcision. How, I wondered, could parents allow their newborns to undergo such a harrowing experience for no reason?As the months passed and the birth of our first son grew nearer, I had everything ready—all of the decisions made, the doctors prepared, and the hospital selected. All of that preparation went out the proverbial window when I contracted pneumonia at 30 weeks. I was admitted to the Naval Hospital and treated for a week before being airlifted to a nearby Army Hospital when my condition worsened. After a few days there, the doctor came in very early one morning to wake me. Our son's heart rate was slowing, and we were at risk of losing him. They needed to immediately perform an emergency Cesarean section to preserve his life. I was terrified, knowing the potential myriad adverse effects his pre-term birth could cause.We were rushed into the OR and within seconds I had an epidural in my back. Moments later, my perfect, tiny but silent baby was whisked from the room to be attended to by a highly skilled and immensely respected NICU team. My husband followed to keep a watchful eye on our son while I was taken to Recovery. A few hours later, I was allowed to join my husband and son in the NICU.Our baby was beautiful, but so tiny that my husband could hold him in one hand. He weighed four pounds and had an enormous needle in the top of his head. The nurse explained to me that the IV needle was in the best location for administering the IV fluids and medications that our baby needed. His pre-term birth had introduced the need for several tests and treatments I had not anticipated. This was immensely distressing for me as someone who wanted to research and understand so that I could make well-informed and ethical decisions. Keep in mind that this was in the days before smartphones. In fact, we didn't even have cell phones at that time! In order to do research, I needed to find a medical text within the hospital that I could read, or get to a library. I had an abdomen full of staples, couldn't drive, and refused to be away from my baby, so going to the library was not an option.Under the conditions, I relied on the hospital staff to help me understand the risks, benefits, and necessities of each procedure or test that they recommended. We formed a relationship of mutual respect. I think this was due to the in-depth [End Page 89] conversations we had during that time. That mutual respect we developed likely led to a remarkable conversation toward the end of our son's first week in the NICU. Our doctor was making his rounds when a nurse asked if we wanted to have our son circumcised that day since the doctor... (shrink)

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

We anticipate a further decline of patients who eventually will become brain dead. The intensive care unit (ICU) is considered a last resort for patients with severe and multiple organ dysfunction. Patients with primary central nervous system failure constitute the largest group of patients in which life-sustaining treatment is withdrawn. Almost all these patients are unconscious at the moment physicians decide to withhold and withdraw life-sustaining measures. Sometimes, however competent ICU patients state that they do not want to live (...) anymore because of the severity of their illness or the poor prognosis and ask for withdrawal of life-sustaining measures like mechanical ventilation. Do we consider the unconscious patient as potential organ donor before withdrawal of mechanical ventilation? This is paradoxically rare in the case of the conscious ICU patient. Is it practically possible and ethically feasible to obtain consent for organ donation from this group of patients? (shrink)

Honoring a living will typically involves treating an incompetent patient in accord with preferences she once had, but whose objects she can no longer understand. How do we respect her precedent autonomy by giving her what she used to want? There is a similar problem with subsequent consent: How can we justify interfering with someone''s autonomy on the grounds that she will later consent to the interference, if she refuses now?Both problems arise on the assumption that, to respect (...) someone''s autonomy, any preferences we respect must be among that person''s current preferences. I argue that this is not always true. Just as we can celebrate an event long after it happens, so can we respect someone''s wishes long before or after she has that wish. In the contexts of precedent autonomy and subsequent consent, the wishes are often preferences about which of two other, conflicting preferences to satisfy. When someone has two conflicting preferences, and a third preference on how to resolve that conflict, to respect his autonomy we must respect that third preference. People with declining competence may have a resolution preference earlier, favoring the earlier conflicting preference (precedent autonomy), whereas those with rising competence may have it later, favoring the later conflicting preference (subsequent consent). To respect autonomy in such cases we must respect not a current, but a former or later preference. (shrink)

The American Urological Association (AUA) and American College of Surgeons (ACS) codes of professionalism require surgeons to disclose the specific roles and responsibilities of trainees to patients during the informed consent process. The objective of this study is to analyze how these requirements are met by urology training programs. An anonymous electronic survey was distributed to the program directors (PDs) of the 143 Accreditation Council for Graduate Medical Education urology residency programs in the United States in 2021. Information was (...) collected regarding program demographics, aspects of the program’s consent process, and the disclosure to patients of the role and participation of residents in their surgery. There were 49 responses to the survey (34.3% response rate). Nearly 70 percent of PDs reported that attending physicians lead the consent process. The topics covered during consent discussion include possible complications (25%), expected recovery time (23%), length of the surgery (22%), the people involved (18%), and their specific roles (7%). Many PDs do not explicitly discuss trainee involvement (48.8%) or when a resident is to perform the majority of the case (87.8%). The majority of PDs (78.8%) communicate medical student involvement, but 73.2 percent reported having a patient decline participation of a trainee after describing their role. Despite the AUA and ACS codes of professionalism, many urologists do not disclose resident involvement in surgery to patients. Further discussions are needed to explore how to better balance resident education and patient autonomy. (shrink)

The carbon emissions of global health care activities make up 4–5% of total world emissions, placing it on par with the food sector. Carbon emissions are particularly relevant for health care because of climate change health hazards. Doctors and health care professionals must connect their health care delivery with carbon emissions and minimize resource use when possible as a part of their obligation to do no harm. Given that reducing carbon is a global ethical priority, the informed consent process (...) in health care delivery must change. I argue that the expanded role of bioethicists in this climate crisis is to promote and support “green informed consent:” the sharing of climate information with patients, offering options for lower-carbon health care, and accepting the patient’s right to decline treatments which are deemed too carbon intensive for their values. (shrink)

ABSTRACTGenetic testing results and research findings raise concerns about access to genetic information by insurers. Recently, the Canadian Life and Health Insurance Association reaffirmed its prerogative to request, for underwriting purposes, the disclosure of clinical and research genetic test results if the participant/patient or his physician has knowledge of the results. Studies have shown that access to genetic information to determine insurability can, in limited instances, lead to actual, or fear of, genetic discrimination, result in individuals refusing to undergo testing (...) or declining participation in genomic research, and being asked to pay higher premiums or denied access to certain types of insurance. Obtaining informed consent for genetic testing and genomic research is crucial and should take into account the potential need to disclose possible insurability risks to patients and participants. Our study analyzed clinical and research consent forms, templates and guidelines from Quebec to investigate two questions: whether consent forms include clauses providing information on potential insurability risks and when such potential risks are included, what information is provided and how it is formulated. Our findings show that current information on insurability risks in Quebec’s forms/guidelines lack coherence, potentially resulting in patients/participants receiving inconsistent information. (shrink)

Th is chapter outlines the experiences of non-consented vaginal examinations that women have shared with Birthrights and the Association for Improvements in the Maternity Services (AIMS). It gives a flavour of the issues that arise in cases brought to our attention, the impact on women who have to live with these experiences, and the lack of opportunity for proper redress faced by women. This chapter uses case studies to illustrate the experiences which lead women to seek support from AIMS and (...) Birthrights. These are real case studies: real women. They are almost certainly the tip of the iceberg. As this chapter will show, one issue with vaginal examinations is that women oft en do not know that they can decline consent, and/or do not feel confident in doing so. Th ere are no statistics held on the number of women who experience non-consented vaginal examinations but, with a system that includes vaginal examinations within standard maternity care, Birthrights and AIMS are certain that many more cases exist than those which have come to our attention. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who (...) participated in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

Background: Informed consent for genetic tests is a well-established practice. It should be based on good quality information and in keeping with the patient’s values. Existing informed consent assessment tools assess knowledge and values. Nevertheless, there is no consensus on what specific elements need to be discussed or considered in the consent process for genetic tests.Methods: We performed a systematic review to identify all factors involved in the decision-making and consent process about genetic testing, from the (...) perspective of patients. Through public databases, we identified studies reporting factors that influence the decision to accept or decline genetic testing. Studies were included if they reported the perspective of patients or at-risk individuals. All articles were thematically coded.Results: 1989 articles were reviewed: 70 met inclusion criteria and 12 additional articles were identified through the references of included studies. Coding of the 82 articles led to the identification of 45 factors involved in decision-making and consent, which were initially divided into three domains: in favor of, against or with an undetermined influence on genetic testing. Each factor was also divided into three subdomains relating to the informed choice concept: knowledge, values or other. The factors in the “other” subdomain were all related to the context of testing (e.g. timing, cost, influence of family members, etc), and were present in all three domains.Conclusions: We describe the network of factors contributing to decision-making and consent process and identify the context of genetic testing as a third component to influence this process. Future studies should consider the evaluation of contextual factors as an important and relevant component of the consent and decision-making process about genetic tests. Based on these results, we plan to develop and test a more comprehensive tool to assess informed consent for genetic testing. (shrink)

We analyzed the patients’ perception of prenatal diagnosis of fetal cardiac pathology, and the reasons for choosing to continue with pregnancy despite being eligible to receive a medical termination of pregnancy. We also identified the challenges, the motives interfering in decision-making, and the consequences of the decisions on pregnancy, child and mother. This descriptive, prospective and longitudinal study was conducted in France, amongst pregnant women who wished to continue their pregnancy despite an unfavorable medical advice. Socio-demographic data were collected through (...) a questionnaire. Such questionnaire covered information assessing the parents/mother’s perception of prenatal diagnosis, and medical termination of pregnancy, their interpretation of the established diagnosis and their motives for not considering pregnancy termination. 72 eligible patients were analyzed over one year: mean age 33 ± 6.89 years, 47 patients had already given birth to ≥1 healthy child. Mean gestational age at the detection of fetal cardiac pathologies was 30 ± 4.37 weeks of amenorrhea. Patients decided to keep the child after 3 ± 1.25 consultations. 56 patients made their decision with their husbands and 16 made their decision alone. Reasons for declining the medical termination were culpability and responsibility, ideologies and convictions, mistrust and hope. Newborns of 67 patients died with a mean survival duration of 38 days. Patient informed consent should be sought before any decision in neonatology, even if conflicting with the medical team’s knowledge and the pregnant mother’s benefits. Decisions to accept or decline pregnancy termination depend on the patients’ psychological character, ideologies, convictions, and mistrust in the diagnosis/prognosis, or hope in the fetus survival. (shrink)

It is reasonable to consider and trust that information taken from us about our medical health and history will be protected by rules on confidentiality and consent. Apart from very rare cases, perhaps of major public interest or for public health reasons, this information will not be shared with others without our consent. However, both a number of reforms in National Health Service patient data management policy (now enshrined in legislation) and developments in the general law on privacy (...) challenge this traditional view of our control and choice over our medical information, as this article will show. In doing so, it analyses the question as to whether in spite of the rhetoric do any of us now really have choice over the access to and use of our medical data? In reality, our choices are limited and in any relationship of trust and shared decision making this ought to be transparent. (shrink)

The Centers for Disease Control and Prevention (CDC) recently recommended that HIV screening should become routine for all adults in the United States. Implicit in the CDC proposal is the notion that pre-test counseling would be more limited than at present, and that written informed consent to screening would no longer be required. If widely implemented, routine testing would mark a tremendous shift in the US HIV screening strategy. There are a number of considerations used to determine what screening (...) tests should be routine, and HIV fits the bill in almost every regard. Yet the stigma associated with HIV infection remains, making the CDC's recommendation highly controversial. Will minimizing requirements for pre-test counseling and special written informed consent lead to unexpected or unwanted HIV testing, or do these stringent counseling and consent requirements needlessly scare people away? Will widespread and routine testing be associated with declining stigmatization, or will it drive some patients away from seeking desperately needed health care? These are high stakes questions, and we're about to find out the answers. (shrink)

Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. (...) Despite its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers. (shrink)

Background: “Therapeutic misconception” arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicised investigational agents.Objective: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms have grown more optimistic (...) in their descriptions of personal benefit over the last decade.Design: Content analysis was performed on 277 consent documents to measure the number of sentences describing possibility of benefit, terminology used for experimental agents, the proportion of statements describing personal versus societal benefits, and whether investigators attempted to thwart therapeutic misconceptions.Results: Consent forms generally used therapeutic terminology to describe study agents, devoted more sentences to describing possible personal benefits than to describing benefits to society, and infrequently explained that a particular benefit was unlikely. Consent documents used by highly active gene transfer researchers tended to portray significantly greater optimism about personal benefit than less active investigators, though they were also significantly more cautious with agent terminology. Finally, therapeutic optimism expressed in consent forms has declined over the past decade.Conclusions: Consent documents used in phase 1 gene transfer trials, although increasingly attentive to possible therapeutic misconceptions, are inappropriately optimistic about direct benefits of trial participation. Such optimism is expressed more emphatically in trials involving highly active gene transfer researchers as principal investigators. (shrink)

Background: Informed consent involves patients being informed, in detail, of information relating to diagnosis, treatment, care and prognosis that relates to him or her. It also involves the patient explicitly demonstrating an understanding of the information and a decision to accept or decline the intervention. Nurses in particular experience problems regarding informed consent. Research question and design: This descriptive study was designed to determine nurse knowledge and practices regarding their roles and responsibilities for informed consent in (...) Turkey. The research was performed using 92 nurses who work at the surgical clinics. Data collection form was prepared by the researchers with assistance from the literature, and the data were evaluated by the SPSS 12.0 data analysis program. Ethical consideration: This study was approved by the Medicine and Health Sciences Research and Ethics Committee of the university. Written consent was received from the nurses. Findings: Among the nurses who participated in this study, 39.1% indicated that they were responsible for obtaining informed consent. It was also found that 90.2% of the nurses informed patients before providing nursing interventions and 32.6% of the nurses obtained consent from patients, and 90.0% of the nurses who indicated that they obtain patient consent only obtain verbal consent. Among all of the nurses, 21.7% agreed that informed consent needs to be obtained in order to protect the medical staff legally. Discussion: It is argued that a lack of official procedures at hospitals regarding informed consent and insufficient information being provided to healthcare providers has caused problems regarding informed consent. Conclusion: The nurses in this study lacked information regarding their role in obtaining informed consent from patients and they often performed incomplete and/or incorrect practices within the framework of their required role. It is believed that an increased level of education along with the creation of official policies and procedures would contribute towards solving these problems. (shrink)

Objective To document the legal guardian-related barriers to consent procurement, and their stated reasons for non-participation in a paediatric critical care research study.Study design A multicentre, prospective, cohort study.Participants Legal guardians of children who participated in a multicentre study on adrenal insufficiency in paediatric critical illness. Data were collected on all consent encounters in the main study.Methods Screening data, reasons for consent not being obtained, paediatric risk of mortality scores and age were collected on all 1707 patients (...) eligible for participation in the Adrenal Insufficiency Study.Results The main barriers to approaching legal guardians for consent were lack of availability of the legal guardians and language barriers . Legal guardians of 917 patients were approached with an overall consent rate of 42% . 81% of the 528 legal guardians who declined consent provided an unsolicited reason for refusal. The three most commonly stated reasons were: being overwhelmed , not wanting anything else done to their child and not wanting an additional medication . In addition, 14.2% cited research-related concerns as the reason for their non-participation.Conclusions Barriers to consent procurement in a non-therapeutic paediatric critical care study appear to occur at many levels with lack of availability of legal guardians, and legal guardians feeling overwhelmed, being the most commonly recorded reasons. Further research into the impact of these findings on the validity and generalisability of the results of such studies is necessary prior to the development and study of future consent models. (shrink)

Background Population based genetics studies are dependent on large numbers of individuals in the pursuit of small effect sizes. Recruiting and consenting a large number of participants is both costly and time consuming. We explored whether an online consent process for large-scale genetics studies is acceptable for prospective participants using an example online genetics study. Methods We conducted semi-structured interviews with 42 members of the public stratified by age group, gender and newspaper readership (a measure of social status). Respondents (...) were asked to use a website designed to recruit for a large-scale genetic study. After using the website a semi-structured interview was conducted to explore opinions and any issues they would have. Responses were analysed using thematic content analysis. Results The majority of respondents said they would take part in the research (32/42). Those who said they would decline to participate saw fewer benefits from the research, wanted more information and expressed a greater number of concerns about the study. Younger respondents had concerns over time commitment. Middle aged respondents were concerned about privacy and security. Older respondents were more altruistic in their motivation to participate. Common themes included trust in the authenticity of the website, security of personal data, curiosity about their own genetic profile, operational concerns and a desire for more information about the research. Conclusions Online consent to large-scale genetic studies is likely to be acceptable to the public. The online consent process must establish trust quickly and effectively by asserting authenticity and credentials, and provide access to a range of information to suit different information preferences. (shrink)

The General Medical Council renewed its guidance on consent in 2020. In this essay, I argue that the 2020 guidance does not advance on the earlier, 2008 guidance in regard to treatments that doctors are obliged to offer to patients. In both, doctors are instructed to not provide treatments that are not in the overall benefit, or clinical interests, of the patient; although, patients are absolutely entitled to decline treatment. As such, consent has two aspects, and different (...) standards apply to each aspect. To explore this paradigm, I propose the reconceptualisation of consent as a person’s freedom to achieve treatment, using Amartya Sen’s approach. Sen explains that freedom has two aspects: process and opportunity. Accordingly, a patient’s freedom to achieve treatment would comprise a process for the identification of proper treatment, followed by an opportunity for the patient to accept or decline this treatment. As per Sen, the opportunity aspect is to be assessed by the standard of public reason, whereas the standard for the process aspect is variable and contingent on the task at hand. I then use this reconceptualised view of consent to analyse case law. I show that senior judges have conceived the patient’s opportunity to be encompassed in information, which is to be decided by public reason. On the other hand, the process aspect relies on the private reason of medical professionals. Given the nature of professionalism, this reliance is inescapable, and it is maintained in the case law that is cited in both guidances. (shrink)

In patients with schizophrenia, consent postmortem for organ donation for transplantation and research is usually obtained from relatives. By means of a questionnaire, the authors investigate whether patients with schizophrenia would agree to family members making such decisions for them as well as compare decisions regarding postmortem organ transplantation and brain donation between patients and significant family members. Study results indicate while most patients would not agree to transplantation or brain donation for research, a proportion would agree. Among patients (...) who declined organ donation for transplantation or brain research, almost half of family members would have agreed to brain donation for research and over 40% to organ transplantation. Male relatives are more likely to agree to organ donation from their deceased relatives for both transplantation and research. The authors argue that it is important to respect autonomy and interests of research subjects even if mentally ill and even if no longer living. Consent may be assisted by appropriate educational interventions prior to patient death. (shrink)

Case 1 reminds us that patients have duties too, while case 2 presents an instance of justified withholding of informationHow refreshing to read these two cases! No conjoined twins, fantastical chimeras, or other incredible scenarios at the fringes of medical reality. Each case highlights the practical and theoretical difficulties that doctors face in their everyday practice.Case 1: In case 1, the patient, who had declined an HIV test, changed his mind and requested an HIV test on the request form without (...) informing the doctor. The pathologist performed the tests and returned the results to the unsuspecting doctor, who duly investigated the matter. The doctor’s anxiety at the situation, as well as the worries of the entire practice and pathology laboratory, must have been deeply unpleasant. Thus the patient, no doubt unintentionally, caused much distress by requesting the HIV test. He was, at the very least, guilty of a lack of foresight and consideration. As a minimum, he should have informed the doctor of his last minute alteration. This would have enabled the doctor to discuss the implications of the test, to organise appropriate counselling, and, most importantly, to receive the results in full knowledge of the situation.As Dr Fraser points out, the experience of case 1 reinforces the importance of taking good medical notes. Even if the patient’s refusal had been documented in the notes, however, this would not have prevented him from requesting the HIV test, and indeed other tests, on the blood form. Pharmacists may still occasionally be faced with situations when they are unsure whether the doctor prescribed 10 capsules of a drug, or 110 capsules, as the patient may have added a “1” in front of the doctor’s original prescription. Similarly, how …. (shrink)

This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women’s responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The minority of the (...) participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care. (shrink)

Background On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person’s autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we conducted a (...) survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law. Methods A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation). Results Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians’ opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered. Conclusions Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations. (shrink)

Ghanaian fertility decline may not be associated with women's having greater control over reproduction. Focus groups of young Ghanaian men and women indicate that attitudes supporting men's dominance in fertility decisions characterize even the highly educated. Young women with high fertility desires anticipate being able to stop childbearing when they want to, but they do not expect to be able to continue if their husband wants to stop. Those with low fertility desires do not anticipate being able to stop (...) without husband consent, but they envision support for continuing childbearing. Women's expected influence appears limited to situations where their fertility desires conform to normative expectations. (shrink)

The chapter traces the history of psychiatric ethics with a focus on the emergence of autonomy and how assumptions and thresholds surrounding informed consent and decision-making capacity have changed over the centuries. Innovators like Philippe PInel and William Tuke are featured in this account of how the 'mad' and the abuses of the 'domestication paradigm' of madness eventually gave way to more humanitarian approaches of treating the 'mad', like moral treatment. The chapter closes with a brief reflection regarding the (...) limits of autonomy and the decline of paternalism in psychiatric ethics. (shrink)

Health ethics can justify the use of vaccination mandates. However, policies that pressurize parents to vaccinate their children can undermine traditional clinical ethics standards (e.g. autonomy and informed consent). The aim of this paper is to argue that the ethical impact of vaccination mandates can only be determined in the context of the clinical encounter. Public debate on the topic tends to be general in nature and, as a result, issues that require clarification to help sustain the trust of (...) service users are underexamined. In addition, ethical debates are hampered by a toxic dichotomy in the public sphere between those (anti-vaccinators) who claim a move away from parental choice is necessarily a serious ethical violation; and others (often health scientists) who neglect serious consideration of ethical issues. This predicament permits flawed ethical claims to be made, and to remain unchallenged. Despite this, ethical concerns – including those relating to trust and individual freedom – are fundamental to sustaining confidence in vaccination. This has recently been highlighted by the Covid-19 pandemic which made accessing childhood vaccinations harder, leading to a further decline in uptake. The pandemic has also revealed the strength of public feeling towards infection control measures that restrict peoples’ freedoms. In this paper I argue that to minimize the ethical disruption associated with the use of vaccination mandates, it is essential to focus more attention on their impact in the clinic and to accurately identify the drivers of such tensions. (shrink)

Biobanks that are run on an opt-in basis depend on people having the motivation to give and to trust in those who control their samples. Yet in the UK trust in the healthcare system has been in decline and there have been a number of health-related scandals that have received widespread media and public attention. Given this background, and the previous public consultations on UK Biobank, the paper explores the way people express their trust and mistrust in the area (...) of medical and genetic information through discussions in six focus groups held in different areas of Britain. The themes that emerged in the discussion were the special character of genetic data; the ease with which information spreads; the public/private divide in genetic research; the potential of genetic information to harm people; choice, consent and lack of control; and the difficulty of establishing trustworthy governing arrangements. The expert agenda of policy-makers and medical ethics does not address the broader concerns expressed by participants. It seems that public consultation and the language of openness and transparency may not be sufficient to establish trust in the governance of genetic databases. Donors will be asked to give freely without any return but the participants' perception of those using the samples is that they are motivated by success and profit rather than healthcare priorities. In this context altruism seems naive and even dangerous. In order to place their trust well people need evidence of a relationship with obligations and expectations on both sides. (shrink)

The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.

An increasing number of non-governmental organisations provide humanitarian assistance, including healthcare. Some faith-based NGOs combine proselytising work with humanitarian aid. This can result in ethical dilemmas that are rarely discussed in the literature. The article explores several ethical issues, using four generic activities of faith-based NGOs: It is discriminatory to deny aid to a needy community because it provides less opportunity for proselytising work. Allocating aid to a community with fewer health needs but potential for proselytising work is unjust, since (...) it neither maximises welfare nor assists the most needy . Faith-based-NGOs may state that proselytising work combined with humanitarian assistance improves spiritual wellbeing and overall benefit. However, proselytising work creates religious doubts, which could transiently decrease wellbeing. Proselytising work is unlikely to be a perceived need of the population and, if carried out without consent, breaches the principle of autonomy. Such work also exploits the vulnerability of disaster victims. Governments that decline the assistance of a faith-based NGO involved in proselytising work may deprive the needy of aid. Three strategies are proposed: Increase knowledge to empower communities, individuals and governments; information on NGOs could be provided through an accessible register that discloses objectives, funding sources and intended spiritual activities. Clearly demarcate between humanitarian aid from proselytising work, by setting explicit guidelines for humanitarian assistance. Strengthen self-regulation by modifying the Code of Conduct of the Red Cross to state criteria for selecting communities for assistance and procedures for proselytising work. (shrink)

January 21, 2010 will go down as a dark day in the history of American democracy, and its decline. The editors of the New York Times did not exaggerate when they wrote that the Supreme Court decision that day "strikes at the heart of democracy" by having "paved the way for corporations to use their vast treasuries to overwhelm elections and intimidate elected officials into doing their bidding" -- more explicitly, for permitting corporate managers to do so, since current (...) laws permit them to spend shareholder money without consent. (shrink)

Introduction -- Aristotle and Locke in the American founding -- Equality, liberty, wisdom, morality, and consent in the idea of political freedom -- Humanizing certitudes and impoverishing doubts : a critique of The closing of the American mind by Allan Bloom -- "The Reichstag is still burning : the failure of higher education and the decline of the West" : a valedictory lecture -- The end of history means the end of freedom -- The American founding as the (...) best regime : the bonding of civil and religious liberty -- The decline and fall of the American idea : reflections on the failure of American conservatism -- Thomas Aquinas meets Thomas Jefferson -- Dred Scott revisited -- Legend of Sleepy Hollow. (shrink)

January 21, 2010 will go down as a dark day in the history of American democracy, and its decline. The editors of the New York Times did not exaggerate when they wrote that the Supreme Court decision that day “strikes at the heart of democracy” by having “paved the way for corporations to use their vast treasuries to overwhelm elections and intimidate elected officials into doing their bidding” – more explicitly, for permitting corporate managers to do so, since current (...) laws permit them to spend shareholder money without consent. (shrink)

In mental health policy, a central ethical dilemma concerns involuntary outpatient commitment (OPC), which aims to treat vulnerable individuals with serious mental illness who decline services. The first concern regards whether coercive services undermine the quality of clinical interactions within treatment, particularly as it relates to psychiatric medication use. The second concern is the unexamined role that OPC, and coercive psychiatric programs more broadly, play in the broader landscape of social welfare policy. To examine these concerns, the purpose of (...) this dissertation is to analyze how the management of psychiatric medications in involuntary outpatient services is undergirded by (a) provider and client interpretations of psychiatric medication effects and (b) moral discourses related to coercion and client autonomy. To achieve this aim, I examined data from a team-based ethnography that consisted of 1000 hours of participant observations and 56 semi-structured interviews with 20 clients, 21 providers, and 12 client family members with diverse backgrounds. I analyzed how medication compliance was discussed, monitored, and enforced in an involuntary outpatient program. My analysis demonstrates that medications were interpreted as a technology to control clinical symptoms (clinical control) though, particularly among clients, were also viewed as a method to control client mental experiences, behavioral expression, and autonomy (social control). Providers believed that medications were a necessary component of services (compulsory compliance) and could reduce client vulnerability to violence victimization and perpetration related to clinical symptoms (medicating vulnerability). To address client noncompliance, providers employed several strategies that I categorized as client manipulation. These strategies included providers, family members, and court officials strategizing ways to undermine client autonomy without clients’ knowledge (concealed collusion), deceiving clients into believing that medications were mandated when they were not (performing coercion), and minimizing the role of client consent and preferences in decision-making processes (circumventing consent). These findings demonstrate the pervasive role of manipulation to gain client medication compliance in OPC, which I named institutional coercion. They also highlight that the broader moral justifications for manipulating clients relate to their status as structurally vulnerable in their community settings and a growing relationship between the erosion of the welfare state and psychiatric coercion. (shrink)

Two continents. Three countries. Mountains, archipelago, a little red dot & more to come. BERIT SOLI-HOLT (Editor): When I think of introductory material, I think of that Derrida documentary when he is asked about what he would like to know about other philosophers. He simply states: their love life. APRIL VANNINI (Editor): And as far as introductions go, I think Derrida brought forth a fruitful discussion on philosophy and thinking with this statement. First, he allows philosophy to open up the (...) personal and second, the ability to conjure the notion of thinking in relation. After all, love lives are spawned from relations, and such are philosophical encounters—the co-emergence of thought and affect. This brings us to discuss the concept of the special issue of continent. called drift . From the Statement of Intent : The discussion that has become drift , a special issue of continent. began in the glow of a bonfire beside a lake near the Thousand Islands of Ontario when co-founders April and Berit came across a conception of a journal that would decline to follow traditional models of invitation and editorship, instead following a generated discourse through relational means. Shedding preemptive articulation of expected outcome and cohesion, we hope to light a fuse of chain interactions with each contributor active in authorial, editorial, and curatorial roles. drift seeks to allow the framing mechanism to choose itself, to find where something can flow or emerge in relation to a series of participants. By setting out a thread of thought to work its own way through writers and artists of various locations, drift operates through links, breaks, pauses, new directions, unintended consequences, twists, holes, bridges. We are attempting to give the scene for an emergence and what can become conceivable when given the opportunity to create chains of thought—linking, welding, fusing, looping, stitching. We hope to explore what is attainable when scholarly/artistic relationships transverse on their own terms instead of articulated by an institutional environment. JEREMY FERNANDO (Guest Editor): I think he was actually more interested in their sex lives. Though at the same time completely refusing to discuss, disclose, his own: I found it rather touching that he blushes whenever speaking of his life with Marguerite. So perhaps in this sense it is very apt to speak of it in terms of love; and the secret that is in each love: that even though it is a relationality between, there are parts of it that remain hidden, not just from everyone else, but even those in that relation itself. What the editors intend to ^do^ to impart this conceptualization is to provide a framework through the choice of a theme and by minimal standardization of form and content guidelines. As initial instigator, each editor will send their contribution to the issue to a fellow colleague, thinker, artist, friend with the invitation to send (via post) the accruing materials to another possible contributor. In this, we hope to engage with many individuals on ideas surrounding a specific theme determined but not limited by the editors of the drift . The end result will take the form of whatever is at hand (as materials can only stay with each contributor for two weeks) and whomever is at hand (the availability of interested and capable parties) through a course of five months. We are curious. What are the ways in which thought can emerge between individuals and places? What occurs when our fundamental mode of inquiry is between each other? How are ethical, social, spacious, political, aesthetic practices created between a chain of contributors. BSH: To introduce what to look forward to in June with the publication of drift isn't quite possible yet. It is in the stages of preparation, barely started, but already begun. I have been thinking about drift as an insect that goes through life cycles, chrysalises, pupas, larva. Each moment of the production and publication of this issue of continent. is its own life. A bug under a pin is not as interesting as one in flight or crawling up your leg. JF: Though the one crawling up your leg is also more likely to bite you. There is always already a danger in letting be, thinking …. Then again, there is also a potential rupture in attempting to seize, pin down, capture. BSH: I think a word we haven't thought about enough yet is capture. I think we are perhaps trying to capture something, or to allow for the moments of this capture along the way, the resulting material being the ripples left in the sand when the water waves away. AV: This question comes to mind when speaking about captures, waves, ripples: How can we activate a ripple? What I find interesting about a wave is the difference in frequencies, movements, forms, style that are activated in between intervals. What is interesting about a wave is that it is activated in relation to what came before. What remains in the sand is a ripple that forms in relation between multiple intervals of stylistic waves. As Deleuze and Parnet have taught us, "We were only two, but what was important for us was less our working together than this strange fact of working between the two of us. We stopped being 'author'. And these 'between-the-twos' referred back to other people, who were different on one side from the other. The desert expanded, but in so doing became more populous." 1 Drift is activation for thinking-with and possibly much more—who knows? There is the intent to subvert the relational qualities between people in journal publishing, but also important to the editors is the subversion of materials. The editors do not shy away from use of contemporary technology and, in fact, have relied and will continue to rely on the wonders of internet connectivity to midwife the drift. The connective infrastructure chosen to relay the developing issue is simply one of bodies, of postal workers and the varying postal systems. Some may find it to be merely be a call of an already dying form, but the editors believe that the conversation exchanged from hand to hand is of explicit difference in quality of engagement due to the complexity of peripheral information transported by physical matter. Different hospitalities and responsibilities are at play in keeping hold of one-of-a-kind materials for a time and entrusting various postal systems to bear the message forward. To have work physically transported through space and time through this kind of infrastructure that is reliant on individuals to literally carry a message is crucial in incorporating traces of bodily presence. AV: Thought is contingent and emergent process that folds, twists, pulls, shifts in multiple directions and we are interested in these multiple directions. JF: And even as thought is contingent on, hinged around, its place, time, venue—on its continents, as it were (we still tend to speak of gestures of thinking as Continental, British, American, European, Asian, etc.)—we might also attempt to respond to the landscape within each thought: its folds, unfoldings, rolls, manoeuvres, geography. BSH: How different is this than Morelli's screw that Julio Cortazar or Horacio Oliveira recounts in Hopscotch? The fable recalls a man who regarded a screw everyday on his stoop. When he perishes, the screw disappears, perhaps into a fellow neighbor's pocket for secret contemplation. Whoever is writing the passage remarks that "Morelli thought that the screw must have been something else, a god or something like that. Too easy a solution. Perhaps the error was in accepting the fact that the object was a screw simply because it was shaped like a screw." JF: Perhaps even more intriguing is the notion that we do not quite know who is inscribing these remarks on Morelli. That even as someone says that it is a screw, perhaps because it is shaped like a screw, the one who names it “screw”—the one whom we are in a relation with in relation to the screw—remains veiled from us. But even as this is so, the notion of the object as “screw” is marked, etched, onto us. BSH: A periodical, marking a period of time, but where? An issue, a magazine, a storehouse of information. To show the remainders of thinkers connecting and surfing. With all this stated, we, as editors of the drift are aware of the active fault, quaking potential, and ethical catastrophe of such a proposed project — the inheritance or the gifting of a project without consent. We are certain that there may be possible oversight on the process of such a project. If such is the case, we hope that oversight and misdirection will not leave this project dormant but rather open up promising new directions, questions, and potential considerations. We are very excited about the accidental propositions that can occur in between. In sum, we'll see what happens. JF: Perhaps, all we can know of the screw is that we are screwed ... NOTE Gilles Deleuze & Claire Parnet. Dialogues II . Revised edition. (New York: Columbia University Press). 2007: 17. (shrink)

The National Health Service (NHS) was the first healthcare system globally to declare ambitions to become net carbon zero. To achieve this, a shift away from metered-dose inhalers which contain powerful greenhouse gases is necessary. Many patients can use dry powder inhalers which do not contain greenhouse gases and are equally effective at managing respiratory disease. This paper discusses the ethical issues that arise as the NHS attempts to mitigate climate change. Two ethical issues that pose a barrier to moving (...) away from metered-dose inhalers are considered: patients who decline an inhaler with a smaller carbon footprint and increased cost. I argue that while a patient is not morally justified in refusing a more environmentally sustainable inhaler due to the expected harms, a doctor may still prescribe a metered-dose inhaler if they believe that switching without consent might undermine trust or substantially worsen the patient’s health. Turning to cost, I argue that the imperative to combat climate change means the NHS should accept small increased financial costs for lower carbon inhalers, even though this provides no additional direct benefit for the patient. I then go on to consider the implications of the preceding analysis for policy and practice. I argue for a policy that minimises the impact of inhalers on the climate by advocating for a principle of environmental prescribing and explore decision-making in practice. While the arguments here pertain primarily to inhalers, the discussion has broader implications for debates around healthcare’s responsibility to be environmentally sustainable. (shrink)

Genetic testing has led to the establishment of the concept of the “previvor”: someone who is not yet sick, but who has a genetic predisposition to disease. The previvor experience demonstrates how the practice of medicine and medical decision making is evolving to render current law and policy increasingly inapplicable to modern medical practice. The introduction of previvorship to the medical landscape raises special issues for the physician-patient relationship and the legal doctrine of informed consent. It challenges some of (...) the most basic assumptions underlying the doctrine, is representative of the doctrine’s declining utility, and is illustrative of the need to transition to a shared decision-making model. Thus, we should begin to envision a legal doctrine that supports a robust shared decision-making approach to address individual preferences and values, the increasing complexity of risk/benefit assessment, and inherent (and sometimes irreducible) uncertainty. Such an approach should emphasize a new, more expansive, and inclusive model of illness. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reflections on InsightDilemmas, Paradoxes, and PuzzlesMarga Reimer (bio)Keywordsinsight, psychosis, treatment adherence, medical model, autonomy, open placebos, rationalityThe Practitioner's DilemmaThe psychiatrist aware of the potential intractability of what Jennifer Radden calls "insightlessness," faces a dilemma. Should she encourage her patient to embrace a medical model of his "troubles," a model whose adoption is likely to motivate treatment adherence? She might then be trying to do the impossible; she might also (...) alienate her patient in the process. Should she instead encourage her insightless patient to embrace his own non-medical model, according to which treatment adherence makes no medical sense whatsoever? She might then see herself as encouraging a kind of uninformed consent: Her insightless patient might be taking powerful, potentially harmful, medication for reasons (such as sound sleep and "peace of mind") that would never medically justify adherence.In my original paper, I suggested that the way out of this dilemma might be to embrace the latter option, while characterizing the very real (and medically based) benefits of treatment adherence in non-medical terms. I now realize that my proposed resolution reflects an oversimplified understanding of what might be called the "practitioner's dilemma." As Michaela Amering (2010) makes clear, the situation for those with mental illness is improving dramatically. With "recovery orientation" as the "guiding principle of mental health policy," the emphasis is on "health promotion, individual strengths, and resilience." The question becomes: Can the practitioner encourage her insightless patient to partake in this "recovery" movement if she does not simultaneously encourage him to embrace a medicalized understanding of his "troubles"?Not obviously. For although a "recovery" model might eschew notions like illness1 and disease, pathology and dysfunction, and even schizophrenia, it will inevitably involve some medical notions. The patient who partakes in the "recovery movement" described by Amering, would seem to have no choice but to accept a model that is essentially medical. Consider the language used by Amering in characterizing that movement. She talks of mental health problems, therapeutic relations, patient self-determination, diagnosis and, of course, recovery. The concepts underlying such language are intrinsic to the patient-oriented movement Amering describes. The question becomes:How can the insightless patient rationally partake in such a movement without embracing some version of the medical model of mental illness? [End Page 85]This question suggests the importance of promoting some kind of insight, even if not insight "into psychosis." At the close of these comments, I consider briefly what such "revisionary" insight might involve.Paradoxes of Conditional and Relinquished AutonomyAutonomy among patients with psychosis presupposes the sort of clear-headedness that arguably comes only with treatment adherence. This may provide some justification for the "coercive treatments" that Anthony (2006) finds so offensive. For patients with psychosis, genuine autonomy is conditional, requiring some degree of insight: Recognition that their "troubles" are at least amenable to medical treatment. Once the patient recognizes this, he can choose freely to decline such treatment (regardless of whether that choice is ultimately respected). Call this the "paradox of conditional autonomy." The conditional nature of autonomy is a familiar point in philosophical discussions regarding free will. There is no genuine freedom without the sort of knowledge required for informed choices. What distinguishes the patient with psychosis from persons more generally is that his autonomy is further conditioned: The knowledge required for autonomous decision making arguably requires some degree of treatment adherence.However, the mentally ill patient has the right, as do all patients, to relinquish autonomy. He may opt for deference to, and dependency on, the relevant experts: Mental health care professionals (Campbell 1994). We are led once again to paradox. To respect the patient's autonomy, the mental health care professional must respect his right to forego autonomy in favor of deference and dependency. This paradoxical situation, involving a kind of deferred autonomy, is not unique to psychiatry but applies to medicine across the board. Indeed, it applies to the human service industry more generally where, as McGorry (1992) suggests, there is an implicit assumption that the service user is to defer to the expertise of the service provider.This assumption is rightly challenged. Suppose Justin and... (shrink)

The objective of the study was to explore parental experiences of being offered participation in a previous neonatal research study involving venepuncture. The method employed was a questionnaire-based exploration of parents' attitudes in those approached to participate in a study of term and preterm immunization responses (Preterm Immunisation Study [PREMIS]). We explored experience of the initial approach, knowledge of study, venepuncture and views on research ‘in general’. In all, 59% of families responded. Highest response rates were for those participating in (...) PREMIS (87% term/69% preterm) and lowest in decliners (34% and 35%). Responding parents participating in PREMIS were well informed, positive about research and did not find the venepuncture problematic. Sixty percent of responding parents who declined PREMIS attributed their declining to the need for venepuncture. In conclusion, parents participating or declining a neonatal study involving venepuncture are different, but participating parents were well informed and seemed able to judge that participation was right for them such that in consenting families venepuncture itself is not problematic. (shrink)

Background Against a background of on the one hand, a declining demography and a conservative family register system that emphasizes the importance of the blood line, and on the other hand, an increase in the number of people undergoing fertility treatment, the absence of a legal regulatory framework concerning ART matters is likely to result in an increasing number of contradictory situations. It is against this background that the paper sets out to examine the judgements of court cases related to (...) ART, with a particular focus on the legal determination of parental status, and to link these to aspects of the legal and socio-ethical environment within which the courts make their judgements. Methods The methods used were thorough investigation of all the court cases concerning ART in the public domain in Japan, including the arguments of the concerned parties and the judgements so far delivered. With the court cases as a central focal point, trends in Japan, including deliberations by government and academic societies, are reviewed, and the findings of surveys on the degree of understanding and attitudes among the people toward ART are summarized. Results In terms of the judgements to date, the central criteria used by the courts in determining parental status were the act of parturition and the consent of the husband of the concerned couple. The government and academic societies have displayed a cautious attitude toward ART, but the findings of attitude surveys among the people at large show a generally positive attitude toward ART. Attitudes toward the overwhelming importance hitherto attached to the bloodline are also seen to be changing. Conclusion The main conclusion is that in the absence of a legal regulatory framework for ART, there is likely to be an increase in the contradictions between the use of outdated legal precedents and the technical development of ART. Since much of the specialist discussion necessary for the formulation of a legal framework has already been carried out, the speedy enactment of comprehensive and at the same time flexible legislation would be highly desirable, but further wide-ranging discussion involving the general public is likely to be needed first. (shrink)

Many anarchists believe that a stateless society could and should feature laws. It might appear that, in so believing, they are caught in a contradiction. The anarchist objects to the state because its authority does not rest on actual consent, and using force to secure compliance with law in a stateless society seems objectionable for the same reason. Some people in a stateless society will have consented to some laws or law-generating mechanisms and some to others – while some (...) will have consented to none. Someone’s obedience to a legal requirement could be justly enforceable absent the state, nonetheless, given either her actual consent to the requirement or to a mechanism responsible for generating it or the coextensiveness of the legal requirement with a moral requirement. And it could thus be just on the anarchist’s own terms to enforce a narrow range of positive legal requirements even against outlaws who had declined to consent to them. (shrink)

Professionalisation of Journalism has been a subject under global scrutiny since the nineteenth century. Contemporary studies show how journalism profession grapples with the implementation of standard journalism education and practices across the globe. The author discovered that the development of journalism has remarkable link with the advent of Christianity, however, an apparent decline of ethical values in higher education and professional practices abound thereby revealing the type of quality of education provided and the substandard nature of journalistic Professionalisation. Empirical (...) research conducted in this regard geared towards assessing the socio-ethical relevance of Professionalisation as beneficial to democratic development, and the challenges journalists encounter that hinder the implementation of professional ethics and cultural values as a contribution to human dignity, rights, justice, solidarity and the common good. To critically examine these phenomena, this research study is anchored of scientific materials. It adopted the see-judge-act (A Theological methodology approach used in appraising socio-ethical situations) as well as qualitative and quantitative methods. The researcher conducted thirteen semi-standardised interviews as well as analysed 200 data samples (twenty-three questions) with Mayring model and (SPSS) was used to evaluate the quantitative data. The research results showed the thirteen different interview partners unanimously consented that journalism in Nigeria must be professionalised and there is need to integrate Christian social ethics and culture driven values into the training curriculum if journalists are to regain their credibility and integrity. The tested hypotheses showed statistical significance (p. (shrink)

Endotracheal intubation (ETI) is a valuable procedure which must be learnt and practised, and performing ETI on cadavers is probably the best way to do this, although lesser alternatives do exist. Performing ETI on a cadaver is viewed with a real and reasonable repugnance and if it is done without proper authorisation it might be illegal. Some form of consent is required. Presumed consent would preferably be governed by statute and should only occur if the community is well (...) informed and therefore in a position of being able to decline. Currently neither statute nor adequate informing exists. Endotracheal intubation on the newly dead may be justifiable according to a Guttman scale if the patient has already consented to organ donation and if further research supports the relevance of the Guttman scale to this question. A "mandated choice" with prior individual consent as a matter of public policy is the best of these solutions, however until such a solution is in place we may not practise endotracheal intubation on the newly dead. (shrink)

The massive growth in global health research in past decades has posed many challenges for its effective ethical oversight, not least of which is how best to provide effective protection of research participants. The extent of the HIV epidemic in sub-Saharan Africa in particular makes research into prevention technologies for HIV, including HIV vaccine research, a global priority. However, the need for vaccine research must be considered in conjunction with the individual's right to informed consent, which is based on (...) the principle of respect for autonomy. One of the primary human rights violations likely to occur in the context of HIV vaccine research is that potential research participants may not fully understand what participation in research studies entails. People who elect to enrol in HIV vaccine trials are required to understand both the potential negative effects of participation (eg, discrimination) as well as complex scientific concepts such as randomisation and prophylaxis in order to be ethically enrolled. In this study, two vignettes are presented to illustrate two core issues in conducting phase III HIV vaccine trials in low-income countries—namely, (1) from the perspective of participants, the extent to which understanding is a prerequisite for consenting to participate in a trial, and (2) from the perspective of trial investigators, whether it is appropriate to persuade eligible people to enrol in a trial, even though their initial reaction is to decline to participate. These vignettes are used to analyse these issues through the prisms of research ethics and human rights in order to identify helpful synergies. It is argued that the human rights perspective provides a helpful lens on ethical issues. (shrink)

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies’ decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested in enrolling (...) their relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies’ decision making regarding research, these findings can help inform policy regarding surrogate consent. (shrink)

Recently, the Israel National Bioethics Council (INBC) issued recommendations permitting egg freezing to prevent both disease- and age-related fertility decline. The INBC report forms the basis of Israel's new policy, being one of the first countries to regulate and authorise egg freezing for what it considers to be non-medical (ie, social) uses. The ethical discussion in the INBC report is reviewed and compared with the scant ethical discourse in the academic literature on egg freezing as a means of preventing (...) age-related loss of fertility. We argue that both the INBC recommendations and the bioethical academic discourse on egg freezing are grounded in liberal ideology, which views technology as primarily enabling. Accordingly, they promote ‘individual autonomy’ as exercised through informed consent. Our study suggests that a relational approach to autonomy may be a more suitable model for considering women's choices about egg freezing. (shrink)