Harmonising green informed consent with autonomous clinical decision-making: a reply to Resnik and Pugh.

Resnik and Pugh recently explored the ethical implications of routinely integrating environmental concerns into clinical decision-making. While we share their concern for the holistic well-being of patients, our response offers a different clinical and bioethical stance on green informed consent and patient autonomy. Contrary to the authors' lack of data to support their concerns about provider and patient willingness to engage in climate-related conversations, we provide evidence supporting their sustainability engagement and stress the importance of a proactive, anticipatory approach in healthcare to align with evolving societal values. If climate change is perceived as a politicised issue, though it is not inherently so, healthcare providers are professionally trained to address sensitive subjects and have a duty to inform patients about potential health risks. Recognising the environmental crisis as a health crisis underscores the direct connection between environmental hazards and patients' well-being. Our perspective advocates for integrating individual considerations, societal responsibilities and systemic changes to promote environmentally sustainable healthcare.

At a Moment's Notice: Community Advisory Board Perspectives on Biobank Communication to Supplement Broad Consent.

INTRODUCTION: To address ethical concerns about the of future research authorization, biobanks employing a broad model of consent can design ongoing communication with contributors. Notifying contributors at the time of sample distribution provides one form of communication to supplement broad consent. However, little is known about how community-informed governance might anticipate contributor responses and inform communication efforts. OBJECTIVE: We explored the attitudes of members of a three-site Community Advisory Board (CAB) network. CAB members responded to a hypothetical proposal for notifying biobank contributors at the time of sample distribution to researchers utilizing the biobank. METHODS: We used regularly scheduled CAB meetings to facilitate 3 large-group and 6 small-group discussions. Discussions were audio-recorded, transcribed, and analyzed for thematic content using descriptive thematic analysis. RESULTS: The results challenged our expectation of general support for the proposed communications. While CAB members identified some advantages, they were concerned about several potential harms to biobank contributors and the biobank. The CABs understood biobank communication in terms of an ongoing relationship with the biobank and a personal contribution to research. CONCLUSION: Our findings contribute to the emerging literature on community engagement in biobanking. Additional communication with biobank contributors can serve a variety of value-based objectives to supplement broad consent. Design of communication efforts by biobanks can be improved by CAB members' anticipation of the unintended consequences of additional contact with contributors. CAB members' holistic interpretation of communication efforts suggests that biobank leadership considers all communication options as part of a more comprehensive communications strategy.

Leaving gift-giving behind: the ethical status of the human body and transplant medicine.

The paper argues that the idea of gift-giving and its associated imagery, which has been founding the ethics of organ transplants since the time of the first successful transplants, should be abandoned because it cannot effectively block arguments for (regulated) markets in human body parts. The imagery suggests that human bodies or their parts are transferable objects which belong to individuals. Such imagery is, however, neither a self-evident nor anthropologically unproblematic construal of the relation between a human being and their body. The paper proposes an alternative conceptualization of that relation, the identity view according to which a human being is identical with their living body. This view, which offers a new ethical perspective on some central concepts of transplant medicine and its ethical and legal standards and institutions, supports widely shared intuitive ethical judgments. On this proposal, an act of selling a human body or one of its parts is an act of trade in human beings, not in owned objects. Transfers of human body parts for treatment purposes are to be seen as sharing in another human being's misfortune rather than as giving owned objects. From the perspective of policy-making, the proposal requires, first, that informed consent for removal of transplant material be obtained from the potential benefactor. Secondly, explicit consent by the prospective benefactor is obligatory in the case of removal of transplant material from a living benefactor. Thirdly, in the case of posthumous retrieval, informed consent by the potential benefactor during their life is not ethically indispensable. Additionally, while refusal of posthumous retrieval expressed by a potential benefactor during their life must be respected, such a refusal needs ethical justification and explanation.

Ethical Issues in Integrated Health Care: Implications for Social Workers.

Integrated health care has come of age. What began modestly in the 1930s has evolved into a mature model of health care that is quickly becoming the standard of care. Social workers are now employed in a wide range of comprehensive integrated health care organizations. Some of these settings were designed as integrated health care delivery systems from their beginning. Others evolved over time, some incorporating behavioral health into existing primary care centers and others incorporating primary care into existing behavioral health agencies. In all of these contexts, social workers are encountering complex, sometimes unprecedented, ethical challenges. This article identifies and discusses ethical issues facing social workers in integrated health care settings, especially related to informed consent, privacy, confidentiality, boundaries, dual relationships, and conflicts of interest. The author includes practical resources that social workers can use to develop state-of-the-art ethics policies and protocols.

Healthcare professionals' and patients' perspectives on consent to clinical genetic testing: moving towards a more relational approach.

BACKGROUND: This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. METHODS: We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK's National Health Service (data collected 2013-2015). We explore two aspects of consent: first, how healthcare professionals consider the act of 'consenting' patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. RESULTS: Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients' understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients' decision-making. Rather, decision-making is socially contextualised - also based on factors outside of information provision. CONCLUSIONS: A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed.

Increasing possibilities - Increasing dilemmas: A qualitative study of Swedish midwives' experiences of ultrasound use in pregnancy.

OBJECTIVE: to explore Swedish midwives' experiences and views of the use of obstetric ultrasound in clinical management of pregnancy, and in situations where maternal and fetal health interests conflict. DESIGN: an exploratory qualitative study based on focus group discussions (FGDs) was undertaken in 2013 as part of the CROss Country Ultrasound Study (CROCUS). Data were analysed using qualitative content analysis. SETTING AND PARTICIPANTS: midwives (N=25) were recruited from four public hospitals located in the northern and central parts of Sweden. FINDINGS: the analysis resulted in three categories. The first 'Acknowledging ultrasound as optimising care but also as creating worry and ethical dilemmas' reflects midwives' experiences of two different aspects of ultrasound use, one being recognition of ultrasound as an important tool to optimise care and pregnancy outcomes, the other being the dilemmas that arise for maternity care in situations of uncertain or unwanted findings. The second category 'Dealing with insufficient informed consent processes and differing expectations of ultrasound' describes routine ultrasound as an unquestioned norm that means its full purpose and use is not always well communicated to, or understood by, expectant parents, resulting in differing expectations of ultrasound outcomes between caregivers and expectant parents. Midwives also experienced expectant parents as having great trust in ultrasound, with perceptions of 'all clear' scan as a 'guarantee' for a healthy baby. The third category 'Balancing maternal and fetal health interests in a context of medico-technical development' included experiences of the fetus being given greater importance in maternity care as diagnostic and fetal treatment possibilities increase; that new methods are often introduced without appropriate ethical discussion; and also that ethical challenges will increase in line with increasing demand for 'quality assurance' in pregnancy. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: midwives described ultrasound as a vital tool in pregnancy surveillance and management, facilitating conditions to be optimised for the woman and her baby during pregnancy, birth and the postpartum period. However, the increasing possibility of obtaining detailed information about the fetus was also experienced as increasing ethical dilemmas in maternity care. This study indicates that there is a need to improve informed consent processes regarding the use of ultrasound for prenatal screening and diagnostic purposes. The ambivalence midwives expressed in relation to management of ultrasound findings furthermore indicates a need for ongoing training for maternity care professionals to increase confidence in counselling women and to promote consistency in management. Finally, it is important to monitor any increasing focus on the fetus by care providers for potential impacts on women's autonomy to make their own decisions about pregnancy and birth.

The changing paradigm of the doctor-patient relationship: Montgomery v Lanarkshire Health Board and developments in the 'duty to warn'.

The standard of risk disclosure required in New Zealand and the UK has differed until recently. Medical practitioners who perform treatment without adequate disclosure run the risk of violating patients' rights, and fail to practice at the high level reasonably expected of them. Before Montgomery v Lanarkshire Health Board, it was the case in the UK that a practitioner need not disclose a particular risk of treatment if a qualified body of medical opinion would also not have disclosed that risk. In this viewpoint, we examine the change brought about by Montgomery, and its implications for New Zealand practitioners.

No Understanding, No Consent: The Case Against Alternative Medicine.

The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession.

A Trust-Based Pact in Research Biobanks. From Theory to Practice.

Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy.

Participants' Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain.

This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent.

Fevered Decisions: Race, Ethics, and Clinical Vulnerability in the Malarial Treatment of Neurosyphilis, 1922-1953.

Physicians deliberately inoculated marginalized patients with malaria, using them as reservoirs to facilitate malarial fever therapy for syphilitic patients. The history presents ethical questions in an evolving historical context.

Protecting Traditional Knowledge Related to Biological Resources: Is Scientific Research Going to Become More Bureaucratized?

For the past several decades, there has been a world debate on the need for protecting traditional knowledge. A global treaty appears to be a distant reality. Of more immediate concern are the steps taken by the global community to protect access to biological resources in the name of protecting traditional knowledge. The Indian experience with implementing the Convention on Biological Diversity has created substantial legal uncertainty in collaborative scientific research between Indians and foreigners apart from bureaucratizing the entire process of scientific research, especially with regard to filing of applications for intellectual property rights. The issue therefore is whether the world needs to better balance the needs of the scientific community with the rights of those who have access to traditional knowledge.

Prenatal screening, reproductive choice, and public health.

One widely held view of prenatal screening (PNS) is that its foremost aim is, or should be, to enable reproductive choice; this is the Pure Choice view. The article critiques this position by comparing it with an alternative: Public Health Pluralism. It is argued that there are good reasons to prefer the latter, including the following. (1) Public Health Pluralism does not, as is often supposed, render PNS more vulnerable to eugenics-objections. (2) The Pure Choice view, if followed through to its logical conclusions, may have unpalatable implications, such as extending choice well beyond health screening. (3) Any sensible version of Public Health Pluralism will be capable of taking on board the moral seriousness of abortion and will advocate, where practicable, alternative means of reducing the prevalence of disease and disability. (4) Public Health Pluralism is at least as well-equipped as the Pure Choice model to deal with autonomy and consent issues.

A new ethical landscape of prenatal testing: individualizing choice to serve autonomy and promote public health: a radical proposal.

A new landscape of prenatal testing (PNT) is presently developing, including new techniques for risk-reducing, non-invasive sampling of foetal DNA and drastically enhanced possibilities of what may be rapidly and precisely analysed, surrounded by a growing commercial genetic testing industry and a general trend of individualization in healthcare policies. This article applies a set of established ethical notions from past debates on PNT for analysing PNT screening-programmes in this new situation. While some basic challenges of PNT stay untouched, the new development supports a radical individualization of how PNT screening is organized. This reformation is, at the same time, difficult to reconcile with responsible spending of resources in a publicly funded healthcare context. Thus, while the ethical imperative of individualization holds and applies to PNT, the new landscape of PNT provides reasons to start rolling back the type of mass-screening programmes currently established in many countries. Instead, more limited offers are suggested, based on considerations of severity of conditions and optimized to simultaneously serve reproductive autonomy and public health within an acceptable frame of priorities. The new landscape of PNT furthermore underscores the ethical importance of supporting and including people with disabilities. For the very same reason, no ban on what may be analysed using PNT in the new landscape should be applied, although private offers must, of course, conform to strict requirements of respecting reproductive autonomy and what that means in terms of counselling.

"I assumed that one was a placebo": exploring the consent process in a sham controlled acupressure trial.

OBJECTIVES: In clinical trials where participants are likely to be able to distinguish between true and sham interventions, informing participants that they may receive a sham intervention increases the likelihood of participants 'breaking the blind' and invalidating trial findings. The present study explored participants' perceptions of the consent process in a sham controlled acupressure trial which did not explicitly indicate participants may receive a sham intervention. DESIGN: Nested qualitative study within a randomised sham controlled trial of acupressure wristbands for chemotherapy-related nausea. Convenience sample of 26 patients participated in semi-structured interviews. Interviews were audio-recorded and transcribed verbatim. Transcripts analysed thematically using framework analysis. SETTING: Study conducted within three geographical sites in the UK: Manchester, Liverpool, and Plymouth. RESULTS: All participants indicated that they believed they were fully informed when providing written consent to participate in the trial. Participants' perceived it was acceptable to employ a sham intervention within the trial of acupressure wristbands without informing potential participants that they may receive a sham treatment. Despite the fact that participants were not informed that one of the treatment arms was a sham intervention the majority indicated they assumed one of the treatment arms would be placebo. CONCLUSIONS: Many trials of acupuncture and acupressure do not inform participants they may receive a sham intervention. The current study indicates patients' perceive this approach to the consent process as acceptable. However, the fact participants assume one treatment may be placebo threatens the methodological basis for utilising this approach to the consent process.

[Psychiatric treatment--legal aspects]. / Rechtliche Aspekte einer Behandlung in der Psychiatrie.

Doctors want to save lives and promote health. But their patients have the right to decide for themselves about what doctors do with them, and they are free to refuse treatment, even if it is unreasonable from a medical perspective. The law acknowledges this freedom even if a patient is incapable of responsible self-determination as a result of (mental) illness. Treatment contrary to the patient's declared intention will be allowed only under specific, narrow circumstances. These requirements must be legally established in a clear and precise manner.