Encontro nacional de Comitês de Ética em Pesquisa - ENCEP bloco 1

Analysis of 20 Years of Ethics Consultations at a U.S. Children's Hospital.

AbstractEmpirical studies of pediatric clinical ethics cases are scant in the biomedical and bioethics literature. In this study, more than 100 detailed records of clinical ethics consultations spanning from 2000 to 2020 at a moderately sized U.S. Mid-Atlantic children's hospital were abstracted and analyzed. Findings of the analysis were generally consistent with other studies in pediatric clinical ethics, with additional insight into aspects of moral distress associated with cases, family engagement with consultations, and other characteristics of interest also documented. Over the 20-year time frame, ethics consults were completed on average twice a year, with a detectable upward trend. Consultations were requested across the spectrum of services and units within the hospital, with critical care environments represented most frequently and genetic and neurological conditions being the most common primary diagnoses. Ethical analysis most commonly related to questions around the principles of autonomy and beneficence.

An Ethical Analysis of Therapy for Severe Congenital Kidney and Urinary Tract Anomalies.

Technological advancements before and after delivery have greatly altered the counseling of pregnant patients facing a fetal diagnosis of severe oligohydramnios or anhydramnios secondary to congenital anomalies of the kidneys and urinary tract. Once considered a nearly uniformly lethal abnormality, long-term survival may now be possible secondary to prenatal innovations aimed at restoring the amniotic fluid volume and the availability of more advanced neonatal dialysis techniques. However, these available therapies are far from perfect. The procedures are onerous for pregnant patients without a guarantee of success, and families must prepare themselves for the complex life-long medical care that will be necessary for surviving individuals. Multidisciplinary counseling is imperative to help pregnant individuals understand the complexity of these conditions and assist them in exercising their right to informed decision-making. Moreover, as with any developing field of medicine, providers must contend with ethical questions related to the treatment options, including questions regarding patient-hood, distributive justice, and the blurred lines between research, innovation, and standard care. These ethical questions are best addressed in a multidisciplinary fashion with consideration of multiple points of view from various subspecialties. Only by seeing the entirety of the picture can we hope to best counsel patients about these highly complex situations and help navigate the most appropriate care path.

Australia II: A Case Study in Engineering Ethics.

Australia II became the first foreign yacht to win the America's Cup in 1983. The boat had a revolutionary wing keel and a better underwater hull form. In official documents, Ben Lexcen is credited with the design. He is also listed as the sole inventor of the wing keel in a patent application submitted on February 5, 1982. However, as reported in New York Times, Sydney Morning Herald, and Professional Boatbuilder, the wing keel was in fact designed by engineer Peter van Oossanen at the Netherlands Ship Model Basin in Wageningen, assisted by Dr. Joop Slooff at the National Aerospace Laboratory in Amsterdam. Based on telexes, letters, drawings, and other documents preserved in his personal archive, this paper presents van Oossanen's account of how the revolutionary wing keel was designed. This is followed by an ethical analysis by Martin Peterson, in which he applies the American NSPE and Dutch KIVI codes of ethics to the information provided by van Oossanen. The NSPE and KIVI codes give conflicting advice about the case, and it is not obvious which document is most relevant. This impasse is resolved by applying a method of applied ethics in which similarity-based reasoning is extended to cases that are not fully similar. The key idea, presented in Peterson's book The Ethics of Technology (Peterson, The ethics of technology: A geometric analysis of five moral principles, Oxford University Press, 2017), is to use moral paradigm cases as reference points for constructing a "moral map".

Rethinking Health Recommender Systems for Active Aging: An Autonomy-Based Ethical Analysis.

Health Recommender Systems are promising Articial-Intelligence-based tools endowing healthy lifestyles and therapy adherence in healthcare and medicine. Among the most supported areas, it is worth mentioning active aging. However, current HRS supporting AA raise ethical challenges that still need to be properly formalized and explored. This study proposes to rethink HRS for AA through an autonomy-based ethical analysis. In particular, a brief overview of the HRS' technical aspects allows us to shed light on the ethical risks and challenges they might raise on individuals' well-being as they age. Moreover, the study proposes a categorization, understanding, and possible preventive/mitigation actions for the elicited risks and challenges through rethinking the AI ethics core principle of autonomy. Finally, elaborating on autonomy-related ethical theories, the paper proposes an autonomy-based ethical framework and how it can foster the development of autonomy-enabling HRS for AA.

Interventions to address antimicrobial resistance: an ethical analysis of key tensions and how they apply in low- income and middle-income countries.

Antimicrobial resistance (AMR) is a global health and one health problem. Efforts to mitigate the problem of AMR are challenging to implement due to unresolved ethical tensions. We present an in-depth ethical analysis of tensions that might hinder efforts to address AMR. First, there is a tension between access and excess in the current population: addressing lack of access requires facilitating use of antimicrobials for some populations, while addressing excessive use for other populations. Second, there is a tension between personal interests and a wider, shared interest in curbing AMR. These personal interests can be viewed from the perspective of individuals seeking care and healthcare providers whose livelihoods depend on using or selling antimicrobials and who profit from the sales and use of antimicrobials. Third, there is a tension between the interests of current populations and the interests of future generations. Last, there is a tension between addressing immediate health threats such as pandemics, and AMR as a 'silent', chronic threat. For each of these tensions, we apply 'descriptive ethics' methods that draw from existing evidence and our experiences living and working in low-income and middle-income countries to highlight how these ethical tensions apply in such settings.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Ethics of early detection of disease risk factors: A scoping review.

BACKGROUND: Scientific and technological advancements in mapping and understanding the interrelated pathways through which biological and environmental exposures affect disease development create new possibilities for detecting disease risk factors. Early detection of such risk factors may help prevent disease onset or moderate the disease course, thereby decreasing associated disease burden, morbidity, and mortality. However, the ethical implications of screening for disease risk factors are unclear and the current literature provides a fragmented and case-by-case picture. METHODS: To identify key ethical considerations arising from the early detection of disease risk factors, we performed a systematic scoping review. The Scopus, Embase, and Philosopher's Index databases were searched for peer-reviewed, academic records, which were included if they were written in English or Dutch and concerned the ethics of (1) early detection of (2) disease risk factors for (3) disease caused by environmental factors or gene-environment interactions. All records were reviewed independently by at least two researchers. RESULTS: After screening 2034 titles and abstracts, and 112 full papers, 55 articles were included in the thematic synthesis of the results. We identified eight common ethical themes: (1) Reliability and uncertainty in early detection, (2) autonomy, (3) privacy, (4) beneficence and non-maleficence, (5) downstream burdens on others, (6) responsibility, (7) justice, and (8) medicalization and conceptual disruption. We identified several gaps in the literature, including a relative scarcity of research on ethical considerations associated with environmental preventive health interventions, a dearth of practical suggestions on how to address expressed concerns about overestimating health capacities, and a lack of insights into preventing undue attribution of health responsibility to individuals. CONCLUSIONS: The ethical concerns arising with the early detection of risk factors are often interrelated and complex. Comprehensive ethical analyses are needed that are better embedded in normative frameworks and also assess and weigh the expected benefits of early risk factor detection. Such research is necessary for developing and implementing responsible and fair preventive health policies.

Who has a meaningful life? A care ethics analysis of selective trait abortion.

Trait Selective Abortions (TSA) have come under critique as a medical practice that presents potential disabled infants as burdens and lacking the potential for meaningful lives. This paper, using the author's background as a disabled person, contends that the philosophy underpinning TSAs reflects liberal society's lack of a theory of needs. The author argues for a care ethics based approach informed by disability analyses to engage with TSAs.

The Extent to Which the Wish to Donate One's Organs After Death Contributes to Life-Extension Arguments in Favour of Voluntary Active Euthanasia in the Terminally Ill: An Ethical Analysis.

In terminally ill individuals who would otherwise end their own lives, active voluntary euthanasia (AVE) can be seen as life-extending rather than life-shortening. Accordingly, AVE supports key pro-euthanasia arguments (appeals to autonomy and beneficence) and meets certain sanctity of life objections. This paper examines the extent to which a terminally ill individual's wish to donate organs after death contributes to those life-extension arguments. It finds that, in a terminally ill individual who wishes to avoid experiencing life he considers to be not worth living, and who also wishes to donate organs after death, AVE maximizes the likelihood that such donations will occur. The paper finds that the wish to donate organs strengthens the appeals to autonomy and beneficence, and fortifies the meeting of certain sanctity of life objections, achieved by life-extension arguments, and also generates appeals to justice that form novel life-extension arguments in favour of AVE in this context.

Antimicrobial stewardship in low- and middle-income countries: Developing a broader perspective through an ethical analysis.

The increase in the number of cases of antimicrobial resistance has gained attention worldwide. The main drivers of this situation are the misuse and overuse of antimicrobials for human and animal health. The imbalance between ensuring appropriate use of antimicrobials and providing equal access in the community makes this an ethical issue. The antimicrobial stewardship programme was initiated in response to this global crisis. Its framework includes interventions targeting the optimisation of antimicrobials in hospitals. Various countries have adopted stewardship interventions, and many success stories have been published. However, the steering of this programme faces hurdles due to the complexity that surrounds decision making in antimicrobial prescription, and the challenges of health systems in lower and middle income countries like India. Addressing these issues will extend the reach of these programmes, increase their sustainability and promote health-related justice to the community.

Exit Duty Generator.

This article presents a revised version of negative utilitarianism. Previous versions have relied on a hedonistic theory of value and stated that suffering should be minimized. The traditional rebuttal is that the doctrine in this form morally requires us to end all sentient life. To avoid this, a need-based theory of value is introduced. The frustration of the needs not to suffer and not to have one's autonomy dwarfed should, prima facie, be decreased. When decreasing the need frustration of some would increase the need frustration of others, the case is deferred and a fuller ethical analysis is conducted. The author's perceptions on murder, extinction, the right to die, antinatalism, veganism, and abortion are used to reach a reflective equilibrium. The new theory is then applied to consumerism, material growth, and power relations. The main finding is that the burden of proof should be on those who promote the status quo.

Toward a Social Bioethics Through Interpretivism: A Framework for Healthcare Ethics.

Recent global events demonstrate that analytical frameworks to aid professionals in healthcare ethics must consider the pervasive role of social structures in the emergence of bioethical issues. To address this, the authors propose a new sociologically informed approach to healthcare ethics that they term "social bioethics." Their approach is animated by the interpretive social sciences to highlight how social structures operate vis-à-vis the everyday practices and moral reasoning of individuals, a phenomenon known as social discourse. As an exemplar, the authors use social bioethics to reframe common ethical issues in psychiatric services and discuss potential implications. Lastly, the authors discuss how social bioethics illuminates the ways healthcare ethics consultants in both policy and clinical decision-making participate in and shape broader social, political, and economic systems, which then cyclically informs the design and delivery of healthcare.

Translational or translationable? A call for ethno-immersion in (empirical) bioethics research.

The shift towards "empirical bioethics" was largely triggered by a recognition that stakeholders' views and experiences are vital in ethical analysis where one hopes to produce practicable recommendations. Such perspectives can provide a rich resource in bioethics scholarship, perhaps challenging the researcher's perspective. However, overreliance on a picture painted by a group of research participants-or on pre-existing literature in that field-can lead to a biased view of a given context, as the subjectivity of data generated in these ways cannot (and should not wholly) be escaped. In response, we propose the implementation of a complementary approach of ethno-immersion in bioethics research. By positioning oneself in the context being researched, the researcher can better understand the realities of that context. The researcher's understanding will, naturally, be subjective too. However, it will act as a better developed and more informed outsider view, when considering the picture painted by participants and previous studies, thus enabling the researcher to introduce more nuance when analysing data. We introduce this approach after examining what we call the context detachment problem, whereby some bioethics scholarship-empirical or otherwise-fails to reflect the reality of the healthcare setting it concerns. Our proposed ethno-immersion (which differs from formal ethnography) is then explored as a response, highlighting its benefits, and answering the question of timing within a research project. Finally, we reflect on the applicability of our proposal to non-empirical bioethics scholarship, concluding that it remains important but may require some adjustments.

Ethics of college vaccine mandates, using reasonable comparisons.

In the paper 'COVID-19 vaccine boosters for young adults: a risk-benefit assessment and ethical analysis of mandate policies at universities,' Bardosh et al argued that college mandates of the COVID-19 booster vaccine are unethical. The authors came to this conclusion by performing three different sets of comparisons of benefits versus risks using referenced data and argued that the harm outweighs the risk in all three cases. In this response article, we argue that the authors frame their arguments by comparing values that are not scientifically or reasonably comparable and that the authors used values that represent grossly different risk profiles and grouped them into a set of figures to create an illusion of fair comparisons. We argue that absent the falsely skewed portrayals of a higher level of risk over benefit in their misrepresented figures, the five ethical arguments they presented completely fall apart.

Anti-natalism is incompatible with Theory X.

The anti-natalist philosopher David Benatar defends a position asserting that all life is harmful, and that it is, therefore, wrong to have children. In this paper, I critique Benatar's less-discussed claim that his anti-natalism provides solutions to population ethics problems, such as the Non-Identity Problem, the Repugnant Conclusion, and the Mere Addition Problem, all of which are presented in Derek Parfit's Reasons and Persons. Since the publication of his Better Never to Have Been, Benatar has continued to claim that its provision of such solutions strengthens his defense of anti-natalism. Although Benatar's view has received much criticism, this argument has not been discussed at length. I undertake a thorough examination of the argument and identify reasons to reject it. The central point of my critique is that the implications of Benatar's views in determining ranges of wrong and not-wrong cases of procreation are extensionally inadequate when applied to the problems of population ethics.

Scientists' Views on the Ethics, Promises and Practices of Synthetic Biology: A Qualitative Study of Australian Scientific Practice.

Synthetic biology is a broad term covering multiple scientific methodologies, technologies, and practices. Pairing biology with engineering, synbio seeks to design and build biological systems, either through improving living cells by adding in new functions, or creating new structures by combining natural and synthetic components. As with all new technologies, synthetic biology raises a number of ethical considerations. In order to understand what these issues might be, and how they relate to those covered in ethics literature on synbio, we conducted an interview study with practicing synthetic biologists affiliated with a synthetic biology centre in Australia. Scientists identified a range of ethical challenges germane to the field, including precarious employment, pressures from industry, gender inequity, and the negative effects of the hyping of synbio. These challenges differed markedly from those identified in the ethics literature, whose treatment of the harms and benefits of synbio remains largely speculative and abstract. In our discussion of the pragmatic, every day ethical issues synthetic biologists face, we illustrate how issues of waste or research integrity play pivotal roles in everything from lived experiences in the laboratory, to long-term research trajectories guiding the field. In a confirmation of the ethical relevance of our participant's views on the field, we argue that the subjects they raise must be included in any ethical analysis of synbio as a field.

The risk of normative bias in reporting empirical research: lessons learned from prenatal screening studies about the prominence of acknowledged limitations.

Empirical data can be an extremely powerful and influential tool in bioethical research. However, when researchers or policy makers look for answers to ethical questions by engaging with empirical research, there can be a tendency (conscious or unconscious) to shape, report, and use empirical research in a way that confirms their own preferred ethical conclusions. This skewing effect - what we call 'normative bias' - is often so subtle it falls short of clear misconduct and thus can be difficult to call out. However, we argue that this subtle influence of bias has the potential to significantly influence debate and policy around highly sensitive ethical issues and must be guarded against. In this paper we share the lessons we have learned through a journey of self-reflection around the effect that normative bias can have when reporting on and referring to empirical data relating to ethical issues. We use a variety of papers from our area of the ethics of routine prenatal screening to illustrate these subtle but often powerfully distorting effects of bias. Our aim in doing so is not to criticise the work of others, as we recognise our own normative bias, but to improve awareness of this issue, remind the need for reflexivity to guard against our own biases, and introduce a new criterion - the idea of a 'limitation prominence assessment' - that can work as a practical way to evaluate the seriousness of the limitations of an empirical study and thus, the risks of the study being misread or misinterpreted through superficial reading.