Ética en investigación: de los principios a los aspectos prácticos / Research ethics: From principles to practical aspects

La realización de cualquier investigación con seres humanos o sus muestras biológicas requiere una valoración ética previa con el fin de evitar riesgos y problemas a todos los actores del proceso. La legislación al respecto es muy amplia, y hace hincapié en la preservación de los derechos de los pacientes en relación con los principios universales de autonomía, beneficencia y justicia. En este manuscrito se revisan las normativas sobre ensayos clínicos, estudios observacionales con medicamentos, proyectos de biobanco o cualquier otro tipo de estudio que se pueda realizar en el ámbito de la salud. Así mismo se analiza el papel de los comités de ética en investigación, la protección de datos y las bases de la integridad científica. (AU)

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity. (AU)

Ethics, climate change and health - a landscape review.

Anthropogenic climate change is unequivocal, and many of its physical health impacts have been identified, although further research is required into the mental health and wellbeing effects of climate change. There is a lack of understanding of the importance of ethics in policy-responses to health and climate change which is also linked to the lack of specific action-guiding ethical resources for researchers and practitioners. There is a marked paucity of ethically-informed health input into economic policy-responses to climate change-an area of important future work. The interaction between health, climate change and ethics is technically and theoretically complex and work in this area is fragmentary, unfocussed, and underdeveloped. Research and reflection on climate and health is fragmented and plagued by disciplinary silos and exponentially increasing literature means that the field cannot be synthesised using conventional methods. Reviewing the literature in these fields is therefore methodologically challenging. Although many of the normative challenges in responding to climate change have been identified, available theoretical approaches are insufficiently robust, and this may be linked to the lack of action-guiding support for practitioners. There is a lack of ethical reflection on research into climate change responses. Low-HDI (Human Development Index) countries are under-represented in research and publication both in the health-impacts of climate change, and normative reflection on health and climate change policy. There is a noticeable lack of ethical commentary on a range of key topics in the environmental health literature including population, pollution, transport, energy, food, and water use. Serious work is required to synthesise the principles governing policy responses to health and climate change, particularly in relation to value conflicts between the human and non-human world and the challenges presented by questions of intergenerational justice.

Out of their minds? Externalist challenges for using AI in forensic psychiatry.

Harnessing the power of machine learning (ML) and other Artificial Intelligence (AI) techniques promises substantial improvements across forensic psychiatry, supposedly offering more objective evaluations and predictions. However, AI-based predictions about future violent behaviour and criminal recidivism pose ethical challenges that require careful deliberation due to their social and legal significance. In this paper, we shed light on these challenges by considering externalist accounts of psychiatric disorders which stress that the presentation and development of psychiatric disorders is intricately entangled with their outward environment and social circumstances. We argue that any use of predictive AI in forensic psychiatry should not be limited to neurobiology alone but must also consider social and environmental factors. This thesis has practical implications for the design of predictive AI systems, especially regarding the collection and processing of training data, the selection of ML methods, and the determination of their explainability requirements.

ChatGPT and Artificial Intelligence in Medical Writing: Concerns and Ethical Considerations.

Artificial intelligence (AI) language generation models, such as ChatGPT, have the potential to revolutionize the field of medical writing and other natural language processing (NLP) tasks. It is crucial to consider the ethical concerns that come with their use. These include bias, misinformation, privacy, lack of transparency, job displacement, stifling creativity, plagiarism, authorship, and dependence. Therefore, it is essential to develop strategies to understand and address these concerns. Important techniques include common bias and misinformation detection, ensuring privacy, providing transparency, and being mindful of the impact on employment. The AI-generated text must be critically reviewed by medical experts to validate the output generated by these models before being used in any clinical or medical context. By considering these ethical concerns and taking appropriate measures, we can ensure that the benefits of these powerful tools are maximized while minimizing any potential harm. This article focuses on the implications of AI assistants in medical writing and hopes to provide insight into the perceived rapid rate of technological progression from a historical and ethical perspective.

The Social Relations of Ethnographic Fieldwork: Access, Ethics and Research Governance.

The focus of this methodological paper is to discuss the challenges of conducting fieldwork, using reflections from our experiences of accessing a research site for ethnographic data collection. The research project aimed to explore nurses' social relations in their workplace and the inequities between and within these relations among nurses of diverse social positions. Due to the sensitive nature of this topic, access to the research site posed several challenges and was further complicated by the bureaucratic ethics process that governs clinical sites in Australia. Although this study was considered a low and negligible risk research, negotiating the ethics process was full of hitches and hindrances resulting in the refusal of access. This paper offers ethnographers a reflection on challenges in accessing clinical sites to conduct research and a discussion of strategies that may be useful to navigate and counter these challenges by managing social relations in the field.

A Scoping Review Of The Literature Of Research Ethics Committees And Ethics Review Framework In Pakistan: What We Know And What We Still Need To Learn.

OBJECTIVE: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. RESULTS: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards. CONCLUSIONS: Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.

How and why to use 'vulnerability': an interdisciplinary analysis of disease risk, indeterminacy and normality.

In recent years, 'vulnerability' has been getting more traction in theoretical, professional and popular spaces as an alternative or complement to the concept of risk. As a group of science and technology studies scholars with different disciplinary orientations yet a shared concern with biomedicine, self and society, we investigate how vulnerability has become a salient and even dominant idiom for discussing disease and disease risk. We argue that this is at least partly due to an inherent indeterminacy in what 'vulnerability' means and does, both within and across different discourses. Through a review of feminist and disability theory, and a discussion of how vulnerability and disease both get recruited into a binary conceptualisation of normal versus abnormal, we argue that vulnerability's indeterminacy is, in fact, its strength, and that it should be used differently than risk. Using COVID-19 management in the UK as an illustration of the current ambivalence and ambiguity in how vulnerability versus risk is applied, we suggest that instead of being codified or quantified, as it has started to be in some biomedical and public health applications, vulnerability and its remedies should be determined in conjunction with affected communities and in ways that are polyvalent, flexible and nuanced. The concept of vulnerability encapsulates an important precept: we must recognise inequality as undesirable while not attempting to 'solve' it in deterministic ways. Rather than becoming fixed into labels, unidirectional causalities or top-down universalising metrics, vulnerability could be used to insist on relational, context-specific understandings of disease and disease risk-in line with contemporary social justice movements that require non-hierarchical and non-universal approaches to problems and solutions.

Turning good intentions into good outcomes: ethical dilemmas at a student-run clinic and a rubric for reflective action.

Student-run clinics represent a unique medical education and healthcare delivery model powered largely by good intentions. These good intentions may produce questionable results, however, when juxtaposed with intense academic pressure to fill one's curriculum vitae with personal achievements, leadership roles and peer-reviewed publications. It becomes a legitimate ethical question whether student-run clinics consistently and materially enrich the care of underserved communities, or merely inspire a litany of rushed, short-term and low-quality projects that sidestep patient welfare or even cause brazen harm. As co-directors of HOMES Clinic, a student-managed clinic which offers free health and social services to people experiencing housing insecurity, we routinely encounter such well-intentioned but ethically questionable proposals. Here, we present four short case studies that dissect apart some of these common yet suspect assumptions underpinning student-run clinics. We then conclude with a rubric for reflective, calibrated action.

Ranking Research Methodology by Risk - a cross-sectional study to determine the opinion of research ethics committee members.

BACKGROUND: When reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards - IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants' time, researchers' time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews. METHOD: We conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey. RESULTS: We collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky). CONCLUSIONS: We discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews.

Ethical challenges in research regarding aging population. / Desafíos a la ética en la investigación frente al envejecimiento poblacional.

Aging population is a global reality that forces public policies based on transdisciplinary research focused on older adults. This raises a series of issues, such as feasability, inequalities, inequities, vulnerability, access to the products generated, and ability to consent, among others. This essay's objective is to reflect on some of the questions that arise from this reality, review basic precepts of research ethics in human beings, and expose the challenges for updating the current guidelines for ethical biomedical research. Aged adults participating in clinical research should be respected, assured of an adequate risk/benefit balance, and selected fairly. The available guidelines generally recognize these basic principles, but they are not entirely guaranteed, as evidenced during the COVID-19 pandemic. This issue poses various ethical challenges and deserves to be considered in the guidelines and regulations for biomedical research with the participation of older adults.

El mundo está experimentando un acelerado proceso de envejecimiento poblacional. Este cambio epidemiológico se asocia a la necesidad de incrementar la investigación orientada a mejorar la calidad de vida en las edades avanzadas. Esta investigación requiere de la participación de personas mayores, tanto en áreas del ámbito científico-tecnológico como en el sociocultural. Esta realidad lleva a plantear una serie de interrogantes relacionadas con la forma como se desarrolla esta actividad con las personas mayores, relacionadas con las brechas, desigualdades e inequidades, su vulnerabilidad, su acceso a los productos generados, su capacidad para consentir, entre otros. El objetivo del ensayo es reflexionar acerca de algunas de estas interrogantes, revisando algunos de los preceptos básicos de la ética de la investigación en seres humanos, y plantear algunas necesidades y desafíos para la actualización en las pautas y guías que la orientan. Se espera que las personas mayores que participan en investigación biomédica sean respetadas, se les asegure un adecuado balance riesgo/beneficio y se seleccionen en forma equitativa. Estos principios básicos, aunque reconocidos en términos generales por las guías y regulaciones éticas disponibles, no están completamente garantizados, como evidenció la pandemia de COVID-19. El tema plantea diversos desafíos y amerita su consideración en las pautas y guías éticas para la investigación biomédica con participación de personas mayores.

Direct-to-Consumer Genomic Testing Through an Ethics Lens: Oncology Nursing Considerations.

BACKGROUND: The use of direct-to-consumer genomic testing (DTCGT) is increasing, but this testing may not be comprehensive and may lack clinical validity and utility. The ethical constructs of beneficence, nonmaleficence, justice, and autonomy provide a framework for coordinating the care of patients and their families. OBJECTIVES: This article provides an overview of the DTCGT process and reviews the ethical implications that affect clinical care. METHODS: A review of the literature was conducted using the following key words: genetics/genomics and direct-to-consumer testing. Common themes were identified, including test types, regulatory standards, marketing practices, ethics, privacy, and nursing implications. FINDINGS: An increased awareness of the clinical and ethical consequences of DTCGT is needed among healthcare providers and the general population. Oncology nurses can assist patients in navigating the field of genomics through consistent and comprehensive risk assessment, patient education about the risks and benefits of DTCGT, and referral to genomics professionals when appropriate.

What Are the Ethical Obligations Related to a Request for Nonbeneficial Treatment?

It is common for a headline to proclaim promising results of a new cancer drug and for medical oncology offices to be flooded with calls from patients hoping that this new "miracle" drug offers them a chance of cure. Conf.

Why All Healthy Laboratory Animals Should Be Rehomed, No Matter How Small.

This paper explores the ethical imperative of rehoming all healthy animals of sentient species after experiments have finished or when they have become otherwise redundant. We take into account disparate perspectives in animal ethics and see how they point in the same direction. We illustrate our case with our own rehoming experience from the joint Animal Welfare Body of Utrecht University and the University Medical Centre Utrecht, the Netherlands. The primary pilot proved successful, after which the principle of rehoming became standing policy and common practice. We discuss several challenges and our responses to those through continuous evaluation of the adoption program.

What Is Wrong with Eating Pets? Wittgensteinian Animal Ethics and Its Need for Empirical Data.

Wittgensteinian approaches to animal ethics highlight the significance of practical concepts like 'pet', 'patient', or 'companion' in shaping our understanding of how we should treat non-human animals. For Wittgensteinian animal ethicists, moral principles alone cannot ground moral judgments about our treatment of animals. Instead, moral reflection must begin with acknowledging the practical relations that tie us to animals. Morality emerges within practical contexts. Context-dependent conceptualisations form our moral outlook. In this paper, we argue that Wittgensteinians should, for methodological reasons, pay more attention to empirical data from the social sciences such as sociology, psychology or anthropology. Such data can ground Wittgensteinians' moral inquiry and thereby render their topical views more dialectically robust.

The Life and Death of Freya the Walrus: Human and Wild Animal Interactions in the Anthropocene Era.

Freya the Walrus, who often climbed onto docked boats to sunbathe and frolic, was euthanized by the Norwegian Department of Fisheries in the Oslo fjord in August 2022, sparking international outrage and media attention. Since walruses are social animals, and since the Anthropocene era of climate change has displaced animals from their Arctic homes, forcing them to migrate, we can expect more human-animal interactions at such places as marinas, where Freya met her end. This paper asks and attempts to answer how we can make such interactions just going forward? In cases such as Freya's, we need to reconcile three competing interests: the animal's interest in living a flourishing life as best they can in a changing climate; the public's interest in a safe and fulfilling wildlife encounter with an animal they have come to know intimately enough to name and follow devotedly on social media; and interests in maintaining private property. Examining these interests through the philosophical lenses of co-sovereignty, capability, and individuality, however, will yield more just results for animals in similar situations of conflict and co-existence with humans in urban spaces. We argue that, going forward, state resources should be expended to safeguard the public from marina access if safety is a genuine concern, while private money should be spent by marinas to enact safe animal removal with a no-kill policy.

A Clinical and Ethical Dilemma: Expectant Management for Ectopic Pregnancy with a Vital Fetus in a Low-Resource Setting.

BACKGROUND: Guidelines recommend the prompt surgical removal of any ectopic pregnancy (EP) in the presence of a vital embryo. This treatment impacts future fertility, particularly in low-resource settings where access to assisted reproductive techniques is limited. In addition, growing evidence is reporting live births after conservative management of initially undiagnosed abdominal pregnancies. Therefore, the discussion on the acceptability of expectant management in selected cases has been recently raised. CASE: We present and discuss the case of a woman with vital first trimester EP who refused surgical treatment at Princess Christian Maternity Hospital, Freetown, Sierra Leone. She was initially diagnosed with a 12 week pregnancy located in the left adnexal region without hemoperitoneum. She refused both surgical treatment and hospital admission and did not come back to the hospital for antenatal care until 26 weeks of gestational age. Therefore, she was admitted and finally delivered, at 34 weeks of gestation, a 1.9 kg healthy baby which was alive. To disentangle the potential conflict between the ethical principles of medical treatment's beneficence and the patient's autonomy, we provide an update on counselling for a patient with early vital EP in a resource-limited setting and discuss the knowledge gap in this area. CONCLUSIONS: Limited access to fertility treatment in low- and middle-income countries may justify the discussion of expectant management as an option in selected cases of uncomplicated vital EP.

The Ethics of Actually Helping People: Targeting Skill Acquisition Goals That Promote Meaningful Outcomes for Individuals with Autism Spectrum Disorder.

As a field that predominately supports individuals with autism spectrum disorder (ASD), we have an ethical duty as behavior analysts to ensure that the goals we write and interventions we prescribe promote best outcomes across the lifespan. This is critical, given that as it stands now, outcomes in adulthood for individuals with ASD are poor in every area assessed. The Ethics Code for Behavior Analysts can be interpreted to provide support for teaching the right goals, the right way, with respect to inherent rights of those we serve, in order to help affect positive changes in these outcomes. The present article highlights ethical themes that are relevant in order to affect these changes that are supported by the Code, as well as actionable steps to take next. The aim is to provide a resource for practitioners to use in clinical practice and in making ethical decisions that will help to improve outcomes for individuals with autism in adulthood. In addition, recommendations are made about integrating these values and approaches in terms of training, supervision, advocacy, and research.

[Ethical principles for the design of a clinical trial in oncology]. / Règles éthiques pour la conception d'un essai clinique en oncologie.

Clinical research in the area of cancer is of utmost importance in order to improve patient care, both in terms of overall survival and quality of life. The implementation of clinical trials on medicinal products, now falling under EU Regulation 536/2014, is conditioned on prior scientific authorisation from the French National Agency for the Safety of Medicines and Health Products and a favorable ethical opinion from a Research Ethics Committee (REC). OBJECTIVE: The objective of this work is to report on the main problematic issues identified during the evaluation of oncology dossiers by the REC in order to present the expected elements and thus optimise the evaluation procedures. METHODS: The National Conference of the Research Ethics Committees analysed the questions raised by the REC during their evaluation of clinical trials of oncology drugs submitted to the European information system in 2022. RESULTS: Out of a total of fourteen dossiers, nine were subject to ethical questions on the protocol and all dossiers required modifications to the information documents. DISCUSSION: The heterogeneous quality of the dossiers reminds the need to submit well-argued, methodologically robust protocols with supervised research procedures that are safe for the participants. The drafting of information documents needs to be thoroughly reconsidered in order to present clear, concise, loyal and respectful documents for patients' rights.