The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional (...) Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

Physicists regularly invoke universal laws, such as those of motion and electromagnetism, to explain events. Biological and medical scientists have no such laws. How then do they acquire a reliable body of knowledge about biological organisms and human disease? One way is by repeatedly returning to, manipulating, observing, interpreting, and reinterpreting certain subjects—such as flies, mice, worms, or microbes—or, as they are known in biology, “model systems.” Across the natural and social sciences, other disciplinary fields have developed canonical examples that (...) have played a role comparable to that of biology’s model systems, serving not only as points of reference and illustrations of general principles or values but also as sites of continued investigation and reinterpretation. The essays in this collection assess the scope and function of model objects in domains as diverse as biology, geology, and history, attending to differences between fields as well as to epistemological commonalities. Contributors examine the role of the fruit fly Drosophila and nematode worms in biology, troops of baboons in primatology, box and digital simulations of the movement of the earth’s crust in geology, and meteorological models in climatology. They analyze the intensive study of the prisoner’s dilemma in game theory, ritual in anthropology, the individual case in psychoanalytic research, and Athenian democracy in political theory. The contributors illuminate the processes through which particular organisms, cases, materials, or narratives become foundational to their fields, and they examine how these foundational exemplars—from the fruit fly to Freud’s Dora—shape the knowledge produced within their disciplines. Contributors Rachel A. Ankeny Angela N. H. Creager Amy Dahan Dalmedico John Forrester Clifford Geertz Carlo Ginzburg E. Jane Albert Hubbard Elizabeth Lunbeck Mary S. Morgan Josiah Ober Naomi Oreskes Susan Sperling Marcel Weber M. Norton Wise. (shrink)

The concept of ‘ownership’ is increasingly central to debates, in the media, health policy and bioethics, about the appropriate management of clinical data. I argue that the language of ownership acts as a metaphor and reflects multiple concerns about current data use and the disenfranchisement of citizens and collectives in the existing data ecosystem. But exactly which core interests and concerns ownership claims allude to remains opaque. Too often, we jump straight from ‘ownership’ to ‘private property’ and conclude ‘the data (...) belongs to the patient’. I will argue here that private property is only one type of relevant relationship between people, communities and data. There are several reasons to doubt that conceptualising data as private property presents a compelling response to concerns about clinical data ownership. In particular I argue that clinical data are co-constructed, so a property account would fail to confer exclusive rights to the patient. A non-property account of ownership acknowledges that the data are ‘about the patient’, and therefore the patient has relevant interests, without jumping to the conclusion that the data ‘belongs to the patient’. On this broader account of ownership, the relevant harm is the severing of the connection between the patient and their data, and the solution is to re-engage and re-connect patients to the data research enterprise. (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...) that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health data (...) for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest. (shrink)

Public-private partnerships are established to specifically harness the potential of Big Data in healthcare and can include partners working across the data chain—producing health data, analysing data, using research results or creating value from data. This domain paper will illustrate the challenges that arise when partners from the public and private sector collaborate to share, analyse and use biomedical Big Data. We discuss three specific challenges for PPPs: working within the social licence, public antipathy to the commercialisation of public sector (...) health data, and questions of ownership, both of the data and any resulting intellectual property or products. As a specific example we consider the case of the UK National Health Service providing patient data to Google’s DeepMind AI program to develop a diagnostic app for kidney disease. This article is an application of the framework presented in this issue of ABR. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. We use four specific values to help analysis these issues: public benefit, stewardship, transparency and engagement. We demonstrate how the Deliberative Framework can support ethical governance of PPPs involving biomedical big data. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

Throughout March and April 2020, debate raged about how best to allocate limited intensive care unit (ICU) resources in the face of a growing COVID-19 pandemic. The debate was dominated by utility-based arguments for saving the most lives or life-years. These arguments were tempered by equity-based concerns that triage based solely on prognosis would exacerbate existing health inequities, leaving disadvantaged patients worse off. Central to this debate was the assumption that ICU admission is a valuable but scarce resource in the (...) pandemic context.In this paper, we argue that the concern about achieving equity in ICU triage is problematic for two reasons. First, ICU can be futile and prolong or exacerbate suffering rather than ameliorate it. This may be especially true in patients with COVID-19 with emerging data showing that most who receive access to a ventilator will still die. There is no value in admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. Second, the focus on ICU admission shifts focus away from important aspects of COVID-19 care where there is greater opportunity for mitigating suffering and enhancing equitable care.We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care. This requires attention to culturally safe care in the following interlinked areas: palliative care, communication and decision support and advanced care planning. (shrink)

This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or protect basic goods; (b) (...) In cases where one party is gambling with basic goods and the other party is not, the distribution of benefits and burdens must be arranged so that they are of greatest benefit to the worst off; (c) In relationships where one party is gambling for basic goods and the other party is not, the party gambling for basic goods must be assured of some guaranteed benefits in addition to the chance of gaining some potential benefits.These principles are applied to the case of HIV international research. I conclude that the research (as described) is mutually advantageous but still exploitative because the distribution of surplus benefits is unfair. It is unfair because research subjects are gambling with and for basic goods but they are not assured of a fair ex-post distribution of benefits. Principles (b) and (c) are not satisfied. Research participants are not accorded enough guaranteed benefits to outweigh the risks they undertake. (shrink)

This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion (...) for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

In their response to ‘Public interest in health data research: laying out the conceptual groundwork’, Grewal and Newson critique us for inattention to the law and putting forward an impracticably broad conceptual understanding of public interest. While we agree more work is needed to generate a workable framework for Institutional Review Boards/Research Ethics Committees, we would contend that this should be grounded on a broad conception of public interest. This broadness facilitates regulatory agility, and is already reflected by some current (...) frameworks such as that found in the guidelines approved under Australia’s Privacy Act. It remains unclear which elements of our broad account Grewal and Newson would reject, or indeed where the substantive disagreement with our position lies. (shrink)

This paper summarises the author 's doctoral research on the development of interpersonal/interorganisational trust in relationships between expatriate and Russian staff working in east‐west enterprises in Russia. There is strong evidence from a variety of researchers to suggest that in order for western businesses investing in Russia to succeed, the dif.cult process of building trust needs to be understood and managed since in the Russian business climate western standards and norms of ethical business have not yet been established. According to (...) research.ndings, western investors doing business in Russia and the long‐term, personal trust that characterises family and friend relationships more congenial and more productive than formal, arm's‐length contacts and contracts. In such a context, it becomes important to identify what creates and destroys trust in the post‐Soviet business environment. This paper describes the causal factors leading to trust or lack of trust in relationships within western‐invested strategic alliances in Russia. The key relationship under consideration is the one between expatriate western staff and managers seconded to the venture on the one hand, and their local Russian staff, counterparts and superiors on the other. (shrink)

Many clinical ethics support services do not involve patients. This is surprising because of the broad commitment to provide patient-centered healthcare. Clinical ethics support services are a component of the healthcare system and have an influence on patient care, and should therefore align with the regulatory and ethical requirements of patient-centered care, just process and cultural competence. First, in order to achieve good patient care, it is essential to involve patients in making their own healthcare decisions. Second, just ethical deliberation (...) requires that the deliberating parties have access to complete, accurate and unbiased information – this is best achieved through direct patient input. These arguments are especially compelling in the case of non-dominant cultural and ethnic groups. Here, we argue that when a clinician refers a case to a clinical ethics support services for consideration, and that case involves a conflict between the views or values of the clinician and the patient, the patient is entitled to, at a minimum: (a) be informed of the referral; (b) have the opportunity to speak directly to the clinical ethics support services prior to deliberation; (c) be provided with any opinion directly from the clinical ethics support services; and (d) have the opportunity to speak to a clinical ethics support services member after the deliberation. We use New Zealand as a case study to support and extrapolate the ethical principles and the minimum patient involvement requirements. We draw on our empirical research with senior doctors at a tertiary New Zealand hospital. Clinicians in our study indicated that they would feel bound by clinical ethics support service advice and that the clinical ethics support service has a significant impact on patient care in the case it reviews. (shrink)

Biotechnology might contribute to solving food safety and security challenges. However, gene technology has been under public scrutiny, linked to the framing of the media and public discourse. The study aims to investigate people’s perceptions and acceptance of food biotechnology with focus on transgenic genetic modification versus genome editing. An online experiment was conducted with participants from the United Kingdom and Switzerland. The participants were presented with the topic of food biotechnology and more specifically with experimentally varied vignettes on transgenic (...) and genetic modification and genome editing. The results suggest that participants from both countries express higher levels of acceptance for genome editing compared to transgenic genetic modification. The general and personal acceptance of these technologies depend largely on whether the participants believe the application is beneficial, how they perceive scientific uncertainty, and the country they reside in. Our findings suggest that future communication about gene technology should focus more on discussing trade-offs between using an agricultural technologies and tangible and relevant benefits, instead of a unidimensional focus on risk and safety. (shrink)

Concerns about exploitation pervade the literature on commercial cross-border reproductive care, particularly egg selling and surrogacy. But what constitutes exploitation, and what moral weight does it have? I consider the relationship between vulnerability, limited choice, consent, and mutually advantageous exploitation. To elucidate the difference between limited choice and consent, I draw on an account of relational autonomy. In the absence of a normative principle of fair distribution, it is unclear whether the providers of reproductive goods and services are treated fairly (...) in such contracts, and therefore whether they have been exploited. I finish with some pragmatic recommendations for minimizing risks and empowering egg sellers and surrogates. (shrink)

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial component to ensuring effective recruitment. The (...) Research In Pregnancy Ethics study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage. (shrink)

In this commentary, we take up Yearby’s call for racism-sensitive research and apply this to the discourse regarding race and diversity in COVID vaccine research. We consider whether efforts...

As the demand for human eggs for stem cell research increases, debate about appropriate standards for recruitment and compensation of women intensifies. In the majority of cases, the source of eggs for research is women undergoing fertility treatment requiring ovarian stimulation and egg retrieval. The principle of "just participant selection" requires that research subjects be selected from the population that stands to benefit from the research. Based on this principle, infertile women should be actively recruited to donate eggs for fertility-related (...) research only. It is unethical to exclusively or predominantly recruit infertile women to donate eggs for stem cell research that concerns general medical conditions. It is preferable to recruit women from the general population to donate eggs for such research, and these women should be viewed as healthy volunteers. To avoid exploitation, these donors should receive compensation for both the direct and indirect costs associated with their donation. (shrink)

This study is an analysis of 186 psychologists' attitudes on what constitutes ethical practice when counseling clients who present with a range of concerns related to their experience of same-sex attraction and behavior. Three different groups of psychologists were surveyed: generalists, specialists in gay and lesbian issues, and religiously affiliated psychologists. Participants also rated the effectiveness of several professional experiences in providing education, direction, sanctions, or support to regulate the practice of counseling nonheterosexual clients. Significant group differences were found regarding (...) what is considered best, acceptable, and unacceptable practice with clients presenting with same-sex attraction issues. Significant differences were also found among the three groups in what respondents rated as effective elements of their clinical experience. Keywords: gay, lesbian, religion, survey. (shrink)

Suele ser decepcionante asistir a la conferencia de algún/a filósofo/a u otro/a pensador/a, artista si es que uno ya lo ha leído, estudiado o seguido su obra por algún tiempo. Leer Sin miedo no ha sido la excepción. De ahí el valor de una reseña de libro, a saber: definir la audiencia para la cual el texto comentado podría ser un aporte. En este sentido, Sin miedo es perfecto para un público poco familiarizado con la obra de Butler o que (...) todavía no la ha estudiado en profundidad, aunque sí le interesa conocerla. Probablemente este libro abre el apetito por ahondar en la propuesta de Butler, que se desarrolla prolíficamente en su vasta escritura. Sin miedo es una publicación que agrupa cinco conferencias que la filósofa dictó entre los años 2018 y 2019, en ciudades como Berlín, Guadalajara, Ciudad de México, La Habana, Buenos Aires y Santiago de Chile. En cada una de ellas, Judith Butler hace un guiño al lugar en el que habla. Es respetuosa de la audiencia y eso marca sus dichos, que concilian el pensamiento elaborado y complejo con una escucha menos enmarcada en el canon académico. Es fácil detectar en estas conferencias ciertos temas que las recorren transversalmente y de los que la autora ha dado cuenta en sus últimas publicaciones: la violencia política que se ejerce hacia determinados grupos de nuestra sociedad, la común vulnerabilidad como un factor que pone en evidencia tanto la interdependencia como la posibilidad de la acción política, y el énfasis que expone respecto de la desigual distribución de la vulnerabilidad, así como de la necesidad de luchar por una democracia que Butler define como radical. (shrink)

En este artı́culo se examinan los usos, significados y la actualidad de la noción de crisis. Esta revisión se basa en el análisis de la polisemia del concepto (I), ası́ como en una revisión no exhaustiva del tratamiento que hacen de este concepto algunos autores como Jürgen Habermas y Bolı́var Echeverria (II). Finalmente, en base a las lecturas de Foucault y Butler, se sostiene la potencialidad de la noción de crisis como herramienta analı́tica para comprender nuestro presente marcado en Chile (...) por la revuelta de octubre de 2019 y luego por la pandemia mundial (III). (shrink)

Resumen: El diálogo fallido entre Estado y pueblo mapuche se enraíza en la formación misma del Estado chileno promovido por una elite que construye una institucionalidad a su imagen y semejanza, ilusamente homogénea e invisibilizadora de las diferencias. No obstante, el mismo espíritu “civilizador” que espera integrar a estas minorías asimilándolas, facilita la inserción de estas minorías en el diálogo postmoderno acerca de la interculturalidad, en el cual se enfrentan a la perspectiva multiculturalista que no da cuenta del acto de (...) reconocimiento que implica convivir con la otredad. (shrink)

La demanda mapuche nos obliga a pensar en un “sujeto incardinado” que sostiene ciertas reivindicaciones propiamente modernas en su reclamo por reconocimiento de la diferencia, al mismo tiempo que desafía la noción de ciudadanía universal y sostiene una demanda anclada territorialmente y basada en un discurso emancipatorio de derechos. En efecto, nos reenfoca en la constitución de una identidad colectiva que es efecto –por una parte– de una exclusión y de un reconocimiento erróneo y –por otra parte– de un entorno (...) global que hace más visibles los fragmentos no anudados, como su contracara. Finalmente, nos enfrentan a la demanda universal de derecho a la vida significativa. Se propone pensar la identidad desde una perspectiva des-esencializada que enfatice –por una parte- el rol del lenguaje en la estructuración de las relaciones sociales y –por otra- la relevancia de lo no-narrativizado del campo social. (shrink)

Si tratta di una lunga recensione critica del libro su Spirito scritto da uno dei suoi migliori conoscitori.

Il testo analizza, attraverso il confronto Cristianesimo-Ebraismo in H.de Lubac e Y. de Montcheuil, il problema del dialogo interreligioso e i suoi rischi.

Il testo analizza i più recenti studi italiani su Vico.

Il testo esamina, alla luce dell'ultimo inedito di Ugo Spirito, pubblicato a mia cura, le posizioni di Ugo Spirito riguardo al problema di Dio, mettendone in rilievo la profobnda continuità e coreneza.

L'articolo indaga l'idea di persona nelle opere di H. de Lubac, alla luce delle sue matrici filosofiche, servendosi in ciò di un ampia carteggio inedito intercorso col Blondel.

Si tratta di una recensione analitica e critica del libro di L. Punzo sul corporativismo di Ugo Spirito, in cui contestano alcune tesi di fondo dell’autore.

Il testo analizza, in tutta l'opera di Henri de Lubac, il problema del rapporto M aurice Blondel -San Tomm aso.

Il saggio analizza la presenza di Aristotele e san Tommaso nei primi scritti di Brentano. Mostra come l’Aquinate venga visto come colui che ha continuato Aristotele, come il suo erede, così come quest’ultimo aveva fatto con Platone. In forza di queste convinzioni, in tutto il pensiero del giovane Brentano, il rapporto Aristotele - San Tommaso assume una funzione di privilegio, capace a suo dire di rispondere veramente alle esigenze dei tempi moderni e, anzi, di dare una soluzione ai problemi che (...) Kant e l’Idealismo tedesco nelle sue molteplici ramificazioni non erano riusciti a fornire. Sin dai suoi primi scritti, quindi, l’intento fondamentale di Brentano è innanzitutto quello di dare una risposta esauriente ai critici dello Stagirita e, poi, di precisare e giustificare da un punto di vista strettamente filosofico, il ricorso alla filosofia aristotelica e al suo più importante commentatore, discepolo e continuatore medioevale, per contribuire a fondare, su basi speculative più solide di quanto avesse fatto la Scolastica deteriore, una «scienza cattolica». Così, proprio in un tempo in cui la filosofia dell’idealismo tedesco esercitava ancora una certa egemonia nella cultura universitaria europea, Brentano, con inaspettata vigoria, ripropone il realismo critico della filosofia perenne, e assume a termine di riferimento e di costante confronto, nei suoi studi e nelle sue pubblicazioni, Aristotele e la grande Scolastica, cioè san Tommaso. (shrink)