Volume 20, Issue 4, May 2020, Page 8-10.

Genomic sequencing is becoming more common both in clinical practice and as a routine aspect of much research. Over the last 15 years there has been ongoing discussion about the implications of gen...

The rapid development of COVID-19 vaccines in 2020 involved an unprecedented clinical research initiative. The case here involves a Phase I clinical trial of “second-generation” COVID-19 vaccines d...

Volume 20, Issue 4, May 2020, Page 102-103.

As medicine and science advance, new ethical questions emerge. Over time, deliberation and analysis result in a somewhat settled approach to a problem. Often the settled approach is based on group...

As part of the regulatory review process, both the Food and Drug Administration and Office for Human Research Protections (U.S. Department of Health and Human Services [HHS]...

Volume 20, Issue 10, October 2020, Page 82-83.

Volume 20, Issue 4, May 2020, Page 111-113.

Volume 20, Issue 10, October 2020, Page 90-91.

Volume 20, Issue 5, June 2020, Page 31-33.

For many rare diseases, the availability of effective interventions is limited or non-existent. In this context, clinical research evaluating emerging interventions may be the only potentially “the...

ABSTRACT Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI studies span a wide spectrum of benefit and risk, and that some CHI studies may involve minimal (...) risk. The categorical exclusion of children from CHIs therefore departs from the standard approach to evaluating research risks, as international regulations and ethical guidance for pediatric research generally permit non‐beneficial research with low risks. The paradigm in research ethics has also shifted from focusing on protecting vulnerable participants to recognizing that inclusion can be important as a matter of justice, providing new reasons to question this default exclusion of children from CHIs. Recognizing that pediatric CHIs can raise complex ethical issues and are easy to sensationalize in ways that may threaten the public’s trust in research and sponsor institutions, we conclude by describing additional complexities that must be addressed before pediatric CHIs beyond licensed vaccine studies might be ethically acceptable. (shrink)

Background Standard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research. Methods We conducted a 3-round, web-based survey using the modified Delphi technique to identify areas of agreement (...) among English-speaking patients at primary care clinics in Washington State and Idaho who had a personal or family history of cancer. In Round 1, respondents rated the importance of 17 items, identified in prior qualitative work, for feeling respected. In Round 2, respondents re-rated each item after reviewing overall group ratings. In Round 3, respondents ranked a subset of the 8 most highly rated items. We calculated each item’s mean and median rankings in Round 3 to identify which approaches were most important for feeling respected in research. Results Forty-one patients consented to the survey, 21 (51%) completed Round 1, and 18 (86% of Round 1) completed each of Rounds 2 and 3. Two sets of rankings were excluded from analysis as speed of response suggested they had not completed the Round 3 ranking task. Respondents prioritized provision of study information to support decision-making (mean ranking 2.6 out of 8; median ranking 1.5) and interactions with research staff characterized by kindness, patience, and a lack of judgment (mean ranking 2.8; median ranking 2) as the most important approaches for conveying respect. Conclusions Informed consent and interpersonal interactions are key ways that research participants experience respect. These can be supported by other approaches to respecting participants, especially when consent and/or direct interactions are infeasible. Future work should continue to engage with patients in community-based settings to identify best practices for research without consent and examine unique perspectives across clinical and demographic groups in different types of research. (shrink)

Currently, there is consensus that community engagement and partnerships are essential to inclusive patient-centered clinical research. Yet there is variation about what it means to do this well an...

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in (...) substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

Background: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. (...) Methods: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. Results: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. Conclusions: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges. (shrink)

Significant challenges arise for clinical care teams when a patient or surrogate decision-maker hopes a miracle will occur. This article answers the question, “How should clinical bioethicists respond when a medical decision-maker uses the hope for a miracle to orient her medical decisions?” We argue the ethicist must first understand the complexity of the miracle-invocation. To this end, we provide a taxonomy of miracle-invocations that assist the ethicist in analyzing the invocator's conceptions of God, community, and self. After the ethicist (...) appreciates how these concepts influence the invocator's worldview, she can begin responding to this hope with specific practices. We discuss these practices in detail and offer concrete recommendations for a justified response to the hope for a miracle. (shrink)

The 2014 Varsity Medical Ethics debate convened upon the motion: “This house believes that genetic information should not be commoditised”. This annual debate between students from the Universities of Oxford and Cambridge, now in its sixth year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the circumstances under which genetic material should be considered patentable, the possible effects of this on the (...) research and development of novel therapeutics, and the need for clear guidelines within this rapidly developing field. (shrink)

The worldwide problem of corruption is one that requires greater knowledge about responsible leadership. Based on the literature on responsible leadership, developmental psychology, and moral development, the purpose of our study is to understand the constructions of the motivational drivers behind the behaviors of a responsible leader. Using biographical and narrative methodologies, we analyzed the individual motivational drivers of Carlos Cavelier, a recognized responsible leaders who grew up and works in Colombia, a social/economic context characterized by institutional fragility and corruption. (...) Our findings suggest that the coherence between the immediate environments of development of the future leader, configured optimal environments in which the leader developed the moral conscience that guides his behavior as a responsible leader. Our study points out the need not to take the development of responsible leaders for granted, and presents propositions that allow for a deeper understanding of the micro‐foundations of responsible leadership, highlighting the importance of the contexts in which leaders are raised and in which they develop. Thus, our study has the potential to be heuristic and generative of future studies. (shrink)

Social struggles have led to the legal recognition of the rights of LGTBI+ people in some countries. Even so, violence against LGTBI+ people is a social problem throughout the world, and has resulted in the vulnerability and victimization of the members of this group. In Spain, no research has been published to date that analyzes this problem in the university context. Considering the scarcity of studies on the identification of this type of violence in Spain, the main objective of this (...) study was to identify violence against LGBTI+ people in Catalan universities. We administered a battery of questions to a sample of 571 university students from six universities in Catalonia (77.8% women) between 17 and 55 years old (M = 21.0; SD = 3.96). Of the 12 situations of violence presented, psychological violence was identified as the most common type. Within our sample, 61.0% reported either being aware of or having experienced some type of violence related to the university context and motivated by the sexual orientation, gender identity, or gender expression of the victim. The results also show that these types of violence in the university context are rarely reported, especially when they do not include physical violence. This study highlights a previously unreported problem and identifies future research avenues in university contexts. (shrink)

Cet ouvrage important reflète le dynamisme actuel en Espagne de la recherche en histoire des femmes, tout en vérifiant la diversité théorique, méthodologique et thématique de ce courant historiographique. Afin de faciliter la présentation nous regroupons par thèmes les 24 travaux inclus dans cette vaste publication. En premier lieu, distinguons les contributions orientées vers l’analyse théorique. Mª Isabel del Val Valdivieso dans « A modo de introducción. La historiografía en los albores del...

Cet ouvrage important reflète le dynamisme actuel en Espagne de la recherche en histoire des femmes, tout en vérifiant la diversité théorique, méthodologique et thématique de ce courant historiographique. Afin de faciliter la présentation nous regroupons par thèmes les 24 travaux inclus dans cette vaste publication. En premier lieu, distinguons les contributions orientées vers l’analyse théorique. Mª Isabel del Val Valdivieso dans « A modo de introducción. La historiografía en los albores del...

Las metáforas se usan en sociología para poder explicar el imaginario de un tema como el secreto. Son capaces de poner de manifiesto la clase de realidad a la que es asociada comúnmente. Así, si el secreto es considerado un objeto, puede ser compartido, si es un lugar, puede ser donde escondamos algo, por el contrario, si pensamos que el secreto es un ser vivo, puede crecer sin que podamos hacer nada al respecto. La lógica metafórica se impone a menudo (...) sobre el sentido original. En este artículo usamos el análisis sociometafórico propuesto por Emmánuel Lizcano a una serie de discursos provenientes de entrevistas y grupos de discusión. (shrink)

This book uses insights from disability studies to understand in a deeper way the ethical implications that genetic technologies pose for Christian thought. Theologians have been debating genetic engineering for decades, but what has been missing from many theological debates is a deep concern for persons with genetic disabilities. In this ambitious and stimulating book, Devan Stahl argues that engagement with metaphysics and a theology of nature is crucial for Christians to evaluate both genetic science and the moral use (...) of genetic technologies, such as human genetic engineering, gene therapy, genetic screenings, preimplantation genetic diagnosis, and gene editing. Using theological notions of creation ex nihilo and natural law alongside insights from disability studies, the book seeks to recast the debate concerning genetic well-being. Following the work of Stanley Hauerwas, Stahl proposes the church as the locus for reimagining disability in a way that will significantly influence the debates concerning genetic therapies. Stahl's project in "genethics" proceeds with an acute awareness of her own liberal Protestant tradition's early embrace of the eugenics movement in the name of scientific and medical advancement, and it constructively engages the Catholic tradition's metaphysical approach to questions in bioethics to surpass limitations to Protestant thinking on natural law. Christianity has all too frequently been complicit in excluding, degrading, and marginalizing people with disabilities, but the new Christian metaphysics developed here by way of disability perspectives provides normative, theological guidance on the use of genetic technologies today. As Stahl shows in her study, only by heeding the voices of people with disabilities can Christians remain faithful to the call to find Christ in "the least of these" and from there draw close to God. This book will be of interest to scholars in Christian ethics, bioethics, moral theology, and practical theology. (shrink)

Examines the promises and perils of bioenhancement technologies for those most vulnerable to health disparities: persons with disabilities, racial and ethnic minorities, and women.

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery (...) can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS. (shrink)

Women’s pain remains underappreciated, undertheorized, and undertreated in both medicine and theology. The ascetic practices of women in pain, however, can help Christians understand and navigate their own pain and suffering, particularly because they are experienced in the context of chronic illness and disability. In what follows, I argue that Christians would do better to view the pain that accompanies disability and chronic illness as a potential resource for spiritual practice rather than an example of sin or evil. I begin (...) with a brief overview of the most common theological explanations for the relationship between disability and sin within contemporary Christian writings on disability. What is often neglected in these conversations is the acknowledgment of pain in the disability experience. Likewise, discussions of evil often attempt to explain the existence of pain and suffering, but rarely address the practical realities of pain. As a way to begin to remedy the lack of attention to the experience of chronic pain for those living with illness and disability, I consider what it would mean to live faithfully with pain by examining the lives of three holy women who provide examples of what it means to interpret, manage, and share their pain within the body of Christ. (shrink)

In clinical research, informed consent is both a legal document and mechanism for respecting the dignity of participating subjects and protecting their rights and wellbeing. It should include information on the purpose of the research, its justification, and the risks and the benefits involved, so as to enable a subject to decide to participate voluntarily. Because it is the researcher’s duty to ensure protection of the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of the subjects who take (...) part in a study, the researcher must establish a permanent dialogue with them to assess the risks and safety inherent in their participation. This condition becomes a dynamic process that neither begins nor ends when informed consent is signed. It goes beyond legality and becomes a question of ethics and legitimacy. (shrink)

This study constructs a measurement scale for Socially Responsible Consumption in the particular context of Colombia. It uses a mixed qualitative and quantitative methodological approach, beginning with four focus groups and ending with a quantitative validation exercise employing Exploratory Factor Analysis. The result is a Socially Responsible Consumption measurement scale consisting of four dimensions that reflect paradigms found in the existing literature. These are, however, expressed differently in Colombia. In particular, Socially Responsible Consumption involves consumer behavior that favors corporate social (...) responsibility practices and the rational consumption of resources and products while recognizing the importance of maintaining a healthy lifestyle through healthcare. (shrink)

In this paper I will show how the medical image, presented to the patient by the physician, participates in medicine's cold culture of abstraction, objectification and mandated normativity. I begin by giving a brief account of the use of anatomical imaging since the Renaissance to show how images have historically functioned in contrast to how they are currently used in medical practice. Next, I examine how contemporary medical imaging techniques participate in a kind of knowledge production that objectifies the human (...) body. Finally, I elucidate how physicians ought to place the medical image within the context of the lived body so as to create a healing relationship with the patient. In all this I hope to show that the medical image, far from a piece of objective data, testifies to the interplay of particular beliefs, practices and doctrines contemporary medicine holds dear. To best treat her patient, the physician must appreciate the influence of these images and appropriately place them within the context of the patient's lived experience. (shrink)

Christians have an obligation to attend to the voices of persons who are crying out that their dignity and very lives are in jeopardy when physician-assisted suicide becomes legalized. The following essay begins with an account of the concept of “disability moral psychology,” which elucidates the unique ways persons with disabilities perceive the world, based on their phenomenological experience. The author then explores the disability critique of PAS and the shared social conditions of persons who are chronically disabled and terminally (...) ill. Finally, the author positions the disability critique within Christian moral deliberations on PAS to unearth its significance for Christian ethics. To bear witness to a compassionate God, theological and ethical judgments concerning PAS must seek perspectives from persons who claim that their dignity and even their lives are in jeopardy by the practice. (shrink)

Ableist attitudes and structures regarding disability are increasingly recognized across all sectors of healthcare delivery. After Dobbs, novel questions arose in the USA concerning how to protect reproductive autonomy while avoiding discrimination against and devaluation of disabled persons. As a case study, we examine the Louisiana’s Department of Public Health August 1st Emergency Declaration, “List of Conditions that shall deem an Unborn Child ‘Medically Futile.’” We raise a number of medical, ethical, and public health concerns that lead us to argue (...) the declaration should be rescinded. The ethically objectionable declaration provides valuable lessons concerning how to uphold both reproductive and disability justice in a post-Dobbs landscape. (shrink)

Over one hundred years after Max Weber delivered his lecture “Science as a Vocation,” his description of the work of the physician in a disenchanted world still resonates. As a chronically ill patient who interacts with physicians frequently, I struggle with reconciling my understanding of my ill body with how my physician makes sense of my illness. My diagnosis created an existential crisis that caused me to search for meaning in my embodied experience, but I soon learned there is little (...) room for such a search within modern biomedicine. Instead, I turned to fine art to help me make sense of my ill body and its purpose in my life. With the aid of my printmaker sister, Darian Goldin Stahl, I have transformed the magnetic resonance images of my body into works of art, which help to re-enchant my body and give purpose to my illness. (shrink)

This work pretends to visualize the importance of the role that in the emergency, consolidation and expansion of the phenomenon of pathological view and over medication of the present childhood and adolescence seem to perform today certain types of criteria on which to base the undertaking of learning problems we are today faced with by children and teenagers in the classroom. To get this aim, we refer to re educated psycho educational practises, from which the cognitive-conductual views are questioned where (...) they supported on, and different interventionist typed are proposed from the clinical psycho pedagogical and psycho educational approach. With the aim of contribute to lectures from this area start to occupy a central place in the schedule developed on these subjects, considering that, frequently, they are postponed and relegated to the educational area, as if it had no connection with “the clinical” and the impact they have in the processes of establishing the subjectivity. (shrink)

Este artículo reflexiona sobre formas de acceder a la realidad social a través del uso de metodologías de investigación online que tienen características híbridas. Primero se dan algunas claves para la construcción y ejecución de grupos de discusión en un contexto online. Una de las características centrales de esta técnica es su composición híbrida, moviéndose entre lo que sería un grupo de discusión y un grupo focal. El paso de la mediación a la conducción marca fuertemente la transición de una (...) fase de grupos de discusión a una fase de grupo focal. Segundo, se reflexiona sobre Facebook y algunos posibles usos que se le puede dar a esta red social digital con la finalidad de llevar a cabo de mejor manera técnicas de investigación aplicadas al contexto online. En este sentido, se reflexiona sobre el avatar o perfil de Facebook en dos direcciones: para efectos de la composición muestral de un grupo de discusión online y como material que ayuda al análisis de las posiciones discursivas que tienen los sujetos estudiados. (shrink)

Los análisis tomados de diferentes fuentes expuestas en las referencias bibliográficas permiten inferir que la migración es un fenómeno natural del ser humano, inevitable e incluso necesario. Según la OIM una de cada siete personas en el mundo es migrante internacional, es decir que, para finales del 2018 existían en el mundo 258 millones de personas que por diversas razones decidieron trasladarse de sus lugares de origen. En los últimos años se ha convertido en uno de los países que más (...) recibe ciudadanos venezolanos, no solamente por la cercanía y la amplía frontera que se comparte, también porque durante muchos años Venezuela recibió colombianos que buscaban mejores condiciones y más seguridad. En estos términos Colombia había tenido una deuda histórica con Venezuela, la cual ha saldado a la fecha siendo el país que más ha recibido migrantes venezolanos. (shrink)

In spite of the advances in our knowledge of cancer biology, most cancers remain not curable with present therapies. Current treatments consider cancer as resulting from uncontrolled proliferation and are non‐specific. Although they can reduce tumour burden, relapse occurs in most cases. This was long attributed to incomplete tumour elimination, but recent developments indicate that different types of cells contribute to the tumour structure, and that the tumour's cellular organization would be analogous to that of a normal tissue, with a (...) main mass of differentiating cells sensitive to anti proliferative agents, together with a small percentage of quiescent, resistant stem cells responsible for replenishing the tumour: the Cancer Stem Cells (CSCs). Anti‐CSCs targeted therapeutic agents would prevent tumour regeneration. New mouse models tailored to exploit this novel concept will be critical to develop CSC‐based anti‐cancer therapies. Here we review the biological basis and the therapeutic implications of the stem‐cell model of cancer. BioEssays 29:1269–1280, 2007. © 2007 Wiley Periodicals, Inc. (shrink)