Much of the sustained attention on pandemic preparedness has focused on the ethical justification for plans for the “crisis” phase of a surge when, despite augmentation efforts, the demand for life...

Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation (...) of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. (shrink)

Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I (...) assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research. (shrink)

As web instruction becomes more and more prevalent at universities across the country, instructors of ethics are being encouraged to develop online courses to meet the needs of a diverse array of students. Web instruction is often viewed as a cost-saving technique, where large numbers of students can be reached by distance education in an effort to conserve classroom and instructor resources. In practice, however, the reverse is often true: online courses require more of faculty time and effort than do (...) many traditional classes. Based on personal experience teaching an online course in health care ethics for students in the Allied Health Professions, it is evident that there are both benefits and challenges in teaching online courses, particularly in ethics. Examples of benefits are (1) the asynchronous nature of web instruction allows students to progress through the course at their own pace and at times that are convenient given their clinical responsibilities; (2) web courses allow for a standardization of content and quality of instruction over a diversity of programs; and (3) examples can be tailored to the differing experiences of students in the course. Some challenges to teaching online ethics courses include (1) the fact that online instruction benefits visual learners and disadvantages those lacking good reading comprehension or strong writing skills; (2) developing meaningful student-student and student-instructor interaction; and (3) teaching ethics involves teaching a process rather than a product. Allowing students to apply their knowledge to real-world cases in their disciplines and encouraging them to share experiences from clinical practice is an effective way to meet several of these challenges. Building an online community is another good way to increase the interaction of students and their engagement with the material. (shrink)

Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and ...

The American Journal of Bioethics, Volume 11, Issue 11, Page 31-38, November 2011.

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over research (...) carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over research (...) carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

Assessing mastery of bioethics in a graduate program requires careful attention not simply to the content knowledge and skill development of students but also to the principles of sound assessment processes. In this article, we describe the rationale, development process, and features of the comprehensive exam we created as a culminating experience of a master’s program in bioethics. The exam became the students’ opportunity to demonstrate the way they were able to integrate course, textual, and practical knowledge gained throughout the (...) experience of the program. Additionally, the exam assessed students’ proficiency in the field of bioethics and their ability to critically and constructively analyze bioethical issues. In this article, we offer tips to other exam creators regarding our experiences with question and answer development, scoring of the exam, and relationships between coursework and exam preparation and completion. We also include a sample rubric for others to see how we determined which student answers were satisfactory. (shrink)

McCarthy, Homan, and Rozier’s presentation of theological anthropology and its contribution to secular bioethics suffers from three primary limitations. First, the article re...

Volume 19, Issue 9, September 2019, Page 44-45.

As the label “Leibnizian-Wolffian School Philosophy” suggests, Christian Wolff has traditionally been regarded as Leibniz’s disciple. Thanks to L. W. Beck, C. A. Corr, J. École, and others, we now know that Wolff was inspired by.

As the label “Leibnizian-Wolffian School Philosophy” suggests, Christian Wolff has traditionally been regarded as Leibniz’s disciple. Thanks to L. W. Beck, C. A. Corr, J. École, and others, we now know that Wolff was inspired by.

As the label “Leibnizian-Wolffian School Philosophy” suggests, Christian Wolff has traditionally been regarded as Leibniz’s disciple. Thanks to L. W. Beck, C. A. Corr, J. École, and others, we now know that Wolff was inspired by.

Falling down a waterfall is a boundary experience that epitomizes a crisis. This philosophical essay draws an analogy to the maladaptation civilization finds itself in. Falling down a waterfall is a singular event, but it has structure. There are stages that lead up to it, and if one survives the fall, there will be stages that follow it. I suggest that such a mishap is analogous to the ecological overshoot. What leads to the overshoot, and what is entailed by it, (...) is a parallel sequence of stages. As a civilization, we are in an unprecedented situation: we have reached the limits of growth. We are overwhelming the load capacities of the global system, with climate change as tangible symptom. Akin to what leads up to a waterfall, the first stage of the civilizational crisis is a petering-out of familiar pathways. The second stage is reality-denial: the pretense that such petering-out cannot be happening. Stage three is the lure of the risky choice – followed by the great geopolitical freak-out, which is stage four, the core of the crisis. We’re in the current; we’re swept over the edge; we’re going down. And if we survive, the worst isn’t over yet, for now other dangers lurk. This is stage five: the stage of lethal irony. You think you’ve made it and win a Darwin Award anyway. But say you scrape by, then the final stage of the crisis will be a transition to lingering perils: an aftermath of heightened vulnerability. (shrink)

Contrary to the classical denial of bodily attributes or human emotions to God, both Samson Raphael Hirsch and Franz Rosenzweig embrace biblical anthropomorphisms. Their views on anthropomorphisms are part of their critiques of philosophy, especially of the basic preconceptions of the philosophical approach to the concept of God. This article analyses their positions by examining Hirsch’s commentaries on scripture (especially Gen 6:6), and Rosenzweig’s “A Note on Anthropomorphisms in Response to the Encyclopedia Judaica’s Article.” Through a close reading and interpretation (...) of Rabad of Posquiére’s famous animadversion against Maimonides’s rule concerning heretics, this paper retraces the rabbinical roots of Hirsch’s and Rosenzweig’s approach to anthropomorphisms. (shrink)

This commentary was submitted to the World Medical Association on behalf of the International Network on Feminist Approaches to Bioethics. Our submission included a description of feminist research ethics, suggestions for specific revisions to the Declaration, and elements found in other international research ethics codes that are important from a feminist perspective. Our goals were to encourage the WMA to craft a declaration that: conceptualizes issues of vulnerability in richer and more nuanced ways, resists the influence of profit motives, and (...) extends the scope of responsibility for ethical research more broadly. (shrink)

This chapter contains sections titled: Introduction: The Problem of Dynamics in the Enlightenment Kant's Starting Point: The Ontology of Force Relativistic Dynamics: The Force–Space Bond The True Estimation of Force: The Marriage of Momentum and Energy Conclusion – Kant's Unlikely Dialectical Inspiration.

The following paper analyzes the effect of the Shakespearean text—and Hamlet in particular—on Levinas’s thought. I argue that Levinas’s reading of Shakespeare’s Hamlet played a decisive role in one of the most crucial phenomenological debates to be found in the Levinasian text, namely, the debate with Heidegger on the meaning of death and on the object of Angst (anguish). Analyzing Levinas’s remarks on Hamlet in his philosophical text, this article demonstrates how Shakespeare inspires Levinas’s anti-Heideggerian thesis about anguish being anguish (...) before eternity (and not anguish before death). Moreover, this article analyzes the Hecuba scene from the perspective of Levinas’s philosophy of substitution (where again Shakespeare occupies a central role), and tries to understand the situation of Shakespeare’s tragedy as being “beyond tragedy.”. (shrink)

The American Journal of Bioethics, Volume 12, Issue 9, Page 6-7, September 2012.

Although online education is becoming increasingly commonplace in health professional education, methods to evaluate student progress and knowledge base adequately remain uncertain. This paper describes a project that attempted to assess whether or not an online course was an effective way to teach applied ethics to students preparing for the health professions by qualitatively analyzing responses to a pre-test and post-test administered to students in the course. While previous studies have reported various findings regarding the success of online ethics courses, (...) our study failed to demonstrate that students gained a greater understanding of key concepts in ethics—respect for autonomy, decisional capacity, informed consent, and role of the provider. Our findings demonstrate the need for better subjective methods of evaluation and raise questions regarding the efficacy of current models of online ethics courses for health professional students. (shrink)

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles require us to (...) look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)

Fierce debates surround the conceptualization and measurement of job-related distress in occupational health science. The use of burnout as an index of job-related distress, though commonplace, has increasingly been called into question. In this paper, we first highlight foundational problems that undermine the burnout construct and its legacy measure, the Maslach Burnout Inventory. Next, we report on advances in research on job-related distress that depart from the use of the burnout construct. Tracing the genesis of the burnout construct, we observe (...) that burnout’s definition was preestablished rather than derived from a rigorous research process and the MBI has little in the way of a theoretical or empirical foundation. Historical analysis suggests that the burnout construct was cobbled together from unchallenged personal impressions and anecdotal evidence before getting reified by the MBI. This state of affairs may account for many of the disconcerting problems encountered in burnout research. We close our paper by presenting the Occupational Depression Inventory, a recently developed instrument reflective of a renewed approach to job-related distress. The ODI has demonstrated robust psychometric and structural properties across countries, sexes, age groups, occupations, and languages. The instrument addresses job-related distress both dimensionally and categorically. A dimensional approach can be useful, for instance, in examining the dynamics of etiological processes and symptom development. A categorical approach can serve screening and diagnostic purposes and help clinicians and public health professionals in their decision-making. It is concluded that the ODI offers occupational health specialists a promising way forward. (shrink)

The American Journal of Bioethics, Volume 11, Issue 12, Page 62-63, December 2011.

Traditional approaches to human subjects protections in the United States focus on the ethical principles from the Belmont Report: respect for persons, beneficence, and justice. Since research regu...

While humanity is altering planet Earth at unprecedented magnitude and speed, representation of the cultural driving factors and their dynamics in models of the Earth system is limited. In this review and perspectives paper, we argue that more or less distinct environmental value sets can be assigned to religion – a deeply embedded feature of human cultures, here defined as collectively shared belief in something sacred. This assertion renders religious theories, practices and actors suitable for studying cultural facets of anthropogenic (...) Earth system change, especially regarding deeper, non-materialistic motivations that ask about humans' self-understanding in the Anthropocene epoch. We sketch a modelling landscape and outline some research primers, encompassing the following elements: extensions of existing Earth system models by quantitative relationships between religious practices and biophysical processes, building on databases that allow for formalisation of such knowledge; design of new model types that specifically represent religious morals, actors and activities as part of co-evolutionary human–environment dynamics; and identification of research questions of humanitarian relevance that are underrepresented in purely economic–technocratic modelling and scenario paradigms. While this analysis is by necessity heuristic and semi-cohesive, we hope that it will act as a stimulus for further interdisciplinary and systematic research on the immaterial dimension of humanity's imprint on the Earth system, both qualitatively and quantitatively. (shrink)

While tens of thousands of people across the United States serve on hospital and other healthcare ethics committees , almost no carefully prepared educational material exists for HEC members. Ethics by Committee is a one volume collection of chapters developed exclusively for this educational purpose. Experts in bioethics, clinical consultation, health law, and social psychology from across the country contribute chapters on ethics consultation, education, and policy development.