In this paper, I explore the ethics of subject selection in the context of biomedical research. I reject a key principle of what I shall refer to as the standard view. According to this principle, investigators should select participants so as to minimise aggregate risk to participants and maximise aggregate benefits to participants and society. On this view, investigators should exclude prospective participants who are more susceptible to risk than other prospective participants. I argue instead that investigators should (...) select subjects in accordance with an alternative principle: formal equality of opportunity. According to this principle, investigators must treat all prospective participants the same unless differential treatment is warranted by the scientific goals of the study or the need to promote participants' medically related interests. All prospective participants (1) who meet the scientifically defined eligibility criteria and (2) for whom participation is consistent with their medically related interests should have an equal, formal opportunity to participate in the study. Prospective participants should not be excluded simply because they are more susceptible to risk than others. (shrink)

Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden (...) sharing; (3) fair opportunity; and (4) fair distribution of third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly. (shrink)

This chapter provides a critical overview and interpretation of fair subject selection in clinical and social scientific research. It first provides an analytical framework for thinking about the problem of fair subject selection. It then argues that fair subject selection is best understood as a set of four subprinciples, each with normative force and each with distinct and often conflicting implications for the selection of participants: fair inclusion, fair (...) burden sharing, fair opportunity, and fair distribution of third-party risks. It then defends an approach to navigating the conflicting imperatives of these subprinciples, one which privileges the need to include epistemically distinct groups in research, before concluding by considering the most pressing research questions regarding fair subject selection. (shrink)

Volume 20, Issue 2, February 2020, Page 25-27.

Volume 20, Issue 2, February 2020, Page 33-35.

Ethics and ethical principles extend to all spheres of human activity. They apply to our dealings with each other, with animals and the environment. They should govern our interactions not only in conducting research but also in commerce, employment and politics. Ethics serve to identify good, desirable or acceptable conduct and provide reasons for those conclusions. Fair subject selection is the first and foremost concern which must be ensured before initiating a research project. Which subjects may enroll (...) in the research is determined by the study’s inclusion or exclusion criteria. One of the important aspects of fair subject selection is to have an oversight system through International Review Board (IRB) to review to conduct the research and to have approval whether subject selection is fair or not. (shrink)

The article by MacKay and Saylor (2020) claims that the principle of fair subject selection yields conflicting imperatives (e.g. in the case of pregnant women) and should be understood as “a bundle of four distinct sub-principles” (i.e. fair inclusion, burden sharing, opportunity, distribution of third-party risks), each having conflicting normative recommendations (MacKay and Saylor 2020). The authors also offer guidance as to how we should navigate between subprinciples that may conflict with each other. The problem is (...) a crucial one since fair subject selection is one of the principles regulating clinical research that produces generalizable knowledge with the potential of improving people’s health. Therefore, there may be cases where the way in which participants are selected directly influences the generalizability (or its lack) of the clinically relevant knowledge and its value (if any) to different groups. In my commentary article, written from the philosophical perspective, I notice a number of interrelated problems which I believe have not been discussed thoroughly in the target article: (1) the precise way in which health care priority setting should influence the content of health research priority setting and fair inclusion principles; (2) the distinction between group and individual benefits and burdens from clinical research; (3) the reference class problem in medical research. (shrink)

Volume 20, Issue 2, February 2020, Page 30-32.

Volume 20, Issue 2, February 2020, Page 22-24.

In their Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” Lynch et al. propose a framework for ethical payment to research participants and apply it to the c...

Given that many clinical research studies struggle to meet their recruitment goals, researchers are eager to identify and employ strategies that will maximize reach to eligible and int...

Volume 20, Issue 2, February 2020, Page 20-22.

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for (...) class='Hi'>subject selection across multiple trials for the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials. (shrink)

Volume 20, Issue 2, February 2020, Page 38-41.

Controlled human infection (CHI) studies involve the deliberate exposure of healthy research participants to infectious agents to study early disease processes and evaluate interventions under controlled conditions with high efficiency. Although CHI studies expose participants to the risk of infection, they are designed to offer investigators unique advantages for studying the pathogenesis of infectious diseases and testing potential vaccines or treatments in humans. One of the central challenges facing investigators involves the fair selection of research subjects to participate (...) in CHI studies. While there is widespread agreement that investigators have a duty to select research participants fairly, this principle also yields conflicting ethical imperatives, for example requiring investigators to both exclude potential participants with co‐morbidities since they face increased risks, but also to include them in order to ensure generalizability. In this paper we defend an account of fair subject selection that is tailored to the context of CHI studies. We identify the considerations of fairness that bear directly on selecting participants for CHI studies and provide investigators and members of IRBs and RECs with a principled way to navigate the conflicting imperatives to which these considerations give rise. (shrink)

In this article we report the findings of a randomised control clinical trial that assessed the impact of a Philosophy for Children program and replicated a previous study conducted in Scotland by Topping and Trickey. A Cognitive Abilities Test was administered as a pretest and a posttest to randomly selected experimental groups and control groups. The students in the experimental group engaged in philosophy lessons in a setting of structured, collaborative inquiry in their language arts classes for one hour per (...) week for a number of weeks. The control group received the standard language arts curriculum in that one hour. The study found that the seventh grade students who had experienced the P4C program showed significant gains relative to those in the seventh grade control group at a high level of statistical significance, but the eighth grade students in the experimental group did not show such gains over the eighth grade control group. It was discovered that the seventh grade teachers started the program early in the school year and continued it for a period of 22 to 26 weeks, while the eighth grade teachers started much later and used the program for only 4 to 10 weeks. Our findings suggest that the P4C program must involve students in activities for a significant period of time before the program shows results, but that a meaningful impact on students’ cognitive abilities can be achieved in about 24 weeks of lessons, less than half the time evidenced by the study by Topping and Trickey. (shrink)

In this article we report the findings of a randomised control clinical trial that assessed the impact of a Philosophy for Children program and replicated a previous study conducted in Scotland by Topping and Trickey. A Cognitive Abilities Test was administered as a pretest and a posttest to randomly selected experimental groups and control groups. The students in the experimental group engaged in philosophy lessons in a setting of structured, collaborative inquiry in their language arts classes for one hour per (...) week for a number of weeks. The control group received the standard language arts curriculum in that one hour. The study found that the seventh grade students who had experienced the P4C program showed significant gains relative to those in the seventh grade control group at a high level of statistical significance, but the eighth grade students in the experimental group did not show such gains over the eighth grade control group. It was discovered that the seventh grade teachers started the program early in the school year and continued it for a period of 22 to 26 weeks, while the eighth grade teachers started much later and used the program for only 4 to 10 weeks. Our findings suggest that the P4C program must involve students in activities for a significant period of time before the program shows results, but that a meaningful impact on students’ cognitive abilities can be achieved in about 24 weeks of lessons, less than half the time evidenced by the study by Topping and Trickey. (shrink)

ObjectiveTo test the relationship between social security satisfaction, social fairness, social trust, and people’s subjective wellbeing in China and the serial mediation effect in this study.MethodsWe utilized the data from Chinese Social Survey in 2017 and 2019, involving 31 provinces across the country. There were 5,398 samples in 2017CSS and 2,580 samples in 2019CSS selected by the research objectives. There were 4,269 women and 3,709 men with the average age of participants being 43.ResultsThe results showed that the actual status of (...) social security satisfaction, social fairness and trust, and SWB were greater than the theoretical status overall. Social security satisfaction [β = 0.454, p < 0.001, 95% CI = ], social fairness [β = 0.065, p < 0.001, 95% CI = ], and social trust [β = 0.108, p < 0.001, 95% CI = ] positively influenced people’s SWB, respectively. Social fairness had a positive effect on social trust. Social fairness and social trust partly mediated the relationship between social security satisfaction and SWB, respectively. Social security satisfaction indirectly influenced SWB through the serial effect of social fairness and social trust. The total effect of SWB explained is 47% in the serial mediation model.ConclusionSatisfactory social security is likely to cause a high level of people’s SWB, social fairness, and social trust. It is beneficial to form a virtuous circle in society. Allowing people to obtain satisfactory social security is conducive to social equity, promoting social trust, and improving people’s SWB. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Selected Letters by William, Henry JamesWilliam James EarleWilliam and Henry James. Selected Letters. Edited by Ignas K. Skrupskelis and Elizabeth M. Berkeley. Introduction by John J. McDermott. Charlottesville VA: University Press of Virginia, 1997. Pp. xxxi + 570. $ 39.95.Almost fifty years of letters to and from the very diversely brilliant James brothers: in this volume a generous, and probably ample, selection of 216 from a total (...) of 740 surviving letters or postcards, from an original total, according to the present editors, of twice as many. This volume of correspondence reflects the deep, unquestioned, unshakable familial (and virtually statutory) closeness of William and Henry who happened, as adults, to be seldom in the same place. There is, it must be said, very little explicit philosophy, narrowly or broadly defined, in these letters, but the philosophical reader will—or ought to—find much raw material for philosophical reflection. For example, a reasonable historicist thesis of how brotherhood, or family connection generally, plays itself out is supported by these documents. The nineteenth century is not the same as the twentieth. For example, here is William’s comment on the will of his sister, Alice, who left more to her companion and care-giver, Katherine Loring, a [End Page 479] women of extraordinary virtue and burden, than to her brother Robertson: “I can well sympathize with Alice’s desire to leave her something handsome; but I must say that her own consent (being apparently privy to the will) strikes me as tant soit peu lacking in delicacy. Surely no one of us would like to be in such a position in her family or any other” (271). This would be, in 1998, a rather unenlightened and ungenerous attitude, but is natural enough in 1892, even if not quite inevitable, not being shared by Alice herself. There is, incidentally, much discussion of wills and bequests, for the Jameses were of the genteel class, people with small family money and modest private incomes for whom the wherewithal to maintain homes with servants and to provide themselves with country houses and recuperative European vacations was always a faintly embarrassing, and occasionally a pressing, problem.It is probably also true that the much-discussed question of Henry’s homosexuality has, somehow, to be recast in historically relative terms. Here is an early report—1869—of Henry’s from Oxford: “As I walked along the river I saw hundreds of the mighty lads of England, clad in white flannel & blue, immense, fair-haired, magnificent in their youth, lounging down the stream in their punts or pulling in straining crews & rejoicing in their godlike strength” (41). This could not, the point is, be said by anyone, gay or straight, in 1998. Yet Henry is neither generally naive nor uncritically anglophile. He says of the Warwickshire scenery, which in a way he likes, that it is “too monotonously sweet & smooth—too comfortable, too ovine, too bovine, too English in a word.” And he adds, a little surprisingly: “It seems like a vast show region kept up at the expense of the poor” (41). This is only one of many appealing comments not sparsely scattered, but unpredictably, in letters of more ordinary news. Here’s one I liked occasioned by seeing theater in Paris: “We talk about it & write about it & criticize & dogmatize & analyse to the end of time: but those brave players stand forth & exemplify it & act—create—produce!” (66).Of course the “wit and wisdom” are not the monopoly of Henry. Here is William being wise: “We all learn sooner or later that we must gather ourselves up and more or less arbitrarily concentrate our interests, throw much overboard to save any” (55–56). Again: “It is a sweet world, in the interstices of its bedevilment & brutality” (321). And William being funny: “Boils are surely the most slowly evolving things in nature—Christian doctrine is nothing to them” (393). He is talking about his own boils and was subject, at every period, to ailments and infirmities: “Since writing to you, I have been swimming in deep seas of influenza, gout and Erysipelas of the face” (443). Or as he, in 1900, sums it up: “My... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:130 Feminist Studies 46, no. 1. © 2020 by Feminist Studies, Inc. Laura Bisaillon, Alana Cattapan, Annelieke Driessen, Esther van Duin, Shannon Spruit, Lorena Anton, and Nancy S. Jecker Doing Academia Differently: “I Needed Self-Help Less Than I Needed a Fair Society” A great deal of harm is being done by belief in the virtuousness of work. — Bertrand Russell, “In Praise of Idleness” We are committed to (...) doing academia in particular ways, and not in others. — Brocher Foundation Feminist Collective I had decided that becoming a university professor might be a good fit; friends and colleagues had suggested that I would be valuable to a university, so I prepared for a restructuring of my family life.1 I read Tokarczyk and Fay’s Working-Class Women in the Academy and Babcock and Laschever’s Women Don’t Ask to gather understandings of the milieu I was entering. I now see that my preparations had not shined sufficient light on the social and structural factors that organize the contemporary university.... As it turns out, the restructuring of our lives within the working conditions, priorities, and rationalities of this professional milieu triggered unanticipated and painful effects.... Had Mountz published her article “Women on the Edge” before I decided on a career migration into the university system and, had I been fortunate enough to discover it, I would have made other career choices.2 1. The authors, who describe themselves as the Brocher Foundation Feminist Collective, indicate their personal narratives in this text using italics. 2. Michelle M. Tokarczyk and Elizabeth A. Fay, eds., Working-Class Women in the Academy: Laborers in the Knowledge Factory (Amherst: University of Massachusetts Press, 1993); Linda Babcock and Sara Laschever, Women Don’t Ask: Negotiation and the Gender Divide (Princeton, NJ: Princeton University Bisaillon et al. 131 Introduction: Personal, Professional, and Political We are seven women who met at the Brocher Foundation in Hermance, Switzerland, in July 2017, where we had been selected to spend a few months as research fellows. This competitively awarded opportunity is open to persons fluent in English, from graduate students to senior scholars, with or without academic appointment, whose scholarship advances knowledge about the ethical, legal, and social implications of health and biotechnologies.3 When we found ourselves on the shores of Lake Leman with the gift of time, we began opening up to each other in unexpected, compelling ways. Whatever our vantage point in the hierarchy of the university system, we discovered that there was remarkable overlap in our experiences as women in academia. When we began writing, our authoring team was composed of two graduate students, four faculty members at the assistant professor rank, and one full professor, residing in Canada, the Netherlands, Romania, the United Kingdom, and the United States. Our plural subject position led us to underexplored and imaginative responses to broader social issues, which we share in this article as the “Brocher Foundation Feminist Collective.” We analyze our experiences from our standpoint as women health researchers laboring in the academy. Our similarities and differences were exciting entry points for discussion and analysis: we are all of eastern or western European descent. We have different countries of birth, mother tongues, ages, disciplinary training and career trajectories, relationships to chronic illness and disability, marital status, and experiences with parenthood. We bring the troubles and contradictions we experience as academics into conversation with each other. We seek to productively illustrate and emphasize that the tensions we see around us, and also feel within us, arise as a result of how the academic system is organized, produced, and sustained across time, place, and space. Press, 2003); Alison Mountz, “Women on the Edge: Workplace Stress at Universities in North America,” The Canadian Geographer 60, no. 2 (2016): 205–18. 3. We experienced this fellowship as a valuable opportunity. But we also recognized that our access to it was mediated by social, economic, or other obligations. As countries in the global north continue to tighten their national border regimes, marginalized academics, especially those from the global South, were less likely to succeed in getting a Swiss visa or securing relevant temporal and economic resources. 132 Bisaillon et al. The promise here, we posit... (shrink)

The idea of cultural evolution, coined by Daniel Dennett, suggests we might be able to formulate a Darwinian type of explanation for the adaptive 'tricks' we learn as human beings. The proposed explanation makes use of the idea of memes. That idea is examined and related to semantic units linked to the terms in a natural language. It is agreed with Dennett that these are of pivotal significance in understanding the structure of human cognition. The alternative is then explored to (...) the chaos of worddemons that Dennett appeals to in explaining why and how we think and enter into discursive relations. Beginning with certain thoughts about language games the essay moves on to consider the relations of power and knowledge that shape discursive reality and explain our subjectivities and actions. This leads to a sketch of Foucaultian theory as an advance in the philosophy of mind required to move beyond fairly gestural accounts of psychological explanation to be found in the standard biologically motivated approaches. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (...) (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

This study examines the procedural ethical considerations surrounding religious exemptions to Covid vaccine mandates, specifically focusing on immigrant healthcare personnel (HCP) and HCPs of color. It emphasizes communication issues with applicants by investigating exemption applications and their accompanying guidelines. While there is extensive literature on the ethical implications of religious exemptions, a notable gap remains in addressing the procedural aspects of religious exemption applications and their reviewing processes. The study scrutinized religious exemption application forms and accompanying guidelines from 32 selected (...) non-teaching and teaching hospitals for the years 2022–2023. The findings highlight significant variability in exemption application criteria and processes across institutions. Importantly, many application forms lacked comprehensive procedural information, which may result in subjective evaluations and potential misinterpretations of non-Western and non-mainstream religious beliefs, especially those of immigrant HCPs and HCPs of color. The study proposes various strategies to advocate for more equitable and transparent procedures, underlining the significance of diversity, equity, and inclusion in the religious exemption review process for vaccine mandates. (shrink)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower (...) socio-economic groups for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

Part I: Consciousness and the metaphysics of experience. Orientations. What I believe. The privacy of experience. Final causes. The importance of subjectivity : an inaugural lecture. Is consciousness mysterious? Consciousness. The distinctiveness of American philosophy. The world of description and the world of acquaintance -- Part II: The metaphysics of time and the absolute. The unreality of time. Ideal immortality. Russell and Bradley on relations. The self and its world in Bradley and Husserl. Absolute idealism. Pantheism -- Part III: Ethics, (...) animal rights, and the environment. The greatest happiness principle. Is the esse of intrinsic value percipi? Pleasure, pain and value. Metaphysics, physicalism, and animal rights. Vivisection, morals, medicine : commentary from an antivivisectionist philosopher. Non-human rights : an idealist perspective. Are there intrinsic values in nature? An idealist's prayer for the world. (shrink)

It is widely agreed that clinical research should satisfy a number of ethical requirements. These include requirements to address a valuable question, to select subjects fairly, and to pose appropriate risks. In contrast, there remains considerable debate over the ethical relevance of investigator intentions: Does it matter ethically whether investigators intend to collect generalizable knowledge or to benefit subjects, or both? Some commentators do not mention investigator intentions when evaluating what makes clinical research ethical (Emanuel, Wendler, and Grady 2000). Others (...) regard investigator intentions as central to the ethics of clinical research (Jonas 1969). These commentators argue that .. (shrink)

This study discusses the results of a survey of 1,800 articles published in American medical journals from 1985--1996. The study finds 9% of these articles reported research that uses only male subjects to examine medical conditions that affect both sexes; the ratio of research on female to male conditions among these articles was greater than 5:1; but 76.5% of the articles reported research that includes both male and female subjects. The study also discusses evidence that sex biases against women (and (...) men) are decreasing. This study also offers some possible psychological, institutional, medical, and economic explanations of the sex biases in medical research published in American journals, and discusses some policy implications of sex biases in medical research. The study concludes by urging others to conduct more empirical research on sex biases in medical research. (shrink)

This response to Edgar Dahl’s paper in this issue of Health Care Analysis clarifies my argument concerning sex selection and shows that our disagreement is less than he believes it is.

The purpose of this article is to show that animal rights are not necessarily at odds with the use of animals for research. If animals hold basic moral rights similar to those of humans, then we should consequently extend the ethical requirements guiding research with humans to research with animals. The article spells out how this can be done in practice by applying the seven requirements for ethical research with humans proposed by Ezekiel Emanuel, David Wendler and Christine Grady to (...) animal research. These requirements are i) social value, ii) scientific validity, iii) independent review, iv) fair subject selection, v) favorable risk-benefit ratio, vi) informed consent, and vii) respect for research subjects. In practice, this means that we must reform the practice of animal research to make it more similar to research with humans, rather than completely abolish the former. Indeed, if we banned animal research altogether, then we would also deprive animals of its potential benefits – which would be ethically problematic. (shrink)

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a (...) safety trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial. (shrink)

The U.S. regulations for the protection of humans in biomedical and behavioral research were "born in scandal and reared in protectionism." This paper discusses the evolution of these regulations and the gaps that still persist in the ongoing effort to strike a balance between protecting vulnerable populations from research risks and providing all individuals and groups with an equal opportunity to benefit from research. In particular, this paper focuses on racial, social, and economic inequities in the selection of research (...) participants; the exclusion and underrepresentation of the elderly in research, and controversies about U.S. clinical trials conducted in developing countries. (shrink)

Dear Readers,Welcome to this issue of our beloved Bangladesh Journal of Bioethics! In this sweltering heat we are all seeking for some cool and comfort. We bring this issue of BJB on different ethical practices and bring up related questions. Are we respecting the rights of every human being when we are either doing research or practicing health service provision? What are the minimum norms and standards to be maintained or are we circumventing those? The issue looks into different issues (...) and provides us with indepth information, queries, fears and reservations.In the article on Knowledge, attitude and practice of medical ethics among medical intern students in a Medical College in Kathmandu, Ramesh P Aacharyaand Yagya L Shakya, report on a Knowledge Attitude and Practice survey of 46 medical undergraduate interns of Maharajgunj Medical Campus. The result of the survey is quite interesting. ‘Doctors know the best irrespective of patients’ opinion was agreed upon by 35 %, ‘Confidentiality cannot be kept in modern era and should be abandoned’ was strongly disagreed by 34.8% and disagreed by 60.9%. The Authors hope that the findings will assist the faculties to strengthen the teaching of medical ethics and guiding the interns for ethical professional conduct. In the article titled Organizational Justice and Employee’s Service Behavior in the Healthcare Organizations in Bangladesh is an agenda for Research, Md. Nuruzzaman and Md. Humayun Kabir Talukder present a conceptual framework and a set of hypotheses regarding the relationships among distributive justice, procedural justice, interactional justice, employee’s citizenship behaviour, role prescribed behaviour and counterproductive behavior in the healthcare organizations in Bangladesh. The authors state that the purpose is to assist the policy makers and service providers in identifying desirable and undesirable HRM practices in order to maintain optimum level of employee commitment for ensuring quality and efficient service delivery to the communities. Though the article is theoretical it may be useful for the policy makers and service providers. If an operational research could be carried out to test the hypothesis the practical utility of the concept could be tested in Bangladesh.Zoheb Rafique in the article Ethical Justification of Conducting Research Trials in Lower and Middle Income Countries Including Pakistan: The Responsibilities of Research Enterprises explores the ethical aspects of research sponsored by commercial agencies. He looks into the factors that influence selection of a study site for a sponsored trial particularly in traditional countries like Pakistan where cultural values add to the problem in assuring that research is conducted in an ethical manner. In this paper, the Author discusses the responsibilities of researchers and funders in low and middle income countries like Pakistan and the ethical justifications of doing research trials in developing countries. He concludes that research participants should be fully informed about the research trial and their participation and it is their right to know all risks and benefits so that they have the option of rejecting participation.The article on Ethical aspects of Dhaka University Tele-medicine System by Ahmed Raihan Abir provides and analysis of the tele- medicine system in Dhaka University. The Author is a member of an extended group at Dhaka University (DU) which has been developing telemedicine equipment and data acquisition software to promote telemedicine practice in Bangladesh. Recently the Telemedicine group of DU and a local NGO named SAMAMA with support from Service innovation fund (SIF) of the Prime Minister Office (PMO) of Bangladesh took the initiative to establish eight rural telemedicine centers and one expert center for the field trial of telemedicine in Bangladesh. The aim of this paper is to examine the ethical challenges of such health care system and the effort to overcome these problems before starting the field trial. The author looks into the details of Data confidentiality and security, Responsibilities of Doctor and Rural Technician, Quality of service and Implications of telemedicine in Bangladesh. He concludes that DU telemedicine project will essentially bring the services of qualified medical experts to the doorsteps of the common people throughout the country, even in the remote rural areas. Although a telemedicine cannot match a face to face consultation, DU tele-medicine system is much better than no consultation at all.Sifat Rahman in the article on Ethical Issues of Fair Subject Selection in Research provides an overview of the criterion for maintaining ethical standards for conducting research. The Author reviews the three fundamental conditions to be met for adhering to strict ethical standards which are: Respect for Persons by protecting the autonomy of people, treating them with courtesy and respect and obtaining informed consent.; Beneficence which incorporates the philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; and Justice by ensuring that reasonable, non-exploitative, and well-considered procedures are administered fairly. Finally the Author concludes that Researchers must be truthful and conduct no deception.Dear Readers, as you can see from the above ethics and maintaining the values in research and services are of utmost importance in the improvement of the quality of life. Through our queries, questions and sense of respect for every living being can our endeavors to ensure ethics in all spheres of development be successful.Dear Readers, please keep on sending your articles, notes or thoughts to us. Your participation will make a difference in the quality of our lives.Best regardsTahera AhmedEditor. (shrink)

Timothy Sprigge was one of the leading exponents of philosophical idealism in the last fifty years. The idealist worldview, long unfashionable, has been coming back into favour, and Sprigge's work has found a new readership. These selected essays focus on the view of consciousness on which his unique system of metaphysics and ethics is based.

Ethics committees like Institutional Review Boards and Research Ethics Committees are typically empowered to approve or reject proposed studies, typically conditional on certain conditions or revisions being met. While some have argued this power should be primarily a function of applying clear, codified requirements, most institutions and legal regimes allow discretion for IRBs to ethically evaluate studies, such as to ensure a favourable risk-benefit ratio, fair subject selection, adequate informed consent, and so forth. As a result, ethics (...) committees typically make moral demands on researchers: require them to act in a way the committee considers ethically right or appropriate. This paper argues that moral demands are legitimate only if publicly justifiable; and as a result, committee decisions are subject to a public justification requirement. Ethics committees can permissibly request for more information, changes to the research protocol or that the research is delayed or even stopped only if these demands are publicly justifiable. This latter claim is in turn justified on the basis that moral demands to φ are permissible only if we are in a position to know that the addressee ought to φ and that we are in a position to know a proposition only if it is publicly justifiable. This argument suggests that ethics committees must consciously and explicitly appeal to public reasons in their decision-making. In cases where public reasons cannot be offered, committees would not be permitted to reject a given study or make approval conditional on an amendment. (shrink)

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical (...) appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research—social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants. (shrink)

In a recent comment on the HFEA’s public consultation on sex selection, Soren Holm claimed that proponents of family balancing are committed to embrace a laissez faire approach. Given that arguments in support of sex selection for family balancing also support sex selection for other social reasons, advocates of family balancing, he asserts, are simply inconsistent when calling for a limit on access to sex selection. In this paper, I argue that proponents of family balancing are (...) in no way inconsistent. Provided their advocacy of family balancing is aimed at preventing a severe distortion of the natural sex ratio, they are entirely justified in insisting on restrictions to sex selection. The real question is whether a concern for the sex ratio does indeed call for a limit on sex selection. Based on a recent survey on gender preferences and data from several Gender Clinics, I argue that a restriction on sex selection to family balancing is unwarranted. In the absence of any evidence for a pending sex ratio distortion, we are actually required to adopt a laissez faire approach to sex selection. (shrink)

A number of fairness issues and principles are developed and discussed from the context of personnel selection. It is noted that not too much attention has been paid to these issues and concerns in the past. A distinction is made between justice and fairness having to do with the procedural components and processes of selection, the nature of the information used to make selection decisions, and the resulting outcomes of the selection process. Ideas for future research (...) and exploration are also extended. (shrink)

Selection within the educational domain breeds a special kind of suspicion. Whether it is the absence of transparency in the selection procedure, the observable outcomes of the selection, or the criteria of selection itself, there is much to corroborate the suspicion many have that selection in practice is unfair. And certainly as it concerns primary and secondary education, the principle of educational equity requires that children not have their educational experiences or opportunities determined by their (...) postcode, their ethnic status, first language, or family wealth. Indeed educational opportunities determined by unearned advantage or disadvantage offend against basic notions of fairness. But are public schools even permitted to select their students, and if so, how can selection procedures used by schools be best structured to achieve equitable ends? In this article we delineate, describe, and defend what we believe are the essential features of selection and also why we need to pay equal attention to both the outcomes and the processes leading to those outcomes. Provided the selection is motivated and guided by the right reasons, as well as appropriately monitored, we argue that selection can be equity promoting. (shrink)