Janet Malek (91–102, 2019) argues that a “clinical ethics consultant’s religious worldview has no place in developing ethical recommendations or communicating about them with patients, surrogates, and clinicians.” She offers five types of arguments in support of this thesis: arguments from consensus, clarity, availability, consistency, and autonomy. This essay shows that there are serious problems for each of Malek’s arguments. None of them is sufficient to motivate her thesis. Thus, if it is true that the religious worldview of (...) clinical ethics consultants should play no role whatsoever in their work as consultants, this claim will need to be defended on some other ground. (shrink)

Clinical ethics consultants (CECs) are not moral authorities. Standardization of CECs’ professional role does not confer upon them moral authority. Certification of particular CECs does not confer upon them moral authority (nor does it reflect such authority). Or, so we will argue. This article offers a distinctly Orthodox Christian response to those who claim that CECs—or any other academically trained bioethicist—retain moral authority (i.e., an authority to know and recommend the right course of action). This article proceeds in (...) three parts. First, we discuss recent movements toward the certification of CECs in the United States, focusing primarily on proposals and programs put forth by the American Society for Humanities and Bioethics (ASBH). Second, we outline two secular reasons to be concerned about the relevant trends toward certification. For one thing, certification is currently being advanced via political dominance, rather than gaining authority by reliance on rigorous philosophical argument or reason. For another, the trends operate on the assumption that there exists a secular, content-full, canonical, morality. There is no such morality. Next, we argue that Orthodox Christians should resist the current trends toward certification of CECs. Specifically, we unpack ways in which the ASBH’s certification program (and those like it) conflict with Orthodox claims about moral authority and the moral life more generally. We conclude that Orthodox Christians should resist the current certification trends. (shrink)

Clinical Ethics Consultations are an important tool for physicians in solving difficult cases. They are extremely common in North America and to a lesser extent also present in Europe. However, there is little data on this practice in Poland. We present results of a survey of 521 physicians practising in Poland concerning their opinion on CECs and related practices. We analysed the data looking at such issues as CECs’ perceived availability, use of CECs, and perceived usefulness of such (...) support. Physicians in our study generally encounter hard ethics cases, even—surprisingly—those who do not work in hospitals. Most physicians have no CEC access, and those that do still do not employ CECs. However, physicians perceive this form of support as useful—even more so among actual users of CECs. We compared these findings with similar studies from other European countries and the North America. We point out peculiarities of our results as compared to those in other countries, with some possible explanations. We hope the results may encourage regulatory debate on the need to formally introduce CECs into the Polish healthcare system. (shrink)

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. (...) Nevertheless, the proposed declaration contains persistent flaws... (shrink)

RD, a 32-year-old male, was admitted to the hospital with hypoxic COVID pneumonia–a potentially life-threatening condition characterized by dangerously low levels of oxygen in the body- during one of the pandemic’s surges. While RD’s age gave the clinical team hope for his prognosis, his ability to recover was complicated by his being unvaccinated and having multiple comorbidities, including diabetes and obesity. His condition worsened to the point that he required extracorporeal membrane oxygenation (ECMO), a machine that maintains the functioning (...) of a person’s heart and lungs. -/- Given its scarcity–only 264 of the over 6,000 hospitals in the United States offer ECMO, according to the Extracorporeal Life Support Organization–as well as its high cost and the inadequate supply of staff required to maintain it, ECMO primarily serves as a bridge to support critically ill patients until they can receive an organ transplant or implanted medical device. For RD, ECMO was started to support him until he could be evaluated for, and possibly receive, a bilateral lung transplant. Despite its intended use as a treatment of last resort, some patients can remain on ECMO for weeks or months. And some are awake, alert, and capable of medical decision-making. -/- RD was one such patient. However, the transplant evaluation committee ruled out RD’s candidacy for bilateral lung transplantation, based on his poor potential for recovery and a lack of family and friends to provide post-transplant support. This determination raised the prospect of continued ECMO treatment being a bridge to nowhere. But RD was comfortable on ECMO and wanted to remain in the ICU. The ICU intensivist contacted the ethics consult service with questions about whether continued ECMO support was medically and ethically inappropriate. (shrink)

Abstract Gender and Ethics Committees: Where’s the Different Voice? -/- Prominent international and national ethics commissions such as the UNESCO Bioethics Commission rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under-representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women’s bodies, and when such committees claim to derive ‘universal’ standards. Are women missing from many ethics committees because of (...) relatively straightforward, if discriminatory, demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ‘anti-female’? It has been argued, for example, that there is a ‘different voice’ in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ‘masculine paradigm’ in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women’s representation on ethics committees in Eastern and Western Europe, a critical analysis of the supposed ‘masculinism’ of the principlist approach, and a case example in which a ‘different voice’ did indeed make a difference. (shrink)

(Pre-publication draft November 2015: Partial content of "Introduction: The 2030 Agenda," Journal of Global Ethics 11:3 [December 2015], 262-270) This introduction briefly explains the process through which the Sustainable Development Goals have developed from their receipt in 2014 to their passage in September 2015 by the UN General Assembly, and it considers their development in prospect. The Millennium Development Goals, which spanned 1990-2015, present a case study that reveals the changeability of such long-term multilateral commitments. They were enmeshed in (...) overlapping and inconsistent national and intergovernmental commitments reaching from 1995 to 2005, and the text of those goals also evolved, stabilizing for the last time in 2007. The Sustainable Development Goals and attendant commitments should be expected to evolve similarly over their fifteen year run. This presents a concern, for among the three committees established by the UN to create the goals, the two committees charged with public consultation were retired as planned in 2014. The process evident thereafter has displayed a shift towards a strategy of enrolling broad public endorsement that leaves such consultation and specific responsibility to those consulted in doubt. This bodes ill for public deliberation on the goals and for public accountability as the agenda proceeds towards 2030. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources (...) such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

Chronic fatigue syndrome or myalgic encephalomyelitis remains a controversial illness category. This paper surveys the state of knowledge and attitudes about this illness and proposes that epistemic concerns about the testimonial credibility of patients can be articulated using Miranda Fricker’s concept of epistemic injustice. While there is consensus within mainstream medical guidelines that there is no known cause of CFS/ME, there is continued debate about how best to conceive of CFS/ME, including disagreement about how to interpret clinical studies of (...) treatments. Against this background, robust qualitative and quantitative research from a range of countries has found that many doctors display uncertainty about whether CFS/ME is real, which may result in delays in diagnosis and treatment for patients. Strikingly, qualitative research evinces that patients with CFS/ME often experience suspicion by health professionals, and many patients vocally oppose the effectiveness, and the conceptualization, of their illness as psychologically treatable. We address the intersection of these issues and healthcare ethics, and claim that this state of affairs can be explained as a case of epistemic injustice. We find evidence that healthcare consultations are fora where patients with CFS/ME may be particularly vulnerable to epistemic injustice. We argue that the marginalization of many patients is a professional failure that may lead to further ethical and practical consequences both for progressive research into CFS/ME, and for ethical care and delivery of current treatments among individuals suffering from this debilitating illness. (shrink)

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should (...) prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. (shrink)

We sometimes seek expert guidance when we don’t know what to think or do about a problem. In challenging cases concerning medical ethics, we may seek a clinical ethics consultation for guidance. The assumption is that the bioethicist, as an expert on ethical issues, has knowledge and skills that can help us better think about the problem and improve our understanding of what to do regarding the issue. The widespread practice of ethics consultations raises these (...) questions and more: -/- • What would it take to be a moral expert? • Is anyone a moral expert, and if so, how could a non-expert identify one? • Is it in any way problematic to accept and follow the advice of a moral expert as opposed to coming to moral conclusions on your own? • What should we think and do when moral experts disagree about a practical ethical issue? -/- In what follows, we address these theoretical and practical questions about moral expertise. (shrink)

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 (...) class='Hi'>clinical sites throughout Germany. 8 ethics committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)

Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that (...) present when subjects are asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or ‘work’, the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context. (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical (...) research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, creating (...) a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. (shrink)

The prospect of vaccinating children and young people (CYP) against COVID raises questions that apply more widely to vaccination in children. When can CYP consent, on their own, for vaccination? What should happen if children and their parents disagree about the desirability of a vaccine? When, if ever, should vaccination proceed despite a child’s dissent or apparent refusal? A range of ethical dilemmas may arise. (Box 1) In this article, we will address general ethical issues relating to consent for vaccination, (...) highlighting their relevance to COVID. We will not address the wider ethical questions of whether or when children should be vaccinated against COVID. (shrink)

Default positions, predetermined starting points that aid in complex decision-making, are common in clinical medicine. In this article, we identify and critically examine common default positions in clinical ethics practice. Whether default positions ought to be held is an important normative question, but here we are primarily interested in the descriptive, rather than normative, properties of default positions. We argue that default positions in clinical ethics function to protect and promote important values in medicine—respect for (...) persons, utility, and justice. Further, default positions in clinical ethics may also guard against harm. Where default positions exist, there are epistemic burdens to overturn them. The person wishing to reject the default position, rather than the person endorsing it, bears this burden. The person who bears the burden of meeting the epistemic requirements must provide evidence proportional to the degree of harm the default position protects against. Default positions that protect against significant harm impose significant epistemic requirements to overturn. This asymmetry not only makes medical decision-making more economical but also serves to promote and protect certain values. The identification and analysis of common and recognizable default positions can help to identify other default positions and the conditions under which their associated epistemic requirements are met. The article concludes with considerations of potential problems with the use of default positions in clinical ethics. (shrink)

Background: This study sought to understand the ethical issues encountered by medical residents during their residencies, evaluate the solutions proffered by them, and present their suggestions. Material/Methods: A survey consisting of 32 questions, including demographic information, was developed and distributed to Intensive Care Unit (ICU) residents from December 2020 to January 2021. A total of 53 completed questionnaires were submitted to the researchers. The data were analyzed using SPSS software version 26.0. Results: Of the participating residents who returned completed forms, (...) 50.9% were male and 49.1% were female, with an overall mean age of 30.5±4.4 years. Most residents’ views on ethical issues concerned themselves, the clinic, and patients/patient relatives. Responses showed a number of commonalities with the views of ICU physicians in other countries. Suggestions for resolving ethical issues solutions included instruction in medical ethics for all staff, increasing and strengthening pathways of communication both inside and outside of the clinics, regular inventory of medical supplies and assessment of equipment to prevent a shortage of resources, and the establishment of a hospital ethics committee. Conclusions: As numerous and varied ethical issues were encountered in the participating ICUs, we propose the following: preparation of an ICU-specific guide for resolving ethical problems, clarification of rules based on legal regulations, determining a hierarchy of responsibilities, and ethics courses for all ICU staff. In addition, hospital managers should support ICU services from both a legal and ethical standpoint. (shrink)

Brummett and Salter propose a useful and timely taxonomy of clinical ethics expertise (2019). As the field becomes further “professionalized” this taxonomy is important, and the core of it is right. It needs some refinement around the edges, however. In their conclusion, Brummett and Salter rightly point out that there is a significant difference between the ethicist whose recommendations are procedure- and process-heavy, consensus-driven, and dialogical and the authoritarian ethicist whose recommendations flow from “private moral views” (Brummett and (...) Salter, 2019). This admission doesn’t go far enough. Brummett and Salter’s taxonomy fails to capture the notion that offering recommendations whose normative force is moral is different in kind from recommendations whose normative force is non-moral, such as those recommendations that are free of moral content or justified by convention. The difference is in kind, not scale. I argue further that clinical ethics expertise, if possible, consists at least in offering recommendations whose normative force is moral. These two claims imply that the taxonomy fails to cut clinical ethics expertise at the joints: the ethicist who offers justified non-moral normative recommendations is a different kind of ethicist from the one who offers justified moral normative recommendations, yet both are categorized as clinical ethics experts. I finish by offering a refinement of the taxonomy that more precisely categorizes clinical ethicists. (shrink)

(Article part 2 of 2) This introduction notes the contributions of authors to the second issue of the Journal of Global Ethics 2015 Sustainable Development Goals Forum. It briefly explains the process through which the Sustainable Development Goals have developed from their receipt in 2014 to their passage in September 2015 by the UN General Assembly, and it considers their development in prospect. The Millennium Development Goals, which spanned 1990–2015, present a case study that reveals the changeability of such (...) long-term multilateral commitments. They were enmeshed in overlapping and inconsistent national and intergovernmental commitments reaching from 1995 to 2005, and the text of those goals also evolved, stabilizing for the last time in 2007. The SDGs and attendant commitments should be expected to evolve similarly over their 15-year run. This presents a concern, for among the three committees established by the UN to create the goals, the two committees charged with public consultation were retired as pl.. (shrink)

Machine intelligence already helps medical staff with a number of tasks. Ethical decision-making, however, has not been handed over to computers. In this proof-of-concept study, we show how an algorithm based on Beauchamp and Childress’ prima-facie principles could be employed to advise on a range of moral dilemma situations that occur in medical institutions. We explain why we chose fuzzy cognitive maps to set up the advisory system and how we utilized machine learning to train it. We report on the (...) difficult task of operationalizing the principles of beneficence, non-maleficence and patient autonomy, and describe how we selected suitable input parameters that we extracted from a training dataset of clinical cases. The first performance results are promising, but an algorithmic approach to ethics also comes with several weaknesses and limitations. Should one really entrust the sensitive domain of clinical ethics to machine intelligence? (shrink)

Dear Colleagues, -/- In this editorial, we would like to share with you important developments in the European Journal of Therapeutics (Eur J Ther). -/- First of all, as the editorial team, we would like you to know that we hold frequent meetings to benefit our esteemed colleagues and continue to work with great devotion in line with our goal of taking the journal further. We have previously shared with you that we have applied to many indexes. It is with (...) great pleasure that we would like to inform you that in the last few months, more of our index applications have been approved. -/- Index Copernicus, as a result of this application, the ICV 2022 value of our journal was determined to be 100 (approved 2023-10-31) [1] BASE (Bielefeld Academic Search Engine) (approved 2023-11-30) [2] Sherpa Romeo (approved 2023-09-27) [3] MIAR (approved 2023-10-16) [4] -/- All indexes in our journal are currently included on the journal web page [5]. -/- As the editorial team, we would like to inform you that we have determined a policy on this issue for our journal [6], taking into account the recommendations of important international ethics committees such as the Committee on Publication Ethics (COPE) [7] and the World Association of Medical Editors (WAME) [8], which have recently become a trendy topic of discussion about AI chatbots and academic studies prepared with the support of such tools. -/- As you know, when our journal was founded in 1990 [9], it was published in two yearly issues. It is an essential responsibility for us to carry our journal, which continued its publication life with three issues a year in 2009 [10] and four issues a year in 2014 [11]. With your valuable support, we would like to announce that we will increase our journal to 6 issues a year as of 2024 (February, April, June, August, October and December) with the rapidly growing progress of our journal. -/- Unfortunately, we cannot share the names of the referees who made significant contributions to our journal in 2023 due to the changes in the article submission interface during the year and the inaccessibility of some data in the previous interface. However, we would like to emphasize again that we are grateful to all of them for their valuable contributions. Moreover, to expand our journal's referee list, we would like to remind you that competent academics who volunteer in this regard can fill out the “Become a Reviewer for the European Journal of Therapeutics” form [12]. -/- Finally, we would like to point out that we have strengthened our editorial team with an academician competent in dentistry, Fatih Sari, DDS, PhD. -/- Fatih Sari, DDS, PhD, is a new Editorial Board Member of the Eur J Ther. Dr. Sari is an Associate Professor in the Department of Prosthodontics at the Gaziantep University Faculty of Dentistry. He is a Vice Dean of the Faculty of Dentistry and Head of Clinical Departments. Dr. Sari is a prosthodontist and a member of the Turkish Dental Association. He has experience in implant-supported fixed prostheses, Cad/Cam applications and dental materials. -/- We look forward to being able to offer you a large number of high-quality and valuable articles over the coming year. In addition, we would like to thank the readers, authors and reviewers of the Eur J Ther for their continuous support. -/- Sincerely yours,. (shrink)

This article examines when deceptive withholding of information is ethically acceptable in research. The first half analyses the concept of deception. We argue that there are two types of accounts of deception: normative and non-normative, and argue that non-normative accounts are preferable. The second half of the article argues that the relevant ethical question which ethics committees should focus on is not whether the person from whom the information is withheld will be deceived, but rather on the reasonableness of (...) withholding the information from the person who is deceived. We further argue that the reasonableness of withholding information is dependent on the context. The last section examines how the context of research should shape our judgements about the circumstances in which withholding information from research participants is ethically acceptable. We argue that some important features of research make it more difficult to justify withholding information in the context of research than elsewhere. (shrink)

In 1919, as the Crow (Apsáalooke) Nation was being forced by the federal government to allot the “surplus” lands on their reservation, tribal member Robert Yellowtail spoke before the United States Senate Committee on Indian Affairs in a speech entitled, “In Defense of The Rights of The Crow Indians and The Indians Generally.” To establish the context of the speech, a brief history of the Apsáalooke Indian nation and tribal member Robert Yellowtail will be given within the framework (...) of United States Indian policy relevant to assimilation and allotment at the time. Classical liberalism, its political philosophy of property and government, illuminates Yellowtail’s arguments through a generative rhetorical analysis. The implications of the analysis are discussed as a case study of liberal political philosophy utilized to make the case for the rights of American Indians to self-determination in a direct challenge to the dominant United States Indian policy paradigm at the time. Contrary to American founding principles, American Indians had been subjected to the same paternalizing policy strategies underlying the July 4th, 1776 rebellion of the American colonies against the British crown. Yellowtail skillfully brought these inconsistencies to light, challenging the paternal paradigm by using the key terms and concepts of classical liberal political philosophy as used by the American Founding Fathers. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role (...) of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

As national and state health care policy -making becomes contentious and complex, there is a need for a forum to debate and explore public concerns and values in health care, give voice to local citizens, to facilitate consensus among various stakeholders, and provide feedback and direction to health care institutions and policy makers. This paper explores the role that regional health care ethics committees can play and provides two contrasting examples of Networks involved in facilitation of public input into (...) and the development of health care policies and adoption of state-wide practices. (shrink)

Mitochondrial DNA (mtDNA) diseases are a group of neuromuscular diseases that often cause suffering and premature death. New mitochondrial replacement techniques (MRTs) may offer women with mtDNA diseases the opportunity to have healthy offspring to whom they are genetically related. MRTs will likely be ready to license for clinical use in the near future and a discussion of the ethics of the clinical introduction ofMRTs is needed. This paper begins by evaluating three concerns about the safety of (...) MRTs for clinical use on humans: (1) Is it ethical to use MRTs if safe alternatives exist? (2) Would persons with three genetic contributors be at risk of suffering? and (3) Can society trust that MRTs will be made available for humans only once adequate safety testing has taken place, and that MRTs will only be licensed for clinical use in a way that minimises risks? It is then argued that the ethics debate about MRTs should be reoriented towards recommendingways to reduce the possible risks of MRT use on humans. Two recommendations are made: (1) licensed clinical access to MRTs should only be granted to prospective parents if they intend to tell their children about their MRT conception by adulthood; and (2) sex selection should be used in conjunction with the clinical use ofMRTs, in order to reduce transgenerational health risks. (shrink)

Healthcare practitioners have access to a range of ethical guidance. However, the normative role of this guidance in ethical decision-making is underexplored. This paper considers two ways that healthcare practitioners could approach ethics guidance. We first outline the idea of deference to ethics guidance, showing how an attitude of deference raises three key problems: moral value; moral understanding; and moral error. Drawing on philosophical literature, we then advocate an alternative framing of ethics guidance as a form of (...) moral testimony by colleagues and suggest that a more promising attitude to ethics guidance is to approach it in the spirit of ‘critical engagement’ rather than deference. (shrink)

We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.

Social scientists and research ethicists have begun, somewhat belatedly, to confront and address the ethical challenges raised by public policy experiments. In doing so however, they have not fully availed themselves of the large and sophisticated literature on the ethics of clinical research which has developed over the past 40 years. While clinical and public policy research are different, I argue that the clinical research ethics literature yields valuable insights for discussions of the ethics (...) of policy experiments. Focusing on seven ethical issues which have received a good deal of attention in public and scholarly discussions of the ethics of policy experiments, I make use of the history of reflection on the ethics of clinical research to provide guidance to researchers planning and conducting policy experiments. (shrink)

Over the last two decades, there was an upsurge of research and innovation in biotechnology and related fields, leading to exciting new discoveries in areas such as the engineering of biological processes, gene editing, stem cell research, CRISPR-Cas9 technology, Synthetic Biology, recombinant DNA, LMOs and GMOs, to mention only a few. At the same time, these advances generated concerns about biosafety, biosecurity and adverse impacts on biodiversity and the environment, leading to the establishment of Research Ethics Committees (RECs) at (...) Higher Education and Research Institutions dedicated to reviewing research with implications for biosafety and the environment. -/- These Biosafety and Environment Research Ethics Committees, referred to as EBRECs, are in the early stages of their establishment and formalisation, and there is much uncertainty about their composition, scope, procedures of decision-making and the principles that should guide their deliberations and assessments. In many respects, EBRECs are venturing into uncharted territory, facing a very wide range of complex research fields, far-reaching research practices and deep concerns new to Review Boards, raising the question to what extent EBRECs can fall back on the fairly well-established principles and procedures of RECs focusing on Human, Health or Animal research, and to what extent they need new or adapted principles and procedures. -/- Against this background, I set out to answer the following three main research questions in this thesis: 1. What is the current state of ethical principles for ethics reviews in the field of environmental and biosafety research ethics? Which principles are currently used in this context, and how? 2. What are the shortcomings of the current principles used by EBRECs and how can they be overcome? 3. What ethical principles must be adopted by environmental and biosafety research ethics committees and guide them in their decision-making? -/- In order to prepare the ground and set the scene for my discussion of these questions, I also formulated four supporting research questions: i. What is environmental research ethics in action? ii. What is biosafety research ethics in action? iii. How are environmental and biosafety ethics related to one another? iv. How should the guidelines and ethical principles related to these two overlapping fields be implemented in the ethics review process? Following my introduction and problem statement in Chapter 1, I devoted Chapters 2 and 3 to an overview of my supporting questions to set the scene for Environmental and Biosafety Research Ethics. In Chapter 4, I turned to my main research question with a discussion of national and international declarations, frameworks and legislation and an investigation of principles in the different research areas to get a picture of applicable principles that can guide EBRECs. -/- The main finding of my thesis is that due to the complexity of EBR, different categories of principles could be the solution for EBRECs. I elaborate on this in Chapter 5, my concluding chapter, in which I also propose a list of core principles that can serve as an accessible and easy-to-use guide for EBRECs in their decision-making. In this proposal, I cluster different kinds of principles in terms of four categories: 1. Principles as a Moral Concept 2. Principles as a Social Concept 3. Principles as a Legal Concept 4. Principles as a Safety Concept . (shrink)

Interventions aiming to slow, stop, or reverse the aging process are starting to enter clinical trials. Though this line of research is nascent, it has the potential to not only prevent prolonged human suffering, but also to extend human well-being. As this line of research develops, it is important to understand the ethical constraints of conducting such research. This paper discusses some of these constraints. In particular, it discusses the ethical difficulties of conducting this research in a way that (...) would produce reliable data regarding the effectiveness of an anti-aging intervention. Clinical trials of such interventions, I argue, will be faced with a dilemma between two confounding variables. Eliminating the variables requires introducing ethically problematic research practices. Thus, researchers must either perform research in ethically problematic ways, or forego the conduct of high-impact clinical research on anti-aging interventions. (shrink)

The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future (...) variants with increased infectivity and/or severity emerge, further rationing may be required. We identify relevant ethical principles and priority groups for access to therapies based on an integrated approach to population health and medical factors. Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors. (shrink)

The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent (...) proposed alternatives are. In the process, it evaluates the justification for continuing to use clinical equipoise as the gold standard for randomized control trials. (shrink)

Most current dental ethics curricula use a deontological approach to biomedical and dental ethics that emphasizes adherence to duties and principles as properties that determine whether an act is ethical. But the actual ethical orientation of students is typically unknown. The purpose of the current study was to determine the ethical orientation of dental students in resolving clinical ethical dilemmas. First-year students from one school were invited to participate in an electronic survey that included eight vignettes featuring (...) ethical conflicts common to the health care setting. The Multidimensional Ethics Scale was used to evaluate the students’ ethical judgments of these conflicts. Students rated each vignette along 13 ethically relevant items using a 7-point scale. Nine of the thirteen items were analyzed because they represent the dominant ethical theories, including deontology. One hundred sixteen dental students successfully completed the survey. Of the analyzed items, those associated with deontology had comparatively weak associations with whether students judged the action to be ethical and whether students judged themselves likely to perform the action. Whether an action was judged to be caring had the strongest association with whether the action was judged to be ethical and whether students judged themselves likely to perform the action. These results suggest that adherence to duties or principles has weaker association with students’ ethical judgments and behavior compared to caring, which was found to be more influential in their ethical judgments and behavior. Current dental school curricula with a primary focus on deontology may no. (shrink)

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

c;inical medicine and language: Peircean and Austin's approach.

A cross-sectional study was done on 50 ethics committee members from 15 different Ethics Committee (EC) over a period of 6 months from February 2018 to June 2018 to understand the structure and function of ECs in Bangladesh. Most of the ECs were male predominant (66.3%) and maximum ECs had technical members (93.33%). Only 8.3% ECs had lay person. Forty percent of the ECs did not update SOP routinely. Most of the ECs had no provision of (...) training for its members (79.2%) and had no budget (71.8%). Maximum ECs service were voluntary (82.22%). Different ECs had different quorum to start the meeting. A little less than half of the respondents (45.76%) felt that their decision had not been noted down if disagreed against majority of vote in the ECs and did not placed in the meeting’s minutes. Maximum respondents (88.18%) did not know whether there was any law in Bangladesh to create a EC. A big percentage (89%) of ECs did not monitored by authorized body to guide and oversee the functioning of ECs. This article concluded that some ECs followed the international rules and regulation to formation and function the ECs but still a handsome number of ECs were lag behind in Bangladesh. The capacity of ECs can only be strengthened by training and various recognition/accreditation programs. (shrink)

Objective: This main aim of the study is to explore COVID-19 pandemic problems from the perspective of public health-clinical care ethics through online mediareports in Turkey. Method: This research was designed as a descriptive and qualitative study that assesses COVID-19 through online media reports on critics between the periods of March 11, 2020 and April 2 2020 as a quantitative as number of reports and qualitative study, across Turkey. Reports were from Turkish Medical Association websites which included newspaper (...) reports. Study data were presented as statistically and qualitative data case and headlines. No ethical or ofTicial permission was sought as the study was conducted through open access internet news sites. Results: This online reports analysis retrieved about 6723 articles about the COVID-19. According to study data, information about COVID-19 were themed as follows: general deTiciencies in taking action and isolation, lack of isolation, passengers and transport vehicles not quarantined ; insufTicient diagnostic tests, decision to test after healthcare professionals become infected, lack of equipment, lack of evaluation outbreak countries [Table 2]. Conclusion and Suggestions: COVID-19 is a pandemic and is a global public health problem that concerns every individual and needs to be handled carefully. This requires a multi-faceted preparation and education. In this context, healthcare professionals should be well trained in this aspect and have all the necessary equipment throughout the process. Additionally, it should work systematically with the cooperation of all health organizations, the Ministry of Health, local governments and of course the media, in order to inform society, fairly distribute the resources and to implement the safety measures effectively. BrieTly, lack of transparency, insufTicient information, limited resources, lack of public health protection measures such as partial quarantine decision, partial implementation of the scientiTic board's re c ommenda ti on s fo r e c on omi c rea s on s, and contradiction of the explanations are revealed as serious ethical problems. (shrink)

Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do not read the information provided as part of the consent process and they habitually provide or refuse their consent without adequate reflection. In principle, these practices call into question the validity of their (...) consent. In this paper we argue that although the ‘no read problem’ and the routinisation of consent may apply to research participants’ consent practices for studies on crowdsourcing platforms, this is not a serious problem. Furthermore, given that the informational requirements for informed consent in these contexts are minimal, we argue that these participants are, nevertheless, sufficiently informed to give valid consent. We conclude that research ethics committees and institutional review boards should only agonise over the precise details of the informed consent process and materials in those rare cases where appreciable risks to research participants need to be managed. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians (...) view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

In its recent statement 'Sex Selection and Preimplantation Genetic Diagnosis', the Ethics Committee of the American Society of Reproductive Medicine concluded that preimplantation genetic diagnosis for sex selection for non-medical reasons should be discouraged because it poses a risk of unwarranted gender bias, social harm, and results in the diversion of medical resources from genuine medical need. We critically examine the arguments presented against sex selection using preimplantation genetic diagnosis. We argue that sex selection should be available, at (...) least within privately funded health care. (shrink)

Having scandalous unethical research practices in the mid and late 20th century, study protocols of biomedical research reviewed by the Ethics Committee (EC) has become the accepted international standard. The Declaration of Helsinki uniformly requires that all biomedical research involving human participants, including research on identifiable human material or data, should be approved by the EC. Today, concerns over the quality of the EC functions worldwide. There are research globally in this regard but no data are available from (...) Bangladesh. Hence, we conducted a questionnaire based pilot study on knowledge and attitude of EC members on bioethics and structure & function of EC in Bangladesh. (shrink)

Background Retraction is a mechanism for alerting readers to unreliable material and other problems in the published scientific and scholarly record. Retracted publications generally remain visible and searchable, but the intention of retraction is to mark them as “removed” from the citable record of scholarship. However, in practice, some retracted articles continue to be treated by researchers and the public as valid content as they are often unaware of the retraction. Research over the past decade has identified a number of (...) factors contributing to the unintentional spread of retracted research. The goal of the Reducing the Inadvertent Spread of Retracted Science: Shaping a Research and Implementation Agenda (RISRS) project was to develop an actionable agenda for reducing the inadvertent spread of retracted science. This included identifying how retraction status could be more thoroughly disseminated, and determining what actions are feasible and relevant for particular stakeholders who play a role in the distribution of knowledge. -/- Methods These recommendations were developed as part of a year-long process that included a scoping review of empirical literature and successive rounds of stakeholder consultation, culminating in a three-part online workshop that brought together a diverse body of 65 stakeholders in October–November 2020 to engage in collaborative problem solving and dialogue. Stakeholders held roles such as publishers, editors, researchers, librarians, standards developers, funding program officers, and technologists and worked for institutions such as universities, governmental agencies, funding organizations, publishing houses, libraries, standards organizations, and technology providers. Workshop discussions were seeded by materials derived from stakeholder interviews (N = 47) and short original discussion pieces contributed by stakeholders. The online workshop resulted in a set of recommendations to address the complexities of retracted research throughout the scholarly communications ecosystem. -/- Results The RISRS recommendations are: (1) Develop a systematic cross-industry approach to ensure the public availability of consistent, standardized, interoperable, and timely information about retractions; (2) Recommend a taxonomy of retraction categories/classifications and corresponding retraction metadata that can be adopted by all stakeholders; (3) Develop best practices for coordinating the retraction process to enable timely, fair, unbiased outcomes; and (4) Educate stakeholders about pre- and post-publication stewardship, including retraction and correction of the scholarly record. -/- Conclusions Our stakeholder engagement study led to 4 recommendations to address inadvertent citation of retracted research, and formation of a working group to develop the Communication of Retractions, Removals, and Expressions of Concern (CORREC) Recommended Practice. Further work will be needed to determine how well retractions are currently documented, how retraction of code and datasets impacts related publications, and to identify if retraction metadata (fails to) propagate. Outcomes of all this work should lead to ensuring retracted papers are never cited without awareness of the retraction, and that, in public fora outside of science, retracted papers are not treated as valid scientific outputs. (shrink)

Post-traumatic stress disorder is a “young” disorder formally recognized in the early 1980s, although the symptoms have been noted for centuries particularly in relation to military conflicts. PTSD may develop after a serious traumatic experience that induces feelings of intense fear, helplessness or horror. It is currently characterized by three key classes of symptoms which must cause clinically significant distress or impairment of functioning: persistent and distressing re-experiencing of the trauma; persistent avoidance of stimuli associated with the trauma and numbing (...) of general responsiveness; and persistent symptoms of hyper-arousal. One of the possible symptoms within the second class is difficulty in remembering an important aspect of the traumatic event.PTSD is not an uncommon condition, with an estimated lifetime prevalence of about 7-9% based on studies conducted in the United States and Canada, with women at higher risk than men. While not everyone who experiences a significant trauma will go on to develop PTSD, about a third will do so. Sexual assault, along with other forms of assaultive violence, pose a comparatively high risk of PTSD. (shrink)

It is common to think of medical and ethical modes of thought as different in kind. In such terms, some clinical situations are made more complicated by an additional ethical component. Against this picture, we propose that medical and ethical modes of thought are not different in kind, but merely different aspects of what it means to be human. We further propose that clinicians are uniquely positioned to synthesise these two aspects without prior knowledge of philosophical ethics.

The COVID-19 pandemic has coincided with the proliferation of ethical guidance documents to assist public health authorities, health care providers, practitioners and staff with responding to ethical challenges posed by the pandemic. Like ethical guidelines relating to infectious disease that have preceded them, what unites many COVID-19 guidance documents is their dependency on an under-developed approach to bioethical principlism, a normative framework that attempts to guide actions based on a list of prima facie, unranked ethical principles. By situating them in (...) relation to the key philosophical debates concerning bioethical principlism, we aim to explore the limits and limitations of pandemic ethical guidance documents as, specifically, ethics documents – documents that fulfil the functions of ethics as a fundamentally normative discipline. This means not only determining whether such ethical guidance documents can, in principle, provide adequate action guidance and action justification, but also, more importantly where pandemics are concerned, determining whether they support consistent decision making and transparent processes of justification. Having highlighted the problems with merely furnishing ethical guidelines with substantive ethical content in terms of principles and values, we argue that organizations that develop these documents should, instead, focus on the procedural dimensions of action guidance and action justification, which extend to questions regarding the make-up of the committees, panels and groups that develop such guidelines, the public transparency of justifications for specific pandemic-related advice or interventions and the development of explicit procedures for transparent and consistent decision making. (shrink)

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised by (...) clinical research conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad. (shrink)