Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings.

OBJECTIVES: To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals. METHODS: Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature. RESULTS: This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties. CONCLUSIONS: These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.

On What Grounds? A Pilot Study of References Used in Clinical Ethics Consultation and Education.

In accordance with standards published by the American Society for Bioethics and Humanities (ASBH), ethics consultants are expected to provide recommendations that align with scholarly literature, professional society statements, law, and policy. However, there are no studies to date that characterize the specific references that ethics consultants and educators use to inform their work. To address this gap, a convenience sample of clinical ethics consultants and educators was surveyed online through two major listservs for clinical ethics, the ASBH Clinical Ethics Consultation Affinity Group (CECAG) and the Association of Bioethics Program Directors (ABPD). Ninety-five ethics consultants and/or educators with diverse educational background, credentials, and experience provided responses. In total, 451 references, 315 of which were unique, were reported. These references were broken into 6 categories after analysis: bioethics literature (divided into articles and books), professional society documents (divided into professional society statements and codes of ethics), federal/state/uniform/case law, hospital/health system policies, official religious teachings, and other. We found extensive variation and minimal overlap in the references respondents used for ethics consultation and education, even when referring to the same topics. Future research directions should include conducting more systematic efforts to characterize the references used by ethics consultants across the US; determining whether demographic characteristics of consultants influence the references used; and ascertaining whether the variation in references used reflects genuine disagreements in consultants' and educators' bioethical analysis or recommendations.

Neuroethics and cultural context: The case of electroconvulsive therapy in Argentina.

As neuroethics continues to grow as an established discipline, it has been charged with not being sufficiently sensitive to the way in which the identification, conceptualization, and management of the ethical issues raised by neuroscience and its applications are shaped by local systems of knowledge and structures. Recently there have been calls for explicit recognition of the role played by local cultural contexts and for the development of cross-cultural methodologies that can facilitate meaningful cultural engagement. In this article, we attempt to fill this perceived gap by providing a culturally situated analysis of the practice of electroconvulsive therapy (ECT) in Argentina. ECT was introduced as a psychiatric treatment in Argentina in the 1930s but it is largely underutilized. While the use of ECT remains low in several countries, what makes the Argentinian case interesting is that the executive branch of government has taken a stance regarding both the scientific and moral appropriateness of ECT, recommending its prohibition. Here, we begin with a recent controversy over the use of ECT in Argentina and explain the legal recommendation to ban its application. Next, we offer an overview of some of the salient aspect of the international and local discussions on ECT. We argue that the governmental recommendation to ban the procedure should be rethought. While acknowledging the role that contexts and local conditions play in shaping the identification and assessment of the relevant ethical issues, we caution against using contextual and cultural considerations to avoid a necessary ethical debate on controversial issues.

The structure of analogical reasoning in bioethics.

Casuistry, which involves analogical reasoning, is a popular methodological approach in bioethics. The method has its advantages and challenges, which are widely acknowledged. Meta-philosophical reflection on exactly how bioethical casuistry works and how the challenges can be addressed is limited. In this paper we propose a framework for structuring casuistry and analogical reasoning in bioethics. The framework is developed by incorporating theories and insights from the philosophy of science: Mary Hesse's ideas on horizontal and vertical relations in analogical reasoning in the sciences, Paul Bartha's articulation model of analogical reasoning and Daniel Steel's insights on mechanism-based extrapolation in biomedical research. Adopting our framework results in two practical benefits: it sets methodological standards for analogical reasoning and enables us to compare and evaluate diverging lines of analogical reasoning in a systematic way. Adopting the framework also has theoretical benefits: it helps to understand how analogical reasoning can have moral normativity; it pinpoints exactly where moral principles or theories enter analogical reasoning; and it helps to understand why casuistry is an attractive method in bioethics and in applied ethics more generally.

Editing the Human Genome with CRISPR/Cas: A Review of its Molecular Basis, Current Clinical Applications, and Bioethical Implications.

Abstract: CRISPR/Cas genes evolved in prokaryotic organisms as a mechanism of defense designed to identify and destroy genetic material from threatening viruses. A breakthrough discovery is that CRISPR/Cas system can be used in eukaryotic cells to edit almost any desired gene. This comprehensive review addresses the most relevant work in the CRISPR/Cas field, including its history, molecular biology, gene editing capability, ongoing clinical trials, and bioethics. Although the science involved is complex, we intended to describe it in a concise manner that could be of interest to diverse readers, including anyone dedicated to the treatment of patients who could potentially benefit from gene editing, molecular biologists, and bioethicists. CRISPR/Cas has the potential to correct inherited diseases caused by single point mutations, to knock-in the promoter of a gene whose expression is highly desirable or knockout the gene coding for a deleterious protein. CRISPR/Cas technique can also be used to edit ex vivo immune cells and reinsert them in patients, improving their efficiency in attacking malignant cells, limiting the infectious potential of viruses or modulating xenotransplant rejection. Very important bioethical considerations on this topic include the need to internationally regulate its use by ad hoc expert committees and to limit its use until safety and bioethical issues are satisfactorily resolved.

Affirming the Existence and Legitimacy of Secular Bioethical Consensus, and Rejecting Engelhardt's Alternative: A Reply to Nick Colgrove and Kelly Kate Evans.

One of the most significant and persistent debates in secular clinical ethics is the question of ethics expertise, which asks whether ethicists can make justified moral recommendations in active patient cases. A critical point of contention in the ethics expertise debate is whether there is, in fact, a bioethical consensus upon which secular ethicists can ground their recommendations and whether there is, in principle, a way of justifying such a consensus in a morally pluralistic context. In a series of recent articles in this journal, Janet Malek defends a positive view of ethics expertise, claiming that secular ethicists should comport their recommendations with bioethical consensus. In response, Nick Colgrove and Kelly Kate Evans deny the existence of a secular bioethical consensus; question why, even if it did exist, consensus should be considered a reliable way of resolving bioethical questions; and recommend a friendlier approach to clinical ethics based on the thought of H. Tristram Engelhardt Jr. In this article, I respond to Colgrove and Evans on all three points. In part one, I show there is a secular bioethical consensus but note it could be better consolidated and created through a more systematic and inclusive process. In part two, I argue that bioethical consensus is morally justified but note that this justification cannot be plausibly based upon claims that it only invokes moral principles available to or shared by all. In part three, I argue Engelhardt's approach cannot be described as "friendlier" to clinical ethics because it is incompatible with many current healthcare laws and policies.

The many metaphysical commitments of secular clinical ethics: Expanding the argument for a moral-metaphysical proceduralism.

The rich moral diversity of academic bioethics poses a paradox for the practice of giving moral recommendations in secular clinical ethics: How are ethicists to provide moral guidance in a pluralistic society? The field has responded to this challenge with a "procedural approach," but defining this term stirs debate. Some have championed a contentless proceduralism, where ethicists work only to help negotiate resolutions among stakeholders without making any moral recommendations. Others have defended a moral proceduralism by claiming that ethicists should make moral recommendations that are grounded in bioethical consensus (e.g., relevant law, policy, professional consensus statements, and bioethics literature), which is secured using moral principles such as respect for persons or justice. In contrast, we develop a moral-metaphysical proceduralism by identifying many metaphysical commitments in points of secular bioethical consensus. The moral-metaphysical view of secular clinical ethics is important because it challenges the discipline to accept the substantive philosophical foundations required to support giving moral recommendations in a pluralistic context, which may lead to further insights about the nature of the field.

Pursuing impact in research: towards an ethical approach.

BACKGROUND: Research proactively and deliberately aims to bring about specific changes to how societies function and individual lives fare. However, in the ever-expanding field of ethical regulations and guidance for researchers, one ethical consideration seems to have passed under the radar: How should researchers act when pursuing actual, societal changes based on their academic work? MAIN TEXT: When researchers engage in the process of bringing about societal impact to tackle local or global challenges important concerns arise: cultural, social and political values and institutions can be put at risk, transformed or even hampered if researchers lack awareness of how their 'acting to impact' influences the social world. With today's strong focus on research impacts, addressing such ethical challenges has become urgent within in all fields of research involved in finding solutions to the challenges societies are facing. Due to the overall goal of doing something good that is often inherent in ethical approaches, boundaries to researchers' impact of something good is neither obvious, nor easy to detect. We suggest that it is time for the field of bioethics to explore normative boundaries for researchers' pursuit of impact and to consider, in detail, the ethical obligations that ought to shape this process, and we provide a four-step framework of fair conditions for such an approach. Our suggested approach within this field can be useful for other fields of research as well. CONCLUSION: With this paper, we draw attention to how the transition from pursuing impact within the Academy to trying to initiate and achieve impact beyond the Academy ought to be configured, and the ethical challenges inherent in this transition. We suggest a stepwise strategy to identify, discuss and constitute consensus-based boundaries to this academic activity. This strategy calls for efforts from a multi-disciplinary team of researchers, advisors from the humanities and social sciences, as well as discussants from funding institutions, ethical committees, politics and the society in general. Such efforts should be able to offer new and useful assistance to researchers, as well as research funding agencies, in choosing ethically acceptable, impact-pursuing projects.

Views on Assisted Suicide and Religious Beliefs.

After the Austrian constitutional court decided to legalise assisted suicide, we conducted this cross-sectional survey study to assess how persons living in Austria viewed the decision, and whether their views associated with religious and/or moral beliefs. We found that persons claiming to be religious were significantly less likely to approve of the court's decision. They also advocated for significantly stricter regulations than non-religious respondents. When asked to give reasons for their response, several religious respondents cited their religious beliefs, highlighting that there is often an association between stronger religious beliefs and less favourable views on assisted suicide.

The Bioethical Dilemma of Gender-Affirming Therapy in Children and Adolescents.

Since the establishment of the first transgender clinic in the United States in 2007, over sixty clinics associated with children's hospitals have opened across the nation and are seeing very young children and adolescents with a diagnosis of gender dysphoria (GD). Once known as gender identity disorder, GD has been redefined by the latest version of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) not as a mental illness but as the distress experienced by individuals related to their biological sex. The widely accepted practice of gender-affirming therapy (GAT) to treat a vulnerable population despite the associated health risks, the lack of supportive scientific evidence for the pharmacological and surgical interventions, along with the unqualified claim that these interventions will decrease the rate of suicide in these individuals presents a significant bioethical dilemma. The growing trend of GD not only impacts the individuals diagnosed but also society, culture, and the integrity of the profession of medicine. This article utilizes the five-box method, an ethical decision-making framework, to address the implications of the proposed treatment. Once applied, it becomes clear that the hormonal and surgical approaches used are not scientifically or ethically justified. The patient's autonomy and preferences should be respected, yet constrained, if there exists a considerable risk to the well-being of the individual without proven benefits. The quality of life of those receiving this treatment has not been shown to be significantly improved long term, and the mental, physical, and spiritual health of individuals with GD is not thoroughly addressed in these clinics. The important social and contextual factors, on both microcosmic and macrocosmic scales, are minimized in favor of promoting an ideology. Ultimately, Catholic moral teaching reveals that this widely recommended treatment violates the body-soul union, disregards the principle of totality and integrity, and debases the dignity of humanity. SUMMARY: This article examines GAT, the paradigm used in treating individuals identifying as transgender, through the lens of an EDMF. Each stage of this widely proposed treatment - social affirmation, pubertal blockade, administration of cross-sex hormones, and sex reassignment surgery - poses harms and risks that are not fully disclosed to minors and families, creating a bioethical dilemma. Dialogue utilizing science and reasoning must be encouraged to assist individuals who experience a gender identity that rejects their biological sex. This approach would also contribute to the well-being of society.

Knowledge, Opinions and Behaviors of Senior Nursing Students in Turkey Regarding Euthanasia and Factors in Islam Affecting These.

The descriptive study was conducted to investigate the knowledge, opinions, behaviors of senior nursing students regarding euthanasia and factors in Islam influencing these. Almost all students (97.7%) knew about euthanasia. Their knowledge, opinions and behaviors were affected by their beliefs about death, religious beliefs and the idea of being subject to euthanasia themselves. Religion influenced whether they wanted euthanasia to be legalized or would carry it out secretly. Students who would be willing for their relatives to undergo euthanasia would not want to participate in this. Knowledge about the concept of euthanasia should be increased and the subject further investigated in many dimensions.

Bioethical problems arising in the study of single-nucleotide gene polymorphisms of occupational diseases.

In Ukraine, about 3 million people work in hazardous and dangerous conditions. The study of hereditary specificity in development of occupational diseases is being actively conducted through molecular genetic analysis of single-nucleotide gene polymorphisms. While studying single-nucleotide gene polymorphisms of occupational diseases, many complicated bioethical questions arise regarding the confidentiality of personal data, the choice between the profession chosen and the risk to one's own health. Complicated bioethical issues that arise when studying single-nucleotide gene polymorphisms of occupational diseases need to be actively discussed, not only by physicians, occupational pathologists, employers, scientists, but also by politicians and lawyers, taking into account ethical and social norms and implications.

The responsibilities of the engaged bioethicist: Scholar, advocate, activist.

The work of a bioethicist carries distinctive responsibilities. Alongside those of any worker, there are responsibilities associated with giving guidance to practitioners, policy makers and the public. In addition, bioethicists are professionally exposed to and required to identify situations of moral trouble, and as a result may find themselves choosing to work as advocates or activists, with responsibilities that are distinct from those generally acknowledged within academia. The requirement for bioethics to make normative judgements entails taking a stance, which means there cannot be a sharp line between 'academic' or 'objective' bioethics, and advocacy/activism, but a continuum of bioethicists' engagement and an associated continuum of responsibilities.

Health ethics and Indigenous ethnocide.

In colonial societies such as Canada the implications of colonialism and ethnocide (or cultural genocide) for ethical decision-making are ill-understood yet have profound implications in health ethics and other spheres. They combine to shape racism in health care in ways, sometimes obvious, more often subtle, that are inadequately understood and often wholly unnoticed. Along with overt experiences of interpersonal racism, Indigenous people with health care needs are confronted by systemic racism in the shaping of institutional structures, hospital policies and in resource allocation decisions. Above all, racism is a function of state law - of the unilateral imposition of the settler society law on Indigenous communities. Indeed, the laws, including health laws, are social determinants of the ill-health of Indigenous peoples. This article describes the problem of Indigenous ethnocide and explores its ethical implications. It thereby problematizes the role of law in health ethics.

Bioethical reflexivity and requirements of valid consent: conceptual tools.

BACKGROUND: Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it'. MAIN BODY: This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of 'how to obtain and ascertain valid consent to participation in health-related research' cannot always be fully answered by exclusive reference to pre-determined criteria/guidance provided by the guidelines and prior research'. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased. CONCLUSIONS: Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be - general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines' nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts.

'Bioethical Realism': A Framework for Implementing Universal Research Ethics.

Implementation of existing ethical guidelines for international collaborative medical and health research is still largely controversial in sub-Saharan Africa for two major reasons: One, they are seen as foreign and allegedly inconsistent with what has been described as an 'African worldview', hence, demand for their strict implementations reeks of 'bioethical imperialism'. Two, they have other discernible inadequacies - lack of sufficient detail, apparent as well as real ambiguities, vagueness and contradictions. Similar charges exist(ed) in other non-Western societies. Consequently, these guidelines have been correctly judged as an inadequate response to the complex and ever shifting dilemmas met by researchers and research regulators in the field. This paper proposes a framework for effective implementation of existing guidelines without much worry about bioethical imperialism and other inadequacies. This framework is proposed using an analogy of Legal Realism, specifically its key assertions on how, in reality, judicial systems operate using general legal rules to settle specific cases. Legal realists assert that in judicial decision-making, general legal rules do not totally dictate court decisions in specific cases. This analogy is used to coin a new term, 'Bioethical Realism.' The framework suggests that local Research Ethics Committees ought to be construed as analogues of judicial courts with the resulting implications. Consequently, just like legal rules are general rules that do not always dictate court decisions, similarly international bioethical guidelines are general ethical rules that should not always dictate local RECs' decisions and such decisions (ought to) enjoy considerable immunity from outsiders.

Survey on Using Ethical Principles in Environmental Field Research with Place-Based Communities.

Researchers of the Northeast Ethics Education Partnership (NEEP) at Brown University sought to improve an understanding of the ethical challenges of field researchers with place-based communities in environmental studies/sciences and environmental health by disseminating a questionnaire which requested information about their ethical approaches to these researched communities. NEEP faculty sought to gain actual field guidance to improve research ethics and cultural competence training for graduate students and faculty in environmental sciences/studies. Some aspects of the ethical challenges in field studies are not well-covered in the literature. More training and information resources are needed on the bioethical challenges in environmental field research relating to maximizing benefits/reducing risks to local inhabitants and ecosystems from research; appropriate and effective group consent and individual consent processes for many diverse communities in the United States and abroad; and justice considerations of ensuring fair benefits and protections against exploitation through community-based approaches, and cultural appropriateness and competence in researcher relationships.

African bioethics: methodological doubts and insights.

BACKGROUND: A trend called 'African bioethics' is growing on the continent due to perceptions of existing bioethics, especially guidelines for international collaborative research, as 'ethical imperialism'. As a potential alternative to 'Western Principlism,' 'African bioethics' is supposed to be indigenous to Africa and reflective of African identity. However, despite many positive insights in the on-going discussions, it is feared that the growth of bioethics in Africa lacks a clear direction. Some of the views threaten to distort the essence of bioethics and its development on the continent. MAIN TEXT: This paper presents some of the dominant views on 'African bioethics', an examination of which reveals some valuable insights into the direction bioethics in Africa ought to take, but at the same time confirms some methodological challenges in some contributions to the discussion. On top of acknowledging critical insights in the discussion, the paper reveals that some views are characterized by arbitrariness and rhetorical discussions based on a strong negative and yet hard-to-accept assumption; doubtful designation; lack of a clearer problem being addressed and consequently obscure question(s) and aim(s) of the discourse. Finally, some methodological insights are proposed to guide bioethics research and scholarship in Africa. Specifically, the paper proposes that in search for the legitimacy of bioethics in Africa, we ought to protect the essence of bioethics by giving considerable attention to the utility of subsequent bioethics. To achieve this we need to specify the problem and proper designation for the discourse; focus on principles qua principles with impartiality and how to ensure their strict implementation; and encourage critical thinking as part of bioethics. CONCLUSION: In cultivating bioethics in Africa, the pursuit of identity is legitimate but must be conditional in light of other competing considerations. We should focus on an objective search for bioethical principles that can be effective in responding to African and global health challenges of moral significance, irrespective of the origin of the principles and at the same time focus more on strategies for ensuring compliance with resulting principles.

Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

The Ethics of Organ Donation in Patients Who Lack the Capacity for Decision Making.

Free and informed consent is the legal and ethical basis for organ donation from living donors, and is a requirement for making an autonomous health decision. In clinical practice, health-care providers are required to respect four bioethical principles: respect for autonomy, beneficence, non-maleficence, and justice (Beauchamp & Childress, 2012), with the best interest of their patients in mind. Yet there are bioethical concerns behind organ procurement from living donors who have never attained capacity, do not yet have the capacity, or have permanently lost the capacity for decision making. A consensus statement by the Live Organ Donor Consensus Group (Abecassis et al., 2000) protects these donors' well-being and autonomy, but there still is a need to raise ethical awareness about the decision-making process regarding vulnerable potential donors. Health-care providers who are staff members in transplant clinics should be aware of the current consensus statement, commit to essential bioethical principles surrounding organ donation, and advocate for vulnerable living donors.