AbstractThe Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report’s creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report’s features. Additionally, we analyze the effect of (...) unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials—which were at first expected to be applicable to research involving children—in addition to implementing policies regarding the public review of protocols that passed ethical review, this report’s principles are clearly reflected in the key notes that should have been referred to when the report was created. (shrink)

The nurse perspective is critical in survey research investigating various aspects of healthcare services, staff, and patient outcomes. Researchers are responsible for ensuring that survey research utilizing survey questionnaires employs research methodological strategies that are aligned with the ethical principles of beneficence, respect for persons, and justice. The purpose of this paper is to discuss best practices to facilitate high-quality survey data collection for nurse survey participants. Recommendations are based on the fundamental ethical principles described in the Belmont Report, an (...) overview of evidence published in the current literature, and the application of practical knowledge. Literature searches conducted in PubMed resulted in the inclusion of over 50 articles from a wide range of disciplines. The results include actionable methods for researchers to consider and follow when conducting survey research utilizing nurse participants. This article serves as a resource to guide researchers through ethically responsible design, implementation, and reporting of nurse survey research. (shrink)

In this paper we argue the need to reimagine research ethics frameworks to include notions of environmental sustainability. While there have long been calls for healthcareethics frameworks and decision-making to include aspects of sustainability, less attention has focused on howresearchethics frameworks could address this. To do this, we first describe the traditional approach to research ethics, which often relies on individualised notions of risk. We argue that we need to broaden this notion of individual risk to consider issues associated with (...) environmental sustainability. This is because research is associated with carbon emissions and other environmental impacts, both of which cause climate change health hazards. We introduce how bioethics frameworks have considered notions of environmental sustainability and draw on these to help develop a framework suitable for researchers. We provide a case study of data-driven health research to apply our framework. (shrink)

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...) what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

For decades, the Belmont Report—and the associated regulatory framework it inspired—has been a cornerstone in the ethical conduct of research involving human subjects. Despite its canonic status, t...

We agree with Saunkeah and colleagues that research ethics principles outlined by the Belmont Report—which guide the procedural basis for “human subjects” research in the United States throu...

We must resist thoroughly reframing climate change as a health issue. For human health–centric ethical frameworks omit dimensions of value that we must duly consider. We need a new, an environmental, research ethic, one that we can use to more completely and impartially evaluate proposed research on mitigation and adaptation strategies.

A recent systematic review of Machine Learning (ML) approaches to health data, containing over 100 studies, found that the most investigated problem was mental health (Yin et al., 2019). Relatedly, recent estimates suggest that between 165,000 and 325,000 health and wellness apps are now commercially available, with over 10,000 of those designed specifically for mental health (Carlo et al., 2019). In light of these trends, the present chapter has three aims: (1) provide an informative overview of some of the recent (...) work taking place at the intersection of text mining and mental health so that we can (2) highlight and analyze several pressing ethical issues that are arising in this rapidly growing field and (3) suggest productive directions for how these issues might be better addressed within future interdisciplinary work to ensure the responsible development of text mining approaches in psychology generally, and in mental health fields, specifically. In Section 1, we review some of the recent literature on text-mining and mental health in the contexts of traditional experimental settings, social media, and research involving electronic health records. Then, in Section 2, we introduce and discuss ethical concerns that arise before, during, and after research is conducted. Finally, in Section 3, we offer several suggestions about how ethical oversight of text-mining research might be improved to be more responsive to the concerns mapped out in Section 2. (shrink)

ZusammenfassungDie Uterustransplantation ermöglicht Frauen mit einer absoluten uterinen Infertilität eine Schwangerschaft mit biologisch eigenem Kind. Das neuartige experimentelle Verfahren wirft eine Reihe von ethischen Fragen auf. Ziel dieses Artikels ist es, relevante ethische Problemkonstellationen im Kontext der Uterustransplantation überblickshaft darzulegen und kritisch zu diskutieren. Als systematischer Rahmen der Darstellung dienen die vier Prinzipien der Medizinethik Autonomie, Nicht-Schaden, Wohltun und Gerechtigkeit nach Beauchamp und Childress. Nach eingehender ethischer Betrachtung plädieren die Autorinnen mit Blick auf die Akkumulation schwerwiegender ethischer Probleme für die (...) Notwendigkeit einer grundlegenden und umfassenden ethischen Debatte über Uterustransplantation. Ausgangspunkt einer solchen Debatte muss eine kritische Reflexion des normativen Stellenwerts des Leidens an einem unerfüllten Kinderwunsch sein. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

In 1974, the United States Congress asked a question prompting a national conversation about ethics: which ethical principles should govern research involving human participants? To embark on an answer, Congress passed the National Research Act, and charged this task to the newly established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission’s mandate was modest however, the results were anything but. The outcome was The Belmont Report: a trio of principles - respect for persons, (...) beneficence, and justice - serving as an ethical compass for scientists, researchers, and institutional review boards (IRBs). Almost 50 years later, the utility, legacy, and ingenuity of The Belmont Report continues to be both admired and challenged. Critics argue that Belmont is not fit for the 21st century, while supporters praise Belmont for its enduring wisdom. The goal of this paper is to equip IRB practitioners with the tools necessary to maximally interpret The Belmont Report and meaningfully engage in ethical analysis that reconsiders outmoded legacy thinking and fixed decision-making. Through historical and contextual reflection, this paper describes how IRB practitioners can contemporize review of ethical human research using their moral imagination – a skill found at the intersection of creativity, deliberation, and empathy. (shrink)

Research Ethics, Volume 18, Issue 1, Page 13-23, January 2022. School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to (...) fuel public mistrust in governmental programs and posed a potential threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents. (shrink)

Genomic data is generated, processed and analysed at an increasingly rapid pace. This data is not limited to the medical context, but plays an important role in other contexts in society, such as commercial DNA testing, the forensic setting, archaeological research, and genetic surveillance. Genomic information also crosses the borders of these domains, e.g. forensic use of medical genetic information, insurance use of medical genomic information, or research use of commercial genomic data. This paper (1) argues that an informed consent (...) approach for genomic information has limitations in many societal contexts, and (2) seeks to broaden the bioethical debate on genomic information by suggesting an approach that is applicable across multiple societal contexts. I argue that the contextual integrity framework, a theory rooted in information technology and big data ethics, is an effective tool to explore ethical challenges that arise from genomic information within a variety of different contexts. Rather than focusing on individual control over information, the contextual integrity approach holds that information should be shared and protected according to the norms that govern certain distinct social contexts. Several advantages of this contextual integrity approach will be discussed. The paper concludes that the contextual integrity framework helps to articulate and address a broad spectrum of ethical, social, and political factors in a variety of different societal contexts, while giving consideration to the interests of individuals, groups, and society at large. (shrink)

Despite growing evidence to the contrary, researchers continue to posit causal links between cannabis, crime, psychosis, and violence. These spurious connections are rooted in history and fueled decades of structural limitations that shaped how researchers studied cannabis. Until recently, research in this area was explicitly funded to link cannabis use and harm and ignore any potential benefits. Post-prohibition cannabis research has failed to replicate the dire findings of the past. This article outlines how the history of controlling cannabis research has (...) led to various harms, injustices, and ethical complications. We compare commonly cited research from both the prohibition and post-prohibition eras and argue that many popular claims about the dangers of cannabis are the result of ethical lapses by researchers, journals, and funders. We propose researchers in this area adopt a duty of care in cannabis research going forward. This would oblige individual researchers to establish robust research designs, employ careful analytic strategies, and acknowledge limitations in more detail. This duty involves the institutional recognition by funders, journals, and others that cannabis research has been deliberately misconstrued to criminalize, stigmatize, and pathologize. (shrink)

Saunkeah et al. argue that the principles of sovereignty and solidarity form the moral foundation for extending the Belmont Principles to tribal communities, by providing tribes with a right...

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...) consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential (...) threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents. (shrink)

The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as “procedural ethics” and the identification and handling of ethical issues by researchers during the research process as “ethics in practice.” While some authors dispute and other authors (...) defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors. (shrink)

Volume 19, Issue 6, June 2019, Page 19-21.

Мета роботи полягає у постметафізичній концептуалізації суб’єкта у клінічному дискурсі філософської антропології. Теоретичний базис дослідження поєднує засоби дискурсивної аналітики і загальні принципи історико-філософської науки. Логіка дослідження збігається із парадигмальним розумінням трансформацій суб’єкта та передбачає перехід від діагностичних стратегій аналізу індивідуального буття як основи патологічності суб’єкта до дослідження терапевтичних моделей концептуалізації комунікації як детермінанти патології та, нарешті, до аналітики суб’єкта в горизонті полісуб’єктної соціальності. Наукова новизна полягає у розкритті основних антропологічних моделей суб’єкта, що відповідають функціям діагностики й терапії. Показано, що, попри (...) революційність певних проектів, що дозволяє їх віднести до постметафізичних, у них залишаються рецидиви метафізичності, які існують в образі суб’єкта, що мислиться як основа справжності. Відповідно до критеріїв практичної імплементації ключовою є трансформація теорій суб’єкта, орієнтованих на самопокладання і автономію, у концепції, сфокусовані на відповідальності, турботі про суще і здійсненні у якості людини. Висновки. Доведено, що образ посткласичного суб’єкта, зосередженого на ідеалі власної автентичності, мусить діагностуватися як патологічний. Показана недоцільність акцентуації виключно на дискурсивності, розмові, результатом якої стає ствердження незалежності внутрішнього, хоч і маргінального світу девіантного суб’єкта. Обґрунтована необхідність доведення проблеми до логіки соціальної взаємодії, у якій виникає та форма смислової організації феноменів, що є нормальною структурою життєвого світу і на основі якої виникає повноцінний суб’єкт із уявленнями про власну самодостатність, і з турботою про суще. (shrink)

Purpose is the post-metaphysical conceptualization of the subject in the clinical discourse of philosophical anthropology. Theoretical basis of research combines the means of discursive analytics and the general principles of historical and philosophical science. The logic of the research coincides with the paradigmatic understanding of the subject’s transformations and suggests a transition from diagnostic strategies of the analysis of individual being as the basis of the pathological nature of the subject to the study of therapeutic models of communication as the (...) determinants of pathology and, finally, to the analytics of the subject in the horizon of polysubject sociality.Originality of the work consists in disclosing the basic anthropological models of the subject, corresponding to the functions of diagnosis and therapy. It is shown that, in spite of the revolutionary nature of certain projects, which allows them to be classified as postmetaphysical, they still have relapses of metaphysics existing in the image of the subject, which is conceived as the basis of authenticity. According to the criteria for practical implementation, the key is the transformation of the theories of the subject oriented toward self-determination and autonomy into concepts focused on responsibility, caring for what exists and how to exercise it as a person. Conclusions. The research proved that the image of the postclassical subject focused on the ideal of his own authenticity should be diagnosed as pathological. It showed that the accentuation is purely inexpedient in terms of discursiveness, conversation, and the result is the assertion of the independence of the internal, albeit marginal, world of the deviant subject. There is grounded the necessity of bringing the problem to the logic of social interaction, which raises the semantic phenomena organization form that is normal structure of the vital world; on its basis a full-fledged subject emerges with ideas about his own self-sufficiency, and concern for what exists. (shrink)