A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard care in (...) medical research ethics, as well as considerations of distributive justice in non-ideal circumstances, I argue that the practice of using the status quo as a control is ethically justifiable. However, I add an important qualification based on the natural duty of rescue to address the concern that my account is overly permissive. (shrink)

The aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. (...) We also propose that a broader definition of manipulation of information should be adopted (than that already existing in the literature) since informational manipulation can affect not only a person’s beliefs but also their desires in decision-making. We conclude that manipulation of information can either be used to protect the potential subject and facilitate the informed consent process or be used to exploit and merely use a person for scientific goals. (shrink)

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

This article is based on a qualitative longitudinal study that followed the subjective experiences of both people living with dementia and their family members during the early stages of the illness. The purpose of this article is to describe and reflect on the ethical and methodological issues that occurred during data collection. The article focuses on the situation of the person with dementia and the family member and the role of the researcher when conducting the research interviews. Based on the (...) results of this study, conducting research interviews with people with dementia and their family members poses several ethical and methodological challenges that must be addressed. In doing so, ethically sound dementia-specific research methods will be actively developed enhancing our understanding of living with dementia and providing new insights into the care of people with dementia and their family members. (shrink)

Without trust there is no credible human health research (HHR). This article accepts this truism and addresses a crucial question that arises: how can trust continually be promoted in an ever-changing and uncertain HHR environment? The article analyses long-standing mechanisms that are designed to elicit trust—such as consent, anonymization, and transparency—and argues that these are best understood as trust represented by proxies of trustworthiness, i.e., regulatory attempts to convey the trustworthiness of the HHR system and/or its actors. Often, such proxies (...) are assumed to operate as markers that trust exists or, at least, has not been lost. But, since trust can neither be “built” nor “secured,” this is a precarious assumption. Worryingly, there is no existing theoretical account of how to understand and evaluate these proxies of trustworthiness as part of a trusted HHR ecosystem. To remedy this, the paper argues for a radical reimagining of trust and trustworthiness as performative acts that ought to be understood in relation to each other and by reference to the common values at stake. It is shown that proxies of trustworthiness are the operational tools used to perform trustworthiness. It advocates for a values-based approach to understanding the relationship between trust and trustworthiness. This establishes a strong basis for an evaluative framework for proxies of trustworthiness, i.e., to determine how to perform trustworthiness well. Five common proxies in HHR are scrutinized from a values perspective. The contribution is to provide a far-reaching normative and practical framework by which existing and future proxies of trustworthiness can be identified, assessed, maintained, or replaced in rapidly changing HHR regulatory ecosystems where trust itself is crucial to the success of the entire HHR enterprise. (shrink)

Philosophy and Literature is an internationally renowned refereed journal founded by Denis Dutton at the University of Canterbury, Christchurch. It is now published by the Johns Hopkins University Press. Since its inception in 1976, Philosophy and Literature has been concerned with the relation between literary and philosophical studies, publishing articles on the philosophical interpretation of literature as well as the literary treatment of philosophy. Philosophy and Literature has sometimes been regarded as iconoclastic, in the sense that it repudiates academic pretensions, (...) insidious jargon and institutional vogue. Dutton, who remains the editor, still writes a regular column. A distinctive feature of Philosophy and Literature was the annual Bad Writing Contest, held from 1995–98, which sought to identify (and publish) the ‘most stylistically lamentable passages’ of academic prose, often to great amusement. (shrink)

Forschung an und mit Menschen muss sich legitimieren, d. h. sie muss ihre wissenschaftliche Qualität, Rechtmäßigkeit und ethische Vertretbarkeit aufzeigen. Zu den Rechtfertigungsbedingungen zählt ein „günstiges“ Verhältnis von Nutzen- und Schadenpotenzialen des Forschungsvorhabens. Unabhängige Ethikkommissionen sind den Forschenden zur Seite gestellt, um sie bei der Prüfung und Sicherstellung der genannten Erfordernisse zu unterstützen. Eine zum Gebrauch durch Ethikkommissionen und Forschende entwickelte Nutzen- und Schadentaxonomie sowie ein Schema zur Systematisierung von Chancen-Risiken-Bewertungen wurde nachträglich auf alle Ethikanträge des Jahres 2006 an die (...) Ethikkommission der Medizinischen Fakultät der Universität zu Lübeck angewandt. Unter den 206 analysierten Studienvorhaben lassen 46 % die Chance eines direkten Eigennutzens für die Studienteilnehmer erkennen. Als gruppennützig wurden 12 % der Studienprojekte eingestuft. Sie lassen unmittelbar nach Studienabschluss oder nach wenigen weiteren Studien ein Nutzenpotenzial für Personen mit den gleichen demographischen und klinischen Merkmalen wie die Studienteilnehmer erwarten. 42 % der Ethikanträge bezogen sich auf fremdnützige Studienvorhaben mit Nutzenchancen für die Heilkunde und/oder medizinische Wissenschaft. Das Risiko eines mehr als geringfügigen Eigenschadens wurde bei 53 % der Studien identifiziert. Die Analyse der jeweiligen Nutzenchancen und Schadenrisiken führte bei insgesamt 33 der 206 Studien (16 %) zu einem negativen Ergebnis: Im Urteil der nachträglich durchgeführten Bewertung übertreffen die Nutzenchancen nicht die Schadenrisiken. Studien mit einem mehr als geringfügigen Eigenschadenpotenzial sowie nicht-eigennützige Studien weisen besonders häufig eine negative Gesamtbilanz auf. Eine Prozeduralisierung der Analyse von Chancen und Risiken kann die Transparenz vorgenommener Analyse- und Vergleichsprozesse steigern. Die Kommunikation zwischen Forschenden und Ethikkommissionen sowie unter Ethikkommissionsmitgliedern bei strittigen Studienvorhaben wird erleichtert, die Standardisierung und Harmonisierung der Beratungsabläufe der Ethikkommissionen unterstützt. (shrink)

Forschung an und mit Menschen muss sich legitimieren, d. h. sie muss ihre wissenschaftliche Qualität, Rechtmäßigkeit und ethische Vertretbarkeit aufzeigen. Zu den Rechtfertigungsbedingungen zählt ein „günstiges“ Verhältnis von Nutzen- und Schadenpotenzialen des Forschungsvorhabens. Unabhängige Ethikkommissionen sind den Forschenden zur Seite gestellt, um sie bei der Prüfung und Sicherstellung der genannten Erfordernisse zu unterstützen. Eine zum Gebrauch durch Ethikkommissionen und Forschende entwickelte Nutzen- und Schadentaxonomie sowie ein Schema zur Systematisierung von Chancen-Risiken-Bewertungen wurde nachträglich auf alle Ethikanträge des Jahres 2006 an die (...) Ethikkommission der Medizinischen Fakultät der Universität zu Lübeck angewandt. Unter den 206 analysierten Studienvorhaben lassen 46 % die Chance eines direkten Eigennutzens für die Studienteilnehmer erkennen. Als gruppennützig wurden 12 % der Studienprojekte eingestuft. Sie lassen unmittelbar nach Studienabschluss oder nach wenigen weiteren Studien ein Nutzenpotenzial für Personen mit den gleichen demographischen und klinischen Merkmalen wie die Studienteilnehmer erwarten. 42 % der Ethikanträge bezogen sich auf fremdnützige Studienvorhaben mit Nutzenchancen für die Heilkunde und/oder medizinische Wissenschaft. Das Risiko eines mehr als geringfügigen Eigenschadens wurde bei 53 % der Studien identifiziert. Die Analyse der jeweiligen Nutzenchancen und Schadenrisiken führte bei insgesamt 33 der 206 Studien (16 %) zu einem negativen Ergebnis: Im Urteil der nachträglich durchgeführten Bewertung übertreffen die Nutzenchancen nicht die Schadenrisiken. Studien mit einem mehr als geringfügigen Eigenschadenpotenzial sowie nicht-eigennützige Studien weisen besonders häufig eine negative Gesamtbilanz auf. Eine Prozeduralisierung der Analyse von Chancen und Risiken kann die Transparenz vorgenommener Analyse- und Vergleichsprozesse steigern. Die Kommunikation zwischen Forschenden und Ethikkommissionen sowie unter Ethikkommissionsmitgliedern bei strittigen Studienvorhaben wird erleichtert, die Standardisierung und Harmonisierung der Beratungsabläufe der Ethikkommissionen unterstützt. (shrink)

The application of human right frameworks is an increasingly important part of efforts to accelerate progress in global mental health. Much of this has been driven by several influential legal and policy instruments, most notably the United Nations’ Convention on the Rights of Persons with Disabilities, as well as the World Health Organization’s QualityRights Tool Kit and Mental Health Action Plan. Despite these significant developments, however, much more needs to be done to prevent human rights violations. This chapter focuses on (...) a critical component of this broader challenge, which is the question of how best to regulate and reduce the use of coercive measures. The recent literature on coercion in psychiatry – which addresses involuntary commitment, seclusion, restraint, and forced medication – represents a useful resource that can help guide tractable solutions in global mental health. These issues are evaluated from the perspective of global health governance, and several general recommendations are made in order to improve monitoring and enforcement, provide guidance for domestic legislative reform, and strengthen health systems. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements (3): therapeutic, preventive, (...) and pure enhancements. This demands a revision of the Assumption (4), alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought (5). While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

The increasing need for innovative research driven by rapid global changes gives doctoral supervisors of early-stage researchers a significant role in facilitating the ethical conduct of qualitative research. In the context of European Commission funding, the demands of research ethics and integrity place a tremendous responsibility on the supervisors of early-stage researchers involved in cross-national projects. This document study seeks to illuminate the role of the supervisors in facilitating research ethics in these projects. Specifically, we describe and discuss the supervisor (...) role associated with five approaches to doctoral supervision of qualitative research, namely those described as ‘Functional’, ‘Enculturation’, ‘Critical thinking’, ‘Emancipation’ and ‘Developing a quality relationship’. The main challenges for supervisors of cross-national research projects are the cultural and linguistic mobilisation of ethical principles in qualitative research processes and the management of the future use of open data. The results from this study have implications for planning and conducting cross-national studies within research involving human participants. These results can guide supervisors in the codification and mobilisation of ethical qualitative research in practice. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South (...) African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations. (shrink)

BackgroundIn their professional practice, teachers can exert a strong influence on students, promoting healthy habits for life through the example of their own lifestyle. The aim of this study was to compare sports habits and attitudes in Physical Activity and Sports Education students at the universities of León and Mostaganem.MethodsWe administered the “Motivations and Attitudes Toward Physical Activity and Sports” questionnaire to 125 Algerian university students from the Institute for Physical Education and Sport and 122 Spanish university students from the (...) Faculty of Physical Activity and Sport Science.ResultsChi-square tests showed significant differences with a large effect size in perceptions of sport and satisfaction with participation.ConclusionThe students from Mostaganem and Leon show many similarities, such as the number of female students in physical education and sport is quite small compared to male students. Both consider that universities should improve sports facilities to promote good practice. The practice of sports by our university students is far superior to that of students with other degrees, suggesting that they will set a good example of healthy habits once they enter their profession. Nevertheless, the participation of female Algerian students in sport was lower than that of Spanish students, and students at León showed more intrinsic motivation for participating in sport than their counterparts at Mostaganem. (shrink)

The need for research to advance scientific understanding must be balanced with ensuring the rights and wellbeing of participants are safeguarded, with some research topics posing more ethical quandaries for researchers than others. Moral injury is one such topic. Exposure to potentially morally injurious experiences can lead to significant distress, including post-traumatic stress disorder, depression, and selfinjury. In this article, we discuss how the rapid expansion of research in the field of moral injury could threaten the wellbeing, dignity and integrity (...) of participants. We also examine key guidance for carrying out ethically responsible research with participants’ rights to self-determination, confidentiality, non-maleficence and beneficence discussed in relation to the study of moral injury. We describe how investigations of moral injury are likely to pose several challenges for researchers including managing disclosures of potentially illegal acts, the risk of harm that repeated questioning about guilt and shame may pose to participant wellbeing in longitudinal studies, as well as the possible negative impact of exposure to vicarious trauma on researchers themselves. Finally, we offer several practical recommendations that researchers, research ethics committees and other regulatory bodies can take to protect participant rights, maximise the potential benefits of research outputs and ensure the field continues to expand in an ethically responsible way. (shrink)

Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is expected to (...) expand, this undifferentiated minimal risk and burden requirement does not suffice any more. In the upcoming revision of the Declaration, the paragraph at stake should be refined in such a way that it is not unnecessarily restrictive or more permissive than can be ethically justified. Our first recommendation is to stimulate research ethics committees to identify more accurately those risks and burdens that the research subjects must undergo solely for research purposes by distinguishing between two types of study procedures instead of between two types of studies. Our second recommendation is to allow for exceptions to the minimal risk and burden requirement in cases of exceptionally valuable studies that involve subjects who can give their assent to participate in the study and that involve at most a minor increase over minimal risk and/or burden. (shrink)

Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals (...) to risks for the benefit of others. Yet, many other activities that expose some individuals to risks for the benefit of others are not subject to extensive regulation and oversight. This difference raises the question of whether clinical research is distinct from these activities in normatively relevant ways and, if so, what implications this difference (or differences) has for how clinical research should be regulated and conducted. The present manuscript attempts to answer this question by comparing clinical research to two other activities that expose some individuals to risks for the benefit of others. This comparison highlights an aspect of clinical research which has received relatively little attention, namely, the active role investigators play in exposing subjects to risks. I argue that this aspect explains much of the ethical concern expressed regarding clinical research. I end by considering the normative significance of this feature and the implications it has for how clinical research should be regulated and conducted. (shrink)

The Standard View in research ethics maintains that, under certain conditions, investigators may deceive subjects and may enroll subjects without their consent. In contrast, it is always impermissible to coerce subjects to enroll, even when the same conditions are satisfied. This view raises a question that, as far as we are aware, has received no attention in the literature. Why is it always impermissible to undermine the validity of subjects’ consent through coercion, but it can be permissible to undermine the (...) validity of subjects’ consent through deception, and it can be permissible to enroll subjects without any consent at all? The present analysis suggests that the answer traces to the conditions on the appropriate treatment of subjects. This conclusion suggests that some requirements for human subjects research, and for valid consent more generally, trace not to the protection of subjects per se but to the proper behavior of agents. (shrink)

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern (...) by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (shrink)

There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, (...) the present manuscript argues that involving host communities in this process helps to promote four important goals: protecting host communities, respecting host communities, promoting transparency, and enhancing social value. (shrink)

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this (...) gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. (shrink)

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) (...) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their patients; (4) address the challenges posed by research containing a mixture of interventions and (5) define ethical standards according to which the risks and potential benefits of research may be consistently evaluated. This response argues that the net risks test meets none of these criteria and concludes that it is not a viable alternative to component analysis. (shrink)

Paying research participants in developing countries like Uganda raises ethical concerns over potential for undue inducement. This article, based on an exploratory study, reviewed 49 research protocols from a national HIV/AIDS research ethics committee database. Payments mainly adhered to the reimbursement and compensation payment models. Offers made were diverse but basic in order to limit undue inducement. Implications in terms of undue inducement and possible impact on participants and research are discussed. We end by recommending standardization across comparable studies in (...) the interests of promoting high-quality research, altruism, voluntariness, and restraining unfair reimbursement practices in research. (shrink)

Concerns have been expressed about adult behaviour at children’s sporting events in New Zealand. As a consequence, covert observation was identified as the optimal research method to be used in studies designed to record the nature and prevalence of adult sideline behaviour at children’s team sporting events. This paper explores whether the concerns raised by the ethics committee about the use of this controversial method, particularly in relation to the lack of informed consent, the use of deception, and researcher safety, (...) were effectively managed. This is achieved by reflecting on the conduct and findings of the research and by drawing on the perspectives of research assistants who carried out the covert observation. The authors argue that in the context of these studies, the ends have justified the means and with careful attention to the design of the study the complex ethical tensions arising from the use of this method can be managed. (shrink)

By their very nature, overseas medical missions (and even domestic medical charities such as free clinics ) are designed to serve vulnerable populations. If these groups were capable of protecting their own interests, they would not need the help of medical volunteers: their medical needs would be met through existing government health programs or by utilizing their own resources. Medical volunteerism thus seems like an unfettered good: a charitable activity provided by well-meaning doctors and nurses who want to give of (...) their time, skills, and resources to help those who would not otherwise be able to take care of their medical needs. In this article, I argue that if medical volunteerism is to be good, however, it must always meet certain basic ethical requirements. These requirements may be (and perhaps often are) overlooked in the rush to organize and carry out short-term medical missions. I illustrate my point with special reference to short-term medical missions designed to provide surgical repair of obstetric vesico-vaginal fistula, a condition in which the tissues that normally separate the bladder from the vagina are destroyed by obstetric trauma, leading to continuous and unremitting incontinence in the affected woman. (shrink)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states (...) various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

The Helsinki Declaration is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration calls for research studies to compare new therapies to the best current therapies. Despite this standard, multiple studies of pain relief interventions in newborns have recruited placebo controls instead of active controls using the best current therapy. These studies are evaluated using the standards required by the Helsinki Declaration, and the reasons for the ethical shortcomings of these studies are explored.

The Helsinki Declaration, first published in 1964, is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration was formulated in response to the abuses of human subjects by the scientists in Nazi Germany and to update the Nuremberg Code. Amended in 1975, 1983, 1989, 1996, and 2000, the Declaration provides the foundation for the United States federal regulations for research involving human subjects.To conform to standards developed in the Declaration, a researcher must fulfill the following: (...) respect the autonomy of the individual; promote and safeguard the individual’s health; provide informed consent without coercion; take special measures with vulnerable populations; compare new therapies to the best current therapies; have a thorough scientific knowledge of the subject; assess risk versus benefit of the intervention; perform studies that will ultimately benefit the population involved in the research; accurately report their findings; and fully disclose ethical concerns in their research protocols. (shrink)

Sankary et al. (2022) report the results of an empirical study on research participant experiences of exiting research at the end of clinical trials of deep-brain-stimulation (DBS) and responsive n...

Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were collected from (...) 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. (shrink)

The Higher School Certificate is a certificate that recognises the successful completion of secondary education in New South Wales, Australia. The most recent enrolment information available suggests that at least 13,472 students undertaking the NSW Higher School Certificate in 2019 conducted research projects that involved human participants. During the course of their high school education current HSC students are taught research design principles and statistics so that they are equipped to plan a research project and determine the meaning of the (...) outcome; however, the students are not systematically taught the application of research ethics during their high school years. This article contends that the NSW HSC curriculum be expanded to include instruction in and application of the fundamentals of research ethics to these high school projects to ensure that all participants involved in these projects are accorded respect and protection as intended by the Australian National Statement on Ethical Conduct in Human Research. (shrink)

Background Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial. Methods This REA (...) was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach. Result Most of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized. Conclusion Through REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient. (shrink)

The number of people with dementia is increasing worldwide. At the same time, family and professional caregivers’ resources are limited. A promising approach to relieve these carers’ burden and assist people with dementia is assistive technology. In order to be useful and accepted, such technologies need to respect the values and needs of their intended users. We applied the value sensitive design approach to identify values and needs of patients with dementia and family and professional caregivers in respect to assistive (...) technologies to assist people with dementia in institutionalized care. Based on semi-structured interviews of residents/patients with cognitive impairment, relatives, and healthcare professionals (10 each), we identified 44 values summarized by 18 core values. From these values, we created a values’ network to demonstrate the interplay between the values. The core of this network was caring and empathy as most strongly interacting value. Furthermore, we found 36 needs for assistance belonging to the four action fields of activity, care, management/administration, and nursing. Based on these values and needs for assistance, we created possible use cases for assistive technologies in each of the identified four action fields. All these use cases already are technologically feasible today but are not currently being used in healthcare facilities. This underlines the need for development of value-based technologies to ensure not only technological feasibility but also acceptance and implementation of assistive technologies. Our results help balance conflicting values and provide concrete suggestions for how engineers and designers can incorporate values into assistive technologies. (shrink)

Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fail to comply, this is particularly true in case of the studies initiated by domestic sponsors or sponsor-investigators and published in Russian language medical journals. This exploratory research aims to discover whether it is a sporadic non-compliance with regulations or a common practice. (...) Methods We searched the Russian language database eLIBRARY for the phrase ‘results of a randomised trial’. We selected publications reporting clinical trials and conducted in Russia. For each of the selected studies, we searched the state register of the approved clinical trials. We assessed whether the investigational medicinal product was approved for marketing in Russia; the therapeutic indications, posology, and administration method in the clinical trial were consistent with the approved labelling; the issue of the journal included an advertisement of the medicinal product in question; and the full description of the methodology corroborated that the clinical trial was randomised, as was stated in the title or abstract. Results Of the 26 selected articles, 22 reported the results of unauthorised clinical trials. Three of those trials were conducted in children. Twenty-one studies reported on data from unauthorised trials for investigational products approved for marketing in Russia. However, in nine cases, the therapeutic indications, posology, or administration method did not match the conditions indicated in the labelling. Moreover, in one case, the unauthorised trial included a drug therapy intervention where the active substance was not approved for use in any medicinal product marketed in Russia. In 14 of the 26 articles, the issue of the journal or the article itself contained an advertisement for the same medicinal product or, in one case, its manufacturer. All publications accompanied by advertisements claimed that the medicinal product in question was efficacious. Conclusions A substantial fraction of the clinical trials initiated by domestic sponsors and reported in Russian medical journals failed to obtain the mandatory prior evaluation and approval from the regulator. This can affect the rights and well-being of the study participants and the scientific validity of the studies. (shrink)

Introduction It is a goal in nursing education to promote students’ dignity and facilitate this core value. Students’ experience of dignity is shaped by the student–supervisor relationship. Literature shows limited knowledge about how nursing students experience their own dignity during education. Research aim The aim of the study is to develop an understanding of how nursing students experience their own dignity in relation to supervisors, and what significance these experiences have in education. Research design Gadamer’s philosophical hermeneutics was chosen as (...) the approach, and narratives and qualitative interviews were conducted. The interpretation process was inspired by Fleming, Gaidys and Robbs. Participants and research context Nineteen nursing students in the final year of their education were included in the study. They represented six different campuses at three different educational institutions. The qualitative interviews took place at the educational institutions. Ethical considerations The research recommendations of the Declaration of Helsinki were followed. Access to the students was given by the educational institutions. All interested students signed a continuous informed consent. Findings Students’ dignity was at stake in encounters with supervisors during education. Decisive for experience of dignity was the supervisor’s ability to confirm the student through acknowledgment, reassurance and seeing them as individuals. Experienced dignity had a crucial impact on students’ life courage and their ability to be present. Discussion The discussion emphasizes the vulnerable dignity of students, the importance of confirmation and the significance perceived dignity has. Conclusion Students’ experiences tilted between perceived dignity and offense, and placed students’ dignity in a vulnerable position. Crucial for perceived dignity was the confirmation the students received from their supervisors. Perceived dignity gave the students courage and increased their ability to be present, which provided better opportunities for learning and development. (shrink)

Introduction: Dignity is a core value in nursing. Nursing education shall prepare students for ethical professional practice and facilitate insight into the phenomenon of dignity and its significance. There is limited knowledge about how nursing students discover dignity in their education. Research aim: The aim of the study is to develop an understanding of how nursing students discover and acquire dignity. Research design: The study has a hermeneutic approach where qualitative interviews of nursing students were employed. The process of interpretation (...) was inspired by text of Fleming, Gaidys and Robbs. Participants and research context: Nineteen nursing students agreed to be included in the study, representing six different campuses at three different educational institutions. All were in the final year of their study. The interviews took place at the educational institutions. Ethical considerations: The educational institutions facilitated recruitment of the students who signed voluntarily for participation and continuous informed consent. The study was approved by The Norwegian Center of Reporting Data. The research recommendations of the Declaration of Helsinki were followed. Findings: The nursing students discovered the expression and significance of dignity through experiences, gained through introspection and in interaction with others during the education. Discussion: The findings are discussed using Gadamer’s concept of experience and how experiences can create new insight. In particular, the students’ experiences with the inner ethical and external aesthetic dimension of dignity are discussed. Conclusion: The study shows that students discovered the inner ethical dignity through experiencing vulnerability, pride and shame. They discovered the external aesthetic dignity through incidents, where they experienced both to be confirmed and not to be confirmed, and through observation of good or bad role models. Crucial negative and positive experiences are important for discovering the expression and significance of dignity. (shrink)

Based on action research as a practitioner‐involving approach, this article communicates the findings of a two‐year study on implementing patient participation as an empowering learning process for both patients and rehabilitation nurses. At a rehabilitation facility for patients who have sustained spinal cord injuries, eight nurses were engaged throughout the process aiming at improving patient participation. The current practice was explored to understand possibilities and obstacles to patient participation. Observations, interviews and logbooks, creative workshops and reflective meetings led to the (...) development and testing of four new rehabilitation initiatives aimed at enhancing patient participation. This study suggests that skills of critical reflection from action research toolbox shed light on both the notion of patient participation and caring in nursing rehabilitation. By actively involving nurses in research, the knowledge development stems from practice and the solutions therefore became practice‐oriented. In addition, the personal and professional development experienced by the involved nurses points to a secondary gain in the form of an analytical and reflective approach to complex issues in relation to patient participation, rehabilitation in general and the individual nurses' sense of professional pride. (shrink)

A growing number of professional associations and occupational groups are creating codes of ethics with the goal of guiding their members, protecting service users, and safeguarding the reputation of the profession. There is a great deal of literature dealing with the question to what extent ethical codes can achieve their desired objectives. The present paper does not contribute to this debate. Its aim is rather to investigate how rational it is to comply with codes of conduct. It is natural and (...) virtually inevitable for a reflective person to ask why one should pay any attention to ethical codes, in particular if following a code is not in one’s own interest. In order to achieve the aim of this paper, I shall discuss reasons that only appear to be reasons for complying with a code. In “Code-independent reasons” section, I shall present genuine practical reasons that, however, turn out to be reasons of the wrong kind. In “Code-dependent reasons” section finally presents the most important reasons for complying with ethical codes. The paper argues that while ethical codes do not necessarily yield reasons for action, professionals can have genuine reasons for complying with a code, which may, however, be rather weak and easily overridden by reasons for deviating from the code. (shrink)

This essay concerns itself with the methodology of practical ethics. There are a variety of methods employed in ethics. Although none have been firmly established as dominant, it is generally agreed that casuistry, or the case-based method, is one important strategy commonly used for resolving ethical issues. Casuists compare the case under consideration to a relevantly similar precedent case in which judgements have already been made, and they use these earlier judgements to determine the proper resolution of the present case. (...) In this article, I try to provide a better understanding of the nature of contemporary casuistry. To accomplish this, I explain the basic features of casuistic reasoning. The second section focuses on the logic of casuistry. By assessing casuistic reasoning from the logical viewpoint, casuistry can be reconstructed as a logically correct method of reasoning. The third section looks at casuistry from the epistemic point of view and investigates the justificatory force of casuistic reasoning. Finally, in the fourth section, I show the usefulness of formal casuistry. (shrink)

In this paper I am concerned with risk–benefit analysis; that is, the comparison of the risks of a situation to its related benefits. We all face such situations in our daily lives and they are very common in medicine too, where risk–benefit analysis has become an important tool for rational decision-making. This paper explores risk–benefit analysis from a logical point of view. In particular, it seeks a better understanding of the common view that decisions should be made by weighing risks (...) against benefits and that an option should be chosen if its benefits outweigh its risks. I devote a good deal of this paper scrutinizing this popular view. Specifically, I demonstrate that this mode of reasoning is logically faulty if “risk” and “benefit” are taken in their absolute sense. But I also show that arguing in favour of an action because its benefits outweigh its risks can be valid if we refer to incremental risks and benefits. (shrink)