Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS researchers, these are not insurmountable and, (...) in fact, present opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers. (shrink)

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

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 (...) class='Hi'>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)

Committees established for the ethical review of research involving animals have become a widespread legal standard around the world. Despite many differences in their composition, powers, and institutional settings, they share many common problems related to the well-established standards of procedural justice in administrative practice. The paper adapts the general theory of procedural justice to the specific context of ethical review committees. From this perspective, the main concerns over the procedural aspects of the ethical evaluation (...) of research projects are identified and examined. They include in particular the standards of the committees’ composition, impartiality, fair hearing, appeal, transparency, and benevolence. Their proper reflection in the regulatory regimes of animal ethics committees is necessary to secure the standards of fairness of the ethical review itself. This, in turn, is a condition of the moral and social legitimacy of all administrative and quasi-administrative procedures, including the committees’ operations. (shrink)

Background:Research Ethics Committees (RECs) or their equivalent review applications for prospective research with human participants. Reviewers use universally agreed principlesi to make decisions...

In 2019, a new national Ethics Review Authority (Etikprövningsmyndigheten, EPM) was created in Sweden. In 2020, Sweden’s Ethical Review of Research Involving Humans Act was revised, tightening this legislation, and increasing penalties for its infraction. This article draws on empirical material generated by artistic research conducted with a norm-critical contemporary music ensemble. Two of the musicians who collaborated with this research identify as disabled. Consequently, in accordance with EPM, my artistic research was subject to mandatory ethics (...) class='Hi'>review. Reflecting critically on my own experience of seeking ethical approval for this artistic research project, I show how EPM’s process of ethics review enacts scientific boundary work in Sweden that privileges the interests of academic disciplines that are already well-established. As a corrective to EPM’s scientific boundary work I propose the application of an ethics of care that recognises the complex relationalities that exist between research institutions, researchers and research participants. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers (...) in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). (...) There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country. (shrink)

As members of the fetal surgery advisory board at a large tertiary care center, we read with great interest Hendriks’ et al. target article proposing a new ethical framework for fetal therap...

The ethical review of research using methods of artificial intelligence and machine learning in health care contexts has become an important challenge for Research Ethics Boards (also refer...

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical (...) review, and studies that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process. (shrink)

Over the past decade, ethical leadership has increasingly become one of the most popular topics in the areas of leadership and business ethics. As a result, there now exists a substantial body of empirical research addressing ethical leadership issues, but the findings reported by this body of research are highly fragmented. The topic has advanced to the stage where a review and synthesis of existing literature can provide great value and help move the scholarly conversation forward. The (...) primary purposes of this article are to review empirical findings from the ethical leadership literature utilizing a framework consisting of the antecedents, mediators, moderators and outcomes of ethical leadership, and suggest a set of interesting research opportunities, thereby facilitating future investigation. We base our synthesis on a review of 62 empirical studies on ethical leadership that were published between 2005 and mid-2015. (shrink)

The burgeoning field of biomedical research involving the mixture of human and animal materials has attracted significant ethical controversy. Due to the many dimensions of potential ethical conflict involved in this type of research, and the wide variety of research projects under discussion, it is difficult to obtain an overview of the ethical debate. This paper attempts to remedy this by providing a systematic review of ethical reasons in academic publications on human-animal chimera research. We (...) conducted a systematic review of the ethical literature concerning human-animal chimeras based on the research question: “What ethical reasons have been given for or against conducting human-animal chimera research, and how have these reasons been treated in the ongoing debate?” Our search extends until the end of the year 2017, including MEDLINE, Embase, PhilPapers and EthxWeb databases, restricted to peer-reviewed journal publications in English. Papers containing ethical reasons were analyzed, and the reasons were coded according to whether they were endorsed, mentioned or rejected. Four hundred and thirty-one articles were retrieved by our search, and 88 were ultimately included and analyzed. Within these articles, we found 464 passages containing reasons for and against conducting human-animal chimera research. We classified these reasons into five categories and, within these, identified 12 broad and 31 narrow reason types.15% of the retrieved passages contained reasons in favor of conducting chimera research, while 85% of the passages contained reasons against it. The reasons against conducting chimera research fell into four further categories: reasons concerning the creation of a chimera, its treatment, reasons referring to metaphysical or social issues resulting from its existence and to potential downstream effects of chimera research. A significant proportion of identified passages fell under Category C. We hope that our results, in revealing the conceptual and argumentative structure of the debate and highlighting some its most notable tendencies and prominent positions, will facilitate continued discussion and provide a basis for the development of relevant policy and legislation. (shrink)

It is difficult to consider, describe or address the ethical issues particular to qualitative research without experience and understanding of the technicalities of qualitative methodologies. The Australian National Statement on the Ethical Conduct of Research Involving Humans charges researchers with a responsibility to demonstrate that they have the appropriate experience, qualifications and competence for their proposed research. Ethical review committees have the responsibility to judge claimed research competence. This article provides practical guidance to researchers and (...) class='Hi'>review committees on using formal qualifications and training, explicit claims of competence, and markers of in/competence to assess qualitative research competence. (shrink)

In the context of a public health emergency it is imperative to conduct research studies that will produce evidence rapidly while upholding ethical standards. The Ebola and Zika outbreaks highlighted the importance of devising agile processes for ethics review in emergencies, and international research ethics guidelines stress the duty to depart from standard processes for ethics review in emergency circumstances. However, before the COVID-19 pandemic it was not entirely clear what emergency procedures should look like. An additional (...) challenge is that while the same substantive ethical standards apply in emergency and non-emergency settings, deciding what these standards entail in the specific circumstances of a pandemic may be difficult. During the COVID-19 pandemic, challenges included identifying thresholds of social and scientific value, along with duties towards research participants, given the absence of therapeutic options; assessing continually changing risk–benefit profiles of studies, given rapidly emerging new evidence; developing appropriate informed consent processes, given lockdown scenarios; and even addressing the ethics of offering unproven interventions outside research settings. Additional issues raised during epidemics include devising feasible and meaningful community engagement strategies, mechanisms to ensure fairness in the distribution of the benefits that may result from research, and equitable and effective data-sharing plans that will inform pandemic response. Learning from these procedural and substantive challenges encountered in the ethics review of COVID-19 research is important for enhancing ethics preparedness for future emergencies. It can also potentially contribute to improving the ethics review of research in non-emergency circumstances. The seven cases in this chapter highlight ethical issues associated with ethics approval of multi-centre studies in pandemics, the need for careful consideration of the social and scientific value of research and challenges encountered when interventions are being transitioned from research to rollout, and issues that can arise when existing regulations and policies may limit capacities to appropriately adapt research to pandemic contexts. (shrink)

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

In this case study, I address the procedural ethics of conversation analysis (CA) and the collection of naturally occurring mundane interactions. I draw from the challenges that emerged from the institutional ethics review of the HIV, health and interaction study (the H2I Study), a CA project that sought to identify the practices through which normative assumptions of HIV and other health conditions are produced in conversations. Consistent with CA’s preference for naturally occurring interactions, the H2I Study collected and analysed (...) everyday telephone calls involving people living with HIV. This article offers practical strategies CA researchers might use to navigate two ethical concerns raised about the collection of naturally occurring mundane interactions. The first questions the merits of collecting naturally occurring mundane interactions. For those unfamiliar with CA, the specific advantages of analysing naturally occurring mundane interactions may not be self-evident. This places an evidentiary burden on CA researchers to warrant the collection of this type of data. To address this concern, I suggest demonstrating in ethics applications the analytic value of CA using publicly available interactions. The second concern questions the use of verbal consent necessary for the collection of naturally occurring mundane interactions. Like most CA research, the H2I Study required flexible informed consent protocols appropriate for spontaneous and unpredictable interactions. Drawing from within and outside the CA literature, I offer three rationales for the use of verbal consent. This article is written as a practical resource for conversation analysts seeking approval from their research ethics board (REB) and for REBs who might be unfamiliar with CA research. This article contributes to a small but growing body of literature that documents not only the kinds of challenges CA researchers encounter from institutional ethics review, but the specific procedural ethics they may employ to secure ethics approval. (shrink)

Background:In the past two decades, interest in the concept of ethical climate and in its research has increased in healthcare. Ethical climate is viewed as a type of organizational work climate, and defined as the shared perception of ethically correct behavior, and how ethical issues should be handled in the organization. Ethical climate as an important element of nursing environment has been the focus of several studies. However, scoping reviews of ethical climate research in nursing (...) have not been conducted to guide further research in this area.Objective:The purpose of this scoping review is to describe and analyze studies focusing on ethical climate in nursing environment to elicit an overall picture of the research in this field.Methods:A scoping review methodology guided by Arksey and O’Malley and Levac et al. was used. Studies were identified by conducting electronic searches on PubMed/MEDLINE, CINAHL, Web of Science Core Collection, PsycINFO, and Scopus and Philosophers’ Index databases. Of 1051 citations, 56 articles matched the inclusion criteria.Ethical considerations:This study was conducted according to good scientific guidelines.Findings:Ethical climate is a topical research area which has been explored with different methods and outcomes, in different environments, and has mainly been perceived positively. The focus of the studies was on finding associations between ethical climate and work-related factors such as job satisfaction, moral distress, and turnover intentions. Methodologically, research was rather homogeneous using quantitative, descriptive, and correlative research designs.Conclusion:Novel perspectives and more diverse methodological approaches paying attentions to issues affecting generalizability of the findings could expand our knowledge in this area. (shrink)

Scientists seeking to conduct research with human subjects must first submit their proposals to research ethics committees (Institutional Review Boards [IRBs], in the United States). Some of these studies pose risks to “bystanders,” i.e., people who may be affected by the research but who are not enrolled as study subjects. Should IRBs expand their scope to include oversight over possible harms to bystanders as well as research subjects? This paper presents arguments against this step. Prior review of research (...) with human subjects, despite its evident burden on the research enterprise, is a necessary caution, because the tension between the objectives of humane treatment of research subjects and sound scientific design and procedure has in the past led to serious abuses. This rationale is inapplicable in the case of bystanders. Moreover, in view of the many and varied effects of both research practices and scientific advances on the broader public over time, those who may be considered to be “bystanders” may potentially expand without limit; requiring IRBs to anticipate these distant and long‐term effects as part of prior ethical review could greatly increase its burden and its deterrent effect on research. While conducting research without concern for serious potential harm to bystanders may be irresponsible and unethical, expanding the scope of prior review by IRBs to include risks to bystanders is not required by the principles governing human subjects research, and the costs and burdens of this expansion may outweigh any expected gains. (shrink)

The National Women's Hospital research scandal saw women being involved in medical research without their knowledge and without the opportunity to make a choice about their participation. The 1988 Cartwright Inquiry into this decades-long study established a template for ethics review in New Zealand. Ethics committees were subsequently established to independently assess the potential benefits as well as risks of research. This book describes the gradual undermining of the independence of New Zealand ethics review and the politicisation of (...) ethics committees between 1988 and 2014. The authors, involved continuously in ethics review matters over the period, have seen substantial change brought about by government in response to another medical research crisis - in Gisborne in the late 1990s - and then between 2008 and 2010 an economic crisis involving foreign pharmaceutical companies. Some New Zealand medical researchers claimed that the ethics review process for clinical trials was too slow and was losing the country its economic advantage. This book traces the changes and the implications for a robust ethics review process in all research environments in New Zealand, especially those affecting Maori. The book includes a set of suggestions and recommendations aimed at enhancing independent ethics review, best practice, and the provision of adequate protection for all citizens. (shrink)

Background:To better understand the kinds of ethical challenges that emerge when using coercion in mental healthcare, and the importance of these ethical challenges, this article presents a systematic review of scientific literature.Methods:A systematic search in the databases MEDLINE, PsychInfo, Cinahl, Sociologicals and Web of Knowledge was carried out. The search terms derived from the population, intervention, comparison/setting and outcome. A total of 22 studies were included.Ethical considerations:The review is conducted according to the Vancouver Protocol.Results:There are (...) few studies that study ethical challenges when using coercion in an explicit way. However, promoting the patient’s best interest is the most important justification for coercion. Patient autonomy is a fundamental challenge facing any use of coercion, and some kind of autonomy infringement is a key aspect of the concept of coercion. The concepts of coercion and autonomy and the relations between them are very complex. When coercion is used, a primary ethical challenge is to assess the balance between promoting good and inflicting harm. In the included studies, findings explicitly related to justice are few. Some studies focus on moral distress experienced by the healthcare professionals using coercion.Conclusion:There is a lack of literature explicitly addressing ethical challenges related to the use of coercion in mental healthcare. It is essential for healthcare personnel to develop a strong awareness of which ethical challenges they face in connection with the use of coercion, as well as challenges related to justice. How to address ethical challenges in ways that prevent illegitimate paternalism and strengthen beneficent treatment and care and trust in connection with the use of coercion is a ‘clinical must’. By developing a more refined and rich language describing ethical challenges, clinicians may be better equipped to prevent coercion and the accompanying moral distress. (shrink)

Aim This study is a systematic review that aims to assess how healthcare professionals manage ethical challenges regarding information within the clinical context.Method and Materials We carried out searches in PubMed, Google Scholar and Embase, using two search strings; searches generated 665 hits. After screening, 47 articles relevant to the study aim were selected for review. Seven articles were identified through snowballing, and 18 others were included following a system update in PubMed, bringing the total number of (...) articles reviewed to 72. We used a Q-sort technique for the analysis of identified articles.Findings This study reveals that healthcare professionals around the world generally employ (to varying degrees) four broad strategies to manage different types of challenges regarding information, which can be categorized as challenges related to confidentiality, communication, professional duty, and decision-making. The strategies employed for managing these challenges include resolution, consultation, stalling, and disclosure/concealment.Conclusion There are a variety of strategies which health professionals can adopt to address challenges regarding information management within the clinical context. This insight complements current efforts aimed at enhancing health professional-patient communication. Very few studies have researched the results of employing these various strategies. Future empirical studies are required to address this. (shrink)

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards _deliberate,_ with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise (...) ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984 ) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990 ) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ provide useful conceptual prompts for considering how ethics review boards might undertake their work. (shrink)

In the wake of the advent of genome editing technology CRISPR-Cas9 (clustered regularly interspaced palindromic repeat (CRISPR)-associated protein 9), there has been a global debate around the implications of manipulating the human genome. While CRISPR-based germline gene editing is new, the debate about the ethics of gene editing is not – for several decades now, scholars have debated the ethics of making heritable changes to the human genome. The arguments that have been raised both for and against the use of (...) genetic technologies in human reproduction reiterate much of the arguments made in the pre-CRISPR debate. As such, it is instructive for South Africa to reflect on these arguments now, in considering our position on the regulation of the use of this novel biotechnology. There are two dominant schools of thought in this area, bioliberalism and bioconservatism. Bioconservatives raise concerns about the risks of genetic manipulation, and argue that it ought to be limited or prohibited to avert these risks to human health and human nature. Bioliberal scholars are more open to the prospect of genetic manipulation, because of its potential utility. In this article, I conclude that in liberal democracies such as our own, bioliberal arguments ought to be seriously considered when formulating policy on human genome editing because of the extent to which they resonate with our Constitutional values and human rights. I further suggest that there is a need for an enquiry into the relevance of African perspectives on the ethical questions that arise concerning germline genome editing. (shrink)

Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review (...) processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics. (shrink)

The expansion of ethics review, beyond its origins in medical research, is the subject of growing critical analysis internationally, especially from social science researchers. Our study builds on this analysis by considering ethics review specifically within tertiary-based educational research. As a foundation for a larger study, we explore the reporting of ethics review within articles from a snapshot of education journals. A cross-sectional review considered 125 articles from 24 journals spanning medical and nurse education, the Scholarship (...) of Teaching and Learning, and educational technology. Among similar types of research our findings highlight variation in institutional ethical review processes and outcomes. Despite most journals providing guidelines for reporting ethics review, adherence to these guidelines by authors or editors was not always evident, but more likely in health-related education journals. We argue that identified areas of variation may reflect the differing influence and proximity of biomedical values. This influence has been under examined in tertiary-based educational research but may contribute to inequitable learning, researching and publishing experiences, potentially adding to negative sentiment about ethics review. (shrink)

With the rise and public accessibility of AI-enabled decision-support systems, individuals outsource increasingly more of their decisions, even those that carry ethical dimensions. Considering this trend, scholars have highlighted that uncritical deference to these systems would be problematic and consequently called for investigations of the impact of pertinent technology on humans’ ethical decision-making. To this end, this article conducts a systematic review of existing scholarship and derives an integrated framework that demonstrates how intelligent decision-support systems (IDSSs) shape (...) humans’ ethical decision-making. In particular, we identify resulting consequences on an individual level (i.e., deliberation enhancement, motivation enhancement, autonomy enhancement and action enhancement) and on a societal level (i.e., moral deskilling, restricted moral progress and moral responsibility gaps). We carve out two distinct methods/operation types (i.e., processoriented and outcome-oriented navigation) that decision-support systems can deploy and postulate that these determine to what extent the previously stated consequences materialize. Overall, this study holds important theoretical and practical implications by establishing clarity in the conceptions, underlying mechanisms and (directions of) influences that can be expected when using particular IDSSs for ethical decisions. (shrink)

Digital Pills are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients’ physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is (...) also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine. To map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP. Our search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users’ interaction with DP, personal sphere, health-related risks and patients’ benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine. We conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution. (shrink)

Based on a general review of international, representative tissue banking policies that were described in the medical, ethics, and legal literature, this paper reviews the range of standards, both conceptually and in existing regulations, relevant to four main factors:(1) commercialization, (2) confidentiality, (3) informed consent, and (4) quality of research. These four factors were selected as reflective of some of the major ethical considerations that arise in the conduct of tissue banking research. The authors emphasize that any policy (...) or ethical guidelines designed to regulate tissue bank research should address all four factors. Whenever this sort of research is conducted between several institutions or several countries, the paper suggests that the relevant entities work collaboratively to harmonize their standards. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating (...) health research resources. Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)

This article summarizes the multitude of empirical studies that test ethical decision making in business and suggests additional research necessary to further theory in this area. The studies are categorized and related to current theoretical ethical decision making models. The studies are related to awareness, individual and organizational factors, intent, and the role of moral intensity in ethical decision making. Summary tables provide a quick reference for the sample, findings, and publication outlet. This review provides insights (...) for understanding organizational ethical decision constructs, where ethical decision making theory currently stands, and provides insights for future empirical work on organizational ethical decision making. (shrink)

Closed Loop medical devices such as Closed Loop Deep Brain Stimulation and Brain Computer Interface are some of the emerging neurotechnologies. New generations of implantable brain–computer interfaces have recently gained success in human clinical trials. These implants detect specific neuronal patterns and provide the subject with information to respond to these patterns. Further, Closed Loop brain devices give control to the subject so that he can respond and decide on a therapeutic goal. Although the implants have improved subjects’ quality of (...) life, their use has raised varied ethical concerns. The aim of this study is to provide an overview of the ethical implications specific to the therapeutic goals of closed loop brain implants. The authors analyze the related work qualitatively and quantitatively so as to help readers in understanding the various ethical implications of closed loop brain implants. (shrink)

There has been growing consensus to develop relevant guidance to improve the ethical review of global health policy and systems research and address the current absence of formal ethics guidance.

BackgroundHealthcare providers have to make ethically complex clinical decisions which may be a source of stress. Researchers have recently introduced Artificial Intelligence (AI)-based applications to assist in clinical ethical decision-making. However, the use of such tools is controversial. This review aims to provide a comprehensive overview of the reasons given in the academic literature for and against their use.MethodsPubMed, Web of Science, Philpapers.org and Google Scholar were searched for all relevant publications. The resulting set of publications was title (...) and abstract screened according to defined inclusion and exclusion criteria, resulting in 44 papers whose full texts were analysed using the Kuckartz method of qualitative text analysis.ResultsArtificial Intelligence might increase patient autonomy by improving the accuracy of predictions and allowing patients to receive their preferred treatment. It is thought to increase beneficence by providing reliable information, thereby, supporting surrogate decision-making. Some authors fear that reducing ethical decision-making to statistical correlations may limit autonomy. Others argue that AI may not be able to replicate the process of ethical deliberation because it lacks human characteristics. Concerns have been raised about issues of justice, as AI may replicate existing biases in the decision-making process.ConclusionsThe prospective benefits of using AI in clinical ethical decision-making are manifold, but its development and use should be undertaken carefully to avoid ethical pitfalls. Several issues that are central to the discussion of Clinical Decision Support Systems, such as justice, explicability or human–machine interaction, have been neglected in the debate on AI for clinical ethics so far.Trial registrationThis review is registered at Open Science Framework (https://osf.io/wvcs9). (shrink)

Two hundred years after it was first published, Mary Shelley’s Frankenstein; or, the modern Prometheus remains relevant. This novel has endured because of its literary merits and because its themes lend themselves to analysis from multiple viewpoints. Scholars from many disciplines have examined this work in relation to controversial scientific research. In this paper, we review the academic literature where Frankenstein is used to discuss ethics, bioethics, science, technology and medicine. We searched the academic literature and carried out a (...) content analysis of articles discussing the novel and films derived from it, analyzing the findings qualitatively and quantitatively. We recorded the following variables: year and language of publication, whether it referred to the novel or to a film, the academic discipline in which it was published, and the topics addressed in the analysis. Our findings indicate that the scientific literature on Frankenstein focuses mainly on science and the personality of the scientist rather than on the creature the scientist created or ethical aspects of his research. The scientist’s responsibility is central to the ethical interest of Frankenstein; this issue entails both the motivation underlying the scientist’s acts and the consequences of these acts. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical (...) areas we discuss include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Background Person-centred care is based on ethical principles, and it is regarded as high-quality care. Care of older persons should embrace person-centredness. During the pandemic, older persons were highlighted as a vulnerable group at risk of developing serious illness and/or suffering death from COVID-19. Several pandemic-related measures were introduced in residential care facilities (RCFs) to reduce this risk, which influenced the possibilities to lead and provide a person-centred care. Aim This study’s aim was to explore ethical challenges in (...) relation to person-centredness during the COVID-19 pandemic, from the perspective of leaders in RCFs. Research design The study had a qualitative descriptive design. Participants and research context Semi-structured interviews were conducted with 26 leaders working in RCFs in Sweden. Data were analysed using conventional content analysis. Ethical considerations The study was approved by the Swedish Ethical Review Authority. The participants received oral and written information about the study and gave written consent. The study was conducted in accordance with the Declaration of Helsinki. Findings The overarching ethical challenge was Having to disregard the individual needs of the person in order to protect the group and society. This included (a) Protecting the group versus promoting the older person’s autonomy; (b) Being forced to lead care based on uncertainty instead of evidence; (c) Striving to provide dignified care but lacking opportunities; and (d) Going far beyond ordinary duty and endangering one’s own and the staff’s health. Discussion The ethical challenges meant being torn between the person’s individual needs and protecting the group and society, with clashing ethical principles as a consequence. Conclusions The leaders faced ethical situations resulting in undignified and compromised person-centred care, which has implications for stakeholders and management who need to address the work conditions in RCFs. (shrink)

The authors review the empirical literature in order to assess which variables are postulated as influencing ethical beliefs and decision making. The variables are divided into those unique to the individual decision maker and those considered situational in nature. Variables related to an individual decision maker examined in this review are nationality, religion, sex, age, education, employment, and personality. Situation specific variables examined in this review are referent groups, rewards and sanctions, codes of conduct, type of (...) ethical conflict, organization effects, industry, and business competitiveness. The review identifies the variables that have been empirically tested in an effort to uncover what is known and what we need to know about the variables that are hypothesized as determinants of ethical decision behavior. (shrink)

The practice of biobank networking—where biobanks are linked together, and researchers share human tissue samples—is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we (...) provide a structured approach to the ethical review of on-sharing of data and tissue for research purposes. (shrink)

Background:Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory...

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that (...) are reinforced by upstream enabling conditions, which are in turn influenced by developmental conditions. Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. (shrink)

Socially assistive devices such as care robots or companions have been advocated as a promising tool in elderly care in Western healthcare systems. Ethical debates indicate various challenges. An important part of the ethical evaluation is to understand how users interact with these devices and how interaction influences users’ perceptions and their ability to express themselves. In this review, we report and critically appraise findings of non-comparative empirical studies with regard to these effects from an ethical (...) perspective.Electronic databases and other sources were queried using a comprehensive search strategy generating 9851 records. Studies were screened independently by two authors. Methodological quality of studies was assessed. For 22 reports on 21 datasets using a non-comparative design a narrative synthesis was performed.Data shows positive findings in regard to attitudes and emotional reactions of users. Varying perception of a social relation and social presence are the most commonly observed traits of interaction. Users struggle with understanding technical complexities while functionality of the devices is limited. This leads to a behavioral alignment of users towards the requirements of the devices to be able to make use of them.This evidence adds to three important ethical debates on the use of socially assistive devices in healthcare in regard to (1) reliability of existing empirical evidence to inform normative judgements, (2) ethical significance of the social presence of devices and (3) user autonomy in regard to behavioral alignment. (shrink)

The burden of research ethics review falls not just on researchers, but on those who serve on research ethics committees (RECs). With the advent of automated text analysis and generative artificial intelligence, it has recently become possible to teach models to support human judgment, for example by highlighting relevant parts of a text and suggesting actionable precedents and explanations. It is time to consider how such tools might be used to support ethics review and oversight. This commentary argues (...) that with a suitable strategy of engagement, artificial intelligence can be used in a variety of ways that can genuinely support RECs and manage their workload and improve the quality of review. It would be wiser to take an active role in the development of AI tools for ethics review, rather than to adopt ad hoc tools after the fact. (shrink)

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including (...) interventional and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues are presented. To accelerate study approval in future public health emergencies, we recommend: internally consistent and complete submissions with information documents in language participants are likely to understand, close collaboration between local and international researchers from research inception, generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, direct information exchange between the chairs of advisory, safety review and ethics committees, more Ethics Committee support for investigators than is standard and a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care. (shrink)