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)

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)

For decades, scholars in the social sciences and humanities have questioned the appropriateness and utility of prior review of their research by human subjects' ethics committees. This essay seeks to organize thematically some of their published complaints and to serve as a brief restatement of the major critiques of ethics review. In particular, it argues that 1) ethics committees impose silly restrictions, 2) ethics review is a solution in search of a problem, 3) ethics committees lack expertise, (...) 4) ethics committees apply inappropriate principles, 5) ethics review harms the innocent, and 6) better options exist. (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)

Using traditional meta-analytic techniques, we compile relevant research to enhance conceptual appreciation of ethical climate theory (ECT) as it has been studied in the descriptive and applied ethics literature. We explore the various treatments of ethical climate to understand how the theoretical framework has developed. Furthermore, we provide a comprehensive picture of how the theory has been extended by describing the individual-level work climate outcomes commonly studied in this theoretical context. Meta-analysis allows us to resolve inconsistencies in previous (...) findings as well as confirm the central tenets of the overall ethical climate framework. In addition, we consider the ethical climate relationships in the larger context of the␣theoretical framework, using path analysis to test the structural relationships. Overall, our results provide evidence of the relationships between ethical climate perceptions and individual-level work outcomes. Based on our analyses, we offer future research directions important for further development of ECT. (shrink)

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and (...) components necessary for the conduct of human behavior research and research capacity building in the host country. (shrink)

This article examines forms of subjectivation propagated through the processes and practices of ethics review in UK Higher Education Institutions. Codified notions of research ethics are particularly prevalent in the university context along with stringent institutional regulation of the procedures surrounding ethics review of research proposals. Michel Foucault’s concept of neoliberal governmentality is argued in this article to help illuminate the combination of power processes reflected in ethics review practices. These operate insidiously in accordance with a neoliberal (...) rationality that champions self-sustaining individuals and the inauguration of human capital. Moreover, ethics review processes and attendant regulatory modes of control compound the construction of the student as a ‘permanent performer’ and the associated requirement for her to self-govern through risk management. A combination of overtly controlling and self-relational mechanisms of neoliberal governmentality are in operation, both of which have the potential to generate particular forms of subjectivation in the university context. Foucault’s conceptualisation of the ethical relation to the self helps indicate alternative, resistant styles of self-confrontation to those correlating with neoliberal governmentality. These are based on autonomous choice-making and self-censoring rather than unquestioning conformity to the regimens of ethics review. (shrink)

This bibliographical study involved first the exploitation of four data-banks: Medline, CNRS, Bioethics and AIDS, with the following key words (in conjunction with AIDS): ethics, human rights, confidentiality, legislation, jurisprudence. A total of 412 references were listed between 1983 and the end of 1987. Examination of the quantitative increase of articles over these years shows that, while references to AIDS and/or HIV infection--referred to as 'AIDS' for brevity--increased by about one third per year, the number of papers treating ethical (...) problems linked to AIDS doubled each year. This increase makes it clear that these problems are important and pressing, that they are evolving rapidly and can be given no easy solution. After reading and analysis of accessible articles in readily comprehensible languages, the different themes can be classified in two categories: 1: Measures intended to protect society (starting with the most coercive); quarantine and isolation; discriminatory measures concerning specific groups; non-respect of the confidential nature of medical information; application of the penal code; screening; obligatory declaration and registration; testing of blood given by donors; vaccination and medical innovations, therapeutic assays; information, education. 2. Measures intended to protect the individual: fundamental rights of the patient: his/her right to confidentiality, to information and to treatment; civil rights: civil liberty, right to education, right to work, etc...; rights of the healthy individual: right of those in contact with the patients, safety of hospital staff, of those receiving blood-transfusions, etc... The legislation adopted in the various countries and the main opinions to be found in these articles are listed and analysed, and for each particular theme it is possible to refer to a list of the 232 most important articles. While the debate seems to concentrate on the conflict between the right of society to protect itself against the spread of infection and the 'civil' rights of the infected minorities, our conclusion tends to reduce this antagonism, showing that, particularly as far as the confidential nature of medical information is concerned, measures intended to protect the individual also protect society. (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...

This study examined Canadian Research Ethics Board practices concerning continuing ethics review of approved studies. A mail-out questionnaire was used to elicit information from Canadian REB representatives about whether their board engaged in continuing ethics review, and, if so, what their methods were. The study found that a majority of REBs conduct continuing ethics review. REBs conduct continuing ethics review of clinical trial research significantly more often than of academic research. The study also found little difference (...) in the frequency of continuing ethics review between academic and other types of REBs. The most commonly reported method for conducting continuing ethics review was a review of ongoing research reports. (shrink)

Global short-term medical volunteerism is growing, and properly conducted, is a tool in the fight for greater global health equity. It is intrinsically ethical (i.e., it involves ethics at every step) and depends upon ethical conduct for its success. At present, ethical guidelines remain in their infancy, which presents a unique opportunity. This paper presents a set of basic ethical principles, building on prior work in this area and previously developed guidelines for international clinical research. The (...) content of these principles, and the benchmarks used to evaluate them, remain intentionally vague and can only be filled by collaboration with those on-the-ground in local communities where this work occurs. Ethical review must additionally take into consideration the different obligations arising from the type of institution, type of intervention, and type of relationship involved. This paper argues that frequent and formalized ethical review, conducted from the beginning with the local community (where this community helps define the terms of debate), remains the most important ethical safeguard for this work. (shrink)

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of (...) proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. (shrink)

This article outlines the potential for Research Higher Degree supervisors at universities and similar institutions to use ethical review as a constructive, dynamic tool in guiding RHD students in the timely completion of effective, innovative research projects. Ethical review involves a bureaucratized process for checking that researchers apply risk management strategies when dealing with human participants. Ethical review can also be a powerful instrument for RHD supervisors in the creative arts if they use it (...) to lead students through processes of imagining, articulating, and improving their methodologies and relationships with research participants. Proposed strategies involve adaptation of theories of visualization and imagination from several disciplines—imagined interaction from the social sciences and psychology, dramatic rehearsal from political science, and creative visualization from the health professions, sports coaching and many other personal–professional development contexts. By using creativity and imagination, supervisors can use ethical review to help students to ‘walk through’ the potential, progressive phases of proposed research in order to refine or redesign both ‘big picture’ strategies and specific steps taken to reach research goals. This can stimulate students to unearth possibilities that improve the quality and quantity of knowledge that their research generates and to avoid or manage problems that might disrupt their research. (shrink)

The ethics review system of research is now well-established, at least in the developed world, although there are many differences in how countries view it and go about managing it. The UK specifically is now seeking to revise its system by speeding up the process of ethics approval but only for some studies. It is proposed that only those studies which pose “no material ethical issues” should be “fast-tracked”. However, it is unclear what this means, who should decide (...) and what should be included in this category. In this paper, we go some way towards answering these questions. While we are certain that the debate is only just beginning, we are equally certain that it will continue to run long after the system has been reformed. To stimulate this conversation and to inform a pilot project of the new system directly, we review two candidates to help give some substance to the notion of “material” ethical issues. Firstly, material could mean a certain type or degree of risk. Second, material could mean how physically invasive the research is. We conclude that there is still much work to be done on making the system of governing health and social care consistent and practicable. (shrink)

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)

Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research practices, including (...) obtaining institutional approval, access to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social, when the study employed quantitative compared to qualitative or mixed methodologies, and when the journal required a statement on ethical declarations. Institutional approval was least likely to be reported in papers that were sole-authored, when these did not mention a funding source, or when published in national journals. Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings. (shrink)

My assigned task in today’s colloquium is to review philosophers’ perspectives on the broad question of whether health care rationing ought to target the elderly. This is a revolutionary question, particularly in a society that is so sensitive to apparent discrimination, and the question must be approached carefully if it is to be successfully dealt with. Three subordinate questions attend this one and must be addressed in the course of answering it. The first such question has to do with (...) the issue of justice: how is it fair to target the elderly in achieving reductions in health care costs? Isn’t the proposal, or for that matter, isn’t targeting any age group, morally objectionable as a species of ageism, just as targeting members of a particular race or sex would be racist or sexist? The second subordinate question has to do with the issue of fittingness. Given that we can show in some way that targeting the elderly is not inherently unjust, why would limiting health care to them be a fitting thing for medicine to do? How would it fit, for example, with the traditional commitments of medicine, to sustain life, to relieve suffering, to heal and cure and restore function? And in particular, if medicine has the ability to save and relieve and restore the elderly, why should it replace that set of commitments with a different set for this particular population? The third subordinate question seems political, an arena reserved for one of my speaker colleagues today. There are, I believe, some underlying philosophical dimensions to its answer, and so I will say something about it. The philosophical/political questions is, Given that rationing health care to the elderly is not patently unjust, and given that a case can be made out that the ends of medicine are not violated by such limitation, shy should the elderly, as a group, assent to such a limitation? I want to address these subordinate questions, for I believe them to be the chief stumbling blocks for the possibility of an affirmative answer to our... (shrink)

A Decent Proposal: Ethical Review of Clinical Research Donald Evans and Martyn Evans Centre for Philosophy and Health Care University of Wales Swansea, UK The investigation and development of modern medicines and medical technology can create numerous ethical dilemmas both for clinical researchers and research ethics committees. A Decent Proposal: Ethical Review of Clinical Research seeks to facilitate and encourage good clinical research by exploring the concerns, responsibilities, general issues and particular pitfalls associated with (...) class='Hi'>ethical aspects of research. It provides practical guidelines for researchers on how to improve the quality of research design, while for those appointed to scrutinise research proposals it offers advice on how to apply consistent, careful and critical reasoning to the process of assessing ethical standards. As such, it will provide invaluable assistance to clinical researchers and ethics committees alike in understanding the moral challenges posed by modern health care. (shrink)

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of (...) identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. (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...

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examines 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES - and (...) in particular, behavioral health - research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work. (shrink)

A growing body of research suggests that follower perceptions of ethical leadership are associated with beneficial follower outcomes. However, some empirical researchers have found contradictory results. In this study, we use social learning and social exchange theories to test the relationship between ethical leadership and follower work outcomes. Our results suggest that ethical leadership is related positively to numerous follower outcomes such as perceptions of leader interactional fairness and follower ethical behavior. Furthermore, we explore how (...) class='Hi'>ethical leadership relates to and is different from other leadership styles such as transformational and transactional leadership. Results suggest that ethical leadership is positively associated with transformational leadership and the contingent reward dimension of transactional leadership. With respect to the moderators, our results show mixed evidence for publication bias. Finally, geographical locations of study samples moderated some of the relationships between ethical leadership and follower outcomes, and employee samples from public sector organizations showed stronger mean corrected correlations for ethical leadership–follower outcome relationships. (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)

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)

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)

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)

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)

Bioethics, Volume 36, Issue 5, Page 576-586, June 2022.

BackgroundDuring a disaster, nurses face complex ethical challenges because of risky situations. It is necessary to identify trends and ethical issues of nurses in disasters to improve the quality...

Action research has repeatedly demonstrated how it can facilitate problem solving and change in many settings through a process of collaboration which is driven by the community at the heart of the research. The ethical review of action research can be challenging for action researchers and research ethics committees. This paper explores how seven ethical principles can be used by action researchers and research ethics committees as the basis for ethical review. This paper concludes by (...) offering some suggestions for a way forward for both action researchers and research ethics committees. (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)

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)

BackgroundOver the past few years, five domains of importance about the current state of bioethics in Saudi Arabia have shaped the perspective of most research: doctor-patient relationship, informed consent, do-not-resuscitate, organ donation, and transplantation, medical students’ knowledge and attitudes about medical ethics curriculum. This systematic review aimed to systematically identify, compile, describe and discuss ethical arguments and concepts in the best-studied domains of bioethics in Saudi Arabia and to present cultural, social, educational, and humane perspectives. MethodsSix databases were (...) searched using Boolean operators from December 2020–June 2021. The search and report process followed the statement and flowchart of preferred reporting items for systematic reviews and meta-analyses.ResutlsThe search resulted in 1651 articles, of which 82 studies were selected for a final review and assessment. There is a gradual increase in research, whereby a substantial increase was observed from 2017. Most of the published articles focused on ‘Organ Donation & Transplantation’ with 33 articles, followed by ‘Doctor-Patient Relations’ with 18 publications. Most of the published articles were from Central Province, followed by Western Province. The authorship pattern showed a collaborative approach among researchers. The thematic analysis of keywords analysis showed that ‘Saudi Arabia,’ ‘attitude PHC,’ ‘organ donation,’ ‘knowledge and education,’ and ‘donation’ have been used the most commonly.ConclusionThis systematic quantitative synthesis is expected to guide researchers, stakeholders, and policymakers about the strengths and gaps in knowledge and attitudes regarding medical ethics in Saudi Arabia, both among the general public and health professionals. (shrink)

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of the (...) CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee’s respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master’s degree research. Descriptive cross-sectional studies were the most frequently reviewed research. The majority were prospective and used quantitative methodologies. The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS’s average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens. (shrink)

Goal-setting has become a popular and effective motivational tool, utilized by practitioners and substantiated with decades of empirical research. However, the potential for goal-setting to enhance performance may come at the cost of ethical behavior. I propose a theoretical model linking attributes of goals and goal-setting practices to unethical behavior through two psychological mechanisms – ethical recognition and moral disengagement; and addressing the moderating role of individual differences (e.g., goal-commitment and conscientiousness), as well as the broader organizational (...) class='Hi'>ethical context. (shrink)

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...

Testicular tissue cryopreservation aims to preserve the future option of genetic reproduction for prepubescent cancer patients who are at risk of infertility as a result of their cancer therapies. This technology is experimental and currently only offered in the research context. As TTCP moves towards becoming more widely available, it is imperative that healthcare providers recognize the complex ethical issues surrounding this technology. This scoping review study identifies and assesses the range and depth of ethical concerns related (...) to this testicular tissue cryopreservation technology. At present, no such scoping review of ethical concerns exists in the TTCP literature. The forty-three full-text articles included in this study yielded twenty-two different ethical considerations discussed in relation to TTCP. It was observed that these ethical considerations fit within a mainstream Principlism approach to bioethics. Accordingly, there are ethical gaps in the TTCP literature that can be identified with alternative moral lenses. In particular, it was found that ethical concerns related to context and relational aspects of identity were absent in nearly all ethical examinations of TTCP. Furthermore, only 9 per cent of articles reviewed in this study focused primarily on the ethics of TTCP, thus demonstrating a need for further in depth ethical analyses of this technology. The results of this study are important for supporting the ethical provision of TTCP and can contribute to policy and guideline development. The findings of this study demonstrate the need for greater depth and diversity in analyses of ethical considerations related to this technology. (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...

BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses from (...) 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.ResultsOf 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.ConclusionOnly one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. (shrink)

Data science, and the related field of big data, is an emerging discipline involving the analysis of data to solve problems and develop insights. This rapidly growing domain promises many benefits to both consumers and businesses. However, the use of big data analytics can also introduce many ethical concerns, stemming from, for example, the possible loss of privacy or the harming of a sub-category of the population via a classification algorithm. To help address these potential ethical challenges, this (...) paper maps and describes the main ethical themes that were identified via systematic literature review. It then identifies a possible structure to integrate these themes within a data science project, thus helping to provide some structure in the on-going debate with respect to the possible ethical situations that can arise when using data science analytics. (shrink)