Historically, prisoners in the United Stateshave served as an inexpensive and readilyavailable source of human subjects forresearch. Coinciding with the civil rightsmovement, however, was an emerging conceptionof prisoners'' rights that led to the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research beingcharged with investigating the use of prisonersas research subjects. The recommendations thatevolved and the subsequent guidelines that havebeen implemented by the Department of Healthand Human Services significantly curtail theuse of prisoners as research subjects. (...) Whilethese measures are designed to protect inmatesfrom the abuses of the past, of particularconcern to many health care officials isexclusion of inmates from experimental HIV/AIDSand hepatitis treatments. This paper addresseswhether the vulnerability of prisoners in theUnited States due to their incarceration issufficient to prohibit them from participationin clinical trials that offer the possibilityof life-saving treatment. It first outlinesthe evolution in moral thinking that has led tolaws broadly prohibiting prisoners frombiomedical research studies and then analyzescases in the law to develop ethical argumentsin support of the view that prisoners should beallowed to participate in clinical trials. Theconclusion is that prisoners should be allowedto participate in such trials. (shrink)

Open peer commentary on the article “Developing a Dialogical Platform for Disseminating Research through Design” by Abigail C. Durrant, John Vines, Jayne Wallace & Joyce Yee. Upshot: The commentary reflects on Durrant et al. from the perspective of a conference participant. It also addresses the dynamics at the meeting point of multidisciplinary practice-led design research.

This study examines the participation strategies of an environmental non-governmental organization (NGO) in community-based conservation (CBC) initiatives in the developing country context of Pakistan. We use local Pakistani concepts and terms to interpret and narrate our study. Drawing on the micro-mobilization literature, our analysis embeds a situated analysis of the_ ‘biradari’_ (kinship) structures that pervade Pakistani social and cultural milieu. We shed light on the importance of various gatekeepers in providing access and ongoing support for CBC initiatives, suggesting NGOs must (...) navigate complex cultural and social structures to manage participation in developing country contexts. Here our findings point to the importance of local knowledge not just in articulating community needs but also in articulating participation strategies. Furthermore, even though ‘elite’ structures have the potential to jeopardize equitable participation and project long-term sustainability, our analysis suggests interacting and gaining ‘_bharosa’_ (trust) of communities’ via these structures is critical to participation. While previous research has called into doubt the efficacy of CBC in advancing conservation, we suggest that frequent and culturally atoned engagement is a must for environmental NGOs working in socially entrenched developing nations. Our research brings to light the complex ethical terrain navigated by environmental NGOs in CBC projects, illuminating the inherent potential for both empowering and subjugating outcomes. (shrink)

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

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to (...) a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (shrink)

The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners’ current involvement in research, we examined UK prisoners’ involvement through review of research applications to the UK National Research Ethics Service. We found that prisoners (...) have extremely limited access to research participation. This analysis was augmented by a survey of those involved in research and research governance (UK researchers and Research Ethics Committee members). Our results suggest that pragmatic concerns regarding the perceived burden of including prisoners are far more prominent in motivating their exclusion than ethical concerns or knowledge of regulations. While prisoners may remain a vulnerable research population due to constraints upon their liberty and autonomy and the coercive nature of the prison environment, routine exclusion from participation may be disadvantageous. Rigorous ethical oversight and the shift in the prevailing attitude towards the risks and benefits of participation suggest that it may be time for research to be more accessible to prisoners in line with the principle of equivalence in prison healthcare. We suggest the necessary first step in this process is a re-examination of current guidance in the UK and other countries with exclusions. (shrink)

This chapter claims that only rarely do critical youth studies and social policy include young people in a truly participatory way. The implications of and reasons for this failure are explored. Moreover, through evidence collected over a 3 year youth-led research programme, the chapter investigates how the tools found within the field of user-led, action research can be used for the construction of evidence-based youth policy and the development of new theoretical and methodological models for critical youth studies. (...) A secondary aim is to identify best practices that encourage true participation of young people in decision-making and democratic structures. -/- . (shrink)

For paediatric medicine to advance, research must be conducted specifically with children. Concern about poor recruitment has led to debate about payments to child research participants. Although concerns about undue influence by such ‘compensation’ have been expressed, it is useful to determine whether children can relate the time and inconvenience associated with participation to the value of payment offered. This study explores children's ability to determine fair remuneration for research participation, and reviews payments to children participating in (...) research. Forty children were interviewed before outpatient visits at two London Hospitals: Great Ormond Street Children's Hospital and the Whittington Hospital District General Hospital. Children were asked to value their involvement in two hypothetical research scenarios – the first an ‘additional blood sample’, the second also involving daily oral oil capsules taken for a fortnight before further venesection. Background knowledge about familiarity with money, and experience with hospitalisation was assessed. The mean valuation of involvement in the second scenario (£13.18) was higher than in the first (£2.84) (p<0.001). This higher valuation persisted when children were categorised into groups ‘aged 12+’ and ‘below 12’. Those undergoing a blood test on the day placed a higher valuation on participation in the second scenario (£10.43, £21.67, p=0.044). These children aged 8–16 demonstrated the capacity to discern a fair valuation for participation in medical research. The monetary sums are influenced by the time and inconvenience involved in the research, and by the extent of recent experience with hospital procedures. The authors review current ethical thinking regarding payments to child research participants and suggest that a fair wage model might be an ethically acceptable way to increase participation of children in research. (shrink)

The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of IRB oversight has led the system to focus on compliance and limit its active oversight disproportionately to studies that could present the risk of physical harm. (...) At the same time, the characteristics of the research enterprise have changed and methodologies now present novel risks that were not envisioned in the regulations. We convened a group of IRB professionals, academic leaders, and others to discuss limitations of the current system, how that system could be changed to recognize evolving risks and an increasing focus on participant and community voice, and how it could better serve the needs of researchers and support the societal project of science as a public good. Recommendations included a call to reexamine the academic incentive structure, to develop a system to support consideration of ethical principles from the time of study design, and to explicitly provide different ethical support and oversight for high-risk interventional trials and lower risk biomedical and social behavioral research. (shrink)

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors’ experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not (...) received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight? (shrink)

BackgroundWhile ethicists have for many years called for human subject trial participants and, in some cases, local community members to benefit from participation in pharmaceutical and other intervention-based therapies, little is known about how these discussions are impacting the practice of research ethics boards that grant ethical approval to many of these studies.MethodsTelephone interviews were conducted with 23 REB members from across Canada, a major funder country for human subject research internationally. All interviews were digitally recorded and transcribed (...) verbatim. After coding, the data was analyzed to identify central themes and topics. Themes were identified, application of the themes was confirmed, and these themes were then used to populate the findings of this manuscript.ResultsOur analysis of the interviews identified two primary themes when considering what benefits are owed to research participants and their communities. 1) Most study participants felt that given that these studies are led by persons in the role of researcher rather than health care provider, they had a limited obligation to provide benefits to study participants. 2) These REB members were all working in Canada, a high income country where most residents enjoy high levels of access to health care. As a result of this context, the study participants tended to focus on ethical concerns including obtaining informed consent and avoiding undue inducement to participate in research rather than ensuring that study participants directly benefit from successful trials.ConclusionsResearch on REB members’ attitudes toward what benefits are owed to study participants and community members is needed in other countries in order to determine how context affects these attitudes. (shrink)

How well the Sustainable Development Goals (SDGs) are achieved will greatly influence the lives of today’s children and decisively shape the rest of the 21st century. Yet, children were largely excluded from opportunities to influence the selection of SDGs and their associated targets and indicators, and major barriers to meaningful child engagement remain. However, child-focused agencies have found that when children are intentionally enabled to participate in seeking accountability, they can influence their families, communities and governments to value their contributions (...) and increase their well-being. In furthering its strategy of building brighter futures for children, World Vision implements Citizen Voice and Action (CV&A), a strategic social accountability approach, into communities where children are severely impoverished. Drawing on empirical evidence from children’s CV&A experiences, this paper enquires into the circumstances under which children are empowered to seek accountability for SDGs. This article identifies shared processes which they and others use to strengthen children’s participation in seeking social justice through social accountability. This paper argues that children possess under-recognised research capabilities to think and reflect systemically, critique, understand, and pursue socially just and equitable outcomes conducive to the SDGs, which under the right circumstances, can influence practices, policies, laws and systems. (shrink)

Background Health ministries in Europe are investing increasingly in innovative digital technologies. Older adults, who have not grown up with digital innovation, are expected to keep up with technological shifts as much as other age groups. This is ethically challenging, as it may threaten a sense of dignity and well-being in older adults. Research objective To clarify the phenomenon of sense of dignity experienced in older adults, concerning how their expectations and needs are met within the context of digitally (...) led healthcare in Norway. Research design A Reflective Lifeworld Research design was chosen, and purposive, in-depth interviews were conducted. Participants and research context The participants were 13 adults 75 years and older from Northern Norway, living at home and not receiving consistent assistance. Ethical considerations Followed the principles of the Helsinki Declaration. This study was approved by the Social Science Data Services in Norway (project number 916119). Interviews were conducted carefully within a safe environment chosen by the participants. Findings Older adults experience that using new digital systems in healthcare makes them become dependent with experiences of helplessness. They feel an increased sense of dependency on other people, and that recognition can assail their experience of personal dignity. Older adults not only expect digitally led healthcare to give them a feeling of safety but also experience feeling insecure concerning privacy and loss of possibilities for dialogue with healthcare providers. They are met by demands from society, which they often struggle to achieve. Conclusion The phenomenon of sense of dignity experienced in older adults, concerning how their expectations and needs are met within digitally led healthcare, indicates a sense of feeling lost in the digital world. Further, innovative healthcare lacks focus on ethical performance. This impacts their perception of dignity, as loss of dignity is noticed especially in its rupture. (shrink)

Psychiatric research often poses special ethical concerns. This chapter first provides historical context, including scandals that stoked public concern about psychiatric research and led to the promulgation of canonical documents and bioethics scholarship, and then explores issues related to the decision-making capacity and safety of participants—including the use of placebos and washout periods, the design of suicide prevention studies, and research in emergency psychiatry. The chapter then describes how shifting models of psychiatric nosology have precipitated conflicts in (...) the determination of research priorities. Finally, the chapter attends to emerging issues related to research in psychedelic psychiatry and the use of artificial intelligence and social media by investigators. (shrink)

The current coronavirus disease 2019 pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of (...) clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations. (shrink)

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and (...) access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research. (shrink)

People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes ‘good’ proxy decision-making for research has remained unexplored. (...) Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of ‘good’ proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients’ values and preferences. (shrink)

The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well (...) as non-participants with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies, and that medical care of industry-sponsored research trials is better than their usual medical care. The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study. The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation. Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants. (shrink)

Social poetics as research and practice: living in and learning from the process of research This paper is both a report of research work carried out by one author of the paper with the other involved in a supervisory role, and a reflection on methodology that was an emergent property of the research process. The research question arose when professional preunderstandings about schizophrenia as a biological disturbance were bracketed as a Husserlian form of phenomenology was (...) adopted. The initial study focused on the meanings three individuals attached to being diagnosed with a mental illness and being involved in psychiatric treatment systems. The exploration of meanings led to the researcher being guided by one study participant in relation to a suitable framework for making sense of her lived experience of being entangled in psychiatric systems. This involved an appreciation of the poetics of interpersonal interaction that was simultaneously fuelled by the researcher’s reading of social poetics in psychology. Thus, the research became a hermeneutic inquiry, focused upon the text of one participant (Beth)1 and the psychiatric system that she and colleagues encountered. Beth’s psychiatric predicament was described by a loss of ‘self’, psychiatric interrogation, and positive and negative features of immersion in the system. A byproduct of taking a poetic approach was that the participant found the research process therapeutic. Thus, social poetics encouraged a beneficial blurring of the boundaries between research and practice. In both arenas, social poetics can lead to a different level of understanding. This is contradictory to mainstream approaches to research that value objectivity with a strict division between the researcher and the subjects, with the aim of producing scientific knowledge. (shrink)

Background: Ethical care in maternity is fundamental to providing care that both prevents harm and does good, and yet, there is growing acknowledgement that disrespect and abuse routinely occur in this context, which indicates that current ethical frameworks are not adequate. Care ethics offers an alternative to the traditional biomedical ethical principles. Research aim: The aim of the study was to determine whether a correlation exists between midwifery-led care and care ethics as an important first step in an action (...) research project. Research design: Template analysis was chosen for this part of the action research. Template analysis is a design that tests theory against empirical data, which requires pre-set codes. Participants and context: A priori codes that represent midwifery-led care were generated by a stakeholder consultative group of nine childbearing women using nominal group technique, collected in Perth, Western Australia. The a priori codes were applied to a predesigned template with four domains of care ethics. Ethical considerations: Ethics approval was granted by the Edith Cowan University research ethics committee REMS no. 2019-00296-Buchanan. Findings: The participants generated eight a priori codes representing ethical midwifery care, such as: 1.1 Relationship with Midwife; 1.2 Woman-centred care; 2.1 Trust women’s bodies and abilities; 2.2. Protect normal physiological birth; 3.1. Information provision; 3.2. Respect autonomy; 4.1. Birth culture of fear and 4.2. Recognition of rite of passage. The a priori codes were mapped to the care ethics template. The template analysis found that midwifery-led care does indeed demonstrate care ethics. Discussion: Care ethics takes into consideration what principle-based bioethics have previously overlooked: relationship, context and power. Conclusion: Midwifery-led care has been determined in this study to demonstrate care ethics, which suggest that further research is defensible with the view that it could be incorporated into the ethical codes and conduct for the midwifery profession. (shrink)

The traditional researcher-driven environment of medical knowledge production is losing its dominance with the expansion of, for instance, community-based participatory or participant-led medical research. Over the past few decades, sociologists of science have debated a shift in the production of knowledge from traditional discipline-based to more socially embedded and transdisciplinary frameworks. Recently, scholars have tried to show the relevance of Mode 2 knowledge production to medical research. However, the existing literature lacks detailed clarifications on how a model of (...) Mode 2 knowledge production can be constructed in the context of medical research. This paper calls for such further clarifications. As a heuristic means, the advocacy for a controversial experimental stem cell therapy is examined. It is discussed that the example cannot be considered a step towards Mode 2 medical knowledge production. Nonetheless, the example brings to the fore some complexities of medical knowledge production that need to be further examined including: the shifting landscape of defining and addressing vulnerability of research participants, the emerging overlap between research and practice, and public health implications of revising the standard notions of quality control and accountability. (shrink)

The interpretive and subjective nature of qualitative research has led to growing utilization of arts-based strategies for data collection, analysis and dissemination. The defining characteristic of all such strategies is that they are largely subjective and intended to invoke personal responses in the ‘audience.’ Following that direction, many qualitative researchers are using metaphor to capture themes emerging from their analysis. In this article, we explore ethical aspects of using metaphor in describing results of qualitative health research and illustrate (...) some of the complexities using a case study of research conducted by one of the authors. Our analysis is designed to sensitize researchers and ethics reviewers to some unique ethical issues inherent to this approach towards data analysis and presentation. Issues related to participant dignity, respect and vulnerability led us to suggest that researchers should take these points into consideration in designing their research and seeking informed consent. Metaphors can be linguistic devices, but also conceptual aids that help develop patterns in analysis or that facilitate re-interpretation. However, there is a thin line between artistic licence for better expression and distorting the participants’ actual experience and meanings. Researchers, and reviewers, must be aware of the danger to participant dignity and integrity when aesthetics overshadow actuality. The use of metaphor may also trigger tensions between researchers and participants, especially if member checking is used. The implications of participant withdrawal must be considered and conveyed to ethics reviewers and participants. It is important to have a plan in place for dealing with some of these issues. These should be detailed in the proposal and communicated to participants. Institutional research ethics boards should, on their part, be prepared to ask questions if such details are lacking in the proposal. (shrink)

The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As a result, researchers came under unprecedented time pressure to develop a vaccine. This case study focuses on the first COVID-19 vaccine, which was approved for use in humans, known as Comirnaty, the BioNTech-Pfizer COVID-19 vaccine or Vaccine BNT162b2. With the benefit of hindsight, we show how close collaboration with regulators and trust-based decisions meant that (...) the race for a COVID-19 vaccine was won without purposefully infecting healthy participants with an infectious agent that can cause severe illness or death and for which no rescue therapy had existed. (shrink)

This article offers a critical examination of various interpretations of “political participation” and shows that there is a lack of consensus among scholars concerning the definition of this particular concept. The lack of consensus has led to various conflicting outcomes (even when applied to the same problem) in the research on political participation. The main purpose of this paper is to offer a new definition of political participation that effectively addresses the challenges facing modern civil societies and the emerging (...) era of Web 3.0. The present study argues that “civic engagement” should be differentiated from political participation such that the former is not counted as part of the latter; civic engagement fosters political participation and refers entirely to social activities. Moreover, I argue that online political actions should be accepted as an integral part of political participation if they fulfil all of the criteria of the phenomenon as defined in this article. (shrink)

Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In (...) 2000, prompted by the discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice.Here, we briefly review the conceptual and practical developments in international research ethics. While much conceptual progress has been made (and the concepts are now appearing …. (shrink)

In recent years, the research participant’s family’s need, if not right, to know their disease risk has comprised a great deal of the genetic testing discourse. This most often arises in the context of clinical genetic tests for hereditary cancers, especially colorectal and breast cancer, and other genetic disorders where the presence of a genetic mutation greatly increases the likelihood of the disease’s manifestation. However, this discussion has not led to comprehensive or cohesive guidance for health care professionals or (...) patients. Indeed, various governmental and professional bodies run the gamut of possibilities, from no disclosure to family without the consent of the patient, to recognition that genetic risk information is important enough to the family to allow exception to traditional notions of confidentiality. (shrink)

Software plays an important role in contemporary research. Aside from its use for administering traditional instruments like surveys and in data analysis, the widespread use of mobile and web apps for social, medical and lifestyle engagement has led to software becoming a research intervention in its own right. For example, it is not unusual to find apps being studied for their utility as interventions in health and social life. Since the software may persist in use beyond the life (...) of an investigation, this raises questions as to the extent of ethical duties for researchers involved in its production and/or study towards the participants involved. Key factors identified include the extent of affect created by the software, the effect it has on a participant’s life, the length of investigation, cost of maintenance and participant agency. In this article we discuss the issues raised in such situations, considering them in the context of post-research duties of care and suggesting strategies to balance the burden on researchers with the need for ongoing participant support. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations (...) for participation. Offers of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)

Pathological archival tissue has been used as a source of research material for many years. The advancement in molecular techniques led to an escalated interest in genetic research on archival tissue. Research on archival tissue has been used without obtaining consents from patients, although the ethical justification for such a practice is unlikely to apply for genetic research that involves whole genome sequencing, for instance. Issues of confidentiality and patients’ autonomy are being raised as institutions consider (...) when approval for this type of research should be granted. In addition, patients’ advocate is mandating some of these changes. In the context of the United Arab Emirates, this paper makes clear the current uncertainties arising from the use of archival tissue in genetic research, as it could be highly invasive of privacy interests and also fails to respect autonomous choice. It further explains what needs to change in order to support such research that is directed at promoting public good, but in a way that is not detrimental to the welfare of patients as research participants. (shrink)

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for (...) the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies. (shrink)

In 2014, SAGE Publications retracted 60 articles authored by Taiwanese researchers due to suspected peer-review fraud. This scandal led to the resignation of the Minister of Education at the time since he coauthored several retracted works. Issues regarding the lack of transparent decision-making processes regarding authorship were further disclosed. Motivated by the scandal, we believe that this is one of the first empirical studies of questionable authorship practices in East Asian academia; we investigate Taiwanese researchers’ perceptions of QAPs. To meet (...) this purpose, a self-reported survey was developed. Four hundred and three local researchers, including research faculty, postdoctoral researchers, and Ph.D. students, participated in the survey. Four major findings resulted. First, the underlying causes of Taiwanese doctoral students’ engagement in QAPs were attributable to their desire to achieve particular academic-related successes and their feeling of reciprocal obligation to support other researchers. Second, the underlying motives for Taiwanese research associates’ engagement in QAPs were attributable to their attempts to achieve particular career successes and of the desire to consolidate their professional networks. Third, the participants generally agreed that QAPs had a long history among local academics but were rarely reported. Fourth, participants’ backgrounds had significant effects on their responses regarding particular authorship issues; however, their gender did not have a significant effect. QAPs are a critical issue in Taiwanese academia; therefore, we discussed the implications of the current findings including subsequent instruction and future research. (shrink)

Individuals working in different industries were forced to change their work environments to their homes and quickly cope with technical and social changes not experienced before the occurrence of COVID-19 pandemic. This led to blurred boundaries between work and family roles, diminishing performance and wellbeing. Within the scope of the Research Topic “Workplace effects of COVID-19 on employees,” this research emphasizes on the positive impact of job autonomy provided by employers in reducing work-family conflicts. Moreover, the effect of (...) work-family conflict on employees’ performance and wellbeing is analyzed. Furthermore, informational support is examined regarding its moderating effect to mitigate work-family conflicts and enhance wellbeing. A survey was administered among employees of small-medium enterprises in Lebanon, through purposive and convenience sampling with 198 participants. The data was analyzed using PLS-SEM, and the results show that job autonomy reduces work-family conflict. This in turn improves performance and wellbeing as individuals have more control on their tasks. Furthermore, informational support provided to the employees serves as a buffer between work-family conflict and wellbeing. These results can be beneficial for managers of small and medium enterprises, seeking to enhance the performance and wellbeing of their employees in the era of the pandemic. Similarly, scholars can benefit from theoretical premises of current study and the potential pathways for future analyses. (shrink)

The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions—or those of their loved ones—in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical trends at the cross-section of medicine and society are facilitating the involvement (...) of patients and creating the digital infrastructure necessary to its sustainment. Such participant-led research has the potential to promote the autonomy of research participants as drivers of discovery and to open novel non-canonical avenues of scientific research. At the same time, however, the extra-institutional, self-appointed, and, often, oversight-free nature of PLR raises ethical concern. This paper explores the complex ethical entanglement of PLR by critically appraising case studies and discussing the conditions for its moral justification. Furthermore, we propose a path forward to ensure the safe and effective implementation of PLR within the current research ecosystem in a manner that maximizes the benefits for both individual participants and society at large, while minimizing the risks. (shrink)

Research ethics committees should ensure that there has been a direct enquiry into research participants' moral and spiritual beliefs so as to ensure that volunteers are not inadvertently being led into doing things that might contravene their beliefs.

Self-, collective, and participative efficacy are strong predictors of sustainability action. Yet, few studies have investigated the dynamics and variability of efficacy beliefs. In this transdisciplinary study, we tested such factors in the context of a peer-to-peer coaching program for sustainability volunteers, embedded in a structured-educational context. Over weekends, 2 qualified coaches trained 36 German bottom-up, student-led sustainability initiatives. These coaches instructed students in team building, envisioning, project planning, and on-campus sustainability practice. While 317 participants completed our pre-questionnaire, N = (...) 165 completed both the pre- and post-questionnaire. As hypothesized, after having participated in the coaching weekend, action skills, collaboration skills, group identification, and self-, collective, and participative efficacy all increased. The latter of these increased, to our knowledge, for the first time in environmental psychology research. Group identification and having a vision emerged as important efficacy predictors, and participative efficacy beliefs in turn predicted volunteering. Moreover, we took initial steps in investigating the interaction of psychological and structural factors from a multilevel perspective. Our analyses revealed that efficacy beliefs on the individual level were higher when the university had a green office and when the student initiative was at a small university. We conclude by proposing an empowerment model for sustainability volunteers and by discussing the practical implications of our findings. (shrink)

Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing ethics committees (...) and their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (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)

Brain–Computer Interface research is an interdisciplinary area of study within Neural Engineering. Recent interest in end-user perspectives has led to an intersection with user-centered design. The goal of user-centered design is to reduce the translational gap between researchers and potential end users. However, while qualitative studies have been conducted with end users of BCI technology, little is known about individual BCI researchers’ experience with and attitudes towards UCD. Given the scientific, financial, and ethical imperatives of UCD, we sought to (...) gain a better understanding of practical and principled considerations for researchers who engage with end users. We conducted a qualitative interview case study with neural engineering researchers at a center dedicated to the creation of BCIs. Our analysis generated five themes common across interviews. The thematic analysis shows that participants identify multiple beneficiaries of their work, including other researchers, clinicians working with devices, device end users, and families and caregivers of device users. Participants value experience with device end users, and personal experience is the most meaningful type of interaction. They welcome end-user input, but are skeptical of limited focus groups and case studies. They also recognize a tension between creating sophisticated devices and developing technology that will meet user needs. Finally, interviewees espouse functional, assistive goals for their technology, but describe uncertainty in what degree of function is “good enough” for individual end users. Based on these results, we offer preliminary recommendations for conducting future UCD studies in BCI and neural engineering. (shrink)

Our aim is to shed light on the relationships between research, knowledge, and policy in the case of goitre and the use of iodine as a preventive measure against it in Norway from the 1850s onward. Goitre was previously widespread in certain areas of Norway, but disappeared around 1950. After many decades of silence about goitre and iodine, an expert report in 2016 argued that action should be taken to prevent iodine deficiency. Already in 1927, an international conference on (...) goitre led to the agreement that the best preventive measure against goitre was to fortify table salt with iodine. The conference had Norwegian participants, but Norwegian health authorities did not follow the recommendations from the conference. To understand why new knowledge and recommendations did not result in new policy, we explore the history of Norwegian research on goitre and iodine, and Norwegian contributions to and the inspiration from international research in the field. Furthermore, we analyse the measures for the prevention and curing of goitre that have been implemented by authorities over time. The preventive measures introduced in Norway from the 1930s were very modest and differed from those in other countries. We argue for the importance of analysing the political context to understand the success or failure of advice given by researchers to policymakers. (shrink)

Open access. This open-access book discusses vulnerability and the protection-inclusion dilemma of including those who suffer from serious poverty, severe stigma, and structural violence in research. Co-written with representatives from indigenous peoples in South Africa and sex workers in Nairobi, the authors come down firmly on the side of inclusion. In the spirit of leaving no one behind in research, the team experimented with data collection methods that prioritize research participant needs over researcher needs. This involved foregoing (...) the collection of personal data and community researchers being involved in all stages of the research. In the process, the term ‘vulnerability’ was illuminated across significant language barriers as it was defined by indigenous peoples and sex workers themselves. The book describes a potential alternative to exclusion from research that moves away from traditional research methods. By ensuring that the research is led by vulnerable groups for vulnerable groups, it offers an approach that fosters trust and collaboration with benefits for the community researchers, the wider community as well as research academics. Those living in low-income settings, in dire situations that are summarized with the term ‘vulnerability’ know best what their problems are and which priorities they have. To exclude them from research for their own protection is a patronizing approach which insinuates that researchers and research ethics committees know best. The team from this book have shown that minimally risky and minimally burdensome research tailored towards the needs of highly marginalized and stigmatized communities can be scientifically valuable as well as inclusive and equitable. I congratulate them. Prof. Klaus Leisinger, President Global Values Alliance, Former personal advisor to Kofi Annan on corporate responsibility. (shrink)

BackgroundInstitutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process.MethodsFour LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be (...) disclosed in the informed consent document (ICD), risk–benefit assessment and justification of the use of a placebo. Another query was issued to the LLMs to generate ICDs for these case scenarios.ResultsAll four LLMs were able to provide answers to the queries related to all seven cases. In general, the responses were homogeneous with respect to most elements. LLMs performed suboptimally in identifying the suitability of the placebo arm, risk mitigation strategies and potential risks to study participants in certain case studies with a single prompt. However, multiple prompts led to better outputs in all of these domains. Each of the LLMs included all of the fundamental elements of the ICD for all case scenarios. Use of jargon, understatement of benefits and failure to state potential risks were the key observations in the AI-generated ICD.ConclusionIt is likely that LLMs can enhance the identification of potential ethical issues in clinical research, and they can be used as an adjunct tool to prescreen research proposals and enhance the efficiency of an IRB. (shrink)

Resilience is the process and outcome of healthy adaptation despite significant adversity. Proliferation of research on the resilience construct has led to scientific concerns about the operationalization and measurement of resilience for assessment science and practice. Various studies that have investigated the psychometric properties and construct validity of the Resilience Scale for Adolescents have yielded inconsistent findings, which could partly be due to variations in the methodological approaches. This study investigated the factor structure and construct validity of the READ (...) in four European regions participating in the Universal Preventive Resilience Intervention Globally Implemented in Schools to Improve and Promote Mental Health for Teenagers project. Participants included adolescents aged 10–15 years from Spain, Iceland, Italy, and Poland. The five-factor model of the READ was similar across gender and participating regions. Construct validity of the READ was supported. After establishing construct separability, incremental validity was supported. The READ is a valid and reliable measure of protective factors involved in resilience and demonstrates promise for cross-cultural applicability. Recommendations for measuring resilience and validating the READ in future investigations are provided. (shrink)

Background Researchers are required to determine whether a person has capacity to consent to a research study before they are able to participate. The Mental Capacity Act and accompanying Code of Practice for England and Wales provide some guidance on this process, but researchers have identified that it can be difficult to determine capacity to consent when a person has complex cognitive or communication needs. This study aimed to understand the experiences and opinions of researchers who recruit people with (...) dementia to research projects, to inform the future development of training resources. Methods A mixed method, cross-sectional, electronic survey was circulated via social media and research networks in England and Wales. The survey remained open for ten weeks and included open and closed questions exploring respondents’ confidence in determining capacity in the context of recruiting people with dementia to consent, their views on training and support they have experienced and their suggestions for future training and support needs. Results 60 respondents completed the survey from across England and Wales. Although 75% of respondents had experience of determining capacity to consent with people with dementia to research, only 13% rated themselves as feeling ‘very confident’ in this. Qualitative content analysis of open responses led to the generation of six themes, explaining researchers’ confidence, competence and future training needs in this area: (1) Researcher uncertainties, (2) Lack of time, (3) Balancing information complexity with accessibility, (4) Gatekeepers, (5) Existing enablers and (6) Envisioning future training. Conclusions Researchers would benefit from specific training in undertaking conversations around consent with people with dementia. People with dementia may have fluctuating capacity, and despite support from caregivers, researchers have little practical guidance on methods of determining a person’s ability to understand or appreciate the information they have provided during the consent process. Given the development of large complex trials within dementia research, there is an urgency to develop specific and practical guidance and training for researchers working with people with dementia and their families. (shrink)

The new class of anti-inflammatory drugs, the COX-2 inhibitors, have been commercially successful to the point of market dominance within a short time of their launch. They attract a price premium on the basis that they are associated with fewer adverse gastric events than traditional anti-inflammatory drugs. This marketing continues even though a pivotal safety study with one of the COX-2 inhibitors, rofecoxib, showed a significant increase in myocardial infarction with rofecoxib use compared with a traditional anti-inflammatory drug. This finding (...) has led to a series of publications containing pooled analyses of existing data that both support and refute the possibility of increased cardiovascular risk with COX-2 inhibitors.These medical journal publications have served to obfuscate rather than provide guidance for medical practitioners. Consideration of a research ethics committee approach to this issue suggests that it would deal with the controversy in a straightforward manner—namely, it would simply inform research participants of the trial results with rofecoxib. The certainty of this research ethics committee approach raises the issue of whether it should be applied in normal medical practice outside of the research environment. A consideration of the legal tests for disclosure of information suggests that therapeutic medical practice should mirror that within the research environment, in this case. (shrink)

The establishment of research ethics committees (REC) in China’s higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in scientific research ethics, as seen in the recent controversies involving a proposed human head transplant and gene-edited babies. At present, the problems for REC in China’s HEI include lack of regulation, informal ethics reviews, lack of supervision and insufficient ethics review capacity. To counteract these problems, suggested measures include (...) mandatory formation of formal ethics committee, administrative support from HEI, ethics approval letter prior to funding application, formulation of regulations and standard operating procedures, selecting and training for members and independent consultants, training for secretaries and staff, ethics training for investigators, and learning from the experience of HEI outside of China, such as the USA and Canada. The establishment of REC in China’s HEI will greatly enhance the overall quality of ethics reviews in China. In addition to better protecting the rights and welfare of human participants, it is also conducive to maintaining the reputation of China’s HEI. (shrink)

An engaging, compelling and disturbing confrontation with evil...a book that will be transformative in its call for individual and collective moral responsibility." - Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human subjects research. While it is comforting to (...) believe that Nazi physicians, nurses, and bioscientists were either incompetent, mad, or few in number, they were, in fact, the best in the world at the time, and the vast majority participated in the government program of "applied biology." They were not coerced to behave as they did-they enthusiastically exploited widely accepted eugenic theories to design horrendous medical experiments, gas chambers and euthanasia programs, which ultimately led to mass murder in the concentration camps. Americans provided financial support for their research, modeled their medical education and research after the Germans, and continued to perform unethical human subjects research even after the Nuremberg Doctors' Trial. The German Medical Association apologized in 2012 for the behavior of its physicians during the Third Reich. By examining the medical crimes of human subjects researchers during the Third Reich, you will naturally examine your own behavior and that of your colleagues, and perhaps ask yourself "If the best physicians and bioscientists of the early 20th century could do evil while believing they were doing good, can I be certain that I will never do the same?" · Presents relatively unknown aspects of human subjects research during the Third Reich · Reveals surprising relationships between German and American human subjects research · Dispels myths about Nazi human subjects research · Compels introspection and self-examination by today's medical and research practitioners · Addresses contemporary bioethical issues affecting vulnerable populations · Brings together experts in the history of medicine during the Third Reich and thoughtful new voices. (shrink)

The government-sponsored Tuskegee syphilis study had a huge impact on U.S. research ethics and policy. Study investigators regarded subjects as “mere means” to their research ends, which led to a variety of ethical violations. Investigators used deception so that subjects would see participation as therapeutic — researchers promoted the therapeutic misconception because this advanced study objectives. The research would produce important information, and this justified lying to research subjects.Today we see this sort of intentional deception as (...) unjustified no matter how important a study might be. But what do we make of the claim that the syphilis study had value? As James Jones reported, its objectives were to test the prevailing views that syphilis affected blacks and whites differently, and that the disease was less harmful to blacks than whites. U.S. Public Health Service researchers and officials assumed the study had sufficient value to justify not only deceiving subjects, but also depriving them of safe and effective treatment. (shrink)