Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar.

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial, where the protocol permitted staff to gain verbal consent at recruitment. Interviews (...) with staff and participating women. Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial. Date of registration 26/03/2014. (shrink)

The use of human tissue for scientific research is a highly sensitive issue. A lack of confidence in patient recruitment is one reason for the failure of many studies to be funded and it is important therefore that recruitment procedures are as effective and sympathetic as possible. The authors recruited patients with uveal melanoma into a postmortem study investigating tumour latency in this cancer. Two approaches were used—firstly a direct approach when patients attended clinic and secondly an (...) initial approach by mail followed by telephone contact. In the first year of study the authors had a take up rate of 88.5%, significantly higher than the average rate of 40% quoted by the National Institute for Clinical Excellence . Key features are a sympathetic personal approach by experienced oncology nurses, the provision of clear information, and the inclusion of the next of kin in the recruitment procedure. (shrink)

Background To allow patients to reflect about a decision to participate in a clinical trial, guidelines suggest a 24-h delay from when they are informed about the trial to when they give consent. In certain clinical settings, this is likely to hamper recruitment. Method After oral and written information about the trial has been given in person, the patient signs the declaration of consent knowing that they will be asked again after 24 h whether they confirm or regret the (...) decision. This procedure can be done by SMS. The investigators must document the response. The procedure was tried in a study in which the doctors were randomly assigned to receive a clinical communication skills course, and encounters with patients were videotaped before and after the course. Results 553 patients were approached, 530 (95.8%) gave initial consent, eight of these later regretted their consent. Discussion The low level of regrets suggests this is an acceptable procedure for patients. Trial registration The RCT was registered before initiation – registration # ISRCTN22153332. (shrink)

Background Non-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and should not occur at (...) all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeutic research. Methods We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory. Results The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeutic research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeutic research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research. Conclusions This paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeutic research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to (...) discuss it with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

Time is money. According to E.P. Thompson, this saying lies at the core of the logic of capitalism. And yet, in the vast literature on state-capital relations, the strategic value of time has remained relatively neglected compared to rent distribution and monetary exchanges. Elaborating on the recruitment of migrants by employers and their intermediaries in Mauritius, this article explores the role of bureaucratic time and delays in businesses’ access to the fundamental resource for economic accumulation: labour. It reveals a (...) bifurcated bureaucratic pathway, a two-speed logic in the Mauritian bureaucracy of migration. On one side is the lengthy and unpredictable process of administering the authorisations to recruit foreign workers; on the other appear what I term the “shortcuts through the red tape”, the exemptions to the bureaucratic procedures and delays that benefit politically connected actors. Drawing on this case study, I contend that the politics of waiting, inherent to bureaucratic routine, matters in the relations between business and the state. (shrink)

Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for an H3Africa genomic study on Rheumatic Heart Disease at the University of Cape Town in (...) South Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study. We used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases, healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa. Most healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease. A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception. The ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to (...) discuss it with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

When, how, and why students use conceptual knowledge during math problem solving is not well understood. We propose that when solving routine problems, students are more likely to recruit conceptual knowledge if their procedural knowledge is weak than if it is strong, and that in this context, metacognitive processes, specifically feelings of doubt, mediate interactions between procedural and conceptual knowledge. To test these hypotheses, in two studies (Ns = 64 and 138), university students solved fraction and decimal arithmetic problems while (...) thinking aloud; verbal protocols and written work were coded for overt uses of conceptual knowledge and displays of doubt. Consistent with the hypotheses, use of conceptual knowledge during calculation was not significantly positively associated with accuracy, but was positively associated with displays of doubt, which were negatively associated with accuracy. In Study 1, participants also explained solutions to rational arithmetic problems; using conceptual knowledge in this context was positively correlated with calculation accuracy, but only among participants who did not use conceptual knowledge during calculation, suggesting that the correlation did not reflect “online” effects of using conceptual knowledge. In Study 2, participants also completed a nonroutine problem‐solving task; displays of doubt on this task were positively associated with accuracy, suggesting that metacognitive processes play different roles when solving routine and nonroutine problems. We discuss implications of the results regarding interactions between procedural knowledge, conceptual knowledge, and metacognitive processes in math problem solving. (shrink)

Introducing part 2 of the Common Knowledge symposium “Antipolitics,” this essay summarizes the “untold story” of the random recruitment of citizens for political office in Western Europe. Although sortition was used extensively in ancient Athens and in late medieval Europe, it is now (except for the randomly selected jury) a largely discontinued practice. While a good deal is known about when and where this procedure was used, there is little surviving documentation of exactly why it was used and of (...) what it was thought to contribute to the political systems in which it was deployed. This untold story, therefore, is not simply about historical instances of use but must also be an analysis and critique of its use. Key points that emerge are that (1) a lottery takes the decision to appoint or elect away from partisan protagonists, so it therefore acts as a mechanism that can break up and disperse power; and (2) a lottery can serve as a trusted mediation or agreement between parties, because the resultant decision is anonymous. (shrink)

By shedding light on accounts from unaccompanied Afghan asylum-seeking minors in Sweden who were child soldiers in Syria, this thesis explores and examines their narratives and their involvement in the civil war in Syria. The research aims to create a deeper understanding of how these children themselves made sense of their participation in the war by answering the following questions: How were the children approached by the recruiters? What kind of reasons for joining the war are put forward by the (...) recruiters and what strategies do the children encounter: a) economic; b) identity formation; c) social deprivation; d) feeling of vulnerability; e) militarization; f) mental development; g) ideology/ religious-sectarian; or all together? How do the children perceive these encounters and make sense of their recruitment to the Shiite Fatemiyoun Brigade? To which extent has the ideology of Shi’ism played an important role for them in joining the Syrian War? This is a qualitative study based on in-depth interviews which combines procedures from two approaches and techniques: an ethnographic approach and a narrative approach that explores the interviewees’ experiences in a period of time and also generates detailed insights. Despite the fact that none of the respondents testified for being recruited at gunpoint or having been ill-treated, the respondents emphasized that they were forced to join due to the bad circumstances they were living in. In addition, many similarities with other cases regarding child soldiering in several countries have been explored in this thesis, for instance factors related to the socio- economic context and the experiences that are related to the children’s development processes. Differences can be located in various details regarding ideologies and indoctrination since the respondents did not share the politico-religious purposes of the recruiters. (shrink)

Research Ethics, Volume 18, Issue 1, Page 24-38, January 2022. Are social science, cross-border research projects, where recruitment and data collection are carried out remotely, required to follow similar ethical and data-sharing procedures as ‘on-the-ground’ studies that use traditional means of recruitment and participant engagement? This article reflects on our experience of dealing with this question when we had to switch to online data collection due to the restrictions posed by the COVID-19 pandemic, such as the inability (...) to travel or work in person with local communities and collaborators. Using social media platforms and online data collection when conducting research brings many advantages, such as being able to communicate remotely but directly with gatekeepers and collaborators, and in reaching potential participants on a global scale. However, neither the guidelines and advice for conducting ethically sound internet-based research, nor the academic literature focussed on building equitable research partnerships between the Global North and the Global South, offer much information regarding the ethical concerns, or address the grey areas, posed by this type of digital and distanced transnational research. In our experience, conducting research remotely made negotiations of access very challenging due to the politics of positionality between Global North and South researchers, lack of clarity on ethical processes and perceptions of gatekeepers who we could not meet in person. We hope the reflections on, and discussion of, our experience encourage deliberation on the present ethical challenges posed by online and social-media-disseminated data collection, particularly in cross-border circumstances. (shrink)

Evaluating the risks and anticipated benefits of medical, behavioral and, social research is a central function of institutional review boards. The calculation that IRBs undertake ultimately determines whether a particular research project involving human participants is permitted to proceed. In medical research the physical harms and even the anticipated benefits of a new procedure or drug are often apparent and quantifiable. In contrast, for social/behavioral research that may involve probing the most intimate feelings, thoughts, and actions of participants, the weighing (...) of risks and anticipated benefits, the calculation of possible harms and the acceptability of that harm require a more intense level of scrutiny.Even the early step of identifying and recruiting participants for a research endeavor may potentially cause harm, making participant selection a focus of IRB analysis. (shrink)

Recent years have seen rapid advancements in selection assessments, shifting away from human and toward algorithmic judgments of candidates. Indeed, algorithmic recruitment tools have been created to screen candidates’ resumes, assess psychometric characteristics through game-based assessments, and judge asynchronous video interviews, among other applications. While research into candidate reactions to these technologies is still in its infancy, early research in this regard has explored user experiences and fairness perceptions. In this article, we review applicants’ perceptions of the procedural fairness (...) of algorithmic recruitment tools based on key findings from seven key studies, sampling over 1,300 participants between them. We focus on the sub-facets of behavioral control, the extent to which individuals feel their behavior can influence an outcome, and social presence, whether there is the perceived opportunity for a social connection and empathy. While perceptions of overall procedural fairness are mixed, we find that fairness perceptions concerning behavioral control and social presence are mostly negative. Participants feel less confident that they are able to influence the outcome of algorithmic assessments compared to human assessments because they are more objective and less susceptible to manipulation. Participants also feel that the human element is lost when these tools are used since there is a lack of perceived empathy and interpersonal warmth. Since this field of research is relatively under-explored, we end by proposing a research agenda, recommending that future studies could examine the role of individual differences, demographics, and neurodiversity in influencing fairness perceptions of algorithmic recruitment. (shrink)

Care staff in Norway usually work in the private homes of people with intellectual disabilities. Staff experience ethical challenges daily in their interactions with their clients. The aim of this paper is to introduce a vignette validation procedure for selection of practice-close vignettes that can be used to elicit and explore staff reflections on ethical challenges in their work. Staff participants were recruited from different municipalities in one county of Norway. To develop vignettes with good internal validity, the validation process (...) consisted of (1) a field study to identify situations to be included as vignettes, (2) a six-step categorization process to select vignettes with good internal validity, (3) transforming the situations into vignettes, including removal of elements that were too leading or constricting, (4) testing the familiarity and relevance of the preliminary sample of vignettes (external validation), (5) final selection of four vignettes to be included in the investigation, and (6) a validation of the four vignettes? familiarity and practical relevance as ethical challenges by the final sample of interviewees. Our preliminary experience indicates that the validation procedure enhanced the selection of vignettes to elicit staff perceptions and reflections on daily ethical challenges. (shrink)

Approximately 20% of adult cancer patients are eligible to participate in a clinical trial, but only 2.5-9% do so. Accrual is even less for minority and medically underserved populations. As a result, critical life-saving treatments and quality of life services developed from research studies may not address their needs. This study questions the utility of the bioethical concern with therapeutic misconception (TM), a misconception that occurs when research subjects fail to distinguish between clinical research and ordinary treatment, and therefore attribute (...) therapeutic intent to research procedures in the safety net setting. This paper provides ethnographic insight into the ways in which research is discussed and related to standard treatment. (shrink)

Despite the rapid adoption of technology in human resource departments, there is little empirical work that examines the potential challenges of algorithmic decision-making in the recruitment process. In this paper, we take the perspective of job applicants and examine how they perceive the use of algorithms in selection and recruitment. Across four studies on Amazon Mechanical Turk, we show that people in the role of a job applicant perceive algorithm-driven recruitment processes as less fair compared to human (...) only or algorithm-assisted human processes. This effect persists regardless of whether the outcome is favorable to the applicant or not. A potential mechanism underlying algorithm resistance is the belief that algorithms will not be able to recognize their uniqueness as a candidate. Although the use of algorithms has several benefits for organizations such as improved efficiency and bias reduction, our results highlight a potential cost of using them to screen potential employees during recruitment. (shrink)

Affecting many spheres of social life, globalization also inevitably affects the functioning of higher education and the legal status of individuals who intend to apply for admission in a country other than the one where they completed a previous stage of their education. The paper considers selected legal aspects of the access to higher education in Poland, primarily in the context of the internationalization of education, and, thus, the internationalization of the recruitment procedure where individual candidates apply for admission (...) to study on the basis of documents authorizing them to pursue higher education in different legal systems. The background for the reflections is the normative content of the right to education and one of its guarantees, namely the principle of equal access to education – in Poland having the status of a constitutional norm. (shrink)

Depuis la fin de la ségrégation raciale, l’Université de Berkeley cherche à rendre son mode de sélection des étudiants plus juste. En observant le passage d’un recrutement tout méritocratique à une prise en compte des identités ethniques et donc communautaires , puis à la centration sur les carrières individuelles dans leur globalité, on voit se transformer les catégories légitimes de lecture de la diversité sociale et, in fine, le mode politique et juridique de gestion de la diversité et de l’égalité.Since (...) the end of segregation, Berkeley University has been seeking fairer recruitment procedures. Three kinds of selection are distinguished : an all-merit based recruitment, a communautarian recruitment that takes into account different ethnic identities , and a holistic recruitment which primarily places emphasis on the individual’s overall career. This evolution enlightens the transformations of the legitimate categories permitting to read the social diversity, and, in the end, the political and legal mode of managing diversity and equality. (shrink)

What is 'fairness' in the context of educational assessment? I apply this question to a number of contemporary educational assessment practices and policies. My approach to philosophy of education owes much to Wittgenstein. A commentary set apart from the main body of the paper focuses on my style of philosophising. Wittgenstein teaches us to examine in depth the fine-grained complexities of social phenomena and to refrain from imposing abstract theory on a recalcitrant reality. I write philosophy of education for policy (...) makers and teachers. Scrutiny of examples plays a vital role in communicating with such an audience. Starting points include 'accommodations' for disabled students, allegedly gender-biased tests, and the recruitment procedures of 'elitist' music conservatoires. A key intuition that fairness is associated with test validity turns out to be seriously flawed. Problems centre on the idea of a 'construct', and the supposed divide between an underlying construct and its behavioural manifestations. Equality of opportunity notions underlie some accusations of unfairness but there are alternative approaches to a just society. Both the judgments about fairness, and the proposed remedies are open to serious philosophical criticisms. There are widespread conceptual difficulties, together with inconsistent and contestable value judgments. (shrink)

The anticipation of ethical issues that may arise with the clinical use of genomic technologies is crucial to envision their future implementation in a manner sensitive to local contexts. Yet, populations in low- and middle-income countries are underrepresented in studies that aim to explore stakeholders’ perspectives on the use of such technologies. Within the framework of a research project entitled “Personalized medicine in the treatment of epilepsy”, we sought to increase inclusiveness by widening the reach of our survey, inviting neurologists (...) from around the world to share their views and practices regarding the use of whole-genome sequencing in clinical neurology and its associated ethics. We discuss herein the compelling scientific and ethical reasons that led us to attempt to recruit neurologists worldwide, despite the lack, in many low- or middle-income countries, of access to genomic technologies. Recruitment procedures and their results are presented and discussed, as well as the barriers we faced. We conclude that inclusive recruitment remains a challenging, albeit necessary and legitimate, endeavour. (shrink)

Стаття присвячена аналізу умов та чинників функціонування органів виконавчої влади та органів місцевого самоврядування в контексті проблеми їх кадрового забезпечення. Розглядається зарубіжний досвід кадрового менеджменту в системі державного та місцевого управління з метою його використання на відповідних рівнях. Надаються рекомендації щодо вдосконалення кадрових процедур підготовки, підбору та призначення державних службовців, включаючи підвищення кваліфікації кадрів.

Clinical genetic research is often regarded as more ethically problematic than other forms of research, and in some countries is subject to specific regulation, requiring researchers to follow specialised guidelines. In this paper, an approach to enhancing the ethical conduct of genetic research is proposed, which is believed to be more effective than simply attempting to follow general guidelines. The potential concerns, likely areas of misunderstanding and negative reactions of the participant group are systematically investigated before starting a study on (...) genetics. This would constitute, in effect, an ethical pilot study, similar to a feasibility pilot study to test equipment, procedures and logistics. The findings of the ethical pilot study would be used to help in designing ethically important aspects of research protocol, such as recruitment procedures, written and other information for potential participants, informed consent processes and reporting of results including ambiguous or uncertain results. (shrink)

This paper presents the results of qualitative research on academic inbreeding in Czech higher education, the first of its kind. Its focus is on exploring the significance of academic inbreeding, its types, practices, and possible solutions. The research for this paper was done among academic staff at eight institutions of higher education in the Czech Republic. It was conceptually informed by ideas about different types of inbred employees (immobile, mobile, silver-corded, and adherent) and available policy tools. The results show that (...) academic inbreeding has long flown under the radar as an issue. Its impact is perceived ambivalently, as both positive and negative, by academics and experts alike. Generally, its avoidance has not been taken into account in staff recruitment, which has allowed it to become widespread among Czech higher education institutions. The policy tools for combatting academic inbreeding include nodality (open recruitment), reorganization of recruitment procedures, capacity-building (including stays abroad), and hortatory proclamations (paying attention to the issue). Overall, the evidence gathered in the course of research suggests that some progress has been made in limiting academic inbreeding at some workplaces, and that what we would call purely immobile inbred employees are giving way to mobile and “silver-corded” inbred academic staff. Finally, Czech higher education institutions register few cases of pseudo-inbreeding, combining work at the same institution where a PhD was taken with an academically relevant position in a state research institute or the Academy of Sciences. (shrink)

This article explores the impact of structural and technological change on women's employment in the UK television industry. It looks at the challenges faced by women in working in what has become since the mid-1980s a largely freelance industry where short-term contracts, informal recruitment procedures and long, unpredictable work schedules mean that women find it increasingly difficult to combine a career and family. Through case studies of individual careers, of a women's magazine programme for S4C Digital and a (...) survey of women's credits on a selection of the newer channels (Sky One, UK Living and Channel 5), it argues that technological advances in digital transmission and production will not improve working conditions and opportunities for women's participation in all areas of the industry if they continue to replicate existing practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Examining the Ethics of Human Subjects ResearchPaul S. Appelbaum (bio)The work of the Advisory Committee on Human Radiation Experiments confirms once again the value of combining empirical and normative approaches to problems in clinical and research ethics. The Committee, like its predecessor, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, spent relatively modest sums of money gathering targeted data to inform (...) its deliberations. The results of the Committee’s research, which are discussed by Nancy Kass and Jeremy Sugarman in this issue of the Kennedy Institute of Ethics Journal, enhance our understanding of the current ethical status of human subjects research, helping to focus attention on areas of particular concern, and lay the basis for future research and policy development.My comments here focus on the two major empirical studies conducted by the Committee—the Research Proposal Review Project and the Subject Interview Study. I will underscore just a few of the primary findings from these studies, consider their limitations, and explore their implications. Readers interested in the details of the studies should consult the Committee’s Final Report (ACHRE 1995), on which I rely in part and which provides additional information on the methodology and findings of the studies.Research Proposal Review ProjectWhat can be learned from the Committee’s review of 125 federally-funded human research studies? In answering that question, one cannot ignore the irony inherent in the Committee’s decision to review documents related to institutional review board (IRB) consideration of the selected protocols. The single most frequent complaint about the current system for protecting human subjects is that IRBs focus almost exclusively on review of consent forms and other research documents, as if they bore some close relationship to what actually transpires between investigators and potential research subjects. Only a small number of studies examine the research consent process. Nevertheless, existing data strongly [End Page 283] suggest that subject recruitment often involves an extended process of courtship, during which the information contained in consent forms is only a small part of the information passed between investigators and subjects (Benson, Roth, and Winslade 1985; Lidz et al. 1984).Indeed, the second of the Committee’s studies—the Subject Interview Study, which is discussed below—appears to confirm these findings. In-depth interviews with 99 individuals who reported that they were former or current research subjects suggest that “[f]or many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality” (ACHRE 1995 [GPO, p. 742; Oxford, p. 471]). 1 Why, then, did the Committee focus its attention on documents that in many cases seem to play only a tangential role in the consent process? As is the case with IRBs around the country, the answer appears to be that consent forms and related documents are the only easily available window on consent transactions. In addition, under the current system, consent forms constitute the part of the process that IRBs can influence most easily. Consequently, it suits almost everyone’s needs—except perhaps those of the research subjects—to pretend that they reflect what actually transpires in the recruitment process. To the Committee’s credit, it was well aware of this dilemma. Nonetheless, it struggled to wring valid lessons from these limited data in its Final Report.Perhaps the most interesting finding from the Research Proposal Review Project is just how poor so many consent forms are. Given the disproportionate emphasis that many IRBs place on the content of the forms, one would expect that investigators by now would have learned to design documents that meet objective standards of adequacy, such as those applied by the Committee. Indeed, except in the most unusual circumstances, doing so would virtually guarantee that the IRB will ask no further questions about subject recruitment procedures. Although the data justify the inference that many investigators do not yet understand which information is essential to communicate to potential subjects, nor have learned how to do so effectively, they also force us to a still more radical conclusion. If the IRBs were doing their jobs, the Committee... (shrink)

Although considerable attention has been paid to the application of leadership in virtual communities, the field of live streaming has not been involved. This exploratory study aimed to explore how different broadcaster leadership traits influence audiences’ loyalty. And audience self-construal was chosen as a key moderator. The top 15 broadcasters from the regional rankings were selected from each of the two popular live streaming platforms, Douyu and YouTube, for the study. And we used snowball sampling with a link to an (...) online questionnaire as a recruitment procedure. 310 audiences with live streaming experience from the Chinese Mainland and Taiwan participated. Hierarchical linear modeling was adopted for the analysis. This study found that broadcasters with servant and charismatic leadership traits positively affected cognitive loyalty. Broadcasters with servant leadership traits also had a positive effect on conative loyalty. Additionally, independent self-construal negatively moderated the relationship between servant leadership and cognitive loyalty. Independent self-construal positively moderated the relationship between authoritarian leadership and conative loyalty. Furthermore, interdependent self-construal negatively moderated the relationship between charismatic leadership and conative loyalty. Interdependent self-construal positively moderated the relationship between authoritarian leadership and conative loyalty. These conclusions extend the understanding of broadcasters’ traits and audiences’ psychology concerning the booming phenomenon of live streaming and can help platform managers motivate audiences’ loyalty on these platforms. (shrink)

A significant part of responsible innovation is engagement with diverse groups of stakeholders; this remains true for projects investigating responsible innovation practices. This chapter discusses strategies for engaging small and medium-sized enterprises in co-creating visions of and plans for implementing responsible innovation, drawing on the example of engagement with United Kingdom cyber security companies. The key aspect of the engagement was building trust between the responsible innovation researchers and the companies. Trust was built by a movement away from traditional (...) class='Hi'>recruitment procedures for research projects, towards proactive engagement with the culture and traditions of the sector – participating in company sponsored talks and conferences, finding ways to communicate effectively, and ensuring a tailored message that fit the expectations and requirements of the sector. This chapter reviews the context in which the recruitment took place, the assumptions made prior to recruitment, the approaches taken, the revisions made to these approaches, and ultimately offers some general recommendations for industry engagement in responsible innovation activities. (shrink)

Mindfulness and compassion meditation are thought to cultivate prosocial behavior. However, the lack of diverse representation within both scientific and participant populations in contemplative neuroscience may limit generalizability and translation of prior findings. To address these issues, we propose a research framework calledIntersectional Neurosciencewhich adapts research procedures to be more inclusive of under-represented groups. Intersectional Neuroscience builds inclusive processes into research design using two main approaches: 1) community engagement with diverse participants, and 2) individualized multivariate neuroscience methods to accommodate (...) neural diversity. We tested the feasibility of this framework in partnership with a diverse U.S. meditation center (East Bay Meditation Center, Oakland, CA). Using focus group and community feedback, we adapted functional magnetic resonance imaging (fMRI) screening and recruitment procedures to be inclusive of participants from various under-represented groups, including racial and ethnic minorities, gender and sexual minorities, people with disabilities, neuropsychiatric disorders, and/or lower income. Using person-centered screening and study materials, we recruited and scanned 15 diverse meditators (80% racial/ethnic minorities, 53% gender and sexual minorities). The participants completed the EMBODY task – which applies individualized machine learning algorithms to fMRI data – to identify mental states during breath-focused meditation, a basic skill that stabilizes attention to support interoception and compassion. All 15 meditators’ unique brain patterns were recognized by machine learning algorithms significantly above chance levels. These individualized brain patterns were used to decode the internal focus of attention throughout a 10-min breath-focused meditation period, specific to each meditator. These data were used to compile individual-level attention profiles during meditation, such as the percentage time attending to the breath, mind wandering, or engaging in self-referential processing. This study provides feasibility of employing an intersectional neuroscience approach to include diverse participants and develop individualized neural metrics of meditation practice. Through inclusion of more under-represented groups while developing reciprocal partnerships, intersectional neuroscience turns the research process into an embodied form of social action. (shrink)

What is the potential for improvements in the functioning of consciousness? The paper addresses this issue using global workspace theory. According to this model, the prime function of consciousness is to develop novel adaptive responses. Consciousness does this by putting together new combinations of knowledge, skills and other disparate resources that are recruited from throughout the brain. The paper's search for potential improvements in consciousness is aided by studies of a developmental transition that enhances functioning in whichever domain it occurs. (...) This transition involves a shift from the use of procedural (implicit) knowledge to declarative (explicit) knowledge. However, the potential of the transition to enhance functioning has not yet been realised to any extent in relation to consciousness itself. The paper assesses the potential for consciousness to use declarative knowledge to improve its own functioning and to thereby enhance human adaptability. A number of sources (including the practices of religious and contemplative traditions) are drawn on to investigate how this potential might be realised. (shrink)

Regarding police procedures with alcohol-intoxicated witnesses, Swedish police officers have previously reported inconsistent and subjective decisions when interviewing these potentially vulnerable witnesses. Most officers have also highlighted the need for national policy guidelines aiding in conducting investigative interviews with intoxicated witnesses. The aims of the two studies presented here were to investigate whether police officers’ inconsistent interview decisions are attributable to a lack of research-based knowledge; their decision to interview, as well as their perceptions of the witnesses’ credibility could (...) be influenced by scientific research; and police officers decision-making and perceptions of witness credibility are biased by pre-existing social norms. In two separate randomized online experiments, police professionals and recruits watched a recorded fictive witness interview to which they were asked to rate the probability of interviewing the witness, the witness’ credibility, and to estimate the witness’ level of intoxication. Results showed that interview probability and perceived witness credibility were affected by witness intoxication level. While it cannot be stated definitely from the present research, these findings provided indications that police officers and recruits lacked research-based knowledge. Results also showed that interview probability, but not perceptions of credibility, was influenced by a research-based message. In line with research, interview probability for the most intoxicated witness increased after reading the message. Unexpectedly, neither interview probability nor witness credibility was affected by social norms. The current findings added to the legal psychology literature by showing that a breath alcohol concentration as low as.04% was enough for police officers and recruits to consider intoxicated witnesses less credible than sober witnesses. Findings also indicated that, despite the lower credibility assessment, police may have some understanding that these witnesses can be interviewed at low intoxication levels. However, this willingness to interview intoxicated witnesses ceased at a BrAC lower than the levels where research has found intoxicated witnesses as reliable as sober witnesses. Future directions for research and policy development as well as theoretical and practical implications of the present findings are discussed. (shrink)

Background Informed consent procedures for large population-based cohort studies should be comprehensive and easy-to-use. This is particularly challenging when participants from different socio-economic groups and multicultural ethnic backgrounds are involved. Recently, more and more studies have tried to use multimedia in informed consent procedures. We describe the development and testing of a digital informed consent app and elaborate on whether this may contribute to a comprehensive and practical procedure to obtain informed consent for public health research. Methods In (...) a sample of parents with young children, we used a mixed method approach to study the user experience of an informed consent app and evaluate whether it can be used to adequately inform people and register their consent. Through semi-structured interviews we investigated participants’ experiences with and opinions about the app, with a special focus on comprehensibility of the content and the usability of the app. Information retention questions were asked to evaluate to what extent participants could recall key aspects of the provided study information. Results The 30 participants in this study used the app between 4 and 15 min to give their consent. Overall, they found the app well-designed, informative and easy to use. To learn more about the study for which informed consent is asked, most of the participants chose to watch the animated film, which was generally found to convey information in a clear manner. The identification process was met with mixed reactions, with some feeling it as a secure way to give consent, while for others it contradicted their view of using data anonymously. Information retention questions showed that while all participants remembered various aspects of the study, fewer than half answered all four questions satisfactorily. Conclusion Our study shows that a well-designed informed consent app can be an effective tool to inform eligible participants and to record consents. Still, some issues remain, including trust barriers towards the identification procedure and lack of information retention in some participants. When implementing consent procedures that incorporate digital formats, it may be beneficial to also invest in a complementary face-to-face recruitment approach. (shrink)

The article is devoted to the study of the borderland as a social and cultural phenomenon. The concept of borderline space can be realized in recruitment and solution of boundary and place. It is necessary to consider that the вorderlands may be considered as geographically and procedurally. It is outlines the history of the formation of the concepts of borderand and frontier. A boundary can be called the limited space, the time, the line of separation of a territory. The (...) border is a line that divides the earth or water of the neighbouring states. Frontier has its own characteristics compared with the border and the boundary. It is the territory of the movable boundary and it is characterized by specificity and complexity of intercultural interactions. The main features of the frontier are uncertainty and instability. He has a higher mobility than cultural heartland, creates new forms of cultural contacts, based on the values of individualism, freedom, respect for the individual, entrepreneurship. In an English-speaking environment there are some notions, that denote a limit, therefore, there are studies of different kinds of boundaries: вoundary studies, вorder studies, frontier studies. Conceptualization of the phenomenon of the borderland was analyzed, it was defined socio-cultural specifics and dynamics. The broadsemantics of the borderland contains inter-ethnic boundaries, the existence of small cultural groups, search of religious symbios is at interfaith space and linguistic diversity of the border of language forms. Its meaning may reflect the colonial character, the unrealizability and the incompleteness of the certain area surrounded by the dominant forces, but it can discover the potential of cultural interaction. It presents a socio-philosophical analysis of domestic and foreign research of the classification of the borderland. As the base of the typology it used classification based on the nature of intercultural communicative processes of borderareas. It is established that borderland is a region with social, cultural, economic, political specifics. It was found that the poly-variance frontier depends on the nature of the border. There is a significant integrating potential of the borderland as a territory of intercultural interaction. (shrink)

Objectives: Bronchoalveolar lavage obtained at bronchoscopy is useful for research on pulmonary defence mechanisms. Bronchoscopy involves some discomfort and risk to subjects. We audited the process of consent, experienced adverse effects and reasons for participation among research bronchoscopy volunteers.Design: 100 consecutive volunteer research subjects attending for bronchoscopy, repeat bronchoscopy or routine recruitment clinic were interviewed. Information was gathered about volunteer motivation, perception of the consent process and adverse effects of bronchoscopy. Suggestions for improvement were requested. Responses were themed by (...) a second investigator prior to data analysis.Results: 81 bronchoscopy-experienced subjects and 19 new volunteers were interviewed. 19 subjects reported adverse symptoms during or after bronchoscopy, but no symptoms were of sufficient severity that they would not repeat the procedure. The frequency of symptoms was not related to gender, the quality of the lavage or the HIV status of the subject. 76 subjects reported that the information given pre-procedure was useful and adequate but 43 had further questions mostly relating to their own results. The reasons given for research participation were access to health assessment , access to treatment when ill , desire to participate in research and remuneration . 7 subjects complained that the remuneration was inadequate.Conclusions: The main incentive to participation in research bronchoscopy was access to healthcare. Informed consent and procedure technique were adequate but subjects would value more feedback about individual and project results. (shrink)

In order to accommodate for the present shortage of oocyte donors, oocyte-donation programs place ads in college newspapers and provide large monetary compensation to encourage participation. Large compensation acts as a strong incentive for young women to undergo the potentially risky procedure of donation. In this enticing situation, it is particularly important for programs to fully inform prospective donors of the risks of the procedure so that they can accurately weigh the costs and benefits of donating. However, because oocyte-donor programs (...) must alleviate the shortage of donors if they wish to maintain a financially viable business, there is reason to fear that they may minimize or misrepresent risks when recruiting egg donors. In this pilot study, the risk information provided by programs (n=19) to prospective oocyte donors in a preliminary phone call inquiry was investigated. The majority of the programs provided incomplete and/or inaccurate risk information. Policy changes are recommended to reduce the potential for undue influence and to standardize and regulate the risk information provided to prospective egg donors. (shrink)

Background: Ethics is a founding component of the nursing profession; however, nurses sometimes find it difficult to constantly adhere to the required ethical standards. There is limited knowledge about the factors that cause a committed nurse to violate standards; moral disengagement, originally developed by Bandura, is an essential variable to consider. Research objectives: This study aimed at developing and validating a nursing moral disengagement scale and investigated how moral disengagement is associated with counterproductive and citizenship behaviour at work. Research design: (...) The research comprised a qualitative study and a quantitative study, combining a cross-validation approach and a structural equation model. Participants and research context: A total of 60 Italian nurses (63% female) involved in clinical work and enrolled as students in a postgraduate master’s programme took part in the qualitative study. In 2012, the researchers recruited 434 nurses (76% female) from different Italian hospitals using a convenience sampling method to take part in the quantitative study. Ethical considerations: All the organisations involved and the university gave ethical approval; all respondents participated on a voluntary basis and did not receive any form of compensation. Findings: The nursing moral disengagement scale comprised a total of 22 items. Results attested the mono-dimensionality of the scale and its good psychometric properties. In addition, results highlighted a significant association between moral disengagement and both counterproductive and citizenship behaviours. Discussion: Results showed that nurses sometimes resort to moral disengagement in their daily practice, bypassing moral and ethical codes that would normally prevent them from enacting behaviours that violate their norms and protocols. Conclusion: The nursing moral disengagement scale can complement personnel monitoring and assessment procedures already in place and provide additional information to nursing management for designing interventions aimed at increasing compliance with ethical codes by improving the quality of the nurses’ work environment. (shrink)

BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford (...) and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures. (shrink)

BackgroundThe potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on (...) the ground and the challenges of community consultation.MethodsThe findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach.ResultsField workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research.ConclusionsCommunity engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field workers conducting informed consent faced complex issues and their understanding, attitudes and communication skills were key influences on ethical practice. Community consultation was a challenging concept to put into practice, illustrating the complexity of assessing information needs and levels of deliberation that are appropriate to a given study. (shrink)

Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working (...) in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. (shrink)

The data were collected during 9.5 months of field work by Sarah Mathew from 2008– 2010. Participants were a representative sample of adult men reliant on nomadic pastoralism for their livelihood. We recruited them in a town close to the ethnic border frequented by nomadic Turkana who live in the surrounding 50 km radius. Recruitment was done with the help of trained local Turkana research assistants. The RA approached potential participants, briefly introduced them to the study, and then asked (...) them to participate. If they agreed, they were brought to the study site described below. We conducted the study in the town center because the risk of raids in the surrounding nomadic settlements was high. We did not recruit from the settled Turkana population in this town center as they are Turkana who have actively pursued schooling and professions outside the pastoral sector, or were forced out of subsistence pastoralism after droughts, epidemics or raids. Nomadic Turkana frequent the perimeter of the town center for a variety of reasons as it is an important trading center and is adjacent to dry season watering holes. Herders from surrounding nomadic settlements frequent the market to sell an animal and purchase tobacco, tea, sugar and flour. Turkana women come to sell milk and collect relief food. Nomadic Turkana periodically come to town to visit their settled relatives. A river runs along the perimeter of town. The wells dug in the dry bed of the river provide water for 1 surrounding nomadic settlements and so herdsmen frequently bring their livestock for watering to the perimeter of town from where we can recruit them.To ensure that our sample is representative of herders within the town perimeter on a given day, we aimed to recruit using the following procedure to the extent that circumstances allowed: First, we specified the age-group that the participant should belong to. Then the RA went to one of the locations where nomadic herders visiting town are found.. (shrink)

Introduction Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients’ baseline levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. Design A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of (...) receiving placebos. Setting Participants recruited from community settings completed the study online. Results 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly. However, few participants correctly answered questions about the nocebo effect and the impact of the colour of a placebo pill. Conclusions The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects. (shrink)

Advancements in machine learning have fuelled the popularity of using AI decision algorithms in procedures such as bail hearings, medical diagnoses and recruitment. Academic articles, policy texts, and popularizing books alike warn that such algorithms tend to be opaque: they do not provide explanations for their outcomes. Building on a causal account of transparency and opacity as well as recent work on the value of causal explanation, I formulate a moral concern for opaque algorithms that is yet to (...) receive a systematic treatment in the literature: when such algorithms are used in life-changing decisions, they can obstruct us from effectively shaping our lives according to our goals and preferences, thus undermining our autonomy. I argue that this concern deserves closer attention as it furnishes the call for transparency in algorithmic decision-making with both new tools and new challenges. (shrink)

Military ethics education programmes must prepare soldiers and other military personnel to carry out their duties responsibly, honourably and, above all, ethically. But the practical, moral, and ethical reasoning employed by soldiers in their professional activities—what I call ‘military ethical thinking’—is deeply challenging. The successful interpretation and application of principles and other demands of military ethical thinking presupposes more fundamental commitments that serve as its grounding. But whether soldiers address questions of grounding in their training and education tends to depend (...) upon their rank and role. The ethics education provided to senior officers, junior officers, NCOs, enlisted soldiers, new recruits, or conscripts varies greatly. Nonetheless, to facilitate coordination and cooperation across ranks and roles, there must be an overall unity and coherence to an ethics education programme. This paper asks which ethical approaches are best suited as grounds of military ethical thinking and education. According to a widely held view, the militaries of many democratic states are committed to ‘hybrid approaches’ to military ethical thinking and education. Here I argue that while hybrid decision-making procedures are valuable tools for soldiers facing ethically challenging situations, hybrid approaches cannot play the fundamental grounding role. Instead, I make a case for grounding military ethics education in a non-reductive virtue ethics which is based around the concept of ‘the good soldier’ and which is able to meet objections commonly put to virtue-based approaches. (shrink)

Background: The phenomenon of forceful physical restraint in pediatric care is an ethical issue because it confronts professionals with the dilemma of using force for the child’s best interest. This is a paradox. The perspective of healthcare professional working in pediatric wards needs further in-depth investigations. Purpose: To explore the perspectives and behaviors of healthcare professionals toward forceful physical restraint in pediatric care. Methods: This qualitative ethnographic study used focus groups with purposeful sampling. Thirty volunteer healthcare professionals (nurses, hospital aids, (...) physiotherapists, and health educators) were recruited in five pediatric facilities in four hospitals around Paris, France, from March to June 2013. The data were processed using NVIVO software (QSR International Ltd. 1999–2013). The data analysis followed a qualitative methodological process. Ethical Considerations: The research was conducted in compliance with the Declaration of Helsinki. Written informed consent was collected systematically from participants. Findings: This study provides elements to help understand why restraint remains common despite its contradiction with the duty to protect the child and the child’s rights. All participants considered the use of forceful physical restraint to be a frequent difficulty in pediatrics. Greater interest in the child’s health was systematically used to justify the use of force, with little consideration for contradictory or ethical aspects. Raising the issue of forceful restraint always triggered discomfort, unease and an outpour of emotions among healthcare professionals. The findings have highlighted a form of hierarchy of duties that give priority to the execution of the technical procedure and legitimize the use of restraint. Professionals seemed to temporarily suspend their ability to empathize in order to apply restraint to carry out a technical procedure. This observation has allowed us to suggest the concept of “transient empathic blindness.” Conclusion: Using physical restraint during pediatric care was considered a common problem by participants. This practice must be questioned, and professionals must have access to training to find alternatives to strong restraint. Conceptualizing this phenomenon with the concept of “transient empathic blindness” could help professionals understand what happens in their minds when using forceful restraint. (shrink)

Background: Genetics research is controversial in Native American communities, and the disposition and ownership of biological specimens are central issues. Within Native communities, there is considerable variety in tribal members’ views. This article reports the results from an ethnographic study conducted with a Native American community in the southwestern United States. The purpose of this study was to examine the relationship (past and present) between the tribe and biomedical/genetics research. Methods: Qualitative interviews were conducted with 53 members of a Native (...) American community. Interviewees were purposively recruited to include an approximately equal number of past research participants and nonparticipants, as well as individuals with and without diabetes. Tribal members were also asked whether they identified as a “traditional person,” an emic category used in the community. Results: Tribal members’ views on specimen disposition were linked with their identification as a traditional or nontraditional person. Individuals identifying as traditional people were more likely to believe that biological specimens should be returned at the end of a study and should not be used after the research participant's death, and that they were the property of the individual who provided them. These perspectives were related to broader concerns about fragmentation of the body-self. Conclusions: Through gaining an understanding of the cultural logic related to specimen disposition, researchers may be able to work more effectively with Native American communities on developing procedures for genetics studies. The process of informed consent and other study procedures can be adapted to be culturally respectful of Native American communities. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (45 CFR (...) 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

Due to the rapid changes in the medical world and the aging population, the need for advanced care planning grows. Despite efforts to make this topic discussed, only a minority of patients discusses the advance directive with their general practitioner. This study aimed to map thresholds: What barriers are identified by GPs and patients in preparing and discussing an advance directive? A cross section survey in patients and GP’s was performed. Citizens were recruited by multimedia and by street interviews. GP’s (...) were recruited by mailing. Most of the 502 citizens already heard of an advance directive but only 17 had declared one while 21 never want one. Eighty percent wants to take the initiative themselves but half of the participants wants the GP to be actively involved. Thirty percent finds the document too difficult to understand. The need to draw an advance directive grew with increasing age. Of the 117 GP’s involved, 65% drafted five or less advance directives the past year. A lack of time, experience and a poor access to the correct administrative requirements were only a few of the barriers. Preparing and drafting an advance directive is a time-consuming and difficult procedure. Patients and GP’s have the right to be informed and instructed on how to prepare an advance directive. (shrink)

The art, craft, and science of policing -- Crime and criminals -- Criminal process and prosecution -- The crime-preventive impact of penal sanctions -- Contracts and corporations -- Financial markets -- Consumer protection -- Bankruptcy and insolvency -- Regulating the professions -- Personal injury litigation -- Claiming behavior as legal mobilization -- Families -- Labor and employment laws -- Housing and property -- Human rights instruments -- Constitutions -- Social security and social welfare -- Occupational safety and health -- Environmental (...) regulation -- Administrative justice -- Access to civil justice -- Judicial recruitment, training, and careers -- Trial courts and adjudication -- Appellate courts -- Dispute resolution -- Lay decision-makers in the legal process -- Evidence law -- Civil procedure and courts -- Collective actions -- Law and courts on development and democratization -- How does international law work? -- Lawyers and other legal service providers -- Legal pluralism -- Public images and understandings of courts -- Legal education and the legal academy -- The (nearly) forgotten early empirical legal research -- Quantitative approaches to empirical legal research -- Qualitative approaches to empirical legal research -- The need for multi-method approaches in empirical legal research -- Legal theory and empirical research -- Empirical legal research and policy-making -- The place of empirical legal research in the law school curriculum -- Empirical legal training in the US academy. (shrink)

Background Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. Methods This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. (...) The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis. Results Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making. Conclusions Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent. (shrink)