Doctoral students in clinical, counseling, and school psychology programs often collaborate with faculty on research projects in their training as scientist-practitioners. Yet, the determination of publications' credit and order of authorship on resulting manuscripts continues to be a major concern and challenging process for professional psychologists and student collaborators. This article describes the use of case-based learning and semi-structured interview approaches to instruct first-year clinical psychology doctoral students in publication ethics during a research seminar. The instructor models (...) ethical decision-making with 1) a discussion of four cases from his own professional experiences and 2) a description of the Authorship Eligibility Assessment form, which he developed for use with junior researchers. The authors advocate for more educational strategies to supplement the APA standards in teaching the ethics of the publication process. Implications in terms of graduate student development and research collaborations in the field of professional psychology were discussed. (shrink)

BackgroundOpen peer review practices are increasing in medicine and life sciences, but in social sciences and humanities they are still rare. We aimed to map out how editors of respected SSH journals perceive open peer review, how they balance policy, ethics, and pragmatism in the review processes they oversee, and how they view their own power in the process.MethodsWe conducted 12 pre-registered semi-structured interviews with editors of respected SSH journals. Interviews consisted of 21 questions and lasted an average (...) of 67 min. Interviews were transcribed, descriptively coded, and organized into code families.ResultsSSH editors saw anonymized peer review benefits to outweigh those of open peer review. They considered anonymized peer review the “gold standard” that authors and editors are expected to follow to respect institutional policies; moreover, anonymized review was also perceived as ethically superior due to the protection it provides, and more pragmatic due to eased seeking of reviewers. Finally, editors acknowledged their power in the publication process and reported strategies for keeping their work as unbiased as possible.ConclusionsEditors of SSH journals preferred the benefits of anonymized peer review over open peer and acknowledged the power they hold in the publication process during which authors are almost completely disclosed to editorial bodies. We recommend journals to communicate the transparency elements of their manuscript review processes by listing all bodies who contributed to the decision on every review stage. (shrink)

In an increasingly globalized world, the accessibility of healthcare and medication has expanded beyond local healthcare systems and national borders. This study aims to investigate the transnational health and self-care experiences of 11 Japanese women who have resided in South Korea for a minimum of six months and have utilized oral contraceptives, including those that were acquired over-the-counter (OTC). Data were gathered through semi-structured interviews and analyzed by utilizing the NVivo software. The analysis yielded three significant thematic categories, (...) namely (1) experiences and perceptions of obtaining and utilizing contraceptive pills, including OTC access; (2) individual and social perceptions of pills and their accessibility in Japan, insights from actual users; and (3) enhancing pill accessibility, transnational health and self-care experiences and perspectives. Participants acknowledged that oral contraceptives are a global product and experienced communication challenges with healthcare providers as a result of differing understandings of these medications. Additionally, this study identified transnational strategies, such as purchasing an adequate supply of pills just before departure and seeking pills from local families or acquaintances. This study not only highlights the implications of clinical care for transnational patients but also underscores their critical global perspectives on access to oral contraceptives. Furthermore, it proposes two models for improving accessibility within the Japanese healthcare system, even in prescription-only contexts, by introducing OTC options. (shrink)

Ambient assisted living technologies are expected to solve a significant number of problems related to elderly care. However, in Japan, limited discourse on the ethical issues concerning their application is hindering the spread of AAL technologies. Against this background, this study explores the ethical perspectives of AAL technology engineers in Japanese companies and the circumstances influencing their perspectives. A qualitative study using semi-structured interviews was conducted. Nineteen Japanese AAL-technology companies were contacted, and nine of them and their engineers (...) responded to the interviews. The contents of the interviews were analyzed with thematic analysis which showed that the engineers had ethical concerns about their products as follows: safety and related conflicts, acceptance of the technology, dependence on the technology, accident liability, fair access to the technologies, and privacy. In relation to these issues, they identified as company employees with regard to the following: responding to social needs, having many users, and cost reduction. They also mentioned being influenced by the Japanese national program for AAL-technology promotion. The engineers experienced dilemmas between the various stakeholders’ interests and they hoped that ethical guidelines for developing AAL technologies would resolve such dilemmas. In conclusion, Japanese AAL-technology engineers tackle ethical issues with regard to the application of their products. The engineers hope for the establishment of guidelines for the ethically responsible development of AAL technologies. The guidelines need to be established and implemented in an interactive manner, in order to avoid their being reduced to a bureaucratic formality. (shrink)

The original article published in volume 10 issue 2 on pp. 143–155 had an error. Table 1 headers “Mobility assistance” and “Automated toilet” were inadvertently removed, while the headers “Movement actuation” and “Conversation partner” were in the wrong columns.

Research in psychopathology is booming in an unprecedented way, at least, in terms of increasing number of publications. Yet, a few questions arise: Does quantity also give us quality? Are the collected data generally of sound quality? How are data typically collected in psychopathology? Are the applied methods of data collection appropriate for this particular field of study? This article explores three different methods of data collection in psychopathology, namely self-rating scales, structured interviews, and semi-structured, phenomenological interviews. (...) To identify the most adequate methodological approach, we first establish the nature of the object of psychopathology and then we critically assess each method’s appropriateness to this field of study. We emphasize fundamental issues that make self-rating scales and structured interviews unfit for the task of adequately examining psychopathology. By contrast, we propose that a semi-structured, phenomenological interview presents a more appropriate method. Finally, we describe two types of semi-structured, phenomenological interviews that can be applied to assess and explore psychopathology, respectively. (shrink)

Research in psychopathology is booming in an unprecedented way, at least, in terms of increasing number of publications. Yet, a few questions arise: Does quantity also give us quality? Are the collected data generally of sound quality? How are data typically collected in psychopathology? Are the applied methods of data collection appropriate for this particular field of study? This article explores three different methods of data collection in psychopathology, namely self-rating scales, structured interviews, and semi-structured, phenomenological interviews. (...) To identify the most adequate methodological approach, we first establish the nature of the object of psychopathology and then we critically assess each method’s appropriateness to this field of study. We emphasize fundamental issues that make self-rating scales and structured interviews unfit for the task of adequately examining psychopathology. By contrast, we propose that a semi-structured, phenomenological interview presents a more appropriate method. Finally, we describe two types of semi-structured, phenomenological interviews that can be applied to assess and explore psychopathology, respectively. (shrink)

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 (...) class='Hi'>semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance, for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows. (shrink)

Wandering is a symptom of dementia that can have devastating consequences on the lives of persons living with dementia and their families and caregivers. Increasingly, caregivers are turning towards electronic tracking devices to help manage wandering. Ethical questions have been raised regarding these location-based technologies and although qualitative research has been conducted to gain better insight into various stakeholders' views on the topic, developers of these technologies have been largely excluded. No qualitative research has focused on developers’ perceptions of ethics (...) related to electronic tracking devices. To address this, we performed a qualitative semi-structured interview study based on grounded theory. We interviewed 15 developers of electronic tracking devices to better understand how they perceive ethical issues surrounding the design, development, and use of these devices within dementia care. Our results reveal that developers are strongly motivated by moral considerations and believe that including stakeholders throughout the development process is critical for success. Developers felt a strong sense of moral obligation towards topics within their control and a weaker sense of moral obligation towards topics outside their control. This leads to a perceived moral boundary between development and use, where some moral responsibility is shifted to end-users. (shrink)

BackgroundDefensive practice occurs when physicians provide services, such as tests, treatments and referrals, mainly to reduce their perceived legal or reputational risks, rather than to advance patient care. This behaviour is counter to physicians’ ethical responsibilities, yet is widely reported in surveys of doctors in various countries. There is a lack of qualitative research on the drivers of defensive practice, which is needed to inform strategies to prevent this ethically problematic behaviour.MethodsA qualitative interview study investigated the views and experiences (...) of physicians in Australia on defensive practice and its contribution to low value care. Interviewees were recruited based on interest in medico-legal issues or experience in a health service involved in ‘Choosing Wisely’ initiatives. Semi-structured interviews averaged 60 min in length. Data were coded using the Theoretical Domains Framework, which encapsulates theories of behaviour and behaviour change.ResultsAll participants (n = 17) perceived defensive practice as a problem and a contributor to low value care. Behavioural drivers of defensive practice spanned seven domains in the TDF: knowledge, focused on inadequate knowledge of the law and the risks of low value care; skills, emphasising patient communication and clinical decision-making skills; professional role and identity, particularly clinicians’ perception of patient expectations and concern for their professional reputation; beliefs about consequences, especially perceptions of the beneficial and harmful consequences of defensive practice; environmental context and resources, including processes for handling patient complaints; social influences, focused on group norms that encourage or discourage defensive behaviour; and emotions, especially fear of missing a diagnosis. Overall, defensive practice is motivated by physicians’ desire to avoid criticism or scrutiny from a range of sources, and censure from their professional peers can be a more potent driver than perceived legal consequences.ConclusionsThe findings call for strengthening knowledge and skills, for example, to improve clinicians’ understanding of the law and their awareness of the risks of low value care and using effective communication strategies with patients. Importantly, supportive cultures of practice and organisational environments are needed to create conditions in which clinicians feel confident in avoiding defensive practice and other forms of low value care. (shrink)

BackgroundInformed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent.MethodsThis was a cross-sectional, qualitative study via a subjective and interpretivist approach. The study was performed by conducting semi-structured interviews (...) of 21 clinicians and researchers. Data analysis was performed using the SPSS version 21® and Atlas Ti version 7.0® programs.ResultsThe deliberative and paternalistic models were influential practices in the physician–patient relationship. In the deliberative model, the child is expected to have a moral awareness of their care. The paternalistic model determined that submission was a way of structuring the child because he or she is considered to be a subject of extreme care.ConclusionsThe differentiated objectification [educational] process recognizes the internal and external elements of the child. Informed consent proved to be an appropriate means for strengthening moral and structuring the child. (shrink)

The present article is a primary introduction to the semi-structured interviewing method SMILE_PH, an acronym for Sense-Making Interviews Looking at Elements of Philosophical Health. Beyond grounding this new methodology theoretically (a work that is started here but will in the future necessitate several developments), the main motivation here is pragmatic: to provide the recent philosophical health movement with a testable method and show that philosophically-oriented interviews are possible in a manner that can be reproduced, compared, tested and used (...) systematically with a population that has received no training in philosophy. The SMILE_PH approach was conceived by the author during an ethically approved pilot study focused on the philosophy of life of persons living with spinal cord injury (SCI), with the intention of rectifying the epistemic obstacles generated by rationalist, Socratic or unstructured ways of in-depth interviewing. The six-step structure of the method is also inspired by hundreds of individual dialogue sessions with philosophical counselees, led by the author between 2018 and 2022: the SMILE_PH method progressively gathers phenomenological data about 1 – our bodily sense, 2 – our sense of self, 3 – our sense of belonging, 4 – our sense of the possible, 5 – our sense of purpose and 6 – our philosophical sense. (shrink)

This article presents an analysis of Turkish film screenings in Belgium as a case study of diasporic media practices in Europe. Turkish blockbusters have only recently become part of the programs of Belgian mainstream film theaters. This study provides insight into both historical and recent dynamics that characterize this new film and audience segment in film exhibition. After analyzing transnational patterns of distribution, selection and promotion, we put forward that changing circulation patterns and the associated power relations define the social (...) and spatial conditions of reception, resulting in the creation of new semi-public diasporic spaces. Thus, the links between the political economy of media and audience research are discussed. The findings of this article are based on archival and press research and a series of semi-structured expert interviews with exhibition and distribution professionals, as well as social workers and representatives from Turkish cultural associations. (shrink)

Existing research on women’s construction of professional identities and, more specifically, on leader identities in the workplace, has traditionally focused mainly on western contexts. This article aims to extend this focus by investigating the position of women in the workplace in India. We do this by discursively analyzing audio-taped semi-structured interviews with women who are working in the corporate sector in India. The aim of these analyses is to present a number of case studies about the unique challenges (...) that women face at the workplace in the urban Indian context, especially when they take up leadership positions. The issues they grapple with are the collision of the traditional dominant discourses on appropriate female behavior and the new professional identities that these women wish to embrace. The paper discusses how these female professionals mainly construct two quite diverging identities: either as nurturing mentors or as aggressive professionals who are involved in activities traditionally viewed as “a man’s domain”. Conclusions are then drawn regarding how these professional identities acquiesce to, counter, or — as is the case in one interview — carefully mould, hegemonic discourses of femininity in India. (shrink)

With disagreement, doubts, or ambiguous grounds in end–of-life decisions, doctors are advised to involve a clinical ethics committee. However, little has been published on doctors’ experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors’ experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen (...) Norwegian physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients’ relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs’ discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs’ discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians. (shrink)

Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. (...) Participants were chosen because they were actively involved in, or in their expert capacity expressed an interest in, ambulance based research. Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance. (shrink)

The management of an infant after a decision to withdraw active treatment creates dilemmas. Both lingering death and active killing are undesirable, but palliative interventions can hasten death. We investigated what staff on our neonatal unit thought were the limits of acceptable practice and why. We administered a structured interview to elucidate their views, and asked them to justify their answers. The interviews were analysed quantitatively and qualitatively. A total of 25 participants (15 nurses and 10 doctors) were (...) recruited. 80% emphasized the importance of pain relief following withdrawal, 60% mentioned meeting parental needs at that time. 76% agreed that death can be a desired consequence of withdrawal, yet 52% felt that death should never be hastened. 96% felt that morphine is acceptable after withdrawal, and 72% would give a higher than normal dose if necessary. 56% would stop paralysis at extubation but not reverse it, while 24% would continue paralysis. 16% would consider a drug that ended life instantly in some cases. A wide variety of views emerged, but there were two main positions, a cautious majority, and a more proactive minority. Apparent contradictions within the majority position could be explained using the doctrine of double effect and the acts and omissions distinction. (shrink)

Tape-recorded semi-structured interviews were conducted with 21 nursing aides and enrolled nurses in the geriatric clinic in Umeå, Sweden. The interviews focused on the difference between the care of demented and non-demented patients and ethical conflicts in dementia care. The results indicate that caregivers have problems in providing the demented patients with opportunities to act autonomously in everyday matters on the ward, mainly due to the difficulty of understanding what the patients wish and the fact that their wishes, (...) when understood, often seem irrational. Measures to provide the demented patients with more opportunities to act autonomously in everyday matters are suggested. (shrink)

BackgroundThe neurotechnology behind brain-computer interfaces (BCIs) raises various ethical questions. The ethical literature has pinpointed several issues concerning safety, autonomy, responsibility and accountability, psychosocial identity, consent, privacy and data security. This study aims to assess BCI users’ experiences, self-observations and attitudes in their own right and looks for social and ethical implications.MethodsWe conducted nine semi-structured interviews with BCI users, who used the technology for medical reasons. The transcribed interviews were analyzed according to the Grounded Theory coding method.ResultsBCI users (...) perceive themselves as active operators of a technology that offers them social participation and impacts their self-definition. Each of these aspects bears its own opportunities and risks. BCIs can contribute to retaining or regaining human capabilities. At the same time, BCI use contains elements that challenge common experiences, for example when the technology is in conflict with the affective side of BCI users. The potential benefits of BCIs are regarded as outweighing the risks in that BCI use is considered to promote valuable qualities and capabilities. BCI users appreciate the opportunity to regain lost capabilities as well as to gain new ones.ConclusionsBCI users appreciate the technology for various reasons. The technology is highly appreciated in cases where it is beneficial in terms of agency, participation and self-definitions. Rather than questioning human nature, the technology can retain and restore characteristics and abilities which enrich our lives. (shrink)

Arab researchers encounter formidable obstacles when conducting and publishing their scientific work. We conducted semi-structured interviews with 17 Arab researchers from various Arab Middle East countries to gain a comprehensive understanding of the difficulties they face in research and publication. We analyzed the transcripts using reflexive thematic analysis. Our findings revealed several key challenges. First, Arab researchers struggle to conduct high-quality research due to limited resources, inadequate funding, and a lack of a supportive research infrastructure. Furthermore, a shortage (...) of teamwork and mentoring diminishes research productivity. Perverse promotion policies, heavy teaching loads, and low salaries force many researchers to seek external income sources, leaving them with insufficient time for research. Regarding publishing in high-impact journals, Arab researchers confront challenges existing of insufficient scientific writing skills, underrepresentation on editorial boards, and unconscious biases against researchers from economically challenged areas. Finally, achieving research integrity is closely tied to lack of access to essential resources. To address these issues, our participants proposed targeted interventions at the institutional and external levels. For example, universities can implement mentoring programs, offer workshops on scientific writing and publishing, and foster a supportive institutional culture for research. Addressing the underrepresentation of Arabic researchers on editorial boards is crucial for equity in global scientific publishing. In conclusion, acknowledging and addressing these challenges will empower Arab researchers, elevate research quality, and promote equitable global scientific collaboration. Our findings provide guidance for universities, governments, and international donors seeking to enhance research and publication practices in the Arab Middle East. (shrink)

Background Self-binding directives (SBDs) are psychiatric advance directives that include the possibility for service users to consent in advance to compulsory care in future mental health crises. Legal provisions for SBDs exist in the Netherlands since 2008 and were updated in 2020. While ethicists and legal scholars have identified several benefits and risks of SBDs, few data on stakeholder perspectives on SBDs are available. Aims The aim of the study was to identify opportunities and challenges of SBDs perceived by stakeholders (...) who have personal or professional experience with legally enforceable SBDs. Methods Data collection was carried out in the Netherlands from February 2020 to October 2021 by means of semi-structured interviews. Participants were selected through purposive sampling and snowball methods. Interviews were conducted with mental health service users (n = 7), professionals (n = 13), and an expert on SBD policy (n = 1), resulting in a total number of 21 interviews. The data were analyzed thematically. Results Perceived benefits of SBDs included increased autonomy, improvement of the therapeutic relationship, possibility of early intervention and prevention of harm, prevention of compulsory care, reduction of the duration of compulsory care and recovery, mitigation of negative experiences around compulsory care, and guidance for professionals in providing compulsory care. Perceived risks included infeasibility of SBD instructions, difficulty in decision-making around SBD activation, limited accessibility of SBDs, disappointment of service users due to non-compliance with SBDs, and limited evaluation and updating of SBD content. Barriers to SBD completion included lack of knowledge of SBDs among professionals, lack of motivation or insight among service users, and lack of professional support for SBD completion. Facilitators of SBD completion and activation included support for SBD completion, involvement of relatives and peer experts, specification of SBD content, and evaluation of compulsory care and SBD content. The new legal framework was regarded as having both positive and negative effects on SBD implementation. Conclusions Stakeholders who have personal or professional experience with legally enforceable SBDs perceive SBDs as having important benefits and tend not to articulate the fundamental ethical concerns about SBDs which can be found in the ethics and legal literature. Instead, they perceive ethical and practical challenges that can be addressed through the implementation of suitable safeguards. (shrink)

Background How often does refractory suffering, which is suffering due to symptoms that cannot be adequately controlled, occur at the end of life in modern palliative care? What are the causes of such refractory suffering? Should euthanasia be offered for refractory suffering at the end of life? We sought to shed light on these questions through interviews with palliative care specialists. Methods Semi-structured interviews with six nurses and six doctors working in palliative care in five Norwegian hospitals. Transcripts (...) were analysed with systematic text condensation, a qualitative analysis framework. Results Informants find that refractory suffering is rare, and that with palliative sedation satisfactory symptom control can nearly always be achieved at the end of life. However, the process of reaching adequate symptom control can be protracted, and there can be significant suffering in the meantime. Both somatic, psychological, social and existential factors can contribute to refractory suffering and potentiate each other. However, informants also place significant weight on factors pertaining to the organization of palliative care services as contributing to insufficient symptom control. Conclusions If refractory suffering is indeed rare, then this arguably weakens a common prima facie argument for the legalization of assisted dying. However, the process of reaching adequate symptom control can be protracted and involve significant suffering. The experiences of palliative care clinicians constitute important empirical premises for the assisted dying debate. The study points to several areas in which palliative care can be improved. (shrink)

The main causes of suicide and how suicide could and should be prevented are ongoing controversies in the scientific literature as well as in public media. In the bill on public health from 2008, the Swedish Parliament adopted an overarching “Vision Zero for Suicide” and nine strategies for suicide prevention. However, how the VZ should be interpreted in healthcare is unclear. The VZ has been criticized both from a philosophical perspective and against the background of clinical experience and alleged empirical (...) claims regarding the consequences of regulating suicide prevention. This study is part of a larger research project in medical ethics with the overarching aim to explore whether the VZ is ethically justifiable. The aim is to enrich the normative discussion by investigating empirically how the VZ is perceived in healthcare. Interviews based on a semi-structured interview guide were performed with 12 Swedish psychiatrists. The interviews were analysed with descriptive qualitative content analysis aiming for identifying perceptions of the Vision Zero for Suicide as well as arguments for and against it. Though most of the participants mentioned at least some potential benefit of the Vision Zero for Suicide, the overall impression was a predominant skepticism. Some participants focused on why they consider the VZ to be unachievable, while others focused more on its potential consequences and normative implications. The VZ was perceived to be impossible to realize, nonconstructive or potentially counterproductive, and undesirable because of potential conflicts with other values and interests of patients as well as the general public. There were also important notions of the VZ having negative consequences for the working conditions of psychiatrists in Sweden, in increasing their work-related anxiety and thwarting the patient-physician relationship. (shrink)

BackgroundHuman embryonic stem cells as a source for the development of advanced therapy medicinal products are considered for treatment of Parkinson’s disease. Research has shown promising results and opened an avenue of great importance for patients who currently lack a disease modifying therapy. The use of hESC has given rise to moral concerns and been the focus of often heated debates on the moral status of human embryos. Approval for marketing is still pending.ObjectiveTo Investigate the perspectives and concerns of patients (...) with PD, patients being the directly concerned stakeholders in the ethical discussion.MethodsQualitative semi-structured interviews related to this new therapy in seventeen patients from two Swedish cities.ResultsThe participants expressed various interests related to the use of human embryos for development of medicinal therapies; however, overall, they were positive towards the use of hESC for treatment of PD. It was deemed important that the donating woman or couple made the choice to donate embryos voluntarily. Furthermore, there were concerns that the industry does not always prioritise the patient over profit; thus, transparency was seen as important. (shrink)

This study aimed to understand the preserved elements of self-identity in persons with moderate to severe dementia attributable to Alzheimer’s disease. A semi-structured interview was developed to explore the narrative self among residents with dementia in a residential care facility and residents without dementia in an independent living setting. The interviews were transcribed verbatim from audio recordings and analyzed for common themes, while being sensitive to possible differences between the groups. The participants with dementia showed evidence of (...) self-reference even though losses in explicit memory were evident. The most noticeable difference between the two groups was time frame reference. Nonetheless, all participants showed understanding of their role in relationships and exhibited concrete preferences. Our findings suggest that memory loss and other cognitive deficits associated with moderate to severe dementia do not necessarily lead to a loss of “self.”. (shrink)

Background Despite its negative impact on patients and nurses, the use of restraint in somatic health care continues in many settings. Understanding the reasons and justifications for the use of restraint among nurses is crucial in order to manage this challenge. Aim To understand nurses’ justifications for restraint use in neurosurgical care. Research design A qualitative, descriptive design was used. Data were analysed with inductive qualitative content analysis. Participants and research context Semi-structured interviews with 15 nurses working in (...) three neurosurgical departments in Sweden. Ethical considerations Approved by The Regional Ethics Committee, Stockholm, Sweden. Findings The analysis resulted in three categories. The category Patient factors influencing restraint use describes patient factors that trigger restraint, such as a diminished decision-making competence, restlessness, and need for invasive devices. The category Specific reasons for justifying restraint describes reasons for restraining patients, such as restraint being used for the sake of the patient or for the sake of others. The category General reasoning in justifying restraint describes how nurses reason when using restraint, and the decision to use restraint was often based on a consequentialist approach where the nurses’ weighed the pros and cons of different alternatives. Discussion Nurses with experience of restraint use were engaged in a constant process of justifying and balancing different options and actions. Restraint was considered legitimate if the benefit exceeded the suffering, but decisions on which restraint measures to use and when to use them depended on the values of the individual nurse. Conclusion How nurses reason when justifying restraint, why they use restraint, and who they use restraint on must be considered when creating programs and guidelines to reduce the use of restraint and to ensure that when it is used it is used carefully, appropriately, and with respect. (shrink)

BackgroundSevere brain injury is a leading cause of death and disability. Diagnosis and prognostication are difficult, and errors occur often. Novel neuroimaging methods can improve diagnostic and prognostic accuracy, especially in patients with prolonged disorders of consciousness (PDoC). Yet it is currently unknown how family caregivers understand this information, raising ethical concerns that disclosure of neuroimaging results could result in therapeutic misconception or false hope.MethodsTo examine these ethical concerns, we conducted semi-structured interviews with caregivers of patients with PDoC (...) who were enrolled in a concurrent neuroimaging research program designed to detect covert consciousness following severe brain injury. Caregivers held surrogate decision-making status for a patient. Interviews were conducted at two time points for each caregiver. The first interview occurred before the disclosure of neuroimaging results. The second occurred after disclosure. Descriptive analysis was applied to the data of four interview topics: (1) expectations for neuroimaging; (2) reactions to evidence of preserved cognition; (3) reactions to null results; and (4) understanding of the results and study.ResultsTwelve caregivers participated in the study; two caregivers shared surrogate decision-making status for one patient with PDoC. Twenty-one interviews were completed; one caregiver declined to participate in the post-disclosure interview. Three patients with PDoC associated with the study displayed evidence of covert consciousness. Overall, caregivers understood the neuroimaging research and results. Caregivers who received results of covert consciousness were generally pleased. However, there was some variation in expectations and reactions to these data and null results.ConclusionThis study, for the first time, reveals caregiver expectations for and reactions to neuroimaging evidence of covert consciousness in patients with PDoC. Caregivers understood the neuroimaging research and results, casting doubt on speculative ethical concerns regarding therapeutic misconception and false hope. However, disclosure of neuroimaging result could be improved. Pre-disclosure consultations might assist professionals in shaping caregiver expectations. Standardization of disclosure might also improve comprehension of the results. (shrink)

Background Gerontechnologies are increasingly used in the care for older people. Many studies on their acceptability and ethical implications are conducted, but mainly from the perspective of principlism. This narrows our ethical gaze on the implications the use of these technologies have. Research question How do participants speak about the impact that gerontechnologies have on the different phases of care, and care as a process? What are the moral implications from an ethic of care perspective? Research design Secondary analysis of (...) semi-structure interviews, whose segments on specific technologies were analysed through reflexive thematic analysis. Participants and research context Sixty-seven Swiss stakeholders involved in the use of gerontechnologies, including professional caregivers, informal caregivers, and older persons themselves. Ethical considerations The research study was evaluated by the Ethics Commission of Northwest and Central Switzerland (EKNZ). All participants received an information document before the interview date detailing the purpose, procedure, and anonymization measures. After explaining the study during the agreed upon interview time and upon receiving their written informed consent, the interview process began. Findings/results Four themes are identified: Identifying care needs, Taking responsibility, Hands-on work, Responding to care. As part of these themes, many codes highlighting the ambivalent impact of gerontechnologies are created, ranging from ‘Expanded capacity for…identifying care needs’ to ‘Create new & (un)necessary…hands-on work’. The moral implications of these results from the care ethics perspective are discussed, through the ethical elements of: attentiveness, responsibility, competence, and responsiveness. Conclusions The moral implications of gerontechnologies on care phases from the care ethics perspective open up several questions on whether they actually help give care a central role in social life and provide more competent care. (shrink)

In European industrialized countries, a large number of companies in the healthcare, hotel, and catering sectors, as well as in the technology sector, are affected by demographic, political, and technological developments resulting in a greater need of skilled workers with a simultaneous shortage of skilled workers (CEDEFOP, 2015, 2016). Consequently, employers have to address workers who have not been taken into account such as low-skilled workers, workers returning from a career break, people with a migrant background, older people, and jobseekers (...) and train them, in order to guarantee the professionalization of this workforce (Festing and Harsch, 2018). Continuing vocational education and training (CVET) is seen as an indispensable tool; because CVET has advantages for both employers and employees, it helps to increase the productivity of companies (Barrett and O’Connell, 2001), to prevent the widening of socioeconomic disparities (Dieckhoff, 2007), and to open up career opportunities for the workforce (Rubenson and Desjardins, 2009). However, participation rate on CVET seems to differ, depending on institutional factors (such as sector and size of the company) and individual characteristics (such as qualification level, migration background, age and time of absence from work) (e.g., Rubenson and Desjardins, 2009; Wiseman and Parry, 2017). In contrast to previous research, our study aims to provide a holistic view of reasons for and against CVET, combining the different perspectives of employers and (potential) employees. The analysis of reasons and barriers was carried out based on semi-structured interviews. Fifty-seven employers, 73 employees, and 42 jobseekers (potential employees) from the sectors retail, healthcare and social services, hotels and catering, and technology were interviewed. Results point to considerable differences in the reasons and barriers mentioned by the disadvantaged groups. These differences are particularly significant between employees on the one side and employers, as well as jobseekers, on the other side, while the reasons to attend CVET of jobseekers are more similar to those of employers. The results can be used to tailor CVET more closely to the needs of (potential) employees and thus strengthen both the qualification and career opportunities of (potential) employees and the competitiveness and productivity of companies. (shrink)

Background While most countries that allow abortion on women’s request also grant physicians a right to conscientious objection (CO), this has proven to constitute a potential barrier to abortion access. Conscientious objection is regarded as an understudied phenomenon the effects of which have not yet been examined in Germany. Based on expert interviews, this study aims to exemplarily reconstruct the processes of abortion in a mid-sized city in Germany, and to identify potential effects of conscientious objection. Methods Five semi- (...) class='Hi'>structured interviews with experts from all instances involved have been conducted in April 2020. The experts gave an insight into the medical care structures with regard to abortion procedures, the application and manifestations of conscientious objection in medical practice, and its impact on the care of pregnant women. A content analysis of the transcribed interviews was performed. Results Both the procedural processes and the effects of conscientious objection are reported to differ significantly between early abortions performed before the 12th week of pregnancy and late abortions performed at the second and third trimester. Conscientious objection shows structural consequences as it is experienced to further reduce the number of possible providers, especially for early abortions. On the individual level of the doctor-patient relationship, the experts confirmed the neutrality and patient-orientation of the vast majority of doctors. Still, it is especially late abortions that seem to be vulnerable to barriers imposed by conscientious objection in individual medical encounters. Conclusion Our findings indicate that conscientious objection possibly imposes barriers to both early and late abortion provision and especially in the last procedural steps, which from an ethical point of view is especially problematic. To oblige hospitals to partake in abortion provision in Germany has the potential to prevent negative impacts of conscientious objection on women’s rights on an individual as well as on a structural level. (shrink)

BackgroundParkinson’s disease (PD) has been considered to be one of the most promising target diseases for forthcoming cell-based therapy. The aim of this study is to explore the views of individuals with cryopreserved embryos on using human embryonic stem cells for treating PD.MethodsThe study was performed as a qualitative, semi-structured interview study in June–October 2020. Participants were recruited at a private fertility clinic located in one of the larger Swedish cities. The clinic provides both publicly financed and (...) privately financed IVF-treatments. All interviews were performed by telephone and analyzed using thematic content analysis. Five main categories emerged from 27 sub-categories.ResultsIn total, 18 interviews were performed with 22 individuals, as either a couple (n = 16) or separately (n = 6). Participants had different views on what a cryopreserved embryo is. Some participants addressed cryopreserved embryos as ‘a lump of cells’, and some in terms of their ‘unborn child’. Conditions for donation of cryopreserved embryos for cell-based treatment in PD were: not losing control of what is happening to the embryo, that donating must be voluntary and based on informed consent with time for reflection, that reimbursement, equality and transparency.ConclusionsUsing cryopreserved embryos to treat PD is associated with fundamental ethical and practical issues. This study shows that IVF couples with left-over embryos may be supportive but there is a need for future research to assess people’s views on using cryopreserved embryos for cell-based treatment in PD on a more aggregated level. (shrink)

Objective The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12–13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Design Qualitative study using semi-structured interviews. Participants A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Results Overriding the parents' wishes was perceived (...) as problematic and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. Conclusions While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting. (shrink)

The assessment of nanotechnology applications such as nanocarrier-based targeted drug delivery has historically been based mostly on toxicological and safety aspects. The use of nanocarriers for TDD, a leading-edge nanomedical application, has received little study from the angle of experts’ perceptions and acceptability, which may be reflected in how TDD applications are developed. In recent years, numerous authors have maintained that TDD assessment should also take into account impacts on ethical, environmental, economic, legal, and social issues in order to lead (...) to socially responsible innovation. Semi-structured interviews were conducted with French and Canadian researchers and research trainees with diverse disciplinary backgrounds and involved in research related to emerging technologies. The interviews focussed on scenarios presenting two types of TDD nanocarriers in two contexts of use. Content and inductive analyses of interviews showed how facets of perceived impacts such as health, environment, social cohabitation, economy, life and death, representations of the human being and nature, and technoscience were weighed in acceptability judgments. The analyses also revealed that contextual factors related to device, to use, and to user influenced the weighting assigned to perceived impacts and thus contributed to variability in interviewees’ judgments of acceptability. Giving consideration to researchers’ perspective could accompany first steps of implementation and development of nanomedicine by producing a first, but wide, picture of the acceptability of nanocarrier-based TDD. (shrink)

Background Improving the ways in which routinely-collected mental health data are shared could facilitate substantial advances in research and treatment. However, this process should only be undertaken in partnership with those who provide such data. Despite relatively widespread investigation of public perspectives on health data sharing more generally, there is a lack of research on the views of people with mental illness. Methods Twelve people with lived experience of mental illness took part in semi-structured interviews via online video (...) software. Participants had experience of a broad range of mental health conditions including anxiety, depression, schizophrenia, eating disorders and addiction. Interview questions sought to establish how participants felt about the use of routinely-collected health data for research purposes, covering different types of health data, what health data should be used for, and any concerns around its use. Results Thematic analysis identified four overarching themes: benefits of sharing mental health data, concerns about sharing mental health data, safeguards, and data types. Participants were clear that health data sharing should facilitate improved scientific knowledge and better treatments for mental illness. There were concerns that data misuse could become another way in which individuals and society discriminate against people with mental illness, for example through insurance premiums or employment decisions. Despite this there was a generally positive attitude to sharing mental health data as long as appropriate safeguards were in place. Conclusions There was notable strength of feeling across participants that more should be done to reduce the suffering caused by mental illness, and that this could be partly facilitated by well-managed sharing of health data. The mental health research community could build on this generally positive attitude to mental health data sharing by following rigorous best practice tailored to the specific concerns of people with mental illness. (shrink)

Objectives“Attachment difficulties” is an umbrella term often used to describe various forms of non-secure attachment. Differentiating “attachment difficulties” from autism spectrum disorder and attention deficit hyperactivity disorder has been characterized as challenging. Few studies have explored how this happens in practice, from the perspective of professionals.DesignQualitative study.MethodsWe conducted in-depth semi-structured interviews with healthcare professionals from five NHS Foundation Trusts in the United Kingdom. Participants were recruited using a combination of snowballing, convenience and purposive sampling. Data were analyzed using (...) a thematic approach.ResultsWe identified six interrelated themes that might reflect difficulties with differential conceptualization. These include: a clinical lexicon of attachment; approaching attachment with caution; contextual factors; perceived characteristic behaviors; assessing attachment and adjacent supports; spotlighting intervention and dual conceptualization.ConclusionOur results indicate some of the ways suspicions around attachment are raised in practice. We advocate for more dialogue between research and practice communities on issues of differential conceptualization. We call for collaboration between a panel of experts consisting of attachment and neurodevelopmental orientated practitioners and researchers, to clarify issues around differentiating between attachment difficulties, ASD, and ADHD. (shrink)

Receiving a diagnosis of autism in adulthood can be a life changing event, impacting identity, relationships, and mental health. A lack of post-diagnostic support has been highlighted by autistic adults, their allies, clinicians, and service providers. It can be a source of distress for autistic adults, reinforcing feelings of social isolation and rejection. Peer support could be a cost-effective, flexible, and sustainable model to provide community-based support for autistic adults. However, there is little research on the value of peer support, (...) despite calls from the autistic community. This qualitative study explored autistic experiences and needs post-diagnosis, identifying specific ways that peer support may benefit them, and exploring the limitations of peer support. Twelve autistic adults who had all received an autism diagnosis in adulthood completed a semi-structured interview focussing on the diagnostic experience, post-diagnostic support needed and provided, engagement with the autistic community, and post-diagnostic peer support. Thematic analysis of interview transcripts resulted in four themes: Mismatch in support needed and provided; Community connection; Flexible and personalised support; and Sustainability. Participants indicated that peer support may be a useful mechanism to support autistic adults’ post-diagnosis and offers unique opportunities not available through other support channels. Though informal peer support exists, it could be more sustainable and effective if well-supported and funded. (shrink)

This article looks at ethical issues when conducting qualitative semi-structured interviews in the field outside of the researcher’s country of residence. What makes this research unique is that I...

IntroductionAfter three decades of the absolute prohibition of abortion, Chile enacted Law 21,030, which decriminalizes voluntary pregnancy termination when the person is at vital risk, when the embryo or fetus suffers from a congenital or genetic lethal pathology, and in pregnancy due to rape. The law incorporates conscientious objection as a broad right at the individual and institutional levels.ObjectivesThe aim of the study was to explore the exercise of conscientious objection in public health institutions, describing and analyzing its consequences and (...) proposals to prevent it from operating as structural violence.Materials and methodsThis study uses a qualitative, post-positivist design. At the national level, according to the chain technique, people who were identified as key actors due to their direct participation in implementing the law were included. Grounded theory was used to analyze the information obtained through a semi-structured interview. The methodological rigor criteria of transferability or applicability, dependability, credibility, auditability, and theoretical-methodological adequacy were met.ResultsData from 17 physicians, 5 midwives, 6 psychologists, 8 social workers, 2 nursing technicians, and 1 lawyer are included. From an inductive process through open coding, conscientious objection as structural violence and strategies to minimize the impact of objection emerge as meta-categories. The first meta-category emerges from the barriers linked to the implementation of the law, the infringement of the rights of the pregnant person, and pseudo conscientious objection, affecting timely and effective access to pregnancy termination. The second meta-category emerges as a response from the participants, proposing strategies to prevent conscientious objection from operating as structural violence.ConclusionConscientious objection acts as structural violence by infringing the exercise of sexual and reproductive rights. The State must fulfill its role as guarantor in implementing public policies, preventing conscientious objection from becoming hegemonic and institutionalized violence. (shrink)

Digital communication between a patient and their clinician offers the potential for improved patient care, particularly for young people with long term conditions who are at risk of service disengagement. However, its use raises a number of ethical questions which have not been explored in empirical studies. The objective of this study was to examine, from the patient and clinician perspective, the ethical implications of the use of digital clinical communication in the context of young people living with long-term conditions. (...) A total of 129 semi-structured interviews, 59 with young people and 70 with healthcare professionals, from 20 United Kingdom -based specialist clinics were conducted as part of the LYNC study. Transcripts from five sites were read by a core team to identify explicit and implicit ethical issues and develop descriptive ethical codes. Our subsequent thematic analysis was developed iteratively with reference to professional and ethical norms. Clinician participants saw digital clinical communication as potentially increasing patient empowerment and autonomy; improving trust between patient and healthcare professional; and reducing harm because of rapid access to clinical advice. However, they also described ethical challenges, including: difficulty with defining and maintaining boundaries of confidentiality; uncertainty regarding the level of consent required; and blurring of the limits of a clinician’s duty of care when unlimited access is possible. Paradoxically, the use of digital clinical communication can create dependence rather than promote autonomy in some patients. Patient participants varied in their understanding of, and concern about, confidentiality in the context of digital communication. An overarching theme emerging from the data was a shifting of the boundaries of the patient-clinician relationship and the professional duty of care in the context of use of clinical digital communication. The ethical implications of clinical digital communication are complex and go beyond concerns about confidentiality and consent. Any development of this form of communication should consider its impact on the patient-clinician-relationship, and include appropriate safeguards to ensure that professional ethical obligations are adhered to. (shrink)

BackgroundHuntington’s disease has a poor prognosis. For HD patients in the Netherlands, one way of dealing with their poor prognosis is by drawing up an advance euthanasia directive. Little is known about the perspectives of HD patients on their AED.AimTo gain insight into patients’ views on and attitudes towards their AED, and changes over time.MethodsA longitudinal qualitative interview study using 1 to 6 semi-structured interviews over a period of maximum three years. Nine HD patients who either had (...) an AED or were thinking about drawing it up participated in this study.ResultsWe identified two themes that characterize patients’ perspectives on their AEDs: general character of the AED; uncertainty around their AED. Ad The conditions that the participants described in their AED were generally not very specific for the person. Mostly they were general notions of unbearable suffering. Familiarity with HD in the family could play a role in drawing up an AED. Ad Participants generally were aware of the tentative character of their AED and could have doubts concerning their own willingness or the willingness of others in the future. Sometimes these doubts were so great, that it prevented them from drawing up an AED. However, patients did not alter their AED during the follow-up period or changed in their view or attitude on their AED.ConclusionHD patients that draw up an AED usually describe general conditions for euthanasia and recognize that these conditions may change as the disease progresses. An AED or the wish to draw one up may be a good conversation starter for conversations about goals and preferences for future care. (shrink)

ObjectivesIndividuals with irregular physical activity participation are defined as fluctuators. This study aimed to comprehend how fluctuators’ perceived barriers and motivators in their subjective theories are exhibited and cognitively represented in relation to their everyday PA practices and lapses.MethodsThe design of “Research Program Subjective Theories” was used to explore and present fluctuators’ cognition concerning PA participation. Thirty fluctuators were invited to a semi-structured interview. By inductive and deductive coding, fluctuators’ verbal data were converted into word categories for (...) extracting commonalities and comparing differences. By retaining the remaining word categories of high frequency and exploring the interrelationships among the remained word categories using statistical analyses, a superstructure including fluctuators’ main PA motivators, barriers, and behavioral outcomes was compiled.ResultsFluctuators face common motivators as barriers, such as lack of time, lack of willpower, lack of social support, and physical reasons. Fluctuators’ subjective theories primarily differed in motivational configurations. The physically motivated fluctuators were more linked with low PA level, while the mixed motivated fluctuators were more likely associated with moderate PA level. The exemplars of the three typical fluctuators were also demonstrated to reveal their real experiences and situations in the daily life context.ConclusionDue to the fact that fluctuation research is still in its infancy, this study represents a significant opportunity to promote knowledge growth in this area. Future studies are recommended to convert findings of the present study into interventions that benefit fluctuators in overcoming perceived barriers and enhancing motivations to eventually participate in regular PA. (shrink)

This article explores the formal and functional characteristics of narratives of ‘good’ and ‘bad’ deaths as they were told by 13 UK-based hospice managers in the course of semi-structured interviews. The interviewees’ responses include a variety of remarkably consistent ‘narratives of successful/frustrated intervention’, which exhibit distinctive formal characteristics in terms of the starting point and core of the action, the choice of personal pronouns and metaphors, and the ways in which positive and negative evaluation is expressed. In functional (...) terms, the hospice managers’ narratives play an important role in representing and constructing their professional views, challenges and identities. Overall, the narratives argue for the role of hospices and professional hospice staff in facilitating a ‘good’ death, and, by presenting a relatively unified view, may potentially preclude alternative perspectives. (shrink)

Direct-to-consumer (DTC) genetic tests (GT) enable consumers to access a wide range of GT, without involving a healthcare professional, promoting an increasing disassociation of genetics from the clinical context. This study explores, through semi-structured interviews, the experiences and attitudes of European clinical geneticists towards DTCGT. Our results indicate that the participants have limited experience of consultations with patients regarding such tests. The majority of participants stated that consumers purchased tests out of curiosity and sought a general interpretation of (...) test results by a healthcare professional. Most respondents were skeptical of the quality of tests, especially regarding their clinical utility. The participants supported the importance of medical supervision and genetic counseling in this context. Finally, most respondents considered it their duty to accept consultations concerning DTCGT results. However, due to concerns over limited time and potential downstream costs, some participants supported that a prioritization system based on guidelines would be necessary. (shrink)

BackgroundIn gender-affirming medical care (GAMC), ethical challenges in decision-making are ubiquitous. These challenges are becoming more pressing due to exponentially increasing referrals, politico-legal contestation, and divergent normative views regarding decisional roles and models. Little is known, however, about what ethical challenges related to decision-making healthcare professionals (HCPs) themselves face in their daily work in GAMC and how these relate to, for example, the subjective nature of Gender Incongruence (GI), the multidisciplinary character of GAMC and the role HCPs play in assessing (...) GI and eligibility for interventions. Given the relevance and urgency of these questions, we conducted a qualitative study among HCPs providing GAMC to transgender adults in the Netherlands.MethodsIn this qualitative research, we conducted 11 semi-structured interviews between May 2020 and February 2021 with HCPs (six mental health professionals, two HCPs in endocrinology, two in plastic surgery, and one in nursing) working in two distinct GAMC settings. We purposively sampled for professional background and years of experience in GAMC. We analyzed our interview data using thematic analysis. As some respondents were more inclined to speak about what should or ought to be done to arrive at good or right decision-making, we identified both ethical challenges and norms. Furthermore, in our analysis, we differentiated between respondents’ explicit and implicit ethical challenges and norms and ascertained the specific context in which these challenges emerged.ResultsRespondents’ ethical challenges and norms centered on (1) dividing and defining decisional roles and bounds, (2) negotiating decision-making in a (multidisciplinary) team, and (3) navigating various decision-making temporalities. These themes arose in the context of uncertainties regarding (1) GAMC’s guidelines, evidence, and outcomes, as well as (2) the boundaries and assessment of GI.ConclusionsThis interview study provides detailed empirical insight into both the explicit and implicit ethical challenges that HCPs experience and their ethical norms regarding decision-making. It also describes how uncertainties and (implicit) normativities concerning GAMC and GI pre-structure the moral environment in which these challenges and norms manifest. We provide normative reflections and recommendations on handling these ethical challenges in a way that is sensitive to the context in which they arise. (shrink)

Background Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.Methods We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to (...) initiation and while ongoing. We used a priori and grounded theory to analyze the data and constant comparative method to induce higher order themes.Results Interviewees perceived determination of scientific value as the responsibility of the investigator and, secondarily, other parties who review or oversee research. Interviewees reported that ongoing trials are rarely reevaluated due to emerging evidence from external sources, evaluation is complex, and there would be value in the development of standards for monitoring and evaluating evidence systematically. Investigators, IRBs, and/or data monitoring committees (DMCs) could undertake these responsibilities. Feasibility assessments are performed but are typically inadequate; potential solutions are unclear.Conclusions There are three domains where current approaches are suboptimal and in which further guidance is needed. First, who has the responsibility for conducting scientific review, whether it be the investigator, IRB, and/or DMC is often unclear. Second, the standards for scientific review (e.g., appropriate search terms, data sources, and analytic plan) should be defined. Third, guidance is needed on the evaluation of ongoing studies in light of potentially new and evolving evidence, with particular reference to evidence from outside the trial itself. (shrink)