Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. (...) Methods We sought to use mabaraza , traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research. (shrink)

In Switzerland, people can be granted access to assisted suicide on condition that the person whose wish is to die performs the fatal act, that he has his decisional capacity and that the assisting person’s conduct is not selfishly motivated. No restrictions relating to the ground of suffering are mentioned in the act. Existential suffering as a reason for wanting to die, however, gives raise to controversial issues. Moreover, existential suffering lacks definition and no consensus exists on how to evaluate (...) and manage it. This study explores the perspectives of care professionals and volunteers from a “right-to-die organization” on existential suffering as a motive for assisted suicide requests. A qualitative study based on face-to-face interviews was conducted with twenty-six participants: palliative care and primary care providers as well as EXIT right-to-die organization volunteers. Elements from the grounded theory approach were used. The twenty-six participants described existential suffering in a multiplicity of individual ways. In total, sixty-three stories were recounted. Their representations were grouped into eight categories: physical decline and its consequences, loneliness, fear of the future, life is over, loss of social significance, loss of hope for a better future, being a financial burden and loss of pleasurable activities. According to all participants, suffering coming from the loss of self-identity was always linked to physical decline, as if one’s image completely defined someone’s identity. Society’s perception of old people and vulnerable people were also often questioned. Another interesting point was that only four stories referring to a “pure” existential suffering were found. This suffering was related to a feeling that life has come to an end, without identification of any other related restriction or suffering. Existential suffering is multifaceted. Legislators and right-to-die organisations have to address the question of what make a AS acceptable. The plurality of existential suffering implies the need of a very personalized care. A better understanding of what it is made of could provide a “toolbox” to people concerned by these requests, helping them to explore it in order to offer suffering people a wider range of alternatives. (shrink)

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...) a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and (...) scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation. (shrink)

Context: The need to reinvigorate medical confidentiality protections is recognised as an important objective in building patient trust necessary for successful health outcomes. Little is known about patient understanding and expectations from medical confidentiality.Objective: To identify and describe patient views of medical confidentiality and to assess provisionally the range of these views.Design: Qualitative study using indepth, open ended face-to-face interviews.Setting: Southeastern Pennsylvania and southern New Jersey, USA.Participants: A total of 85 women interviewed at two clinical sites and three community/research (...) centres.Main outcome measures: Subjects’ understanding of medical confidentiality, beliefs about the handling of confidential information and concerns influencing disclosure of information to doctors.Results: The subjects defined medical confidentiality as the expectation that something done or said would be kept “private” but differed on what information was confidential and the basis and methods for protecting information. Some considered all medical information as confidential and thought confidentiality protections functioned to limit its circulation to medical uses and reimbursement needs. Others defined only sensitive or potentially stigmatising information as confidential. Many of these also defined medical confidentiality as a strict limit prohibiting information release, although some noted that specific permission or urgent need could override this limit.Conclusions: Patients share a basic understanding of confidentiality as protection of information, but some might have expectations that are likely not met by current practice nor anticipated by doctors. Doctors should recognise that patients might have their own medical confidentiality models. They should address divergences from current practice and provide support to those who face emotional or practical obstacles to self-revelation. (shrink)

BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...) a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

Moral injury has primarily been studied from a clinical perspective to assess, diagnose and treat the outcomes of morally injurious experiences in healthcare and military settings. Little is known about the lived experiences of those who have had their moral values transgressed in business settings. Public scandals such as Enron suggest that moral injury may also occur in for-profit business settings. In this qualitative study, we examine the lived experiences of 16 employees in for-profit business organisations who identified as (...) having suffered moral injury. Using semi-structured narrative interviews, our findings offer insights into the values that employees feel are transgressed and the pathways between morally injurious experiences and the long-term outcomes. Based on our findings, we propose a conceptual pathway to moral injury, which suggests that experiencing moral transgressions has a profound impact on employees as they feel a threat to their “good-me” identity, however, employees employ various coping strategies to minimise the impact during the event. Employees exited the organisation and often changed career paths to protect themselves from further injury and to make up for moral failure. This study advances our understanding of the experience of moral injury in business settings and the pathway explaining how and why people react differently to moral transgressions. (shrink)

BackgroundLow literacy of study participants in Sub - Saharan Africa has been associated with poor comprehension during the consenting process in research participation. The concerns in comprehension are far greater when consenting to participate in genomic studies due to the complexity of the science involved. While efforts are made to explore possibilities of applying genomic technologies in diseases prevalent in Sub Saharan Africa, we ought to develop methods to improve participants’ comprehension for genomic studies. The purpose of this (...) study was to understand different approaches that can be used to seek consent from individuals with low literacy in Sub-Saharan African countries in genomic research to improve comprehension.MethodsUsing qualitative study design, we conducted focus-group discussions, in-depth interviews and participant observations as data collection methods. This study was embedded in a hospital based genomic study on Sickle Cell Disease at Muhimbili National Hospital in Tanzania. Thematic content analysis was used to analyse the transcripts and field notes.ResultsFindings from this study show that literacy level has little influence on understanding the research details. According to the participants of this study, the methods used to provide information, the language, and time spent with the study participants were the key factors influencing understanding. The availability of group sessions held before individual consent to allow for a detailed questions and answers format was agreed to be the best method to facilitate the comprehension.ConclusionThe quality of the consenting process of participants will be influence by a number of factors. The type of research consented for, where the research will be implemented and who are the potential study participants are amongst the factors that need to be assessed during the consenting. Measures to improve participants’ comprehension need to be developed when consenting participants with low literacy level in genomic studies. (shrink)

Imagination is extremely important for science, yet very little is known about how scientists actually use it. Are scientists taught to imagine? What do they value imagination for? How do social and disciplinary factors shape it? How is the labor of imagining distributed? These questions should be high priority for anyone who studies or practices science, and this paper argues that the best methods for addressing them are qualitative. I summarize a few preliminary findings derived from recent interview-based (...) and observational qualitative studies that I have performed. These finding include: (i) imagination is only valued for use in addressing maximally specific problems, and only when all else fails; (ii) younger scientists and scientists who are members of underrepresented groups express less positive views about imagination in general, and have less confidence in their own imaginations; (iii) while scientists seem to employ various epistemological frameworks to evaluate imaginings, overall they appear to be epistemic consequentialists about imagination, and this holds also for their evaluations of the tools they use to extend the power of their imaginations. I close by discussing the epistemic and ethical consequences of these findings, and then suggesting a few research avenues that could be explored next as we move forward in the study of scientific imagination. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The (...) role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The (...) role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

Imagination is necessary for scientific practice, yet there are no in vivo sociological studies on the ways that imagination is taught, thought of, or evaluated by scientists. This article begins to remedy this by presenting the results of a qualitative study performed on two systems biology laboratories. I found that the more advanced a participant was in their scientific career, the more they valued imagination. Further, positive attitudes toward imagination were primarily due to the perceived role of imagination (...) in problem-solving. But not all problem-solving episodes involved clear appeals to imagination, only maximally specific problems did. This pattern is explained by the presence of an implicit norm governing imagination use in the two labs: only use imagination on maximally specific problems, and only when all other available methods have failed. This norm was confirmed by the participants, and I argue that it has epistemological reasons in its favour. I also found that its strength varies inversely with career stage, such that more advanced scientists do (and should) occasionally bring their imaginations to bear on more general problems. A story about scientific pedagogy explains the trend away from (and back to) imagination over the course of a scientific career. Finally, some positive recommendations are given for a more imagination-friendly scientific pedagogy. (shrink)

BackgroundBalancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide different stakeholders in an attempt to determine the rights and/or obligations held on human biological materials and data.MethodsTwenty-eight informants in the Benelux and Scandinavia were interviewed in order to capture the perspectives of experts and stakeholders in relation to the rights and obligations held by custodians and applicants with (...) respect to access to HBM and data.ResultsThere was no consensus among the informants on whether the custodian of a biobank should decide upon the scientific merits and the utility of an access request. Nearly all informants agreed that a new request or an amendment to the initial request has to be submitted when an applicant wants to use leftover HBM in a new or follow-up project. Several informants felt that it might be justified to charge higher access fees to external or industrial applicants that did not contribute to the collection of HBM and data. Most informants agreed that a custodian of a biobank could request the sharing and return of research results. It was furthermore argued that some of the benefits of research projects should be fed back into biobanks.ConclusionsThe interviews revealed a rather complex web of rights and obligations allocated to the custodian and the applicant in relation to access to HBM and data stored in biobanks. Some rights and obligations are negotiated on a case-by-case basis, while others are stipulated in access arrangements. We did find a consensus on the attribution of certain general rights to the custodians and the applicant. (shrink)

In Switzerland, people can be granted access to assisted suicide on condition that the person whose wish is to die performs the fatal act, that he has his decisional capacity and that the assisting person...

Background One of the objectives of medicine is to relieve patients' suffering. As a consequence, it is important to understand patients' perspectives of suffering and their ability to cope. However, there is poor insight into what determines their suffering and their ability to bear it. Purpose To explore the constituent elements of suffering of patients who explicitly request euthanasia or physician-assisted suicide (EAS) and to better understand unbearable suffering from the patients' perspective. Patients and methods A qualitative study using (...) in-depth face-to-face interviews was conducted with 31 patients who had requested EAS. The grounded theory approach was used to analyse the data. Results Medical, psycho-emotional, socio-environmental and existential themes contributed to suffering. Especially fatigue, pain, decline, negative feelings, loss of self, fear of future suffering, dependency, loss of autonomy, being worn out, being a burden, loneliness, loss of all that makes life worth living, hopelessness, pointlessness and being tired of living were constituent elements of unbearable suffering. Only patients with a psychiatric (co)diagnosis suffered unbearably all the time. Conclusions Unbearable suffering is the outcome of an intensive process that originates in the symptoms of illness and/or ageing. According to patients, hopelessness is an essential element of unbearable suffering. Medical and social elements may cause suffering, but especially when accompanied by psycho-emotional and existential problems suffering will become ‘unbearable’. Personality characteristics and biographical aspects greatly influence the burden of suffering. Unbearable suffering can only be understood in the continuum of the patients' perspectives of the past, the present and expectations of the future. (shrink)

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards need to determine if the regulations have been met.Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were (...) chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results: Respondents noted that: emergency exception to informed consent studies require lengthy review; community consultation and notification regulations are vague and hard to implement; current regulations, if applied correctly, protect human subjects; legal counsel is an important aspect of reviewing exception to informed-consent protocols; and IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects. (shrink)

Balancing the rights and obligations of custodians and applicants in relation to access to biobanks is of utmost importance to guarantee trust and confidence. This study aimed to reveal which issues divide dif..

Mother-to-child transmission of the Human Immunodeficiency –Virus is a serious public health problem, contributing up to 90% of childhood HIV infections. In Tanzania, the prevention-of-mother-to-child-transmission feature of the HIV programme was rolled out in 2000. The components of PMTCT include counselling and HIV testing directed at antenatal clinic attendees. It is through the process of Provider Initiated Counseling and Testing that counselling is offered participant confidentiality and voluntariness are upheld and valid consent obtained. The objective of the study was to (...) explore antenatal clinic attendees’ experiences of the concept of voluntariness vis- a- vis the implementation of prior counseling and subsequent testing for HIV under the PITC as part of their antenatal care. In-depth interviews were conducted with17 antenatal clinic attendees and 6 nursing officers working at the Muhimbili National Hospital antenatal clinic. The study data were analyzed using qualitative content analysis. Antenatal clinic attendees’ accounts suggested that counselling and testing for HIV during pregnancy was voluntary, and that knowledge of their HIV status led them to access appropriate treatment for both mother and her newborn baby. They reported feeling no pressure from nursing officers, and gave verbal consent to undergo the HIV test. However, some antenatal clinic attendees reported pressure from their partners to test for HIV. Healthcare providers were thus faced with a dilemma of disclosure/ nondisclosure when dealing with discordant couples. Antenatal clinic attendees at MNH undertook the PITC for HIV voluntarily. This was enhanced by their prior knowledge of HIV, the need to prevent mother- to- child transmission of HIV, and the effectiveness of the voluntary policy implemented by nursing officers. (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)

A qualitative analysis of societal silences, demonstrating how the unsaid directs social action and shapes individual and collective lives.

BackgroundThere is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A (...) class='Hi'>qualitative study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research.MethodsThis study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed.ResultsOn the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted.Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns.ConclusionsStudy findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants. (shrink)

Student researchers encounter ethical issues daily, but little is known about their unique perspectives. This article presents the results of 30 qualitative semi-structured interviews exploring students’ views and experiences around ethical issues in research groups. During the interviews, students were asked to describe challenges and successes they have encountered in their lab, their conception of what counts as an “ethical issue in research,” and how they handle these issues when they arise. Against this background, the article discusses students’ conceptions (...) of ethical issues in research environments, the types of issues students reported facing, how these issues were ultimately resolved, and finally, the factors, internal qualities, and lessons learned that help students thrive in research environments, as well as some of the challenges students face – especially international students. Many of the ethical challenges interviewees discussed focused on interpersonal issues, highlighting the intense collaboration most graduate students have with their colleagues and supervisors. Findings from this study point to the need for targeted training programs for students and faculty supervisors focusing on building mentoring relationships and finding space in the lab where open communication can occur around ethical research practices. (shrink)

Coastal environments are increasingly shown to have a positive effect on our health and well-being. Various mechanisms have been suggested to explain this effect. However, so far little focus has been devoted to emotions that might be relevant in this context, especially for people who are directly or indirectly exposed to the coast on a daily basis. Our preregistered qualitative study explored how coastal residents experience the emotions they feel at the coast and how they interpret the effect these (...) emotions have on them. We conducted semi-structured interviews with a purposive sample of eight Belgian coastal residents aged 21–25 years old. The interviews were analyzed with the approach of interpretative phenomenological analysis. Five superordinate themes were identified and indicate that, for our participants, the coast represents a safe haven in which they can experience emotional restoration, awe, and nostalgia. These emotional states are accompanied with adaptive emotion regulating strategies, such as reflection and positive reappraisal, that may facilitate coping with difficult thoughts and feelings. Our study demonstrates the importance of investigating specific emotions and related processes triggered at the coast and how these could contribute to the therapeutic value of the coast. (shrink)

Background Interest in biobanking for collection of specimens for non-communicable diseases research has grown in recent times. This paper explores the perspectives of Nigerians on donation of specimen for the biobanking research. Methods We conducted 16 Focus Group Discussions (FGD) with individuals from different ethnic, age and socio-economic groups in Kano (North), Enugu (Southeast), Oyo States (Southwest) and Abuja, the Federal Capital Territory (Central) of Nigeria. We used topic guides and prompt statements to explore the knowledge and understanding of interviewees (...) to general issues about biobanking of biospecimens, their use and specifically about role of biobanking in non-communicable diseases research. Results A total of 123 individuals participated in 16 focus group discussions in 2011. Our participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it and saw it as a worthwhile venture. Half of our study participants supported use of broad consent, a quarter supported restricted consent while the remaining quarter were in favour of tiered consent. Most discussants support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. The majority preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the course of the research instead of financial compensation. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs. Conclusions Our study demonstrates that our participants accepted biobanking once they understand it but there were different attitudes to elements of biobanking such as type of consent. Our study highlights the need to carefully document population attitudes to elements of modern scientific research and the consenting process. (shrink)

Admitting hospital patients: a qualitative study of an everyday nursing task In recent years new modes of nursing work have been introduced globally in response to radical changes in healthcare policies, technology and new ideologies of citizenship. These transformations have redefined orthodox nurse–patient relationships and further complicated the division of labour within health‐care. One distinctive feature of the work of registered nurses has been their initial assessment of patients being admitted to hospital, and it is of interest that this (...) area of nursing practice remains central to the registered nurse's role at a time where other areas of practice have been relinquished to other occupational groups. This qualitative study, drawing on conversation analysis and ethnographic techniques, explores this area of everyday nursing work. Initial nursing assessments have attracted considerable interest in the nursing literature, where it is clearly stated that assessments should be patient centred and seen as the important first step on the road to a therapeutic nurse–patient relationship. Results from this study lead to the conclusion that the actual nursing practice of patient assessment on admission to hospital is at odds with the recommendations of the literature and that a more routinised, bureaucratic form of work is devised by nurses as a means of expediting the process of admission. (shrink)

The scarcity of resources during the COVID‐19 pandemic caused ethical dilemmas in prioritizing patients for treatment. Medical and ethical guidance only emphasizes clinical procedures but does not consider the sociocultural aspect. This study explored the perception of former COVID‐19 patients and their families on the decision‐making process of the patient's selection at a time of scarcity of resources. The result will inform the development of an ethical guide for allocating scarce resources that aligns with Indonesian culture. We conducted qualitative (...) research with in‐depth interviews between May ‐ December 2022 involving sixteen participants from various cities in Indonesia. We transcribed the interviews and analyzed the results using thematic analysis. This study found that doctor's decisions often differed from patient's expectations in allocating scarce resources, and therefore, it should be communicated appropriately. Medical decisions were not sufficiently made ethically, but must also be made communicatively. In Indonesia's strong communal culture, community involvement was essential to distributing limited resources. A better approach to ethical education, including adequate communication skills, is necessary to prepare health professionals for facing unpredictable future pandemics. (shrink)

Background In June 2016, Canada legalized medical assistance in dying (MAiD). From the outset, some healthcare institutions (including faith-based and non-faith-based hospitals, hospices, and residential aged care facilities) have refused to allow aspects of MAiD onsite, resulting in patient transfers for MAiD assessments and provision. There have been media reports highlighting the negative consequences of these “institutional objections”, however, very little research has examined their nature and impact. Methods This study reports on findings from 48 semi-structured qualitative interviews conducted (...) with MAiD assessors and providers, MAiD team members (working to coordinate care and lead MAiD programs in institutions and health authorities), and family caregivers on their experiences with institutional objection. Participants were recruited from the Canadian provinces of British Columbia, Ontario, and Nova Scotia. Data were analyzed using inductive thematic analysis. Results Themes identified were: (1) basis for institutional objection (with objections commonly rooted in religious values and a particular philosophy of palliative care); (2) scope of objection (demonstrating a wide range of practices objected to); (3) lack of transparency regarding institutional position; (4) impacts on patients; (5) impacts on health practitioners; and (6) catalysts for change. Participants reported that many institutions’ objections had softened over time, lessening barriers to MAiD access and adverse impacts on patients and health practitioners. Participants attributed this positive change to a range of catalysts including advocacy by health practitioners and family members, policymaking by local health authorities, education, and relationship building. Nevertheless, some institutions, particularly faith-based ones, retained strong objections to MAiD, resulting in forced transfers and negative emotional and psychological impacts on patients, family members, and health practitioners. Conclusions This paper adds to the limited evidence base about the impacts of institutional objection and can inform practical and regulatory solutions in Canada and abroad. Reform is needed to minimize the negative impacts on patients, their caregivers, and health practitioners involved in MAiD practice. (shrink)

The arts provide openings for symbolic expression by engaging the sensory experience in the body they become a source of insight through embodied cognition and emotion, enabling meaning-making, and acting as a catalyst for change. This synthesis of sensation and enactive, embodied expression through movement and the arts is capitalized on in The BodyMind Approach®. It is integral to this biopsychosocial, innovative, unique intervention for people suffering medically unexplained symptoms applied in primary healthcare. The relevance of embodiment and arts practices (...) in TBMA are discussed in relation to the views of participants in the pursuit of self-management. If widely employed TBMA could have an enormous impact, reach, and significance for patients and global health services. This original pre-clinical trial of qualitative research reports on the perceptions of participant patients with generic MUS, a world-wide issue usually treated by either psychological therapy or physiotherapy. TBMA is not a therapy but a health education program founded upon the concept of an integration of psychological elements with physiological, bodily, and sensory experiences. Thematic analysis of qualitative data sets from open-ended questions in semi-structured interviews and a written questionnaire post intervention is presented. Five aspects which appear to be key to learning self-management were derived from analyzing the data: body with mind connections; importance of facilitation; potential benefits; preparedness for change; self-acceptance/compassion. This article advances the discourse on the nature of self-management for MUS through changing the mind-set and the relationship participants have with their bodily symptom/s through employing embodied methods and arts practices, challenging current, and solely verbal, psychological conceptual frameworks. Rigor lies in the method of data analysis using cross verification of credibility between reported findings and scrutiny by stakeholders. We conclude that facilitated TBMA groups employing embodied methods and arts practices can act as a method for developing the self-management of MUS and improving wellbeing. (shrink)

There are two fundamental models to understanding the phenomenon of natural life. One is thecomputational model, which is based on the symbolic thinking paradigm. The other is the biologicalorganism model. The common difficulty attributed to these paradigms is that their reductive tools allowthe phenomenological aspects of experience to remain hidden behind yes/no responses (behavioraltests), or brain ‘pictures’ (neuroimaging). Hence, one of the problems regards how to overcome meth-odological difficulties towards a non-reductive investigation of conscious experience. It is our aim in (...) thispaper to show how cooperation between Eastern and Western traditions may shed light for a non-reductive study of mind and life. This study focuses on the first-person experience associated withcognitive and mental events. We studied phenomenal data as a crucial fact for the domain of livingbeings, which, we expect, can provide the ground for a subsequent third-person study. The interventionwith Jhana meditation, and its qualitative assessment, provided us with experiential profiles based uponsubjects' evaluations of their own conscious experiences. The overall results should move towards anintegrated or global perspective on mind where neither experience nor external mechanisms have thefinal word. (shrink)

To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual's decision to participate in research. Guided by Seedhouse's (2005) Rational Field Theory, we conducted qualitative, in‐depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision‐making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz (...) people have a distinctive decision‐making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio‐cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries. (shrink)

ObjectivesWomen who underwent chemotherapy for metastatic breast cancer used both adaptive and maladaptive coping strategies but had low implementation levels. The present study explores the qualitative experience of coping strategies for women with MBC undergoing CT in Beijing.MethodsA hermeneutic phenomenological approach was employed on twenty Chinese MBC women undergoing CT. These interviews were transcribed verbatim, coded using thematic analysis, and analyzed using NVivo 11.ResultsThree themes are highlighted: Maintaining hope; Spiritual growth, and Self-perceived support resources.ConclusionThe present study results have led (...) to a greater understanding of the tremendous impact of CT on MBC women’s lives. This research provides insight into the scope of maintaining hope. Spiritual growth and self-perceived support resources were crucial factors to coping strategies among MBC women to improve their quality of life.Clinical RelevanceBy attaining the adaptive coping strategies and further understanding about Chinese MBC women, health care professionals are encouraged to appraise MBC women’s specific problems and adopt effective interventions to improve MBC women’s psychosocial wellbeing. (shrink)

Background In this qualitative analysis we aimed to explore addiction physicians’ perspectives on safer injection education for people who inject drugs, especially: (1) on possible means of introducing safer injection education in the medical environment, (2) on the compatibility of safer injection education with each physician’s core values and goals, and (3) on possible reasons for the ethical dilemma in safer injection education. Methods We conducted semi-structured interviews with eleven physicians practicing addiction medicine in France in clinical and harm (...) reduction settings. Results All participants were in favor of educational interventions for people who inject drugs. Nonetheless, these interventions varied from simple advice to injection supervision and they were seen as less acceptable when they concerned the practical and material aspects of injection. Some participants found that physicians practicing in clinical settings, where patients consult mostly to stop their drug use, should not practice safer injection education. On the contrary, other participants claimed that safer injection education was essential in all settings and was not a choice but rather a duty for addiction physicians. The ethical dilemma of such intervention when delivered by medical staff was viewed as a complex phenomenon, related to the representations of intravenous drug use and to societal expectations from physicians. Conclusion Physicians’ views on safer injection education for people who inject drugs reveal an emotionally charged subject related to the structural organization of addiction management in France. Such education is marked by an arduous history of harm reduction policies in France. IRB registration: #00011928. (shrink)

BackgroundWithholding and withdrawing treatment are deemed ethically equivalent by most Bioethicists, but intensivists often find withdrawing more difficult in practice. This can lead to futile treatment being prolonged. Time-limited trials have been proposed as a way of promoting timely treatment withdrawal whilst giving the patient the greatest chance of recovery. Despite being in UK guidelines, time-limited trials have been infrequently implemented on Intensive Care Units. We will explore the role of time in Intensive Care Unit decision-making and provide a UK (...) perspective on debates surrounding time-limited trials.MethodsThis qualitative study recruited 18 participants (nine doctors, nine nurses) from two Intensive Care Units in North West England for in-depth, one-to-one semi-structured interviews. A thematic analysis was performed of the data.ResultsOur findings show time is utilised by Intensive Care Unit staff in a variety of ways including managing uncertainty when making decisions about a patient’s prognosis or the reversibility of a disease, constructing relationships with patients’ relatives, communicating difficult messages to patients’ relatives, justifying resource allocation decisions to colleagues, and demonstrating compassion towards patients and their families.ConclusionsTime shifts the balance towards greater certainty in Intensive Care Unit decision-making, by demonstrating futility, and can ease the difficult transition for staff and families from active treatment to palliation. However, this requires clear and open communication, both within the Intensive Care Unit team and with the family, being prioritised when time is used in decision-making. (shrink)

Background The opioid epidemic has enabled rapid and unsurpassed use of big data on people with opioid use disorder to design initiatives to battle the public health crisis, generally without adequate input from impacted communities. Efforts informed by big data are saving lives, yielding significant benefits. Uses of big data may also undermine public trust in government and cause other unintended harms. Objectives We aimed to identify concerns and recommendations regarding how to use big data on opioid use in ethical (...) ways. Methods We conducted focus groups and interviews in 2019 with 39 big data stakeholders who had interest in or knowledge of the Public Health Data Warehouse maintained by the Massachusetts Department of Public Health. Results Concerns regarding big data on opioid use are rooted in potential privacy infringements due to linkage of previously distinct data systems, increased profiling and surveillance capabilities, limitless lifespan, and lack of explicit informed consent. Also problematic is the inability of affected groups to control how big data are used, the potential of big data to increase stigmatization and discrimination of those affected despite data anonymization, and uses that ignore or perpetuate biases. Participants support big data processes that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. Recommendations for ethical big data governance offer ways to narrow the big data divide, enact shared data governance, cultivate public trust and earn social license for big data uses, and refocus ethical approaches. Conclusions Using big data to address the opioid epidemic poses ethical concerns which, if unaddressed, may undermine its benefits. Findings can inform guidelines on how to conduct ethical big data governance and in ways that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. (shrink)

Background Generally, there is unanimity about the value of community engagement in health-related research. There is also a growing tendency to view genetics and genomics research (GGR) as a special category of research, the conduct of which including community engagement (CE) as needing additional caution. One of the motivations of this study was to establish how differently if at all, we should think about CE in GGR. Aim To assess the perspectives of genetics and genomics researchers in Uganda on CE (...) in GGR. Method A cross-sectional qualitative study was conducted at Makerere University and Uganda Virus Research Institute. Twenty-five individuals participated, the majority being male (sixteen). Participants included nineteen genetics and genomics researchers (researchers and research coordinators), two CE officers, three nurses and one nursing counsellor. Data were collected using in-depth interviews and analyzed in a thematic manner using NVivo version 12 Plus. Study findings Thirteen of the respondents had conducted CE in their GGR in either a geographical and disease-specific community. Some respondents said CE principles are the same and there is no need for special consideration for CE in GGR. Others gave ethical issues in GGR that require special consideration for CE in such research and these were categorized into six themes: GGR is new to communities, Difficulty in communicating GGR by the researchers, Genes are shared in communities, Cultural sensitivities against GGR, Community attitude toward GGR, Some GGR studies take long to end, and Negotiation of research benefits. Special considerations for CE when conducting GGR were suggested and categorized into seven themes: creating awareness of GGR in communities, obtaining both community acceptance and individual consent, CE team composition, involve communities in solving GGR challenges, prolong CE in some GGR, develop guidelines for CE in GGR, and legal considerations on GGR. Conclusion GGR was characterized by special issues that require special CE considerations for such research. (shrink)

In this pilot qualitative study 13 clinical bioethicists from across Canada were interviewed about their experiences of conflicts of interest and/or conflicting interests in their professional roles. The interviews generated five composite cases. Participants reported being significantly impacted by these experiences both personally and professionally.

The aim of this study was to investigate patients' experiences of not being treated well in medical health care in Stockholm County, Sweden. The study was conducted by implementing qualitative content analysis using categorization of empirical material for 2006 and 2007 provided by the Patients' Advisory Committee (Patientnämnden) in Stockholm. Complaints about not being treated well accounted for 13% of all complaints to the Patients' Advisory Committee. A sample of those who complained about their medical treatment shows that about (...) 30% of these complaints also involved experiences of being badly received. Categorization of the complaints about being badly treated resulted in the following 11 categories: (1) rude, aggressive or arrogant behaviour; (2) being ignored; (3) being denied examinations or treatments; (4) lack of empathy among personnel; (5) lack of respect for personal integrity; (6) lack of time/waiting time; (7) personnel not separating private issues from their professional role; (8) injustice and discrimination; (9) sexual harassment; (10) coercion and violence and (11) unspecified bad treatment. In relation to the total number of patients, women were over-represented in all categories. In conclusion, what patients react most strongly against is when health-care personnel treat them disrespectfully by not abiding by established social norms. The results indicate that the combination of failure in medical treatment and not receiving an apology often leads patients to complain to the Patients' Advisory Committee. (shrink)

While certain substantial moral dilemmas in health care have been given much attention, like abortion, euthanasia or gene testing, doctors rarely reflect on the moral implications of their daily clinical work. Yet, with its aim to help patients and relieve suffering, medicine is replete with moral decisions. In this qualitative study we analyse how doctors handle the moral aspects of everyday clinical practice. About one hundred consultations were observed, and interviews conducted with fifteen clinical doctors from different practices. It (...) turned out that the doctors’ approach to clinical cases followed a rather strict pattern across specialities, which implied transforming patients’ diverse concerns into specific medical questions through a process of ‘essentialising’: Doctors broke the patient’s story down, concretised the patient’s complaints and categorised the symptoms into a medical sense. Patients’ existential meanings were removed, and the focus placed on the patients’ functioning. By essentialising, doctors were able to handle a complex and ambiguous reality, and establish a medically relevant problem. However, the process involved a moral as well as a practical simplification. Overlooking existential meanings and focusing on purely functional aspects of patients was an integral part of clinical practice and not an individual flaw. The study thus questions the value of addressing doctors’ conscious moral evaluations. Yet doctors should be aware that their daily clinical work systematically emphasises beneficence at the expense of others—that might be more important to the patient. (shrink)

BackgroundDoctors and the Sri Lanka Medical Association recognise the importance of do not attempt cardiopulmonary resuscitation decisions and disclosure; however, few previous studies exist examining these practices in Sri Lanka. Resuscitation decisions have seen significant changes in the UK in recent years, with a legal imperative for clear communication and a move to understand patients’ preferred outcomes before recommending clinical guidance.MethodsParticipants from two Sri Lankan hospitals were selected purposively to represent a range of specialties and seniorities for semi-structured interview.ResultsFifteen (...) participants of varying seniorities were recruited. Practice of do not resuscitate and informing patients is highly variable; there is no definitive guidance published on best practice of these issues in Sri Lanka. Participants felt that inpatients were generally not aware of their medical conditions or treatments. With the poor social and palliative care service provision in Sri Lanka comes... (shrink)

Introduction: The humanities enrich and transform the practice of medicine. What remains to be seen, however, is how best to integrate humanities into the medical curriculum to optimize both educational and patient-related outcomes. The present study considers the structure of an innovative student-driven humanities curriculum and seeks to understand its strengths and limitations, as well as make recommendations for improvement. Methods: The Penn State College of Medicine, University Park Regional Campus uses an inquiry-based approach to education, whereby students are responsible (...) for creating learning objectives in four core pillars of exploration: Foundational Science, Clinical Science, Health Systems Science, and Health Humanities. This study explores student-derived humanities learning objectives (HLO) across four years of the curriculum. Results: 420 HLOs met criteria for analysis and were coded as instrumental (developing direct clinical skill), non-instrumental (non-skill based), or both. Of these, 125 (30%) were instrumental, 239 (57%) were non-instrumental, and 56 (13%) were coded as both. Most instrumental HLO centered around communication skills. Non-instrumental HLO most commonly focused on bearing witness and critiquing a particular experience within a social and/or political context. Conclusions: Findings from this study contribute to the development of a humanities curriculum in a student-directed learning program. Non-instrumental HLO lacked a theoretical framework to guide student’s investigations to a deeper level of analysis. Student-directed learning offers many strengths, but can be enhanced through external direction from humanities trained faculty, particularly given that many medical students have a limited humanities background. (shrink)

Background With growth of genomics research in Africa, concern has arisen about comprehension and adequacy of informed consent given the highly technical terms used in this field. We therefore decided to study whether there are linguistic and cultural concepts used to communicate heritability of characters, traits and diseases in an indigenous African population. Methods We conducted Focus Group Discussions among 115 participants stratified by sex, age and socio-economic status and Key Informant Interviews among 25 stakeholders and Key Opinion Leaders among (...) Yoruba living in Ibadan, Nigeria. We used Atlas-ti v.8.3.17 software to analyze the data, using thematic approach. Results The study participants identified several linguistic and cultural concepts including words, proverbs, and aphorisms that are used to describe heritable characters, traits and diseases in their local dialect. These included words that can be appropriated to describe dominant and recessive traits, variations in penetrance and dilution of strength of heritable characteristics by time and inter-marriage. They also suggested that these traits are transmitted by “blood”, and specific partner’s blood may be stronger than the other regardless of sex. Conclusions Indigenous Yoruba populations have words and linguistic concepts that describe the heritability of characters, traits and diseases which can be appropriated to improve comprehension and adequacy of informed consent in genomics research. Our methods are openly available and can be used by genomic researchers in other African communities. (shrink)

This paper explores organizational spirituality, uncovers it as spiralling dynamics of both positive and negative potentialities, and proposes how leaders can shape these dynamics to improve the human conditions at the workplace. Based on case study of five Turkish organizations and drawing on the emerging discourse on spirituality in organizations literature, this study provides a deeper understanding of how dynamic patterns of spirituality operate in organizations. Insights from participant observation, organizational data, and semi-structured interviews yield three key themes of organizational (...) spirituality: reflexivity, connectivity, and responsibility. Each of these themes has been found to be connected to upward spirals (inspiration, engagement, and calling) and downward spirals (incivility, silence, and fatigue). The study provides a detailed and holistic account of the individual and organizational processes through which spirituality is enacted both positively and negatively, exploring its dynamic and dualistic nature, as embodied in the fabric of everyday life and culture. (shrink)

Developing caring competences is considered to be one of the most important aims of undergraduate nursing education and the role of clinical placement is recognised as special in this regard. Students' reflection on caring, their experience and obstacles in being caring is recommended as a key strategy in the process of teaching and studying the nursing discipline. Therefore, the aim of this study was to describe the concept of caring, its manifestations and possible obstacles while caring, as perceived by first‐year (...) nursing students before and after their first clinical placement. Qualitative content analysis of 15 Polish students' narratives written before and after their clinical experience in the form of text‐diaries was undertaken. The findings revealed that students entered their nursing education with a deep humanistic vision of caring both on theoretical and practical levels and the first clinical placement has enriched this vision. Expressive caring was more appreciated by students than the instrumental one and their concept of caring was coherent with the caring behaviours as described in their narratives. Several internal and external obstacles for caring have been reported by students, indicating a specific tension between their ideal of caring and their practical experience of caring in the clinical reality. (shrink)

Editors have a responsibility to retract seriously flawed articles from their journals. However, there appears to be little consistency in journals’ policies or procedures for this. In a qualitative study, we therefore interviewed editors of science journals using semi-structured interviews to investigate their experience of retracting articles. We identified potential barriers to retraction, difficulties in the process and also sources of support and encouragement. Our findings have been used as the basis for guidelines developed by the Committee on Publication (...) Ethics. (shrink)