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  • Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-16
    Christoph Schickhardt; Henrike Fleischer; Eva C. Winkler

    As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

  • Important situations that capture moral distress in paediatric oncology
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-13
    Margareta af Sandeberg; Cecilia Bartholdson; Pernilla Pergert

    The paediatric Moral Distress Scale-Revised (MDS-R) was previously translated and adapted to Swedish paediatric oncology. Cognitive interviews revealed five not captured situations among the 21 items, resulting in five added items: 22) Lack of time for conversations with patients/families, 23) Parents’ unrealistic expectations, 24) Not to talk about death with a dying child, 25) To perform painful procedures, 26) To decide on treatment/care when uncertain. The aim was to explore experiences of moral distress in the five added situations in the Swedish paediatric MDS-R, among healthcare professionals (HCPs) in paediatric oncology. In this national cross-sectional survey, the Swedish paediatric MDS-R, including five added items, were used. Descriptive statistics, non-parametric analysis of differences between professions and a MDS-R score for each item were calculated. Internal consistency was tested using Cronbach’s alpha and inter-item correlation test. HCPs (n = 278) at all six Swedish paediatric oncology centres participated (> 89%). The Regional Ethical Review Board had no objections. Consent was assumed when the survey was returned. Nursing assistants (NAs) reported higher intensity and lower frequency on all added items; registered nurses (RNs) reported a higher frequency on item 22–25; medical doctors (MDs) reported higher MDS-R score on item 26. On item 22, intensity was moderate for RNs and MDs and high for NAs, and frequency was high among all. Item 22, had the second highest MDS-R score of all 26 for all professional groups. On item 23, the level of disturbance was low but it occurred often. The 26-item version showed good internal consistency for the overall sample and for all professional groups. However, item 22 and 24 could be viewed as redundant to two of the original 21. In accordance with other studies, the intensity was higher than the frequency, however, the frequency of the added items was higher than of the original items. In line with previous research, item 22 and 23 are important elements of moral distress. RNs experience the situations more often while NAs find them more disturbing. The results indicate that the added items are important in capturing moral distress in paediatric oncology.

  • Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-10
    Jennifer Ilo Van Nuil; Thi Thanh Thuy Nguyen; Thanh Nhan Le Nguyen; Van Vinh Chau Nguyen; Mary Chambers; Thi Dieu Ngan Ta; Laura Merson; Thi Phuong Dung Nguyen; Minh Tu Van Hoang; Michael Parker; Susan Bull; Evelyne Kestelyn

    Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. In our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.

  • Refusals to perform ritual circumcision: a qualitative study of doctors’ professional and ethical reasoning
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-10
    Liv Astrid Litleskare; Mette Tolås Strander; Reidun Førde; Morten Magelssen

    Ritual circumcision of infant boys is controversial in Norway, as in many other countries. The procedure became a part of Norwegian public health services in 2015. A new law opened for conscientious objection to the procedure. We have studied physicians’ refusals to perform ritual circumcision as an issue of professional ethics. Qualitative interview study with 10 urologists who refused to perform ritual circumcision from six Norwegian public hospitals. Interviews were recorded and transcribed, then analysed with systematic text condensation, a qualitative analysis framework. The physicians are unanimous in grounding their opposition to the procedure in professional standards and norms, based on fundamental tenets of professional ethics. While there is homogeneity in the group when it comes to this reasoning, there are significant variations as to how deeply the matter touches the urologists on a personal level. About half of them connect their stance to their personal integrity, and state that performing the procedure would go against their conscience and lead to pangs of conscience. It is argued that professional moral norms sometimes might become more or less ‘integrated’ in the professional’s core moral values and moral identity. If this is the case, then the distinction between conscience-based and professional refusals to certain healthcare services cannot be drawn as sharply as it has been.

  • Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-08
    Andrea Martani; Lester Darryl Geneviève; Christopher Poppe; Carlo Casonato; Tenzin Wangmo

    Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients’ physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine. To map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP. Our search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users’ interaction with DP, personal sphere, health-related risks and patients’ benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine. We conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution.

  • Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-06
    Marta S. Palmeirim; Amanda Ross; Brigit Obrist; Ulfat A. Mohammed; Shaali M. Ame; Said M. Ali; Jennifer Keiser

    In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania. A total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65). In contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures). In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.

  • What is it like to use a BCI? – insights from an interview study with brain-computer interface users
    BMC Med. Ethics (IF 2.507) Pub Date : 2020-01-06
    Johannes Kögel; Ralf J. Jox; Orsolya Friedrich

    The 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. We 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. BCI 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. BCI 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.

  • Assessing attitudes towards medical assisted dying in Canadian family medicine residents: a cross-sectional study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-27
    Aaron Wong; Amy T. Hsu; Peter Tanuseputro

    Medical Assistance in Dying (MAID) in Canada came into effect in 2016 with the passing of Bill C-14. As patient interest and requests for MAID continue to evolve in Canada, it is important to understand the attitudes of future providers and the factors that may influence their participation. Attitudes towards physician hastened death (PHD) in general and the specific provision of MAID (e.g., causing death by lethal prescription or injection) are unknown among Canadian residents. This study examined residents’ attitudes towards PHD and MAID, and identified factors (e.g., demographics, clinical exposure to death and dying) that may influence their decision to participate in PHD and provide MAID. A cross-sectional survey was adapted from prior established surveys on MAID to reflect the Canadian setting. All Canadian family medicine programs were invited to participate. The survey was distributed between December 2016 and April 2017. Analysis of the results included descriptive statistics to characterize the survey participants and multivariable logistic regressions to identify factors that may influence residents’ attitudes towards PHD and MAID. Overall, 247 residents from 6 family medicine training programs in Canada participated (response rate of 27%). While residents were most willing to participate in treatment withdrawal (52%), active participation in PHD (41%) and MAID by prescription of a lethal drug (31%) and lethal injection (24%) were less acceptable. Logistic regressions identified religion as a consistent and significant factor impacting residents’ willingness to participate in PHD and MAID. Residents who were not strictly practicing a religion were more likely to be willing to participate in PHD (OR = 17.38, p < 0.001) and MAID (lethal drug OR = 10.55, p < 0.01, lethal injection OR = 8.54, p < 0.05). Increased clinical exposure to death and dying crudely correlated with increased willingness to participate in PHD and MAID, but when examined in multivariable models, only a few activities (e.g., declaring death, completing a death certificate) had a statistically significant association. Other significant factors included the residents’ sex and location of training. Residents are hesitant to provide MAID themselves, with religious faith being a major factor impacting their decision.

  • Dying too soon or living too long? Withdrawing treatment from patients with prolonged disorders of consciousness after Re Y
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-30
    Richard Huxtable

    In the ruling in Y [2018], the UK Supreme Court has confirmed that there is no general requirement for the courts in England and Wales to authorise the withdrawal of clinically assisted nutrition and hydration from patients with prolonged disorders of consciousness. The perceived requirement, which originated in a court ruling in 1993, encompassed those in the vegetative state and those in the minimally conscious state. The ruling in Y confirms that the court may still be approached to decide difficult or contested cases, but there is otherwise no routine requirement that the judges be approached. There is much to welcome in this ruling, particularly as it means that these decisions for these patients are no longer (unusually) singled out for a judicial decision, with all the financial and emotional costs that court proceedings can entail. However, there is also a risk that the ruling might have unwelcome consequences. First, there is the possibility that patients might die too soon, particularly if doctors should now adopt the courts’ previous reasoning, which has suggested that patients in the vegetative state lack interests, so treatment may – perhaps must – be withdrawn. Secondly, there is the converse possibility that patients might live too long, since empirical research suggests that – whether intentionally or not – patients’ families, clinicians, and the health system appear to promote treatment-by-default. Rather than adopt general positions, which may be contestable and potentially risky, this article argues, on a pluralistic basis, that the individual patient should be the focus of any decision made in his or her ‘best interests’. The existing legal framework in England and Wales, which is provided by the Mental Capacity Act 2005, already points in this direction, although more efforts may be needed to ensure that those involved in making these decisions are suitably educated and supported. Fortunately, new guidance from the British Medical Association could help clinicians and families to make decisions in the future, which are appropriate for the incapacitated individual patient in question.

  • Culture and personal influences on cardiopulmonary resuscitation- results of international survey
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-26
    Janet Ozer; Gadi Alon; Dmitry Leykin; Joseph Varon; Limor Aharonson-Daniel; Sharon Einav

    The ethical principle of justice demands that resources be distributed equally and based on evidence. Guidelines regarding forgoing of CPR are unavailable and there is large variance in the reported rates of attempted CPR in in-hospital cardiac arrest. The main objective of this work was to study whether local culture and physician preferences may affect spur-of-the-moment decisions in unexpected in-hospital cardiac arrest. Cross sectional questionnaire survey conducted among a convenience sample of physicians that likely comprise code team members in their country (Indonesia, Israel and Mexico). The questionnaire included details regarding respondent demographics and training, personal value judgments and preferences as well as professional experience regarding CPR and forgoing of resuscitation. Of the 675 questionnaires distributed, 617 (91.4%) were completed and returned. Country of practice and level of knowledge about resuscitation were strongly associated with avoiding CPR performance. Mexican physicians were almost twicemore likely to forgo CPR than their Israeli and Indonesian/Malaysian counterparts [OR1.84 (95% CI 1.03, 3.26), p = 0.038]. Mexican responders also placed greater emphasison personal and patient quality of life (p < 0.001). In multivariate analysis, degree of religiosity was most strongly associated with willingness to forgo CPR; orthodox respondents were more than twice more likely to report having forgone CPR for apatient they do not know than secular and observant respondents, regardless of the country of practice [OR 2.12 (95%CI 1.30, 3.46), p = 0.003]. In unexpected in-hospital cardiac arrest the decision to perform or withhold CPR may be affected by physician knowledge and local culture as well as personal preferences. Physician CPR training should include information regarding predictors of patient outcome at as well as emphasis on differentiating between patient and personal preferences in an emergency.

  • Research approvals iceberg: helping it melt away
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-24
    Simon E. Kolstoe; David Carpenter

    In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network.

  • Response to Correspondence from Kolstoe and colleagues concerning our paper entitled, Research approvals iceberg: How a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-24
    Mila Petrova; Stephen Barclay

    In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate research ethics with governance and funding processes. Amongst the key concerns of the authors are: 1) that our paper exemplifies a typical conflation of concepts such as governance, integrity and ethics, with significant consequences for claims around the responsibility and accountability of the organisations involved; 2) that, as a consequence of this conflation, we misrepresent the ethics review process, including in fundamental aspects such as the ethics approval-opinion distinction; 3) that it is difficult to see scope for greater integration of processes such as applying for funding, research approvals, Patient and Public Involvement, etc., as suggested by us. Here we present an alternative point of view towards the concerns raised.

  • Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-21
    Maureen Mupeta Kombe; Joseph Mumba Zulu; Charles Michelo; Ingvild F. Sandøy

    One important ethical issue in randomised controlled trials (RCTs) is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities’ perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. In this explorative study, in-depth semi-structured interviews were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls (RISE) project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a “lottery” because they wanted all schools to receive equal or balanced benefits of the interventions. Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials (CRCTs) should consider carefully how to explain randomisation.

  • Can clinical ethics committees be legitimate actors in bedside rationing?
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-19
    Morten Magelssen; Kristine Bærøe

    Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees (CECs) sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Aided by two frameworks for legitimate priority setting, we discuss how CECs can contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC’s deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions.

  • Ethical concerns with the use of intelligent assistive technology: findings from a qualitative study with professional stakeholders
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-19
    Tenzin Wangmo; Mirjam Lipps; Reto W. Kressig; Marcello Ienca

    Advances in artificial intelligence (AI), robotics and wearable computing are creating novel technological opportunities for mitigating the global burden of population ageing and improving the quality of care for older adults with dementia and/or age-related disability. Intelligent assistive technology (IAT) is the umbrella term defining this ever-evolving spectrum of intelligent applications for the older and disabled population. However, the implementation of IATs has been observed to be sub-optimal due to a number of barriers in the translation of novel applications from the designing labs to the bedside. Furthermore, since these technologies are designed to be used by vulnerable individuals with age- and multi-morbidity-related frailty and cognitive disability, they are perceived to raise important ethical challenges, especially when they involve machine intelligence, collect sensitive data or operate in close proximity to the human body. Thus, the goal of this paper is to explore and assess the ethical issues that professional stakeholders perceive in the development and use of IATs in elderly and dementia care. We conducted a multi-site study involving semi-structured qualitative interviews with researchers and health professionals. We analyzed the interview data using a descriptive thematic analysis to inductively explore relevant ethical challenges. Our findings indicate that professional stakeholders find issues of patient autonomy and informed consent, quality of data management, distributive justice and human contact as ethical priorities. Divergences emerged in relation to how these ethical issues are interpreted, how conflicts between different ethical principles are resolved and what solutions should be implemented to overcome current challenges. Our findings indicate a general agreement among professional stakeholders on the ethical promises and challenges raised by the use of IATs among older and disabled users. Yet, notable divergences persist regarding how these ethical challenges can be overcome and what strategies should be implemented for the safe and effective implementation of IATs. These findings provide technology developers with useful information about unmet ethical needs. Study results may guide policy makers with firsthand information from relevant stakeholders about possible solutions for ethically-aligned technology governance.

  • When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-17
    Orna Ehrlich; Laura Wingate; Caren Heller; Inmaculada de Melo-Martin

    Much like academic-industry partnerships, industry financial support of patient advocacy organizations (PAOs) has become very common in recent years. While financial conflicts of interest (FCOI) between PAOs and industry have received more attention in recent years, robust efforts to mitigate these conflicts are still limited. The authors outline the possible benefits and ethical concerns that can result from financial interactions between biomedical companies and PAOs. They argue that the use of novel strategies, such as the creation of a standing ethics committee, could be helpful in managing FCOIs and ensuring the warranted trust of PAO’s constituents. Although ethics committees to address FCOIs are common in the academic context, its use by PAOs is still limited. The authors conclude by describing the process of development and implementation of such an ethics committee at the Crohn’s & Colitis Foundation. While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. One such strategy is the creation of a standing independent ethics committee to guide PAOs on new and/or existing programs and protocols as they pertain to their industry relationships.

  • Engaging people with lived experience in the grant review process
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-16
    Katherine Rittenbach; Candice G. Horne; Terence O’Riordan; Allison Bichel; Nicholas Mitchell; Adriana M. Fernandez Parra; Frank P. MacMaster

    People with lived experience are individuals who have first-hand experience of the medical condition(s) being considered. The value of including the viewpoints of people with lived experience in health policy, health care, and health care and systems research has been recognized at many levels, including by funding agencies. However, there is little guidance or established best practices on how to include non-academic reviewers in the grant review process. Here we describe our approach to the inclusion of people with lived experience in every stage of the grant review process. After a budget was created for a specific call, a steering committee was created. This group included researchers, people with lived experience, and health systems administrators. This group developed and issued the call. After receiving proposals, stage one was scientific review by researchers. Grants were ranked by this score and a short list then reviewed by people with lived experience as stage two. Finally, for stage three, the Steering Committee convened and achieved consensus based on information drawn from stages one and two. Our approach to engage people with lived experience in the grant review process was positively reviewed by everyone involved, as it allowed for patient perspectives to be truly integrated. However, it does lengthen the review process. The proposed model offers further practical insight into including people with lived experience in the review process.

  • Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-05
    Yanni Wu; Michelle Howarth; Chunlan Zhou; Mingyu Hu; Weilian Cong

    Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05). The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

  • Are physicians on the same page about do-not-resuscitate? To examine individual physicians’ influence on do-not-resuscitate decision-making: a retrospective and observational study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-04
    Yen-Yuan Chen; Melany Su; Shu-Chien Huang; Tzong-Shinn Chu; Ming-Tsan Lin; Yu-Chun Chiu; Kuan-Han Lin

    Individual physicians and physician-associated factors may influence patients’/surrogates’ autonomous decision-making, thus influencing the practice of do-not-resuscitate (DNR) orders. The objective of this study was to examine the influence of individual attending physicians on signing a DNR order. This study was conducted in closed model, surgical intensive care units in a university-affiliated teaching hospital located in Northern Taiwan. The medical records of patients, admitted to the surgical intensive care units for the first time between June 1, 2011 and December 31, 2013 were reviewed and data collected. We used Kaplan–Meier survival curves with log-rank test and multivariate Cox proportional hazards models to compare the time from surgical intensive care unit admission to do-not-resuscitate orders written for patients for each individual physician. The outcome variable was the time from surgical ICU admission to signing a DNR order. We found that each individual attending physician’s likelihood of signing do-not-resuscitate orders for their patients was significantly different from each other. Some attending physicians were more likely to write do-not-resuscitate orders for their patients, and other attending physicians were less likely to do so. Our study reported that individual attending physicians had influence on patients’/surrogates’ do-not-resuscitate decision-making. Future studies may be focused on examining the reasons associated with the difference of each individual physician in the likelihood of signing a do-not-resuscitate order.

  • Experience of oncology residents with death: a qualitative study in Mexico
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-05
    Asunción Álvarez-del-Río; Edwin Ortega-García; Luis Oñate-Ocaña; Ingrid Vargas-Huicochea

    Physicians play a fundamental role in the care of patients at the end of life that includes knowing how to accompany patients, alleviate their suffering and inform them about their situation. However, in reality, doctors are part of this society that is reticent to face death and lack the proper education to manage it in their clinical practice. The objective of this study was to explore the residents’ concepts of death and related aspects, their reactions and actions in situations pertaining to death in their practice, and their perceptions about existing and necessary training conditions. A qualitative approach was used to examine these points in depth based on interviews conducted with seven oncology residents. Participants do not have a clear concept of death and, although it is seen as a common phenomenon, they consider it an enemy to beat. The situations to which respondents react more frequently with frustration and sadness after the death of patients were when they felt emotionally involved, if they identify with the patient, in cases of pediatric patients and with patients who refuse treatment. To deal with death, participants raise barriers and attempt to become insensitive. Although residents in this study recognize the importance of training to learn how to better deal with death, it seems they are not fully invested in reaching more of it. Participants face death in a daily basis without the necessary training, which appears to impact them more than they are willing to accept. They do not achieve their goals managing situations regarding death as well as they assume they do. Despite recognizing the need of more training and support for better coping with death, they prefer to continue to learn from their experience. Not applicable.

  • Dual consent? Donors’ and recipients’ views about involvement in decision-making on the use of embryos created by gamete donation in research
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-12-02
    I. Baía; C. de Freitas; C. Samorinha; V. Provoost; S. Silva

    Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research. From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients. The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors’ consent (26.4% vs. 11.4% among recipients). Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.

  • Mention of ethical review and informed consent in the reports of research undertaken during the armed conflict in Darfur (2004–2012): a systematic review
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-06-13
    Ghaiath Hussein; Khalifa Elmusharaf

    Armed conflict in Darfur, west Sudan since 2003 has led to the influx of about 100 international humanitarian UN and non-governmental organizations to help the affected population. Many of their humanitarian interventions included the collection of human personal data and/or biosamples, and these activities are often associated with ethical issues. A systematic review was conducted to assess the proportion of publicly available online reports of the research activities undertaken on humans in Darfur between 2004 and 2012 that mention obtaining ethical approval and/or informed consent. This systematic review is based on a systematic literature search of Complex Emergency Database, ReliefWeb, PubMed), followed by a hand search for the hardcopies of the eligible reports archived in the Centre for Research on the Epidemiology of Disasters (CRED) in Brussels. The online search showed that out of the 68 eligible studies, 13.2% (9) reported gaining ethical approval and 42.6% (29) that an informed consent was obtained from the participants. The CRED search included 138 eligible reports. None of these reports mentioned gaining ethical approval and 17 (12.3%) mentioned obtaining informed consent from their participants. The proportion of studies reporting ethical review and informed consent was smaller than might be expected, so we suggest five possible explanations for these findings. This review provides empirical evidence that can help in planning ethical conduct of research in humanitarian settings.

  • Who should decide about children’s and adolescents’ participation in health research? The views of children and adults in rural Kenya
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-06-14
    Vicki Marsh; Nancy Mwangome; Irene Jao; Katharine Wright; Sassy Molyneux; Alun Davies

    International research guidance has shifted towards an increasingly proactive inclusion of children and adolescents in health research in recognition of the need for more evidence-based treatment. Strong calls have been made for the active involvement of children and adolescents in developing research proposals and policies, including in decision-making about research participation. Much evidence and debate on this topic has focused on high-income settings, while the greatest health burdens and research gaps occur in low-middle income countries, highlighting the need to take account of voices from more diverse contexts. Between January and March 2014, 56 community representatives and secondary school students were involved in eight group discussions to explore views on the acceptability of involving children and adolescents in research, and how these groups should be involved in decision-making about their own participation. Discussions were voice-recorded and transcriptions analyzed using Framework Analysis, combining deductive and inductive approaches. Across these discussions, the idea of involving children and adolescents in decision-making about research participation was strongly supported given similar levels of responsibility carried in everyday life; existing capacity that should be recognized; the opportunity for learning involved; varying levels of parental control; and generational shifts towards greater understanding of science for adolescents than their parents. Joint decision-making processes were supported for older children and adolescents, with parental control influenced by perceptions of the risks involved in participation. Moves towards more active involvement of children and adolescents in planning studies and in making decisions about their participation are supported by these findings from Kenya. Important emerging considerations include the need to take account of the nature of proposed studies and prevailing attitudes and understanding of research in identifying children’s and adolescents’ roles. More research is needed to expand diversity and develop approaches to joint assent and consent processes that would fairly represent children’s and adolescents’ wishes and interests, towards their long term benefit.

  • Ethical challenges of integration across primary and secondary care: a qualitative and normative analysis
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-03
    Alex McKeown; Charlotte Cliffe; Arun Arora; Ann Griffin

    This paper explores ethical concerns arising in healthcare integration. We argue that integration is necessary imperative for meeting contemporary and future healthcare challenges, a far stronger evidence base for the conditions of its effectiveness is required. In particular, given the increasing emphasis at the policy level for the entire healthcare infrastructure to become better integrated, our analysis of the ethical challenges that follow from the logic of integration itself is timely and important and has hitherto received insufficient attention. We evaluated an educational intervention which aims to improve child health outcomes by making transitions between primary to secondary care more efficient, ensuring children and parents are better supported throughout. The programme provided skills for trainee paediatricians and general practitioners (GPs) in co-designing integrated clinical services. The key ethical challenges of integrated care that arose from a clinical perspective are: professional identity and autonomy in an integrated working environment; the concomitant extent of professional responsibility in such an environment; and the urgent need for more evidence to be produced on which strategies for integrating at scale can be based. From our analysis we suggest a tentative way forward, viewed from a normative position broadly situated at the intersection of deontology and care ethics. We adopt this position because the primary clinical ethical issues in the context of integrated care concern: how to ensure that all duties of care to individual patients are met in a newly orientated working environment where clinical responsibility may be ambiguous; and the need to orientate care around the patient by foregrounding their autonomous preferences and ensuring good patient clinician relationships in clinical decision-making.

  • Trust and the ethical challenges in the use of whole genome sequencing for tuberculosis surveillance: a qualitative study of stakeholder perspectives
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-04
    Carly Jackson; Jennifer L. Gardy; Hedieh C. Shadiloo; Diego S. Silva

    Emerging genomic technologies promise more efficient infectious disease control. Whole genome sequencing (WGS) is increasingly being used in tuberculosis (TB) diagnosis, surveillance, and epidemiology. However, while the use of WGS by public health agencies may raise ethical, legal, and socio-political concerns, these challenges are poorly understood. Between November 2017 and April 2018, we conducted semi-structured interviews with 22 key stakeholders across the fields of governance and policy, public health, and laboratory sciences representing the major jurisdictions currently using WGS in national TB programs. Thematic analysis of the interviews was conducted using NVivo 11. Respondents identified several ethical and practical challenges associated with WGS in TB care and surveillance, all related to issues of trust, including: 1) the power of public health; 2) data sharing and profits derived from surveillance efforts; and 3) concerns regarding who has access to, and can benefit from, the technology. Additional challenges included: the potential utility that WGS adds to a public health program, the risks associated with linking necessary epidemiological metadata to the genomic data, and challenges associated with jurisdictional capacity to implement the technology. Successful implementation of WGS is dependent on fostering relationships of trust between those working with genomics technology and those directly impacted by it, including clinicians. Building trust (a) between the public and the public health agencies and (b) within public health agencies themselves is critical due to the inherent complexity of WGS and its implementation for communicable disease control purposes.

  • Bioethical reflexivity and requirements of valid consent: conceptual tools
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-04
    John Barugahare

    Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it’. This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of ‘how to obtain and ascertain valid consent to participation in health-related research’ cannot always be fully answered by exclusive reference to pre-determined criteria/guidance provided by the guidelines and prior research’. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased. Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be – general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines’ nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts.

  • The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-04
    Joseph Mumba Zulu; Ingvild Fossgard Sandøy; Karen Marie Moland; Patrick Musonda; Ecloss Munsaka; Astrid Blystad

    There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters’ participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and informed consent process. The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions (4) were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews (11) were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis. The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot. Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people’s capability to consent or not consent to a study in an informed manner.

  • Is the non-identity problem relevant to public health and policy? An online survey
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-05
    Keyur Doolabh; Lucius Caviola; Julian Savulescu; Michael J. Selgelid; Dominic Wilkinson

    The non-identity problem arises when our actions in the present could change which people will exist in the future, for better or worse. Is it morally better to improve the lives of specific future people, as compared to changing which people exist for the better? Affecting the timing of fetuses being conceived is one case where present actions change the identity of future people. This is relevant to questions of public health policy, as exemplified in some responses to the Zika epidemic. There is philosophical disagreement about the relevance of non-identity: some hold that non-identity is not relevant, while others think that the only morally relevant actions are those that affect specific people. Given this disagreement, we investigated the intuitions about the moral relevance of non-identity within an educated sample of the public, because there was previously little empirical data on the public’s views on the non-identity problem. We performed an online survey with a sample of the educated general public. The survey assessed participants’ preferences between person-affecting and impersonal interventions for Zika, and their views on other non-identity thought experiments, once the non-identity problem had been explained. It aimed to directly measure the importance of non-identity in participants’ moral decision-making. We collected 763 valid responses from the survey. Half of the participants (50%) had a graduate degree, 47% had studied philosophy at a university level, and 20% had read about the non-identity problem before. Most participants favoured person-affecting interventions for Zika over impersonal ones, but the majority claimed that non-identity did not influence their decision (66% of those preferring person-affecting interventions, 95% of those preferring impersonal ones). In one non-identity thought experiment participants were divided, but in another they primarily answered that impersonally reducing the quality of life of future people would be wrong, harmful and blameworthy, even though no specific individuals would be worse off. Non-identity appeared to play a minor role in participants’ moral decision-making. Moreover, participants seem to either misunderstand the non-identity problem, or hold non-counterfactual views of harm that do not define harm as making someone worse off than they would have been otherwise.

  • A reflection on ethical and methodological challenges of using separate interviews with adolescent-older carer dyads in rural South Africa
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-08
    Dumile Gumede; Nothando B. Ngwenya; Stella Namukwaya; Sarah Bernays; Janet Seeley

    This article discusses our reflections on ethical and methodological challenges when conducting separate interviews with individuals in dyads in the uMkhanyakude district, South Africa. Our work is embedded in an ethnographic study exploring care relationships between adolescents and their older carers in the context of a large-donor funded HIV programme. We use these reflections to discuss some of the challenges and present possible management strategies that may be adopted in conducting dyadic health research in resource-poor settings. Drawing from the relational agency, three rounds of separate interviews and participant observation were undertaken with dyads of adolescents aged between 13 and 19 and their older carers aged 50+ from October 2017 to September 2018. A reflexive journal was kept to record the interviewer's experiences of the whole research process. We identified methodological and ethical challenges from these data during the thematic analysis. A total of 36 separate interviews were conducted with six pairs of adolescent-older carer dyads (n = 12 participants). Five themes emerged: recruitment of dyads, consenting dyads, confidentiality, conducting separate interviews with adolescents and older carers, and interviewer-dyad interaction. We also illustrated how we dealt with these challenges. Results from this study can guide the recruitment, consenting and collecting data for health studies that employ a similar form of enquiry in LMICs. However, ethical and methodological challenges should be recognised as features of the relationships between cross-generation dyads rather than weaknesses of the method.

  • Do we understand the intervention? What complex intervention research can teach us for the evaluation of clinical ethics support services (CESS)
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-15
    Jan Schildmann; Stephan Nadolny; Joschka Haltaufderheide; Marjolein Gysels; Jochen Vollmann; Claudia Bausewein

    Evaluating clinical ethics support services (CESS) has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. In this paper, we argue that a first necessary step for progress is to better understand the intervention(s) in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, we introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS. To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS.

  • Implementing ethics reflection groups in hospitals: an action research study evaluating barriers and promotors
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-16
    Henriette Bruun; Reidar Pedersen; Elsebeth Stenager; Christian Backer Mogensen; Lotte Huniche

    An ethics reflection group (ERG) is one of a range of ethics support services developed to better handle ethical challenges in healthcare. The aim of this article is to evaluate the implementation process of interdisciplinary ERGs in psychiatric and general hospital departments in Denmark. To our knowledge, this is the first study of ERG implementation to include both psychiatric and general hospital departments. The implementation and evaluation strategies are inspired by action research, using a qualitative approach and systematic text condensation of 28 individual interviews and 4 focus groups with clinicians, ethics facilitators and ward managers. The implementation process was influenced by both structural factors and factors related to clinicians having different values, interests and experiences. Structural barriers and promotors in the process to implement ERG included the following sub-categories: Organizational factors, recruitment and training of ethics facilitators, the deliberation model, planning and recruitment of participants to the ERGs, the support of the ward managers and the project group. Barriers and promotors found among clinicians included the following sub-categories: Expectations and pre-understandings of ERGs, understandings of a physician’s job, challenges experienced by ethics facilitators. At the end of the study, when it was decided that the ERGs should be continued, the implementation strategies were remodeled by the participants to meet new challenges. The study of ERG implementation identified important structural and professional barriers and promotors that are likely to be relevant to anyone wanting to implement ethics support services across various types of healthcare services.

  • Experiences from a community advisory Board in the Implementation of early access to ART for all in Eswatini: a qualitative study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-16
    Charmaine Khudzie Mlambo; Eva Vernooij; Roos Geut; Eliane Vrolings; Buyisile Shongwe; Saima Jiwan; Yvette Fleming; Gavin Khumalo

    Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards (CABs) is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini (formerly known as Swaziland), which was implemented as part of the MaxART Early Access to ART for All study. Trained Swazi research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: (1) promoting ethical conduct, in particular privacy, consent and confidentiality; (2) communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and (3) liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning.

  • Do codes of ethics and position statements help guide ethical decision making in Australian immigration detention centres?
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-23
    Ryan Essex

    Australian immigration detention has been called state sanctioned abuse and a crime against humanity. The Australian healthcare community has been closely involved with these policies, calling for their reform and working within detention centres to provide healthcare. As well as having a devastating impact on health, immigration detention changes the scope and nature of healthcare, with its delivery described as a Sisyphean task. In this article I will explore the guidance that is available to clinicians who work within detention centres and argue that codes, guidelines and positions statements provide little help in relation to ethical decision making. First I will outline guidance that can be found in codes of ethics and position statements, focusing on particularly relevant principles, such as advocacy, clinical independence and the clinicians’ relationship to human rights. I will then highlight the disparity between this guidance and the delivery of healthcare within detention by drawing on the testimony of clinicians who formerly worked in these environments. While this disparity should be cause for alarm and at a minimum call into question how codes and positions statements are being used (if at all), there are more fundamental reasons why codes and position statements fail to provide guidance in these circumstances. I will outline a more general criticism of codes of ethics and use this to suggest a way forward, including looking beyond codes and position statements to guide action within Australian immigration detention.

  • Global health ethics: critical reflections on the contours of an emerging field, 1977–2015
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-25
    Gail Robson; Nathan Gibson; Alison Thompson; Solomon Benatar; Avram Denburg

    The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how the term “global health ethics” has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles (88%) were written by authors in high-income countries (HIC), as defined by the World Bank country classifications, 8 articles (5%) were written by authors in low- or middle-income countries (LMIC), and 13 articles (7%) were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics (n = 10), Developing World Bioethics (n = 9), and Bioethics (n = 7). We coded the articles by level of engagement within the ethical domain at different levels: (1) interpersonal, (2) institutional, (3) international, and (4) structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship.

  • Informed consent and community engagement in open field research: lessons for gene drive science
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-07-27
    Jerome Amir Singh

    The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.

  • Model consent clauses for rare disease research
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-08-01
    Minh Thu Nguyen; Jack Goldblatt; Rosario Isasi; Marlene Jagut; Anneliene Hechtelt Jonker; Petra Kaufmann; Laetitia Ouillade; Fruszina Molnar-Gabor; Mahsa Shabani; Eric Sid; Anne Marie Tassé; Durhane Wong-Rieger; Bartha Maria Knoppers

    Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection. A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.

  • Regulatory and policy tools to address unproven stem cell interventions in Canada: the need for action
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-08-06
    Timothy Caulfield; Blake Murdoch

    The marketing of unproven direct-to-consumer stem cell interventions is becoming widespread in Canada. There is little evidence supporting their use and they have been associated with a range of harms. Canada has been slower to act against clinics offering these interventions than other jurisdictions, including the United States. Here, we outline the regulatory and policy tools available in Canada to address this growing problem. Health Canada’s regulations governing cell therapies are complex, but recent statements make it clear that Health Canada believes it has jurisdiction over many of the currently marketed stem cell interventions. Still, further regulatory clarity is needed from Health Canada, as are increased directed enforcement efforts on interventions that fall within their scope. The Competition Bureau, via the Competition Act, prohibits advertisers from making materially false or misleading promotional representations. The Competition Bureau could collaborate with the scientific community to analyze the claims of existing clinics in Canada, and impose sanctions upon those who breach the established standard. Professional regulators, including provincial colleges of physicians and surgeons, have considerable power over what products and services their members can offer. Every college of physicians in Canada requires, via policy and codes of ethics, that doctors maintain evidence-based practices. This requirement is incompatible with offering many unproven stem cell interventions. Litigation may be another tool, including the use of fraud, misrepresentation and/or negligence claims for failing to meet the required standard of care. Finally, political pressure on federal and provincial lawmakers could encourage changes to marketing, cell therapy and professional regulations that would allow a more comprehensive response. In sum, there are many existing tools that can be used to protect the public from unproven stem cell interventions. Increased bureaucratic will and grassroots efforts are needed in order to effect a positive policy response.

  • Parental decision-making following a prenatal diagnosis that is lethal, life-limiting, or has long term implications for the future child and family: a meta-synthesis of qualitative literature
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-08-08
    Claire Blakeley; Debbie M. Smith; Edward D. Johnstone; Anja Wittkowski

    Information on the factors influencing parents’ decision-making process following a lethal, life-limiting or severely debilitating prenatal diagnosis remains deficient. A comprehensive systematic review and meta-synthesis was conducted to explore the influencing factors for parents considering termination or continuation of pregnancy following identification of lethal, life-limiting or severely debilitating fetal abnormalities. Electronic searches of 13 databases were conducted. These searches were supplemented by hand-searching Google Scholar and bibliographies and citation tracing. Thomas and Harden’s (2008) thematic synthesis method was used to synthesise data from identified studies. Twenty-four papers were identified and reviewed, but two papers were removed following quality assessment. Three main themes were identified through systematic synthesis. Theme 1, entitled ‘all life is precious’, described parents’ perception of the importance of the fetus’ life, a fatalistic view of their situation alongside moral implications as well as the implications decisions would have on their own life, in consideration of previous life experiences. Theme 2 (‘hope for a positive outcome’) contained two sub-themes which considered the parent’s own imagined future and the influence of other people’s experiences. Finally, Theme 3 (‘a life worth living’) presented three sub-themes which may influence their parental decision-making: These described parental consideration of the quality of life for their unborn child, the possibility of waiting to try for another pregnancy, and their own responsibilities and commitments. The first review to fully explore parental decision-making process following lethal, life-limiting, or severely debilitating prenatal diagnosis provided novel findings and insight into which factors influenced parents’ decision-making process. This comprehensive and systematic review provides greater understanding of the factors influential on decision-making, such as hope, morality and potential implications on their own and other’s quality of life, will enable professionals to facilitate supported decision-making, including greater knowledge of the variables likely to influence parental choices.

  • What Egyptians think. Knowledge, attitude, and opinions of Egyptian patients towards biobanking issues
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-08-09
    Ahmed S. Abdelhafiz; Eman A. Sultan; Hany H. Ziady; Ebtesam Ahmed; Walaa A. Khairy; Douaa M. Sayed; Rana Zaki; Merhan A. Fouda; Rania M. Labib

    Biobanking is a relatively new concept in Egypt. Building a good relationship with different stakeholders is essential for the social sustainability of biobanks. To establish this relationship, it is necessary to assess the attitude of different groups towards this concept. The objective of this work is to assess the knowledge, attitude, and opinions of Egyptian patients towards biobanking issues. We designed a structured survey to be administered to patients coming to the outpatient clinics in 3 university hospitals in Egypt. The survey included questions estimating the level of knowledge about the term “Biobank”, together with questions about the attitudes and opinions about related issues. Two hundred and fifty-nine patients participated in the survey. Eighty-one percent of participants reported that they never heard about the term before. About 85% expressed that they would be willing to donate their samples for research and about 87% thought that sample donation did not contradict their religious beliefs. Fifty eight percent were willing to participate in a genetic research project, 27.8% supported sharing their sample with pharmaceutical companies, and 32.4% agreed to share their samples with institutions abroad. Although there is limited knowledge about biobanking among Egyptian patients, many had a positive attitude towards sample donation and didn’t show religious concerns against it. However, they showed concerns regarding participation in genetic research and with sharing their samples across borders or with pharmaceutical companies. Public education about biobanking is possible, taking into consideration the specific cultural and legal framework in Egypt.

  • Umbrella and basket trials in oncology: ethical challenges
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-08-23
    Karolina Strzebonska; Marcin Waligora

    Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute – Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study. We discuss three ethical requirements for clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunity to be enrolled and benefit from the trial, but due to insufficient accrual, the trial may generate clinically insignificant findings. Inadequate sample size in study arms and the use of surrogate endpoints may result in a drug approval without confirmed efficacy. Moreover, complexity, limited quality and availability of tumor samples may not only introduce bias and result in unreliable and unrepresentative findings, but also can potentially harm patients and assign them to an inappropriate therapy arm. Secondly, we refer to benefits and risks. Novel clinical trials can gain important knowledge on the variety of tumors, which can be used in future trials to develop effective therapies. However, they offer limited direct benefits to patients. All potential participants must wait about 2 weeks for the results of the genetic screening, which may be stressful and produce anxiety. The enrollment of patients whose tumors harbor multiple mutations in treatments matching a single mutation may be controversial. As to informed consent – the third requirement we discuss, the excessive use of phrases like “personalized medicine”, “tailored therapy” or “precision oncology” might be misleading and cause personal convictions that the study protocol is designed to fulfill the individual health-related needs of participants. We suggest that further approaches should be implemented to enhance scientific validity, reduce misunderstandings and risks, thus maximizing the benefits to society and to trial participants.

  • Ghent University Hospital’s protocol regarding the procedure concerning euthanasia and psychological suffering
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-02
    M. Verhofstadt; K. Audenaert; K. Van Assche; S. Sterckx; K. Chambaere

    Notwithstanding fears of overly permissive approaches and related pleas to refuse euthanasia for psychological suffering, some Belgian hospitals have declared that such requests could be admissible. However, some of these hospitals have decided that such requests have to be managed and carried out outside their walls. Ghent University Hospital has developed a written policy regarding requests for euthanasia for psychological suffering coming from patients from outside the hospital. The protocol stipulates several due care criteria that go beyond the requirements of the Belgian Euthanasia Law. For instance, the legally required first and second consulted physicians should all be psychiatrists and be affiliated with a psychiatry department of a Flemish university hospital. Moreover, euthanasia for psychological suffering can only be performed if the advices of these consulted physicians are positive. Importantly, preliminary reflection by the multidisciplinary Hospital Ethics Committee was introduced to discuss every request for euthanasia for psychological suffering coming from outside the hospital. In this way, the protocol supports psychiatrists faced with the complexities of assessing such requests, improves the quality of euthanasia practice by ensuring transparency and uniformity, and offers patients specialised support and guidance during their euthanasia procedure. Nevertheless, some concerns still remain (e.g. relating to possible unrealistic patient expectations and to the absence of aftercare for the bereaved or for patients whose requests have been refused).

  • When the law makes doors slightly open: ethical dilemmas among abortion service providers in Addis Ababa, Ethiopia
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-05
    Emily McLean; Dawit Nima Desalegn; Astrid Blystad; Ingrid Miljeteig

    In 2005, Ethiopia changed its abortion law to curb its high maternal mortality. This has led to a considerable reduction in deaths from unsafe abortions. Abortion is now legal if the woman’s pregnancy is a result of rape or incest, if her health is endangered, if the fetus has a serious deformity, if she suffers from a physical or mental deficiency, or if she is under 18 years of age. The word of the woman, if in compliance with the law, is sufficient to qualify for an abortion. In this context, where the law makes the door slightly open, health workers become important in deciding who gets access to safe services and who doesn’t, thus creating considerable ethical dilemmas. The objective of this study was to explore abortion service providers’ personal experiences and reflections, perceptions of the abortion law, and ethical and dilemmas that arise. Data collection took place from March to May 2016 in Addis Ababa, at different health clinics providing abortion services. Thirty in-depth interviews and three focus group discussions were conducted with 41 abortion service providers at governmental and non-governmental clinics. Content analysis was drawn upon in the interpretation of the findings. When working in a context where the law has slightly opened the door for abortion seeking women, the health workers describe conflicting concerns, burdensome responsibilities, and ambiguity concerning how to interpret and implement the law. They describe efforts to balance their religious faith and values against their professional obligations and concern for women’s health and well-being. This negotiation is particularly evident in the care of women who fall outside the law’s indications. They usually handle ethical dilemmas and decision-making alone without guidance. Moreover, many health workers face a stigma from fellow colleagues not performing abortions and therefore keep their job a secret from family and friends. Health workers in Ethiopia experience ethical dilemmas trying to maneuver between the abortion law, their personal values, and their genuine concern for the health of women. More research is needed to further explore this.

  • Influence of response shift and disposition on patient-reported outcomes may lead to suboptimal medical decisions: a medical ethics perspective
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-11
    Iris D. Hartog; Dick L. Willems; Wilbert B. van den Hout; Michael Scherer-Rath; Tom H. Oreel; José P. S. Henriques; Pythia T. Nieuwkerk; Hanneke W. M. van Laarhoven; Mirjam A. G. Sprangers

    Patient-reported outcomes (PROs) are frequently used for medical decision making, at the levels of both individual patient care and healthcare policy. Evidence increasingly shows that PROs may be influenced by patients’ response shifts (changes in interpretation) and dispositions (stable characteristics). We identify how response shifts and dispositions may influence medical decisions on both the levels of individual patient care and health policy. We provide examples of these influences and analyse the consequences from the perspectives of ethical principles and theories of just distribution. If influences of response shift and disposition on PROs and consequently medical decision making are not considered, patients may not receive optimal treatment and health insurance packages may include treatments that are not the most effective or cost-effective. We call on healthcare practitioners, researchers, policy makers, health insurers, and other stakeholders to critically reflect on why and how such patient reports are used.

  • Public and physicians’ support for euthanasia in people suffering from psychiatric disorders: a cross-sectional survey study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-11
    Kirsten Evenblij; H. Roeline W. Pasman; Agnes van der Heide; Johannes J. M. van Delden; Bregje D. Onwuteaka-Philipsen

    Although euthanasia and assisted suicide (EAS) in people with psychiatric disorders is relatively rare, the increasing incidence of EAS requests has given rise to public and political debate. This study aimed to explore support of the public and physicians for euthanasia and assisted suicide in people with psychiatric disorders and examine factors associated with acceptance and conceivability of performing EAS in these patients. A survey was distributed amongst a random sample of Dutch 2641 citizens (response 75%) and 3000 physicians (response 52%). Acceptance and conceivability of performing EAS, demographics, health status and professional characteristics were measured. Multivariable logistic regression analyses were performed. Of the general public 53% were of the opinion that people with psychiatric disorders should be eligible for EAS, 15% was opposed to this, and 32% remained neutral. Higher educational level, Dutch ethnicity, and higher urbanization level were associated with higher acceptability of EAS whilst a religious life stance and good health were associated with lower acceptability. The percentage of physicians who considered performing EAS in people with psychiatric disorders conceivable ranged between 20% amongst medical specialists and 47% amongst general practitioners. Having received EAS requests from psychiatric patients before was associated with considering performing EAS conceivable. Being female, religious, medical specialist, or psychiatrist were associated with lower conceivability. The majority (> 65%) of the psychiatrists were of the opinion that it is possible to establish whether a psychiatric patient’s suffering is unbearable and without prospect and whether the request is well-considered. The general public shows more support than opposition as to whether patients suffering from a psychiatric disorder should be eligible for EAS, even though one third of the respondents remained neutral. Physicians’ support depends on their specialization; 39% of psychiatrists considered performing EAS in psychiatric patients conceivable. The relatively low conceivability is possibly explained by psychiatric patients often not meeting the eligibility criteria.

  • Clinical ethics dilemmas in a low-income setting - a national survey among physicians in Ethiopia
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-13
    Ingrid Miljeteig; Frehiwot Defaye; Dawit Desalegn; Marion Danis

    Ethical dilemmas are part of medicine, but the type of challenges, the frequency of their occurrence and the nuances in the difficulties have not been systematically studied in low-income settings. The objective of this paper was to map out the ethical dilemmas from the perspective of Ethiopian physicians working in public hospitals. A national survey of physicians from 49 public hospitals using stratified, multi-stage sampling was conducted in six of the 11 regions in Ethiopia. Descriptive statistics were used and the responses to the open-ended question “If you have experienced any ethical dilemma, can you please describe a dilemma you have encountered in your own words?” were analyzed using a template analysis process. A total of 587 physicians responded (response rate 91,7%), and 565 met the inclusion criteria. Twelve of 24 specified ethically challenging situations were reported to be experienced often or sometimes by more than 50% of the physicians. The most frequently reported challenge concerned resource distribution: 93% agreed that they often or sometimes had to make difficult choices due to resource limitation, and 83% often or sometimes encountered difficulties because patients were unable to pay for the preferred course of treatment. Other frequently reported difficulties were doubts about doing good or harming the patient, relating to conflicting views, concern for family welfare, disclosure issues and caring for patients not able to consent. Few reported dilemmas related to end-of-life issues. The 200 responses to the open-ended question mirrored the quantitative results. Ethiopian physicians report ethical challenges related more to bedside rationing and fairness concerns than futility discussions and conflicts about autonomy as described in studies from high-income countries. In addition to the high report of experienced challenges, gravity of the dilemmas that are present in their narratives are striking. Recognition of the everyday experiences of physicians in low-income settings should prompt the development of ethics teaching and support mechanisms, discussion of ethical guidelines as well as increase our focus on how to improve the grave resource scarcity they describe.

  • The effects of industry funding and positive outcomes in the interpretation of clinical trial results: a randomized trial among Dutch psychiatrists
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-18
    Joeri K. Tijdink; Yvo M. Smulders; Lex M. Bouter; Christiaan H. Vinkers

    Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the study funding source influence the appraisal of an RCT, and do positive findings influence perceived credibility and clinical relevance? This study investigates whether psychiatrists’ appraisal of a scientific abstract is influenced by industry funding disclosures and a positive outcome. Dutch psychiatrists were randomized to evaluate a scientific abstract describing a fictitious RCT for a novel antipsychotic drug. Four different abstracts were created reporting either absence or presence of industry funding disclosure as well as a positive or a negative outcome. Primary outcomes were the perceived credibility and clinical relevance of the study results (10-point Likert scale). Secondary outcomes were the assessment of methodological quality and interest in reading the full article. Three hundred ninety-five psychiatrists completed the survey (completion rate 45%). Industry funding disclosure was found not to influence perceived credibility (Mean Difference MD 0.12; 95% CI − 0.28 to 0.47, p?) nor interpretation of its clinical relevance (MD 0.14; 95% CI − 0.54 to 0.27, p?). A negative outcome was perceived as more credible than a positive outcome (MD 0.81 points; 95% Confidence Interval (CI) 0.43 to 1.18, p?), but did not affect clinical relevance scores (MD -0.14; 95% CI − 0.54 to 0.27). In this study, industry funding disclosure was not associated with the perceived credibility nor judgement of clinical relevance of a fictional RCT by psychiatrists. Positive study outcomes were found to be less credible compared to negative outcomes, but industry funding had no significant effects. Psychiatrists may underestimate the influence of funding sources on research results. The fact that physicians indicated negative outcomes to be more credible may point to more awareness of existing publication bias in the scientific literature.

  • Secularity, abortion, assisted dying and the future of conscientious objection: modelling the relationship between attitudes
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-09-18
    Morten Magelssen; Nhat Quang Le; Magne Supphellen

    Controversies arise over abortion, assisted dying and conscientious objection (CO) in healthcare. The purpose of the study was to examine the relationship between attitudes towards these bioethical dilemmas, and secularity and religiosity. Data were drawn from a 2017 web-based survey of a representative sample of 1615 Norwegian adults. Latent moderated structural equations modelling was used to develop a model of the relationship between attitudes. The resulting model indicates that support for abortion rights is associated with pro-secular attitudes and is a main “driver” for support for assisted dying and opposition to conscientious objection. This finding should be regarded as a hypothesis which ought to be tested in other populations. If the relationship is robust and reproduced elsewhere, there are important consequences for CO advocates who would then have an interest in disentangling the debate about CO from abortion; and for health systems who ought to consider carefully how a sound policy on CO can safeguard both patient trust in the services and the moral integrity of professionals. It is suggested that if religiosity wanes and pro-secular and pro-abortion attitudes become more widespread, support for CO might decline, putting into question whether present policies of toleration of conscientious refusals will remain acceptable to the majority.

  • Euthanasia requests in dementia cases; what are experiences and needs of Dutch physicians? A qualitative interview study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-04
    Jaap Schuurmans; Romy Bouwmeester; Lamar Crombach; Tessa van Rijssel; Lizzy Wingens; Kristina Georgieva; Nadine O’Shea; Stephanie Vos; Bram Tilburgs; Yvonne Engels

    In the Netherlands, in 2002, euthanasia became a legitimate medical act, only allowed when the due care criteria and procedural requirements are met. Legally, an Advanced Euthanasia Directive (AED) can replace direct communication if a patient can no longer express his own wishes. In the past decade, an exponential number of persons with dementia (PWDs) share a euthanasia request with their physician. The impact this on physicians, and the consequent support needs, remained unknown. Our objective was to gain more insight into the experiences and needs of Dutch general practitioners and elderly care physicians when handling a euthanasia request from a person with dementia (PWD). We performed a qualitative interview study. Participants were recruited via purposive sampling. The interviews were transcribed verbatim, and analyzed using the conventional thematic content analysis. Eleven general practitioners (GPs) and elderly care physicians with a variety of experience and different attitudes towards euthanasia for PWD were included. Euthanasia requests appeared to have a major impact on physicians. Difficulties they experienced were related to timing, workload, pressure from and expectations of relatives, society’s negative view of dementia in combination with the ‘right to die’ view, the interpretation of the law and AEDs, ethical considerations, and communication with PWD and relatives. To deal with these difficulties, participants need support from colleagues and other professionals. Although elderly care physicians appreciated moral deliberation and support by chaplains, this was hardly mentioned by GPs. Euthanasia requests in dementia seem to place an ethically and emotionally heavy burden on Dutch GPs and elderly care physicians. The awareness of, and access to, existing and new support mechanisms needs further exploration.

  • Ethical issues associated with HIV molecular epidemiology: a qualitative exploratory study using inductive analytic approaches
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-07
    Farirai Mutenherwa; Douglas R. Wassenaar; Tulio de Oliveira

    HIV molecular epidemiology is increasingly recognized as a vital source of information for understanding HIV transmission dynamics. Despite extensive use of these data-intensive techniques in both research and public health settings, the ethical issues associated with this science have received minimal attention. As the discipline evolves, there is reasonable concern that existing ethical and legal frameworks and standards might lag behind the rapid methodological developments in this field. This is a follow-up on our earlier work that applied a predetermined analytical framework to examine the perspectives of a sample of scientists from the fields of epidemiology, public health, virology and bioethics on key ethical issues associated with HIV molecular epidemiology in HIV network research. Fourteen in-depth interviews were conducted with scientists from the fields of molecular epidemiology, public health, virology and bioethics. Inductive analytical approaches were applied to identify key themes that emerged from the data. Our interviewees acknowledged the potential positive impact of molecular epidemiology in the fight against HIV. However, they were concerned that HIV phylogenetics research messages may be incorrectly interpreted if not presented at the appropriate level. There was consensus that HIV phylogenetics research presents a potential risk to privacy, but the probability and magnitude of this risk was less obvious. Although participants acknowledged the social value that could be realized from the analysis of HIV genetic sequences, there was a perceived fear that the boundaries for use of HIV sequence data were not clearly defined. Our findings highlight distinct ethical issues arising from HIV molecular epidemiology. As the discipline evolves and HIV sequence data become increasingly available, it is critical to ensure that ethical standards keep pace with biomedical advancements. We argue that the ethical issues raised in this study, whether real or perceived, require further conceptual and empirical examination.

  • Why research ethics should add retrospective review
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-10
    Angus Dawson; Sapfo Lignou; Chesmal Siriwardhana; Dónal P. O’Mathúna

    Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

  • Legal medicine implications in fibrinolytic therapy of acute ischemic stroke
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-14
    Monica Sabau; Simona Bungau; Camelia Liana Buhas; Gheorghe Carp; Lucia-Georgeta Daina; Claudia Teodora Judea-Pusta; Bogdan Adrian Buhas; Claudia Maria Jurca; Cristian Marius Daina; Delia Mirela Tit

    Before the advent of fibrinolytic therapy as a gold standard method of care for cases of acute ischemic stroke in Romania, issues regarding legal medicine aspects involved in this area of medical expertise were already presented and, in the majority of cases, the doctors seem to be unprepared for these situations. The present research illustrates some of the cases in which these aspects were involved, that adressed a clinical center having 6 years of professional experience in the application of fibrinolytic treatment for stroke. The following cases report either situations in which the afore mentioned therapy was not rightfully administrated or legal aspects regarding the obtainment of informed consent. Obtaining informed consent is a mandatory procedure, which takes time, to the detriment of application of fibrinolytic treatment.

  • Broad consent for biobanks is best – provided it is also deep
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-15
    Rasmus Bjerregaard Mikkelsen; Mickey Gjerris; Gunhild Waldemar; Peter Sandøe

    As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.

  • How do researchers acquire and develop notions of research integrity? A qualitative study among biomedical researchers in Switzerland
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-16
    Priya Satalkar; David Shaw

    Structured training in research integrity, research ethics and responsible conduct of research is one strategy to reduce research misconduct and strengthen reliability of and trust in scientific evidence. However, how researchers develop their sense of integrity is not fully understood. We examined the factors and circumstances that shape researchers’ understanding of research integrity. This study draws insights from in-depth, semi-structured interviews with 33 researchers in the life sciences and medicine, representing three seniority levels across five research universities in Switzerland. The results of this study indicate that early education, moral values inculcated by the family and participation in team sports were the earliest influences on notions of honesty, integrity and fairness among researchers. Researchers’ personality traits, including degree of ambition and internal moral compass, were perceived as critical in determining the importance they attributed to conducting research with high ethical standards. Positive and negative experiences in early research life also had a significant impact on their views regarding research integrity. Two thirds of the study participants had not received any formal training in research integrity. Their awareness of training opportunities at their institutions was also limited. Age-appropriate development of honesty and integrity starts as early as primary education. Research integrity training should be offered from the bachelors level and continue throughout the entire professional life of researchers. Although these courses may not imbue researchers with integrity itself, they are essential to improving the research culture, reinforcing integrity norms, and discouraging researchers who lack personal integrity from engaging in research misconduct.

  • Forming and implementing community advisory boards in low- and middle-income countries: a scoping review
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-17
    Yang Zhao; Thomas Fitzpatrick; Bin Wan; Suzanne Day; Allison Mathews; Joseph D. Tucker

    Community advisory boards (CABs) have expanded beyond high-income countries (HICs) and play an increasing role in low- and middle-income country (LMIC) research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. We searched five databases (PubMed, Embase, Global Health, Scopus, and Google Scholar) for publications describing or evaluating CABs in LMICs. Two researchers independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies (65) were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa (17), China (8), and Thailand (7) having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs (53/88, 60%) focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs.

  • Engaging research ethics committees to develop an ethics and governance framework for best practices in genomic research and biobanking in Africa: the H3Africa model
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-18
    Paulina Tindana; Aminu Yakubu; Ciara Staunton; Alice Matimba; Katherine Littler; Ebony Madden; Nchangwi Syntia Munung; Jantina de Vries

    In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned.

  • Effect of written outcome information on attitude of perinatal healthcare professionals at the limit of viability: a randomized study
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-22
    V. Papadimitriou; B. Tosello; R. Pfister

    Differences in perception and potential disagreements between parents and professionals regarding the attitude for resuscitation at the limit of viability are common. This study evaluated in healthcare professionals whether the decision to resuscitate at the limit of viability (intensive care versus comfort care) are influenced by the way information on incurred risks is given or received. This is a prospective randomized controlled study. This study evaluated the attitude of healthcare professionals by testing the effect of information given through graphic fact sheets formulated either optimistically or pessimistically. The written educational fact sheet included three graphical presentations of survival and complication/morbidity by gestational age. The questionnaire was submitted over a period of 4 months to 5 and 6-year medical students from the Geneva University as well as physicians and nurses of the neonatal unit at the University Hospitals of Geneva. Our sample included 102 healthcare professionals. Forty-nine responders (48%) were students (response rate of 33.1%), 32 (31%) paediatricians (response rate of 91.4%) and 21 (20%) nurses in NICU (response rate of 50%). The received risk tended to be more severe in both groups compared to the graphically presented facts and current guidelines, although optimistic representation favoured the perception of “survival without disability” at 23 to 25 weeks. Therapeutic attitudes did not differ between groups, but healthcare professionals with children were more restrained and students more aggressive at very low gestational ages. Written information on mortality and morbidity given to healthcare professionals in graphic form encourages them to overestimate the risk. However, perception in healthcare staff may not be directly transferable to parental perception during counselling as the later are usually naïve to the data received. This parental information are always communicated in ways that subtly shape the decisions that follow.

  • Hospital ethics reflection groups: a learning and development resource for clinical practice
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-24
    H. Bruun; L. Huniche; E. Stenager; C. B. Mogensen; R. Pedersen

    An ethics reflection group (ERG) is one of a number of ethics support services developed to better handle ethical challenges in healthcare. The aim of this article is to evaluate the significance of ERGs in psychiatric and general hospital departments in Denmark. This is a qualitative action research study, including systematic text condensation of 28 individual interviews and 4 focus groups with clinicians, ethics facilitators and ward managers. Short written descriptions of the ethical challenges presented in the ERGs also informed the analysis of significance. A recurring ethical challenge for clinicians, in a total of 63 cases described and assessed in 3 ethical reflection groups, is to strike a balance between respect for patient autonomy, paternalistic responsibility, professional responsibilities and institutional values. Both in psychiatric and general hospital departments, the study participants report a positive impact of ERG, which can be divided into three categories: 1) Significance for patients, 2) Significance for clinicians, and 3) Significance for ward managers. In wards characterized by short-time patient admissions, the cases assessed were retrospective and the beneficiaries of improved dialogue mainly future patients rather than the patients discussed in the specific ethical challenge presented. In wards with longer admissions, the patients concerned also benefitted from the dialogue in the ERG. This study indicates a positive significance and impact of ERGs; constituting an interdisciplinary learning resource for clinicians, creating significance for themselves, the ward managers and the organization. By introducing specific examples, this study indicates that ERGs have significance for the patients discussed in the specific ethical challenge, but mostly indirectly through learning among clinicians and development of clinical practice. More research is needed to further investigate the impact of ERGs seen from the perspectives of patients and relatives.

  • Relational autonomy: what does it mean and how is it used in end-of-life care? A systematic review of argument-based ethics literature
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-26
    Carlos Gómez-Vírseda; Yves de Maeseneer; Chris Gastmans

    Respect for autonomy is a key concept in contemporary bioethics and end-of-life ethics in particular. Despite this status, an individualistic interpretation of autonomy is being challenged from the perspective of different theoretical traditions. Many authors claim that the principle of respect for autonomy needs to be reconceptualised starting from a relational viewpoint. Along these lines, the notion of relational autonomy is attracting increasing attention in medical ethics. Yet, others argue that relational autonomy needs further clarification in order to be adequately operationalised for medical practice. To this end, we examined the meaning, foundations, and uses of relational autonomy in the specific literature of end-of-life care ethics. Using PRESS and PRISMA procedures, we conducted a systematic review of argument-based ethics publications in 8 major databases of biomedical, philosophy, and theology literature that focused on relational autonomy in end-of-life care. Full articles were screened. All included articles were critically appraised, and a synthesis was produced. Fifty publications met our inclusion criteria. Twenty-eight articles were published in the last 5 years; publications were originating from 18 different countries. Results are organized according to: (a) an individualistic interpretation of autonomy; (b) critiques of this individualistic interpretation of autonomy; (c) relational autonomy as theoretically conceptualised; (d) relational autonomy as applied to clinical practice and moral judgment in end-of-life situations. Three main conclusions were reached. First, literature on relational autonomy tends to be more a ‘reaction against’ an individualistic interpretation of autonomy rather than be a positive concept itself. Dichotomic thinking can be overcome by a deeper development of the philosophical foundations of autonomy. Second, relational autonomy is a rich and complex concept, formulated in complementary ways from different philosophical sources. New dialogue among traditionally divergent standpoints will clarify the meaning. Third, our analysis stresses the need for dialogical developments in decision making in end-of-life situations. Integration of these three elements will likely lead to a clearer conceptualisation of relational autonomy in end-of-life care ethics. This should in turn lead to better decision-making in real-life situations.

  • Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-10-28
    Gillie Gabay; Yaarit Bokek-Cohen

    There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence. Informants were 12 Israelis (6 men and 6 women), aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon discharge. Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity. Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons. Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent.

  • Lessons learned from implementing a responsive quality assessment of clinical ethics support
    BMC Med. Ethics (IF 2.507) Pub Date : 2019-11-01
    Eva M. Van Baarle; Marieke C. Potma; Maria E. C. van Hoek; Laura A. Hartman; Bert A. C. Molewijk; Jelle L. P. van Gurp

    Various forms of Clinical Ethics Support (CES) have been developed in health care organizations. Over the past years, increasing attention has been paid to the question of how to foster the quality of ethics support. In the Netherlands, a CES quality assessment project based on a responsive evaluation design has been implemented. CES practitioners themselves reflected upon the quality of ethics support within each other’s health care organizations. This study presents a qualitative evaluation of this Responsive Quality Assessment (RQA) project. CES practitioners’ experiences with and perspectives on the RQA project were collected by means of ten semi-structured interviews. Both the data collection and the qualitative data analysis followed a stepwise approach, including continuous peer review and careful documentation of the decisions. The main findings illustrate the relevance of the RQA with regard to fostering the quality of CES by connecting to context specific issues, such as gaining support from upper management and to solidify CES services within health care organizations. Based on their participation in the RQA, CES practitioners perceived a number of changes regarding CES in Dutch health care organizations after the RQA: acknowledgement of the relevance of CES for the quality of care; CES practices being more formalized; inspiration for developing new CES-related activities and more self-reflection on existing CES practices. The evaluation of the RQA shows that this method facilitates an open learning process by actively involving CES practitioners and their concrete practices. Lessons learned include that “servant leadership” and more intensive guidance of RQA participants may help to further enhance both the critical dimension and the learning process within RQA.

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