BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to medical ethics, heathcare and bioethics.

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  • Does growing up with a physician influence the ethics of medical students’ relationships with the pharmaceutical industry? The cases of the US and Poland

    Marta Makowska (BioMed Central, 2017-08-01)
    Abstract Background Medical schools have a major impact on future doctors’ ethics and their attitudes towards cooperation with the pharmaceutical industry. From childhood, medical students who are related to a physician are exposed to the characteristics of a medical career and learn its professional ethics not only in school but also in the family setting. The present paper sought to answer the research question: ‘How does growing up with a physician influence medical students' perceptions of conflicts of interest in their relationships with industry?’ Methods An anonymous questionnaire was completed by 451 medical students from four Philadelphia medical schools and 554 medical students from Warsaw Medical University during 2013. Medical schools in these two cities were chosen because they are both university cities with similar population sizes. Students who had and who did not have a family member working as a physician were compared using chi-square analysis. Data were analysed for each country separately. Results For both the US and Poland, there were statistically significant differences (p < .05) between medical students with a physician as a family member and other students with respect to views regarding relationship with the pharmaceutical industry. In both groups, this difference occurred for three important dimensions: students’ relationship with the pharmaceutical industry; students’ views on physicians’ rights to cooperate with the pharmaceutical industry; trust in the pharmaceutical industry. In the US, students related to a doctor were characterized by more restrictive opinions on all three dimensions than other students (e.g., 27.8% of the former students vs. 31.4% of the latter students thought doctors had unrestricted rights to cooperate with the industry). However, the contrary was observed in Poland: students with a physician in the family had less strict views than their colleagues (e.g., 56.8% of the former vs. 39.7% of the latter thought that doctors should have unrestricted rights of cooperation). Conclusions In Poland, a former communist country, physicians transmit a more liberal approach towards collaboration with the pharmaceutical industry to their student relatives than those in the US.
  • The development of a brief and objective method for evaluating moral sensitivity and reasoning in medical students

    Kai Ichiro; Akabayashi Akira; Slingsby Brian; Nishimura Tadashi; Yamagishi Akiko (BioMed Central, 2004)
    <p>Abstract</p> <p>Background</p> <p>Most medical schools in Japan have incorporated mandatory courses on medical ethics. To this date, however, there is no established means of evaluating medical ethics education in Japan. This study looks 1) To develop a brief, objective method of evaluation for moral sensitivity and reasoning; 2) To conduct a test battery for the PIT and the DIT on medical students who are either currently in school or who have recently graduated (residents); 3) To investigate changes in moral sensitivity and reasoning between school years among medical students and residents.</p> <p>Methods</p> <p>Questionnaire survey: Two questionnaires were employed, the Problem Identification Test (PIT) for evaluation of moral sensitivity and a portion of the Defining Issues Test (DIT) for moral reasoning. Subjects consisted of 559 medical school students and 272 residents who recently graduated from the same medical school located in an urban area of Japan.</p> <p>Results</p> <p>PIT results showed an increase in moral sensitivity in 4<sup>th </sup>and 5<sup>th </sup>year students followed by a decrease in 6<sup>th </sup>year students and in residents. No change in moral development stage was observed. However, DIT results described a gradual rising shift in moral decision-making concerning euthanasia between school years. No valid correlation was observed between PIT and DIT questionnaires.</p> <p>Conclusion</p> <p>This study's questionnaire survey, which incorporates both PIT and DIT, could be used as a brief and objective means of evaluating medical students' moral sensitivity and reasoning in Japan.</p>
  • When the law makes doors slightly open: ethical dilemmas among abortion service providers in Addis Ababa, Ethiopia

    Emily McLean; Dawit Nima Desalegn; Astrid Blystad; Ingrid Miljeteig (BMC, 2019-09-01)
    Abstract Background 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. Methods 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. Results 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. Conclusions 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.
  • Umbrella and basket trials in oncology: ethical challenges

    Karolina Strzebonska; Marcin Waligora (BMC, 2019-08-01)
    Abstract Background 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. Main body 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. Conclusions 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

    M. Verhofstadt; K. Audenaert; K. Van Assche; S. Sterckx; K. Chambaere (BMC, 2019-09-01)
    Abstract Background 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. Main text 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. Conclusion 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).
  • 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

    Claire Blakeley; Debbie M. Smith; Edward D. Johnstone; Anja Wittkowski (BMC, 2019-08-01)
    Abstract Background 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. Methods 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. Results 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. Conclusion 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.
  • Regulatory and policy tools to address unproven stem cell interventions in Canada: the need for action

    Timothy Caulfield; Blake Murdoch (BMC, 2019-08-01)
    Abstract Background 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. Main body 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. Conclusions 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.
  • What Egyptians think. Knowledge, attitude, and opinions of Egyptian patients towards biobanking issues

    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 (BMC, 2019-08-01)
    Abstract Background 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. Methods 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. Results 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. Conclusion 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.
  • Do we understand the intervention? What complex intervention research can teach us for the evaluation of clinical ethics support services (CESS)

    Jan Schildmann; Stephan Nadolny; Joschka Haltaufderheide; Marjolein Gysels; Jochen Vollmann; Claudia Bausewein (BMC, 2019-07-01)
    Abstract Background 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. Main body 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. Conclusion 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

    Henriette Bruun; Reidar Pedersen; Elsebeth Stenager; Christian Backer Mogensen; Lotte Huniche (BMC, 2019-07-01)
    Abstract Background 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. Methods 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. Results 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. Conclusion 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

    Charmaine Khudzie Mlambo; Eva Vernooij; Roos Geut; Eliane Vrolings; Buyisile Shongwe; Saima Jiwan; Yvette Fleming; Gavin Khumalo (BMC, 2019-07-01)
    Abstract Background 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. Methods 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. Results 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. Conclusion 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.
  • Global health ethics: critical reflections on the contours of an emerging field, 1977–2015

    Gail Robson; Nathan Gibson; Alison Thompson; Solomon Benatar; Avram Denburg (BMC, 2019-07-01)
    Abstract Background 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. Methods 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. Results 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. Conclusions This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship.
  • Model consent clauses for rare disease research

    Minh Thu Nguyen; Jack Goldblatt; Rosario Isasi; Marlene Jagut; Anneliene Hechtelt Jonker; Petra Kaufmann; Laetitia Ouillade; Fruszina Molnar-Gabor; Mahsa Shabani; Eric Sid; et al. (BMC, 2019-08-01)
    Abstract Background 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. Methods 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. Results 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. Conclusion 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.
  • Informed consent and community engagement in open field research: lessons for gene drive science

    Jerome Amir Singh (BMC, 2019-07-01)
    Abstract Background 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. Discussion 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. Conclusions 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.
  • Is the non-identity problem relevant to public health and policy? An online survey

    Keyur Doolabh; Lucius Caviola; Julian Savulescu; Michael J. Selgelid; Dominic Wilkinson (BMC, 2019-07-01)
    Abstract Background 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. Methods 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. Results 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. Conclusions 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.
  • Who should decide about children’s and adolescents’ participation in health research? The views of children and adults in rural Kenya

    Vicki Marsh; Nancy Mwangome; Irene Jao; Katharine Wright; Sassy Molyneux; Alun Davies (BMC, 2019-06-01)
    Abstract Background 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. Methods 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. Results 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. Conclusions 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.
  • Bioethical reflexivity and requirements of valid consent: conceptual tools

    John Barugahare (BMC, 2019-07-01)
    Abstract Background 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’. Main body 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. Conclusions 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.
  • Trust and the ethical challenges in the use of whole genome sequencing for tuberculosis surveillance: a qualitative study of stakeholder perspectives

    Carly Jackson; Jennifer L. Gardy; Hedieh C. Shadiloo; Diego S. Silva (BMC, 2019-07-01)
    Abstract Background 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. Method 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. Results 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. Conclusions 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.
  • Ethical challenges of integration across primary and secondary care: a qualitative and normative analysis

    Alex McKeown; Charlotte Cliffe; Arun Arora; Ann Griffin (BMC, 2019-07-01)
    Abstract Background 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. Methods 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. Results 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. Conclusions 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.
  • A reflection on ethical and methodological challenges of using separate interviews with adolescent-older carer dyads in rural South Africa

    Dumile Gumede; Nothando B. Ngwenya; Stella Namukwaya; Sarah Bernays; Janet Seeley (BMC, 2019-07-01)
    Abstract Background 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. Methods 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. Results 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. Conclusions 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.

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