Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of (...) these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)

The concept of community is increasingly the focus of political argument in Britain, the United States and elsewhere around the world. The sense people have of belonging to coummunities provides a powerful motivation which continues to affecct the political and social face of the world. Recently, debate about the relationship between individuals and their communities has become central to the making of both, American and European social policy. In the United Kingdom this is especially apparent in the area of health (...) care, where ideas of community have informed recent legislation concerning community care, community health trusts and the Children Act among others. This volume explores the focus of interest in community and the emerging theoretical oppostion between communitarianism and liberalism, as well as the practical, theoretical and ethical issues relating to community in the health care professions, including a discussion of the health service as Civil Association, an analysis of liberal and communitarian views on the allocaiton of health care resources, an exploration of the use of genetic information and an examination of health care decision making for incapacitated elderly patients. (shrink)

We thank all the thoughtful authors for their insightful comments. In this response, we try to address some of themes that emerged from the commentaries. We leave aside some of those comments that...

Realizing the benefits of translating psychiatric genomics research into mental health care is not straightforward. The translation process gives rise to ethical challenges that are distinctive from challenges posed within psychiatric genomics research itself, or that form part of the delivery of clinical psychiatric genetics services. This article outlines and considers three distinct ethical concerns posed by the process of translating genomic research into frontline psychiatric practice and policy making. First, the genetic essentialism that is commonly associated with the genomics (...) revolution in health care might inadvertently exacerbate stigma towards people with mental disorders. Secondly, the promises of genomic medicine advance a narrative of individual empowerment. This narrative could promote a fatalism towards patients' biology in ways that function in practice to undermine patients' agency and autonomy, or, alternatively, a heightened sense of subjective genetic responsibility could become embedded within mental health services that leads to psychosocial therapeutic approaches and the clinician-patient therapeutic alliance being undermined. Finally, adopting a genomics-focused approach to public mental health risks shifting attention away from the complex causal relationships between inequitable socio-economic, political, and cultural structures and negative mental health outcomes. The article concludes by outlining a number of potential pathways for future ethics research that emphasizes the importance of examining appropriate translation mechanisms, the complementarity between genetic and psychosocial models of mental disorder, the implications of genomic information for the clinician-patient relationship, and funding priorities and resource allocation decision making in mental health. (shrink)

The practice of medicine frequently involves the unconsented restriction of liberty. The reasons for unilateral liberty restrictions are typically that being confined, strapped down, or sedated are necessary to prevent the person from harming themselves or others. In this paper, we target the ethics of chemical restraints, which are medications that are used to intentionally restrict the mental states associated with the unwanted behaviors, and are typically not specifically indicated for the condition for which the patient is being treated. Specifically, (...) we aim to identify the conditions under which chemical restraints are ethically permissible. It is wrong to assume that what is morally true of physical restraints is also true of chemical restraints. Our aim is thus to identify the conditions under which chemical restraints are permissible while distinguishing these conditions from those of the application of physical restraints. (shrink)

Two potentially lifesaving protocols, emergency preservation and resuscitation and uncontrolled donation after circulatory determination of death, currently implemented in some U.S. emergency departments, have similar eligibility criteria and initial technical procedures, but critically different goals. Both follow unsuccessful cardiopulmonary resuscitation and induce hypothermia to “buy time”: one in trauma patients suffering cardiac arrest, to enable surgical repair, and the other in patients who unexpectedly die in the ED, to enable organ donation. This article argues that to fulfill patient-focused fiduciary obligations (...) and maintain community trust, institutions implementing both protocols should adopt and publicize policies to guide ED physicians to utilize either protocol for particular patients, in order to address the appearance of conflict of interest arising from the protocols' similarities. It concludes by analyzing ethical implications of incentives that may influence institutions to develop the expertise required for uDCDD but not EPR. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

Despite the lack of evidence for their effectiveness, the use of physical restraints for patients is widespread. The best ethical justification for restraining patients is that it prevents them from harming themselves. We argue that even if the empirical evidence supported their effectiveness in achieving this aim, their use would nevertheless be unethical, so long as well known exceptions to informed consent fail to apply. Specifically, we argue that ethically justifiable restraint use demands certain necessary and sufficient conditions. These conditions (...) are that the physician obtain informed consent for their application, that their application be medically appropriate, and that restraints be the least liberty-restricting way of achieving the intended benefit. It is a further question whether their application is ever medically appropriate, given the dearth of evidence for their effectiveness. (shrink)

As the federal government distributed remdesivir to some of the states COVID-19 hit hardest, policymakers scrambled to develop criteria to allocate the drug to their hospitals. Our state, Michigan, was among those states to receive an initial quantity of the drug from the U.S. government. The disparities in burden of disease in Michigan are striking. Detroit has a death rate more than three times the state average. Our recommendation to the state was that it should prioritize the communities that bear (...) a disproportionate burden of suffering in the allocation of the new potential treatment. This recommendation is justified not only for new drugs with uncertain effects, but also for drugs of certain benefit or vaccines. For states with significant health disparities, such as Michigan, this allocation priority may help to repair them. In fact, any other allocation strategy may make them worse. (shrink)

Default positions, predetermined starting points that aid in complex decision-making, are common in clinical medicine. In this article, we identify and critically examine common default positions in clinical ethics practice. Whether default positions ought to be held is an important normative question, but here we are primarily interested in the descriptive, rather than normative, properties of default positions. We argue that default positions in clinical ethics function to protect and promote important values in medicine—respect for persons, utility, and justice. Further, (...) default positions in clinical ethics may also guard against harm. Where default positions exist, there are epistemic burdens to overturn them. The person wishing to reject the default position, rather than the person endorsing it, bears this burden. The person who bears the burden of meeting the epistemic requirements must provide evidence proportional to the degree of harm the default position protects against. Default positions that protect against significant harm impose significant epistemic requirements to overturn. This asymmetry not only makes medical decision-making more economical but also serves to promote and protect certain values. The identification and analysis of common and recognizable default positions can help to identify other default positions and the conditions under which their associated epistemic requirements are met. The article concludes with considerations of potential problems with the use of default positions in clinical ethics. (shrink)

In this paper we discuss ethical implications of the use of mobile phone apps in the control of the COVID-19 pandemic. Contact tracing is a well-established feature of public health practice during infectious disease outbreaks and epidemics. However, the high proportion of pre-symptomatic transmission in COVID-19 means that standard contact tracing methods are too slow to stop the progression of infection through the population. To address this problem, many countries around the world have deployed or are developing mobile phone apps (...) capable of supporting instantaneous contact tracing. Informed by the on-going mapping of ‘proximity events’ these apps are intended both to inform public health policy and to provide alerts to individuals who have been in contact with a person with the infection. The proposed use of mobile phone data for ‘intelligent physical distancing’ in such contexts raises a number of important ethical questions. In our paper, we outline some ethical considerations that need to be addressed in any deployment of this kind of approach as part of a multidimensional public health response. We also, briefly, explore the implications for its use in future infectious disease outbreaks. (shrink)

In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic (...) bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders (...) involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders. (shrink)

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

ABSTRACT A key selling point of pharmacogenetics is the genetic stratification of either patients or diseases in order to target the prescribing of medicine. The hope is that genetically ‘tailored’ medicines will replace the current ‘one‐size‐fits‐all’ paradigm of drug development and usage. This paper is concerned with the relationship between difference and justice in the use of pharmacogenetics. This new technology, which facilitates the identification and use of difference, has, we shall argue, the potential to lead to injustice either by (...) the inappropriate use of difference or through the inappropriate failure to use difference. We build on empirical data from a detailed study of the range of options for the development of pharmacogenetics to present a consideration of the ethical issues that surround patient and disease stratification. In it we explore the ways in which the use of pharmacogenetics may lead to the creation of new, genetically stratified, forms of difference and new forms of injustice based on these divisions. We also examine the ways in which existing forms of difference and social stratification may interact with the use of pharmacogenetics. In conclusion, we suggest how an understanding of these ethical issues could usefully inform future policy discussions. (shrink)

Biomedical research is an increasingly multidisciplinary activity bringing together a range of different academic fields and forms of expertise to investigate diseases that are increasingly understood to be complex and multifactorial. Recently the discipline of ethics has been starting to find a place in large-scale biomedical collaborations. In this article we draw from our experience of working with the Malaria Genomic Epidemiology Network and other research projects to reflect upon the integration of ethics into biomedical research. We examine the way (...) in which ethics input may be valuable to research, the forms it tends to take, and also the problems and limitations of such collaborations. (shrink)

This new edition of The Cambridge Medical Ethics Workbook builds on the success of the first edition by working from the 'bottom up', with a widely praised case ...

The aim of this study is to assess patients' recall of their previous research participation. Recall was established during interviews and compared with entries from clinical notes. Participants were 49 patients who had previously participated in different types of research. Of the 49 patients, 45 (92%) interviewees recalled 69 of 109 (63%) study participations. Level of recall varied according to the type of research, some participants clearly recalled the details of research aims, giving consent and research procedures. Others recalled procedures (...) (e.g. DNA testing) but were unclear about their purpose. There was no significant effect of time on recall. Some types of research participation (e.g. DNA testing) may be recalled as clinical care. We argue that such misunderstandings may have the potential to undermine participants' ongoing consent, particularly in ongoing/longitudinal studies. Valid consent may be best achieved by re-assessing the scope of consent and relating it to the nature of the interventions themselves rather than the reasons for undertaking them. (shrink)

Offering philosophical insights into the popular morning brew, _Coffee -- Philosophy for Everyone_ kick starts the day with an entertaining but critical discussion of the ethics, aesthetics, metaphysics, and culture of coffee. Matt Lounsbury of pioneering business Stumptown Coffee discusses just how good coffee can be Caffeine-related chapters cover the ethics of the coffee trade, the metaphysics of coffee and the centrality of the coffee house to the public sphere Includes a foreword by Donald Schoenholt, President at Gillies Coffee Company.

Next SectionBackground There is an established link between depression and interest in hastened death in patients who are seriously ill. Concern exists over the extent of depression in patients who actively request euthanasia/physician-assisted suicide (PAS) and those who have their requests granted. Objectives To estimate the prevalence of depression in refused and granted requests for euthanasia/PAS and discuss these findings. Methods A systematic review was performed in MEDLINE and PsycINFO in July 2010, identifying studies reporting rates of depression in requests (...) for and cases of euthanasia/PAS. One author critically appraised the strength of the data using published criteria. Results 21 studies were included covering four countries. There was considerable heterogeneity in methods of assessing depression and selecting patients. In the highest quality studies, in the Netherlands and Oregon, 8–47% of patients requesting euthanasia/PAS had depressive symptoms and 2–17% of completed euthanasia/PAS cases had depressive symptoms. In the Netherlands, depression was significantly higher in refused than granted requests, and there was no significant difference in the rate of depression between euthanasia cases and similar patients who had not made a request for euthanasia. Conclusion It is unclear whether depression increases the probability of making a request for euthanasia/PAS, but in the Netherlands most requests in depressed patients are rejected, leaving a depression rate in cases that is similar to the surrounding population. Less evidence is available elsewhere, but some level of depression has been identified in patients undergoing euthanasia/PAS in all the countries studied. Whether the presence of depression is ever compatible with an ethical decision on euthanasia/PAS is discussed. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement between stakeholders to determine the (...) social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

BackgroundObtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy will (...) assist in developing appropriate consent guidelines.MethodsWe conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software.ResultsAll participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting.ConclusionThe health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent.Trial registration Not applicable. (shrink)

Should those who work on ethics welcome or resist moves to open access publishing? This paper analyses arguments in favour and against the increasing requirement for open access publishing and considers their implications for bioethics research. In the context of biomedical science, major funders are increasingly mandating open access as a condition of funding and such moves are also common in other disciplines. Whilst there has been some debate about the implications of open-access for the social sciences and humanities, there (...) has been little if any discussion about the implications of open access for ethics. This is surprising given both the central role of public reason and critique in ethics and the fact that many of the arguments made for and against open access have been couched in moral terms. In what follows I argue that those who work in ethics have a strong interest in supporting moves towards more open publishing approaches which have the potential both to inform and promote richer and more diverse forms of public deliberation and to be enriched by them. The importance of public deliberation in practical and applied ethics suggests that ethicists have a particular interest in the promotion of diverse and experimental forms of publication and debate and in supporting new, more creative and more participatory approaches to publication. (shrink)

The UK Genethics Club was established in November 2001 in order to provide a national forum of ethics support for the profession of clinical genetics in the UK. The forum brings together health professionals, medical ethicists and lawyers and support is provided through detailed discussion of cases and sharing of good practice. Clinical genetics professionals had previously voiced concerns about making extremely difficult ethical decisions, with profound implications, in something of a vacuum. Professionals saw a lack of guidance in the (...) area and lack of time for discussion of difficult cases as reasons for this. This paper describes the origins of the group and gives (anonymized) examples of some of the types of issues discussed. (shrink)

This volume explores the focus of interest in community and the emerging theoretical opposition between communitarianism and liberalism, including the practical, theoretical and ethical issues that relate to community in the healthcare professions.

Physics has been thought to truly represent reality since at least Galileo, and the foundations of physics are always established using philosophical ideas. In particular, the elegant naming of physical entities is usually very influential in the acceptance of physical theories. We here demonstrate (using current developments in thermodynamics as an example) that both the epistemology and the ontology of physics ultimately rest on poetic language. What we understand depends essentially on the language we use. We wish to establish our (...) knowledge securely, but strictly speaking this is impossible using only analytic language. Knowledge of the meanings of things must use a natural language designed to express meaning, that is, poetic language. Although the world is really there, and although we can indeed know it truly, this knowledge is never either complete or certain but ultimately must rest on intuition. Reading a recently discovered artefact with a palaeo-Hebrew inscription as from the first century, we demonstrate from it that this ontological understanding long predates the Hellenic period. Poetic language is primary, both logically and temporally. (shrink)

Confidentiality in genetic testing posesimportant ethical challenges to the currentprimacy of respect for autonomy and patientchoice in health care. It also presents achallenge to approaches to decision-makingemphasising the ethical importance of theconsequences of health care decisions. In thispaper a case is described in which respect forconfidentiality calls both for disclosure andnon-disclosure, and in which respect forpatient autonomy and the demand to avoidcausing harm each appear to call both fortesting without consent, and testing only withconsent. This creates problems not only forclinicians, (...) families and patients, but also forthose who propose clinical bioethics as a toolfor the resolution of such dilemmas.In this paper I propose some practical waysin which ethical issues in clinical geneticsand elsewhere, might be addressed. Inparticular I call for a closer relationshipbetween ethics and communication in health caredecision-making and describe an approach to theethics consultation that places particularemphasis on the value of interpersonaldeliberation in the search for moralunderstanding. I reach these conclusionsthrough an analysis of the concept of `moraldevelopment'' in which I argue that theachievement of moral understanding is anecessarily intersubjective project elaboratedby moral persons. (shrink)

IntroductionDeep brain stimulation (DBS) is increasingly used to treat the symptoms of various neurologic and psychiatric conditions. People can undergo the procedure during reproductive years but the safety of DBS in pregnancy remains relatively unknown given the paucity of published cases. We thus conducted a review of the literature to determine the state of current knowledge about DBS in pregnancy and to determine how eligibility criteria are approached in clinical trials with respect to pregnancy and the potential for pregnancy.MethodsA literature (...) review was conducted in EMBASE to identify articles involving DBS and pregnancy. Two reviewers independently analyzed the articles to confirm inclusion. Data extracted for analysis included conditions treated, complications at all stages of pregnancy, neonatal/pediatric outcomes, and DBS target. A second search was then conducted using www.clinicaltrials.gov. The same two reviewers then assessed whether each trial excluded pregnant individuals, lactating individuals, or persons of childbearing age planning to conceive. Also assessed was whether contraception had to be deemed adequate prior to enrollment.ResultsThe literature search returned 681 articles. Following independent analysis and agreement of two reviewers, 8 pregnancy related DBS articles were included for analysis. These articles described 27 subjects, 29 pregnancies (2 with subsequent pregnancies), and 31 infants (2 twin pregnancies). There was 1 preterm birth at 35 weeks, and 3 patients who experienced discomfort from the DBS battery (i.e., impulse generator) placement site. All 27 patients had a DBS device implanted before they became pregnant, which remained in use throughout their pregnancy. There was exclusion of pregnant individuals from 68% of 135 interventional trials involving DBS. Approximately 44% of these trials excluded persons of childbearing age not on “adequate contraception” or wishing to conceive in the coming years. Finally, 22% excluded breastfeeding persons.ConclusionThe data from 29 pregnancies receiving DBS treatment during pregnancy was not associated with unexpected pregnancy or post-partum complication patterns. Many clinical trials have excluded pregnant individuals. Documentation of outcomes in larger numbers of pregnancies will help clarify the safety profile and will help guide study designs that will safely include pregnant patients. (shrink)

The European Biomedical Ethics Practitioner Education Project (EBEPE), funded by the BIOMED programme of the European Commission, is a five-nation partnership to produce open learning materials for healthcare ethics education. Papers and case studies from a series of twelve conferences throughout the European Union, reflecting the ‘burning issues’ in the participants' healthcare systems, have been collected by a team based at Imperial College, London, where they are now being edited into a series of seven activity-based workbooks for individual or group (...) study. These draft workbooks are now being read by a network of critical readers across Europe, whose comments will be incorporated into the final versions of the workbooks. The result will be the first European-wide and Europe-centred resource for teaching students, practitioners, and members of ethics committees. Topics covered include: • Resource allocation and rationing • The rights of children and young people • Long-term care of the elderly • Mental health and mental illness • Autonomy and patient choice • Decisions at the end of life • A study guide to using the workbooks The collaborative nature of the project has highlighted differentiated national approaches in medical ethics. Against the British and Dutch rights-orientated approach have emerged two other alternative models: the Nordic preference for administrative resolution of entitlement disputes, and the southern European emphasis on deontological codes. A genuinely European reconstruction of autonomy and rights, using hermeneutic, feminist and narrative approaches to counterbalance individualistic models, is emerging across the workbooks. The programme has also uncovered national differences in how ethics should be taught, with the workbooks' style being an experiential approach. Thus the EBEPE project is developing new models in both substantive and pedagogic senses, about both what should be taught and how it should be presented. (shrink)