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The literature suggests that recent advances in research, such as genomic studies, may have further complicated consent processes due to the complex nature of these studies and unfamiliarity with the concepts and methodologies involved. Some empirical studies in Africa have reported that although there is general support for genomic studies, particularly on the reuse of samples, there are also concerns about how the interests of key stakeholders such as participants (i.e. sample donors) and the broader local communities from which samples are collected can and should be ascertained and protected. The focus of the paper by Mweemba et al. reports on the findings of a qualitative study with participants recruited for an H3Africa study on rheumatic heart disease in Zambia. The study suggests that conventional ethics standards and practices may not be sufficiently responsive to participant and community concerns and interests in addressing the ethical complexity of the ethical challenges in research. [Extracted from the article]

The Prenatal Assessment of Genome and Exomes (PAGE) project is a UK-wide study aiming to gain a better understanding of genetic variants causing developmental problems during pregnancy. A further aim of the study is to provide an evidence-base for the introduction of prenatal whole genome and exome sequencing (PWGES) into prenatal diagnostics provided by the NHS, which is expected in 2018. This paper presents the findings of a qualitative interview study undertaken with 20 health professionals and researchers involved in the PAGE project, and explores their implications for understandings of ‘good practice’ in the uses of prenatal genomics clinically. A number of critical issues are identified that will need to be addressed in the development of a model of good ethical practice for prenatal genomics: consent, management of expectations, return of results, and professional duties in the context of PWGES. The analysis presented identifies and illustrates a great deal of complexity and qualitative richness in these issues as they arise in the day-to-day work of genomics professionals. Inclusive, critical discussion of these findings, together with the findings from other empirical studies, normative analysis and scientific discoveries resulting from PAGE, will be required to inform the development of appropriate guidelines of good ethical practice that address the needs and concerns to be encountered in daily clinical practice. [ABSTRACT FROM AUTHOR]

An enduring debate concerns how responsibility for patient safety should be distributed between organisational systems and individual professionals. Though rule-based, calculus-like approaches intended to support a 'just culture' have become popular, they perpetuate an asocial and atomised account. In this article, we use insights from practice theory - which sees organisational phenomena as accomplished in everyday actions, with individual agency and structural conditions as a mutually constitutive, dynamic duality - along with contributions from the political science and ethics literature as a starting point for analysis. Presenting ethnographic data from five hospitals, three in one high-income country and two in low-income countries, we offer an empirically informed, normative rethinking of the role of personal accountability, identifying the collective nature of the healthcare enterprise and the extent to which patient safety depends on contributions from many hands. We show that moral responsibility for actions and behaviours is an irreducible element of professional practice, but that individuals are not somehow 'outside' and separate from 'systems': they create, modify and are subject to the social forces that are an inescapable feature of any organisational system; each element acts on the other. Our work illustrates starkly the structuring effects of the broader institutional and socioeconomic context on opportunities to 'be good'. These findings imply that one of the key responsibilities of organisations and wider institutions in relation to patient safety is the fostering of the conditions of moral community. [ABSTRACT FROM AUTHOR]

This paper engages with the question of what it is to 'do good medical ethics' in two ways. It begins with an exploration of what it might mean to say that health professionals practise good medical ethics as part of practising good ethical medicine. Using the example of the Genethics Club, a well-established national ethics forum for genetics professionals in the UK, the paper develops an account of moral craftsmanship grounded in the concepts of shared moral commitments and practices, moral work, ethics and living morality. In the light of this discussion, the paper goes on to consider what it might mean for a specialist in medical ethics, a bioethicist, to do good medical ethics. Finally, a research agenda focusing on the challenges of thinking about good medical ethics in a global context and a proposal for an innovative approach to bioethics methodology is outlined. [ABSTRACT FROM AUTHOR]

Summary: Community engagement is increasingly promoted in developing countries, especially in international health research, but there is little published experience. The Shoklo Malaria Research Unit (SMRU) conducts research with refugees, migrant workers, displaced people, and day migrants on the Thai-Burmese border, and has recently facilitated the set up of the Tak Province Border Community Ethics Advisory Board (T-CAB). Valuable lessons have been learnt from consultation with the T-CAB especially in the area of participant recruitment and the informed consent process. A lot of new research questions have emerged from consultation with the T-CAB. This paper describes our experience, lessons learnt and the unique challenges faced working with the T-CAB from its initial conception to date. We conclude that consultation with the T-CAB has made improvements in our research in particular operational and ethical aspects of our studies. [Copyright &y& Elsevier]

The authors reflect on the fair distribution of research resources. They note that there is only a small portion of medical research that addressed problems in the world's poorest people. They mention that the Ad Hoc Committee on Health Research and International Conference on Health Research for Development endorsed five core recommendations to address the need for a more equitable distribution of research resources. They explore the ethical issues in collaborative global health research.

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. [ABSTRACT FROM AUTHOR]

The objective of this study is to describe researchers', health-care providers' and other stakeholders' views of ethical review and research governance procedures. The study design involved qualitative semi-structured interviews. Participants included 60 individuals who either undertook research in the subspecialty of cancer genetics (n = 40) or were involved in biomedical research in other capacities (n = 20), e.g. research governance and oversight, patient support groups or research funding. While all interviewees observed that oversight is necessary to protect research participants, ethical review and research governance (ERG) arrangements were described negatively throughout these interviews. Interviewees identified a number of problems with ERG, including: over-bureaucratization, overstandardization of information requirements for different types of research, a lack of standardization in the types of information required by different committees for the same research and a lack of consistency in different committees' responses. A number of solutions were proposed including streamlining application procedures and harmonizing committees' responses and information requirements. Recent reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK, hence the introduction of the Integrated Research Application System (IRAS) is long overdue. However, while IRAS may solve some of the problems identified by interviewees, it remains to be seen to what extent it will impact upon the very negative perceptions of ethics and research governance procedures reported here. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Genetics can pose special challenges to the principle of confidentiality within the health professional-patient relationship, since genetic information is by its nature both individual and familial. Most professional guidelines allow confidentiality to be broken in rare circumstances, where it will prevent a ‘serious’, ‘imminent’ and ‘likely’ harm. We argue that the types of harms that may result from genetic medicine are particularly diverse. Using clinical examples, we explore ethical issues that arise when balancing individual and family member interests. As genetic testing becomes more, widespread situations will arise where clinicians are faced with a choice between preserving the confidentiality of one patient and preventing harm to another. Professionals need to incorporate the notion of familial implications in their counseling of individuals. Since such dilemmas have been relatively rare in the pre-genetic age, we call for a wider debate on the balance between confidentiality and harm to others.European Journal of Human Genetics (2004) 12, 93-97. doi:10.1038/sj.ejhg.5201118 Published online 12 November 2003 [ABSTRACT FROM AUTHOR]

Developments in genetic testing and increased public awareness of inherited disease have led to increasing interest in and concern about the ethical issues raised by clinical genetics. We looked at methods for ethical management of genetic testing, and investigated the advantages and limitations of use of ethical guidelines in clinical genetics. We believe that a key element in successful management of genetic testing in addition to guidelines will be availability of ethics training and support for geneticists, nurses, and counsellors. Clinical ethics committees and clinical ethicists can act as a useful focus for such training and advice if their role is seen to be genuinely supportive by health professionals and patients. We also argue that increased public involvement at the national level in policy debate about control of genetic testing is needed. [ABSTRACT FROM AUTHOR]

In this paper I analyse the ethical implications of the concept of ‘evidence-based patient choice’ in the light of criticism of the ‘individualism’ of patient-centred medicine. I argue that individualism in the sense used by the critics of patient centred medicine is not an inevitable consequence of an emphasis on patient choice and that a concern with the promotion of individual choices is not incompatible with ‘communitarian’ values. Indeed, I argue that any ethical approach to decision-making in health-care must be capable of taking seriously both the moral status of the individual (and of his or her choices) and the moral significance of the social dimensions of such choices. The best way to ensure respect for the principle of autonomy, I suggest, is to facilitate and encourage social interactions of a particular, deliberative, kind. This is also the best way to ensure that the broader public interest is taken into account in decision-making. [ABSTRACT FROM AUTHOR]

Authoritative international guidelines stipulate that for minors to participate in research, consent must be obtained from their parents or guardians. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. These populations are under-represented in all types of clinical research. We propose that, for research with a prospect of direct benefit that has been approved by relevant ethics committees, the default position should be that minors who are able to provide valid consent and meet the following criteria should be able to consent for themselves regardless of age and whether they have reached majority: the minor must be competent and mature relative to the decision; their consent must be voluntary and they must be relatively independent and used to decision making of comparable complexity. In addition, the context must be appropriate, the information related to the research must be provided in a manner accessible to the minor and the consent must be obtained by a trained consent taker in surroundings conducive for decision making by the minor. In this paper, we have argued that consent by mature minors to research participation is acceptable in some situations and should be allowed. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This article reports on clinical geneticists who collect and store information on family history without explicit consent. The Data Protection Act of 1998, along with an increasing cultural focus on consent and confidentiality, has drawn attention to the assumption that information about family members is in the public domain because it has been shared within the family and therefore explicit consent is not required.

Examines the ethical issue of who owns genetic information. Example of case where a woman, whose young son was diagnosed with Duchenne's muscular dystrophy, proved to be the carrier of the disease; How her sister was pregnant and said she would abort the pregnancy if the child she carried had also inherited the disease; Decision of the child's mother not to release test results and information about her son even to her sister; Dilemma of the treating doctors; Options; Medical ethics of the personal account model of patient confidentiality; Ethics of the joint account model of information sharing; Belief that in the field of genetic medicine, the joint account model should be followed.

Abstract: The practice of medicine involves not only scientific and technical knowledge, but also value judgements. Such judgements should be properly analysed and assessed, just as scientific evidence should be properly evaluated. Assessment of value judgements may require several different approaches, including reasoning from fundamental moral theory or from general principles, clarification of key concepts, and comparison with specific cases to ensure consistency. Focusing on the logical structure of argument can help ensure that rhetorical devices are not used to make an invalid argument persuasive. Doctors must be prepared to justify their decisions and actions with regard to both the evidential scientific basis, and the ethical values and process of decision-making. It is sometimes helpful, when faced with an issue in medical ethics, to step back and consider fundamental approaches to ethics. Two contrasting approaches have been particularly influential in western ethics in general, and in medical ethics in particular: consequentialist ethics (notably utilitarianism) and duty-based ethics. [Copyright &y& Elsevier]

In this article, the author discusses the medical ethics research related to malaria on the border between Thailand and Burma. Limits and nature of responsibilities related to researchers during and after research is discussed. Also discussed are the challenges related to researchers on developing good practice.

Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights. [ABSTRACT FROM AUTHOR]

The article discusses need for balance between supply and demand for medical resources amid COVID-19 pandemic. Topics discussed include importance of ethical values, maximizing benefits, and treating equally for allocating medical resources in the COVID-19 pandemic; need for operationalizing the value of maximizing benefits of treatment; and consideration of prognosis like how long the patient is likely to live if treated to assign priority for intensive care access.