Navigating abortion law dilemmas: experiences and attitudes among Ethiopian health care professionals.

BACKGROUND: Ethiopia's 2005 abortion law improved access to legal abortion. In this study we examine the experiences of abortion providers with the revised abortion law, including how they view and resolve perceived moral challenges. METHODS: Thirty healthcare professionals involved in abortion provisions in Addis Ababa were interviewed. Transcripts were analyzed using systematic text condensation, a qualitative analysis framework. RESULTS: Most participants considered the 2005 abortion law a clear improvement-yet it does not solve all problems and has led to new dilemmas. As a main finding, the law appears to have opened a large space for professionals' individual interpretation and discretion concerning whether criteria for abortion are met or not. Regarding abortion for fetal abnormalities, participants support the woman's authority in deciding whether to choose abortion or not, although several saw these decisions as moral dilemmas. All thought that abortion was a justified choice when a diagnosis of fetal abnormality had been made. CONCLUSION: Ethiopian practitioners experience moral dilemmas in connection with abortion. The law places significant authority, burden and responsibility on each practitioner.

Back to WHAT? The role of research ethics in pandemic times.

The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

Still a moral dilemma: how Ethiopian professionals providing abortion come to terms with conflicting norms and demands.

BACKGROUND: The Ethiopian law on abortion was liberalized in 2005. However, as a strongly religious country, the new law has remained controversial from the outset. Many abortion providers have religious allegiances, which begs the question how to negotiate the conflicting demands of their jobs and their commitment to their patients on the one hand, and their religious convictions and moral values on the other. METHOD: A qualitative study based on in-depth interviews with 30 healthcare professionals involved in abortion services in either private/non-governmental clinics or in public hospitals in Addis Ababa, Ethiopia. Transcripts were analyzed using systematic text condensation, a qualitative analysis framework. RESULTS: For the participants, religious norms and the view that the early fetus has a moral right to life count against providing abortion; while the interests and needs of the pregnant woman supports providing abortion services. The professionals weighed these value considerations differently and reached different conclusions. One group appears to have experienced genuine conflicts of conscience, while another group attempted to reconcile religious norms and values with their work, especially through framing provision of abortion as helping and preventing harm and suffering. The professionals handle this moral balancing act on their own. In general, participants working in the private sector reported less moral dilemma with abortion than did their colleagues from public hospitals. CONCLUSIONS: This study highlights the difficulties in reconciling tensions between religious convictions and moral norms and values, and professional duties. Such insights might inform guidelines and healthcare ethics education.

The rise of reimbursement-based medicine: the case of bone metastasis radiation treatment.

It has been hypothesised that the reimbursement system pertaining to radiotherapy is influencing prescription practices for patients with cancer with bone metastases. In this paper, we present and discuss the results of an empirical study that was undertaken on patient records, referred to radiotherapy for the treatment of bone metastases, in a medium-size city, in southern Brazil, during the period of March 2006 to March 2014. Our findings seem to confirm this hypothesis: after a change in the reimbursement method, radiation prescriptions were adapted accordingly, in order to maximise profits. Once such patients become highly vulnerable due to their diagnoses, they also become susceptible to a subtle form of exploitation; physicians let patients believe that more radiation will be better for their health, and they do so despite knowing otherwise, and as it seems, out of pecuniary interests.

Bioethics and imagination: towards a narrative bioethics committed to social action and justice.

Recently, the involvement of various authors coming from the social sciences and the arts has reinforced the humanistic component of bioethics. Their contributions vary from very theoretical perspectives to rather practical ones. In this paper, Martha Nussbaum's books, The Fragility of Goodness (1986), Love's Knowledge (1990), Cultivating Humanity (1997) and Creating Capabilities (2011) are analysed from the vantage point of narrative bioethics. It is argued that Nussbaum's notions of 'Narrative', 'Imagination' and 'Cultivation' open up the possibility of developing an action-oriented form of narrative bioethics, that is, a bioethics committed to social action and justice.

Ethical issues in nanomedicine: Tempest in a teapot?

Nanomedicine offers remarkable options for new therapeutic avenues. As methods in nanomedicine advance, ethical questions conjunctly arise. Nanomedicine is an exceptional niche in several aspects as it reflects risks and uncertainties not encountered in other areas of medical research or practice. Nanomedicine partially overlaps, partially interlocks and partially exceeds other medical disciplines. Some interpreters agree that advances in nanotechnology may pose varied ethical challenges, whilst others argue that these challenges are not new and that nanotechnology basically echoes recurrent bioethical dilemmas. The purpose of this article is to discuss some of the ethical issues related to nanomedicine and to reflect on the question whether nanomedicine generates ethical challenges of new and unique nature. Such a determination should have implications on regulatory processes and professional conducts and protocols in the future.

What is it to do good medical ethics? On the concepts of 'good' and 'goodness' in medical ethics.

In his book The Varieties of Goodness Georg Henrik von Wright advocates that a useful preliminary to the study of the word 'good' is to compile a list of familiar uses and try to group them under some main headings. The present paper aims at exploring the question, 'What is it to do good medical ethics?', and notably from the vantage point of everyday expressions of the word 'good' and von Wright's grouping of them into six different types of goodness.

The whole and the art of medical dialectic: a platonic account.

The aim of this paper is to investigate Plato's conception of the whole in the Phaedrus and the theory of medical dialectic underlying this conception. Through this analysis Plato's conception of kairos will also be adressed. It will be argued that the epistemological holism developed in the dialogue and the patient-typology emerging from it provides us with a way of perceiving individual situations of medical discourse and decision-making that makes it possible to bridge the gap between observations of a professional nature, i.e. of diagnostics and therapy--of whom to treat and in what magnitude--and individual patients' perceptions of their situation. Besides, it will be argued that such a patient-typology represents a conceptual framework to assess and deal normatively with patients' ailments and needs that is more robust than the current standards in use, i.e. the Subjective Standard, the Reasonable Person Standard and the Professional Practice Standard. Finally, it will be argued that the possession of kairos, which according to Plato is the hallmark of a true physician, represents a normative conception of time that today's medicine is in need of revisiting.

Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA.

OBJECTIVE: To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. METHOD: This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA. RESULTS: Some US academic health "centers" IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects' research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection's (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority. CONCLUSIONS: REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

Illness as a condition of our existence in the world: on illness and pathic existence.

This paper seeks to find different ways of addressing illness as an experience essential to the understanding of being a human being. As a conceptual point of departure, we suggest the notion of 'pathic existence' as developed by the German physician and philosopher Viktor von Weizsäcker (1886-1957). Through an analysis of his conceptualisation of the pathic and of pathic categories, we demonstrate how this auxiliary typology may be of help in unveiling different modes of ill-being, or Kranksein. Furthermore, we show how illness plays a paradigmatic role in this type of existence. We discuss how von Weizsäcker's claim of illness as "a way of being human" indicates how such a view of the illness existence both differs from and touches upon other streams of thought within the philosophy of medicine and medical ethics. Finally, we highlight some of the normative implications emerging from this perspective of relevance in today's medicine.

Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives.

OBJECTIVE: To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs' activities after the approval of trial protocols for clinical studies. METHOD: This is a qualitative study. The participants in this study are members or representatives of a research ethics committee from the member countries of the European Network of Research Ethics Committees (EUREC) and the United Kingdom. Thematic analysis was the method to assess interview transcripts. RESULTS: Interviews of REC representatives from 19 countries across Europe reveals that REC post-approval activities are predominantly limited to review and approval of protocol amendments. The majority of the RECs do not have mandatory continuing reviews or receipt of notifications of adverse events or protocol violations. In fact, most post-approval activities are the remit of the regulatory authorities. The interviewed members were also of the opinion that RECs in the EU do not have the legislative support, the organizational structure, the expert staff nor time to do active post approval follow-up. CONCLUSIONS: Post-approval follow-up activities for clinical studies by RECs is a valuable resource and means for early detection and resolution of protocol deviations and violations. However, a majority of RECs within Europe do not have active post-approval follow-up of approved protocols. The interviews revealed that resource challenges such as time, personnel, and organizational structure contribute to the lack of follow-up by RECs. Some RECs in the represented countries do not identify post-approval follow-up as part of their mandate but instead place emphasis on the culture of trust between the RECs and researchers. Current EU Regulations do not directly address the role of the REC after the approval of clinical trials.

A waste of time: the problem of common morality in Principles of Biomedical Ethics.

From the 5th edition of Beauchamp and Childress' Principles of Biomedical Ethics, the problem of common morality has been given a more prominent role and emphasis. With the publication of the 6th and latest edition, the authors not only attempt to ground their theory in common morality, but there is also an increased tendency to identify the former with the latter. While this stratagem may give the impression of a more robust, and hence stable, foundation for their theoretical construct, we fear that it comes with a cost, namely the need to keep any theory in medical ethics open to, and thereby aware of, the challenges arising from biomedical research and clinical practice, as well as healthcare systems. By too readily identifying the moral life of common morality with rule-following behaviour, Beauchamp and Childress may even be wrong about the nature of common morality as such, thereby founding their, by now, classic theory on quicksand instead of solid rock.

In the ruins of Babel: pitfalls on the way toward a universal language for research ethics and benefit sharing.

At the end of a paper on international research ethics published in the July-August 2010 issue of the Hastings Center Report, London and Zollman argue the need for grounding our duties in international medical and health-related research within a broader normative framework of social, distributive, and rectificatory justice. The same goes for Thomas Pogge, who, in a whole range of publications during the past years, has argued for a human-rights-based approach to international research. In a thought-provoking paper in the June 2010 issue of the American Journal of Bioethics, Angela J. Ballantyne argues that "the global bioethics priority" in medical and health-related research ethics today is how to do research fairly in an unjust world.

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents.

AIM: To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union. DESIGN: A qualitative content analysis of 19 normative documents on clinical research as outlined by the International Compilation of Human Research Standards 2020 edition and other related documents for the EU and USA. RESULTS: After the approval of research protocols, RECs' general role is to receive reports from researchers on the trials' progress. Additionally, RECs receive notifications of protocol amendments, deviations and, to a lesser extent, violations, which is the remit of the regulatory/competent authorities. RECs are expected to issue opinions on clinical trials' progress and give supplemental opinions/approval or withdraw/suspend/terminate previous favorable opinions on adverse events or safety concerns that may arise. RECs are to receive an end of the trial report. CONCLUSION: The role of RECs post approval of protocols is to protect human participants through activities such as continuing review of: (a) progress reports, (b) notifications of significant protocol amendments, (c) adverse events, (d) protocol deviations, and (e) protocol violations. Although some international guidelines such as the Declaration of Helsinki emphasize the right to monitor, RECs' predominant activity is document review. In the USA, RECs are authorized to issue approvals and terminate/suspend previously issued approvals. However, in the EU, the approach is to relegate to member states to decide the extent of legislative power they wish to give to the RECs. The REC's opinion on the end of trial report is identified as an area for further exploration.

Between the needy and the greedy: the quest for a just and fair ethics of clinical research.

The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise.

Hidden risks associated with clinical trials in developing countries.

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems.