When Listening to the People: Lessons from Complementary and Alternative Medicine (CAM) for Bioethics

Complementary and alternative medicines (CAM) have become increasingly popular over recent decades. Within bioethics CAM has so far mostly stimulated discussions around their level of scientific evidence, or along the standard concerns of bioethics. To gain an understanding as to why CAM is so successful and what the CAM success means for health care ethics, this paper explores empirical research studies on users of CAM and the reasons for their choice. It emerges that there is a close connection to fundamental principles of medical ethics. The studies also highlight that CAM’s holistic ontology of health and illness has an empowering effect on people in caring for their health, and on an even deeper level, safeguards against biomedicine’s reducing image of oneself as biological body-machine. The question is raised what lessons bioethics should draw from this emancipatory social movement for its own relationship with biomedicine.     

Systems Bioethics and Stem Cell Biology

The complexities of modern science are not adequately reflected in many bioethical discussions. This is especially problematic in highly contested cases where there is significant pressure to generate clinical applications fast, as in stem cell research. In those cases a more integrated approach to bioethics, which we call systems bioethics, can provide a useful framework to address ethical and policy issues. Much as systems biology brings together different experimental and methodological approaches in an integrative way, systems bioethics integrates aspects of the history and philosophy of science, social and political theory, and normative analysis with the science in question. In this paper we outline how a careful analysis of the science of stem cell research can help to refocus the discussions related to the clinical applications of stem cells. We show how inaccurate or inadequate scientific assumptions help to create a set of unrealistic expectations and badly inform ethical deliberations and policy development. Systems bioethics offers resources for moving beyond the current impasse.     

Bioethics and practical justice in the post‐COVID‐19 era

The ethical concept of justice, as it relates to the development and deployment of innovative health technologies, commands the fair and equitable distribution of burdens and benefits. In bioethics, specific guidance on practical strategies for achieving what this concept of justice demands are somewhat elusive. Drawing on issues of justice arising or likely to arise in the context of the search for a vaccine or cure for COVID‐19, this paper argues for a focus on the concept of “practical justice” in post‐pandemic bioethics work. To illustrate the value and promise of this concept, the paper reflects on an approach to achieving practical justice in health biotechnology research that is grounded in a commitment to offer technical assistance to developing and under‐resourced nations.     

Patient-Centred Care: Qualitative Findings on Health Professionals’ Understanding of Ethics in Acute Medicine

In recent years the literature on bioethics has begun to pose the sociological challenge of how to explore organisational processes that facilitate a systemic response to ethical concerns. The present discussion seeks to make a contribution to this important new direction in ethical research by presenting findings from an Australian pilot study. The research was initiated by the Clinical Ethics Committee of Redland Hospital at Bayside Health Service District in Queensland, Australia, and explores health professionals’ understanding of the nature of ethics and their experience with ethical decision-making within an acute medical ward. This study focuses on the actual experience, understanding and attitudes of clinical professionals in a general medical ward. In particular, the discussion explores the specific findings from the study concerned with how a multi-disciplinary team of health professionals define and operationalise the notion of ethics in an acute ward hospital setting. The key issue reported is that health professionals are not only able to clearly articulate notions of ethics, but that the notions expressed by a multi-disciplinary diversity of participants share a common definitional concept of ethics as patient-centred care. The central finding is that all professional groups indicated that there is a guiding principle to address their ethical sense of the ‘good’ or the ‘ought’ and that is to act in a way that furthered the interests of patients and their families. The findings affirm the importance of a sociological perspective as a productive new direction in bioethical research.     

A moderate Buddhist animal research ethics

Though there is a burgeoning interest in applied Buddhist ethics, Buddhist animal research ethics remains an underdeveloped area. In this paper I will explore how some central Buddhist ethical considerations can usefully engage our use of other animals (henceforth, animals) in science. As the scientific use of animals is broad, I will narrow my focus to laboratory science. I will show that, though a Buddhist abolitionism would not be unmotivated, it is possible to reject it. While doing so, it will be important to resist emphasizing elements of Buddhist thought that merely provide reasons to adopt the dominant ethical framework governing laboratory animal research ethics, known as the 3Rs. Though I will suggest how a Buddhist animal research ethics can sometimes permit the use of animals in harmful research, it will also require ethical constraints that resonate with some of the more progressive elements in ‘Western’ bioethics.     

Standard Operating Procedures,ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP’s which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, “financial gain” and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.     

Standard Operating Procedures,ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP’s which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, “financial gain” and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.     

The need for systematic reviews of reasons

There are many ethical decisions in the practice of health research and care, and in the creation of policy and guidelines. We argue that those charged with making such decisions need a new genre of review. The new genre is an application of the systematic review, which was developed over decades to inform medical decision-makers about what the totality of studies that investigate links between smoking and cancer, for example, implies about whether smoking causes cancer. We argue that there is a need for similarly inclusive and rigorous reviews of reason-based bioethics, which uses reasoning to address ethical questions. After presenting a brief history of the systematic review, we reject the only existing model for writing a systematic review of reason-based bioethics, which holds that such a review should address an ethical question. We argue that such a systematic review may mislead decision-makers when a literature is incomplete, or when there are mutually incompatible but individually reasonable answers to the ethical question. Furthermore, such a review can be written without identifying all the reasons given when the ethical questions are discussed, their alleged implications for the ethical question, and the attitudes taken to the reasons. The reviews we propose address instead the empirical question of which reasons have been given when addressing a specified ethical question, and present such detailed information on the reasons. We argue that this information is likely to improve decision-making, both directly and indirectly, and also the academic literature. We explain the limitations of our alternative model for systematic reviews.     

Biobanking and deceased persons

Early biomedical research focused primarily on the study of specific diseases or sets of diseases within small groups of living research participants. Accordingly, the first ethical frameworks governing biomedical research addressed short-term, limited-scope research involving living research participants. Due to recent interest in longitudinal population studies and biobanking, research is increasingly long term. This shift raises several ethical and legal issues concerning the impact of a participant’s death on research. This paper offers an overview of these issues in the context of longitudinal biobanking genetic research. Our first part outlines the legal and ethical frameworks that govern the effect of the participants’ death on consent. This will be followed by an analysis of the legal and ethical frameworks that govern the secondary use of deceased participants’ data and samples and the return of deceased participants’ individual research results to biological family members. In our second part, we will review the current literature and discuss the above mentioned issues using the bioethics “principlism” theory before concluding.     

Community outreach: a focus on bioethics

The author suggests that the infusion of bioethics into all aspects of the animal research community's work provides a framework for making decisions. Such deliberations, grounded in ethical theories and principles, can help to reinforce the position that both the research process and the people involved in it are morally sound. Pro-biomedical research groups around the country are therefore investing time and effort in bioethics training.     

Bioethics for human geneticists: models for reasoning and methods for teaching.

The ethical issues raised by the Human Genome Project (HGP) and by human genetics in general are not entirely novel. In fact, the ethical issues surrounding genetic research and the provision of genetic services fit into the evolution of bioethics, a field of inquiry which has its roots in concerns of the 1970s, concerns about the dignity and self-determination of individuals and about the development of medical technologies. Although bioethics has been largely occupied with patient-centered concerns, attention is currently shifting toward socially oriented issues, such as the justice of the existing health-care system. Genetic counseling has already incorporated many of the lessons of early bioethics and, as a profession, adheres to a consultand-centered ethic which reflects the values incorporated into the doctrine of informed consent, which is a cornerstone of bioethics. The mandate of the Ethical, Legal, and Social Implications Program of the HGP--to anticipate ethical problems arising from advances in genetics and to educate the public about genetics--reflects not only the nonpaternalistic approach of early bioethics but also bioethics' increasing attention to the ethical import of systemic and institutional factors, as well as an anticipatory and preventive approach to dealing with ethical concerns. Because bioethics has so much to contribute to current consideration of ethical issues in human genetics, it is important to provide training in ethics to those working in the field. Guidelines for using a case-oriented approach are suggested.     

Ethics and infectious disease

Bioethics apparently suffers from a misdistribution of research resources analogous to the '10/90' divide in medical research. Though infectious disease should be recognized as a topic of primary importance for bioethics, the general topic of infectious disease has received relatively little attention from the discipline of bioethics in comparison with things like abortion, euthanasia, genetics, cloning, stem cell research, and so on. The fact that the historical and potential future consequences of infectious diseases are almost unrivalled is one reason that the topic of infectious disease warrants more attention from bioethicists. The 'Black Death' eliminated one third of the European population during the 14th Century; the 1989 flu killed between 20 and 100 million people; and, in the 20th Century smallpox killed perhaps three times more people than all the wars of that period. In the contemporary world, epidemics (AIDS, multi-drug resistant turberculosis, and newly emerging infectious diseases such as SARS) continue to have dramatic consequences. A second reason why the topic of infectious disease deserves further attention is that it raises difficult ethical questions of its own. While infected individuals can threaten the health of other individuals and society as a whole, for example, public health care measures such as surveillance, isolation, and quarantine can require the infringement of widely accepted basic human rights and liberties. An important and difficult ethical question asks how to strike a balance between the utilitarian aim of promoting public health, on the one hand, and libertarian aims of protecting privacy and freedom of movement, on the other, in contexts involving diseases that are--to varying degrees--contagious, deadly, or otherwise dangerous. Third, since their burden is most heavily shouldered by the poor (in developing countries), infectious diseases involve issues of justice--which should be a central concern of ethics. I conclude by providing sociological and historical explanations of why the topic of infectious disease has not already received more attention from bioethicists.     

什么是生命伦理学？——从历史发展的视角

生命伦理学是20世纪60年代兴起于美国的一门新兴学科,旨在应对生命科学和生物技术的发展或医疗保健的演变使人类面临的种种伦理难题。生命伦理学的兴起有着特殊的社会历史背景。它在发展过程中出现的一些里程碑式的案例,对生命伦理学的发展产生了深远的影响。从其发展特征上看,生命伦理学和医学伦理学紧密联系,有着更为广泛的研究内容和独特的专业特性。生命伦理学要有效回应现代医学和生命科学的发展给人类带来的伦理难题,既要准确地界定伦理问题,又要以适当的方式将伦理学基础理论应用到具体问题当中。对生命伦理学的基本理论进行概述。     

Fair Resource Allocation to Health Research: Priority Topics for Bioethics Scholarship

This article draws attention to the limited amount of scholarship on what constitutes fairness and equity in resource allocation to health research by individual funders. It identifies three key decisions of ethical significance about resource allocation that research funders make regularly and calls for prioritizing scholarship on those topics – namely, how health resources should be fairly apportioned amongst public health and health care delivery versus health research, how health research resources should be fairly allocated between health problems experienced domestically versus other health problems typically experienced by disadvantaged populations outside the funder's country, and how domestic and non‐domestic health research funding should be further apportioned to different areas, e.g. types of research and recipients. These three topics should be priorities for bioethics research because their outcomes have a substantial bearing on the achievement of health justice. The proposed agenda aims to move discussion on the ethics of health research funding beyond its current focus on the mismatch between worldwide basic and clinical research investment and the global burden of disease. Individual funders’ decision‐making on whether and to what extent to allocate resources to non‐domestic health research, health systems research, research on the social determinants of health, capacity development, and recipients in certain countries should also be the focus of ethical scrutiny.     

Heterogeneous assemblages of bioethics and science: the “pre-embryo” debate in America

This paper explores the “pre-embryo” debate in America to analyze the relationship between scientific uncertainty and moral decision-making. This paper explores how an ethical debate among bioethicists around the term “pre-embryo” has been transformed into a scientific “fact” debate between developmental biology and embryology. This transformation is driven by the scientism of ethical reasoning that stresses scientific claims to increase the credibility of ethical claims. This paper concludes that the “pre-embryo” debate is not an ethical controversy over a unified science but rather credibility struggles between two heterogeneous assemblages of science and bioethics.     

International research ethics: progress, but not perfection

To the uninitiated researcher, bioethics can be a confusing and sometimes bureaucratic process. The recent debates in international research ethics have both increased understanding of contentious issues while extending confusion to the international arena. Here, we attempt to demystify bioethics, or more specifically international research ethics, by defining ethics in the context of morality, reviewing core Western ethical principles, and highlighting challenges in international research ethics.     

The right to withdraw from controlled human infection studies: Justifications and avoidance

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow-up. In this article, I provide support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests.     

Ethical hurdles for translational research

The notion of translational research has gained considerable currency over the past few years. While such an approach promises great scientific and clinical advances, the penumbra of translational research tends to incorporate prioritizing scientific projects based upon their potential for translation; tight financial connections between sponsors, scientists and clinical investigators; and sometimes research involving biological approaches for which there is little experience determining safety. It is these aspects of translational research that raise some serious ethical challenges. In this report, we examine three specific areas that raise ethical questions: (1) the potential implications of prioritizing research objectives based on the potential for translation; (2) cautions related to moving from bench to bedside (and back again); and (3) unique questions for translational research initiatives in academic medical centers. Based on this examination, it is clear that the financial and ethical costs as well as benefits of taking a translational approach need to be considered. In the meantime, exquisite attention needs to be paid whenever translational research is likely to affect the traditional fiduciary responsibilities of scientists, clinicians and institutions to research subjects, patients and students. Successful mechanisms that might be developed to address any untoward effects should be shared and evaluated.