If bioethical questions cannot be resolved in a widely acceptable manner by rational argument, and if they can be regulated only on the basis of political decision-making, then bioethics belongs to the political sphere. The particular kind of politics practiced in any given society matters greatly: it will determine the kind of bioethical regulation, legislation, and public policy generated there. I propose approaching bioethical questions politically in terms of decisions that cannot be “correct” but that can be “procedurally legitimate.” Two (...) procedures in particular can deliver legitimate bioethical decisions, once combined: expert bioethics committees and deliberative democracy. Bioethics so understood can exceed bioethics as a moral project or as a set of administrative principles to regulate medical practice; it can now aspire to a democratic project that involves ordinary citizens as far as reasonably possible. I advance this argument in four steps: (1) using the example of human germline gene editing, (2) I propose a general understanding of proceduralism, and (3) then combine two types and (4) conclude with a defense of majoritarian proceduralism. I develop this argument in terms of one example: germline gene editing. (shrink)

Managing the interplay of private information within families creates challenges, especially when the information involves member identity, a complex and emotionally charged issue. Ravelingien and...

Recent advances in our understanding of the human genome have raised high hopes for the creation of personalized medicine able to predict diseases well before they occur, or that will lead to individualized and therefore more effective treatments. This possibility of a more accurate science of the prevention and surveillance of disease also illuminates the field of public health, where the translation of genomic knowledge could provide tools enhancing the capacity of public health authorities to promote health and prevent diseases. (...) But beyond scientific considerations, the use of genomics in public health research and interventions gives rise to several ethical and social issues of great importance. Considering the impact that PHG could have on the future of public health while still paying attention to the uncertainty surrounding the use of genomic databases for the benefit of populations, this article seeks to explore the promise of genomics in public health and the ethical issues that emerge from its application. (shrink)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...) by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely-defined concepts. Autonomy is the human capacity for self-determination; beneficence denotes the virtue of good deeds, coercion is the intentional (...) threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity. (shrink)

The “right not to know” has generated significant discussion, especially regarding genetic information. In this paper, I argue that this purported right is better understood as a preference and that treating it as a substantive right has led to confusion. To support this claim, I present three critiques of the way the right not to know has been characterized. First, I demonstrate that the many conceptualizations of this right have hampered debate. Second, I show that the way autonomy is conceptualized (...) in this literature is also problematic. Third, I examine the notion of a right in more detail, to support my third critique: that the right to know and the right not to know genetic information are often erroneously treated as having equivalent status. On my understanding, the claim being made is better thought of as a preference, not a right, and a preference not to know certain information becomes only one of several considerations relevant to medical decision making. (shrink)

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to (...) benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries. (shrink)

Cloning research caught a great deal of attention when Dolly the sheep was born (§4). While some fear surrounded the attainment (§§14-15), Wilmutʼs research itself has grown well, providing a less vicious manner to gain ES cells (§12). In this article, we review the progress of cloning research along with the concern of medical circles about its application to reproductive cloning, that is to say, making replicas of human beings (§§16-21). Note that all the content is ascribed to the author (...) alone, not to Musashino University. (shrink)