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Governance Framework for Biomedical Research in Singapore: A Risk-Based Account.

Global Bioethics and New Evolutionary Challenges.

Animal Experimentation: Right vs Rights.

Bioethics - A Plethora of Perspectives.

Clinical Ethics Committees in Western Europe: A Developmental Model for Asia.

Bioethics: An Overview.

The Terasem Mind Uploading Experiment is a multi-decade test of the comparability of single person actual human consciousness as assessed by expert psychological review of their digitized interactions with same person purported human consciousness as assessed by expert psychological interviews of personality software that draws upon a database comprised of the original actual person's digitized interactions. The experiment is based upon a hypothesis that the paper analyzes for its conformance with scientific testability in accordance with the criteria set forth by Karl Popper. Strengths and weaknesses of both the hypothesis and the experiment are assessed in terms of other tests of digital consciousness, scientific rigor and good clinical practices. Recommendations for improvement include stronger parametrization of endpoint assessment and better attention to compliance with informed consent in the event there is emergence of software-based consciousness.

CRISPR-Cas9 is a revolutionary genome-editing tool. Understanding how Cas9 recognizes DNA and how to control its function will be critical in improving the system. We used single-molecule FRET to elucidate a key validation step during DNA target recognition. We also used X-ray crystallography to show how a Cas9 inhibitor is able to permit DNA binding but prevent cleavage. Finally, CRISPR research is notable not just for the exciting applications, but also for its profound ethical implications.

The coronavirus pandemic has placed renewed focus on expanded access (EA) programs to provide compassionate use exceptions to the waves of patients seeking medical care in treating the novel disease. While commendable, justifiable, and compassionate, EA programs are not designed to collect the necessary vital clinical data that can be later used in the New Drug Application process before the U.S. Food and Drug Administration (FDA). In particular, they lack the necessary rigor of properly crafted and controlled randomized controlled trials (RCT) which ensure that each patient closely monitored for side effects and other potential dangers associated with the drug, that the data is documented, stable and are traceable and that the patient population is well defined with the defined target condition. Overall, while RCTs is deemed to be of the most reliable methodologies within evidence-based medicine, morally, however, they are problematic in EA programs. Nevertheless, actionable data ought to be collected from EA patients. To this end, we look to the growing incorporation of real-world data real-world evidence as increasingly useful substitutes for data collected via RCTs, including the ethical, legal and social implications thereof. Finally, we suggest the use of digital twins as an additional method to derive causal inferences from real-world trials involving expanded access patients.

Innovations in human-centered biomedical informatics are often developed with the eventual goal of real-world translation. While biomedical research questions are usually answered in terms of how a method performs in a particular context, we argue that it is equally important to consider and formally evaluate the ethical implications of informatics solutions. Several new research paradigms have arisen as a result of the consideration of ethical issues, including but not limited for privacy-preserving computation and fair machine learning. In the spirit of the Pacific Symposium on Biocomputing, we discuss broad and fundamental principles of ethical biomedical informatics in terms of Olelo Noeau, or Hawaiian proverbs and poetical sayings that capture Hawaiian values. While we emphasize issues related to privacy and fairness in particular, there are a multitude of facets to ethical biomedical informatics that can benefit from a critical analysis grounded in ethics.

The unstoppable acceleration of the scientific and technological development that is revolutionizing our socioeconomic systems in recent years has made the critical aspects and the inadequacy of medical epistemology more and more evident. Several elements have underlined the insufficiency of traditional ethical points of reference in Medicine, like the change of individual needs, the technical possibility of long-term management of heavy diseases, the change of the social and health systems caused by the interaction of different ethnic groups and cultures, several problems linked to the fair distribution of resources in regime of fiscal scarcity involving all the industrialized countries of our world. This brought to the necessity for Medicine to modify its coordinates, adjusting them on the person, and not on the disease.

In order to reach this objective, the author strategically suggests Systemics as the epistemological guidance of the knowledge process, which can make the scientific method operate in an ethical and cultural horizon centered on the human being valorization, on the respect of his/her needs and the respect of his/her environment.

A systemic approach of the medical thought can allow the re-orientation of the clinical look from a biological to a biographic one, the re-definition of the aim of the medical intervention as the restoration and support of self-organizing and self-regulating processes of the biological system, the achieving of a social and health expenditure's saving through a major appropriateness of prescription and an inherent preventive valence of medical interventions, the offer of new and larger horizons for the development of scientific research.

CRISPR-Cas9 is a revolutionary genome-editing tool. Understanding how Cas9 recognizes DNA and how to control its function will be critical in improving the system. We used single-molecule FRET to elucidate a key validation step during DNA target recognition. We also used X-ray crystallography to show how a Cas9 inhibitor is able to permit DNA binding but prevent cleavage. Finally, CRISPR research is notable not just for the exciting applications, but also for its profound ethical implications.

The United States’ All of Us Research Program is a longitudinal research initiative with ambitious national recruitment goals, including of populations traditionally underrepresented in biomedical research, many of whom have high geographic mobility. The program has a distributed infrastructure, with key programmatic resources spread across the US. Given its planned duration and geographic reach both in terms of recruitment and programmatic resources, a diversity of state and territory laws might apply to the program over time as well as to the determination of participants’ rights. Here we present a listing and discussion of state and territory guidance and regulation of specific relevance to the program, and our approach to their incorporation within the program’s informed consent processes.

There is a disconnect between data practices in biomedicine and public understanding of those data practices, and this disconnect is expanding rapidly every day (with the emergence of synthetic data and digital twins and more widely adopted Artificial Intelligence (AI)/Machine Learning tools). Transparency alone is insufficient to bridge this gap. Concurrently, there is an increasingly complex landscape of laws, regulations, and institutional/ programmatic policies to navigate when engaged in biocomputing and digital health research, which makes it increasingly difficult for those wanting to “get it right” or “do the right thing.” Mandatory data protection obligations vary widely, sometimes focused on the type of data (and nuanced definition and scope parameters), the actor/entity involved, or the residency of the data subjects. Additional challenges come from attempts to celebrate biocomputing discoveries and digital health innovations, which frequently transform fair and accurate communications into exaggerated hype (e.g., to secure financial investment in future projects or lead to more favorable tenure and promotion decisions). Trust in scientists and scientific expertise can be quickly eroded if, for example, synthetic data is perceived by the public as “fake data” or if digital twins are perceived as “imaginary” patients. Researchers appear increasingly aware of the scientific and moral imperative to strengthen their work and facilitate its sustainability through increased diversity and community engagement. Moreover, there is a growing appreciation for the “data work” necessary to have scientific data become meaningful, actionable information, knowledge, and wisdom–not only for scientists but also for the individuals from whom those data were derived or to whom those data relate. Equity in the process of biocomputing and equity in the distribution of benefits and burdens of biocomputing both demand ongoing development, implementation, and refinement of embedded Ethical, Legal and Social Implications (ELSI) research practices. This workshop is intended to nurture interdisciplinary discussion of these issues and to highlight the skills and competencies all too often considered “soft skills” peripheral to other skills prioritized in traditional training and professional development programs. Data scientists attending this workshop will become better equipped to embed ELSI practices into their research.