The ethics of engineered living materials.

Engineered living materials (ELMs) combine living and non-living entities. Their associated ethical concerns must be addressed to promote safety, promote sustainability, and regulate societal impacts. This article identifies key ethical and safety issues by reflecting on fundamental ethical principles. It further discusses a future ethical roadmap for sustainable research in ELMs.

Artificial Intelligence Aided Ethics in Frontier Research.

Emergent technologies are frequently demonized due to the fear of the unknown. The doubts and alarms are more often than not sparked by their own developers, in a secret wish to become the masters of such fears, and thereby increase their control and influence upon laymen. The story is as old as the use of fire by the sorcerers guiding most ancient rituals. Now it seems to be the turn of artificial intelligence (AI), which is being continuously tainted with quasi-apocalyptic shadows, despite its remarkable potentials for supporting highly desirable societal transformations.

Principles for Just Prioritization of Expensive Biological Therapies in the Danish Healthcare System.

The Danish healthcare system must meet the need for easy and equal access to healthcare for every citizen. However, investigations have shown unfair prioritization of cancer patients and unfair prioritization of resources for expensive medicines over care. What is needed are principles for proper prioritization. This article investigates whether American ethicists Tom Beauchamp and James Childress's principle of justice may be helpful as a conceptual framework for reflections on prioritization of expensive biological therapies in the Danish healthcare system. We present an empirical study exploring the principles for prioritizing new expensive biological therapies. This study includes qualitative interviews with key Danish stakeholders experienced in antibody therapy and prioritizing resources for expensive medicines. Beauchamp and Childress's model only covers government-funded primary and acute healthcare. Based on the interviews, this study indicates that to be helpful in a Danish context this model should include equal access for citizens to government-funded primary and acute healthcare, costly medicine, and other scarce treatments. We conclude that slightly modified, Beauchamp and Childress's principle of justice might be useful as a conceptual framework for reflections on the prioritization of expensive biological therapies in the Danish healthcare system.

Equity in digital healthcare - the case of Denmark.

As digital healthcare services are expanding in use and purpose in a Danish context so are the functionalities embedded in these, constituting citizens' access to healthcare services and personal health data. In Denmark, the impact of inequalities in digital healthcare remains largely unexplored, making it crucial to pay close attention to this aspect as the digital transformation of the sector progresses. According to the Danish Health Act (2019), the Danish healthcare system is required to ensure easy and equal access to healthcare, high-quality treatment, coherent patient pathways, freedom of choice, easy access to information, transparency, and short waiting times for every citizen. These are focal law-based requirements influenced by the digitalisation of healthcare. Hence, based on insights from a highly digitalised country, in this case, Denmark, this paper aims to initiate a discussion on inequities in digital healthcare, address current challenges, and consider future directions by elaborating on conceptual, ethical, evidence-informed, and methodological issues linked to inequities in digital healthcare. Specifically, this paper discusses why inequities in digital healthcare in a Danish context need increased attention, how health equity is embedded in Danish legislation and how it can be approached from an ethical perspective. The central focus revolves around the essential principles of empowerment, emancipation, and equity, which are being highlighted to emphasise that the digitalisation of healthcare should actively work towards preventing and avoiding the perpetuation of healthcare inequalities. The paper concludes by discussing future directions for ensuring a more sustainable, robust, and equitable digital healthcare system.

Ethical Principles in the Analysis of Prostate Cancer Diagnostics.

Recent developments in prostate cancer diagnostics call for appropriate tools to frame the ethical assessment of diagnostic practice. The first aim is to identify ethically important features and ethical principles of key importance for prostate cancer diagnostics. Next, we need to argue which ethical theory justifies these principles and can therefore be used for ethical assessment in the field. The standard medical procedure for prostate cancer diagnostics offered by the Danish health care system is used as an example.

Empirical Investigation of Ethical Challenges Related to the Use of Biological Therapies.

The aim of this study was to investigate the ethical dilemma of prioritising financial resources to expensive biological therapies. For this purpose, the four principles of biomedical ethics formulated by ethicists Tom Beauchamp and James Childress were used as a theoretical framework. Based on arguments of justice, Beauchamp and Childress advocate for a health care system organised in line with the Danish system. Notably, our study was carried out in a Danish setting.

Cultural aspects related to informed consent in health research: A systematic review.

BACKGROUND: In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. OBJECTIVE AND RESEARCH DESIGN: This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. FINDINGS: Our findings indicate that cultural perspectives relating to the informed consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. DISCUSSION AND CONCLUSION: The researchers' awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research.

Why should nanoscience students be taught to be ethically competent?

During the education of scientists at the university level the students become more and more specialized. The specialization of the students is a consequence of the scientific research becoming specialized as well. In the interdisciplinary field of nanoscience the importance of specialization is also emphasized throughout the education. Being an interdisciplinary field of study the specialization in this area is not focused on scientific disciplines, but on the different branches of the research. Historically ethics has not been a priority in science education, however, in recent years the importance of such teachings has been highly recognize especially in medicine, biotechnology and engineering. The rapid development, the many new and unknown areas and the highly specialized focus of nanotechnology suggest the importance of having ethically competent researchers. In this article the importance of ethical competence in nanoscience research is argued for by an example of a dilemma that could occur in a research project. The dilemma is analyzed using two different ethical views, generating two different choices for action. It is seen that the dilemma can have more than one solution and that ethical competence can help in justifying the choice of solution in a specific situation. Furthermore it is suggested that a way to reach this competence is through education in ethics incorporated into the nanoscience education curriculum.

[Unspecific effects of certain siRNA molecules used in the treatment of age related macular degeneration]. / Uspecifikke effekter af visse RNAI-molekyler brugt til behandling af aldersrelateret maculadegeneration.

In clinical trials on age-related macular degeneration, small interfering RNAs (siRNAs) targeting vascular endothelial growth factor or its receptor are used to inhibit angiogenesis. However, novel data suggests that certain siRNA molecules can act unspecifically, without even entering a cell. The sequence- and target-independent suppression of the angiogenesis seems to be mediated via extracellular binding to the toll-like receptors TLR3.

Ethical perspectives on RNA interference therapeutics.

RNA interference is a mechanism for controlling normal gene expression which has recently begun to be employed as a potential therapeutic agent for a wide range of disorders, including cancer, infectious diseases and metabolic disorders. Clinical trials with RNA interference have begun. However, challenges such as off-target effects, toxicity and safe delivery methods have to be overcome before RNA interference can be considered as a conventional drug. So, if RNA interference is to be used therapeutically, we should perform a risk-benefit analysis. It is ethically relevant to perform a risk-benefit analysis since ethical obligations about not inflicting harm and promoting good are generally accepted. But the ethical issues in RNA interference therapeutics not only include a risk-benefit analysis, but also considerations about respecting the autonomy of the patient and considerations about justice with regard to the inclusion criteria for participation in clinical trials and health care allocation. RNA interference is considered a new and promising therapeutic approach, but the ethical issues of this method have not been greatly discussed, so this article analyses these issues using the bioethical theory of principles of the American bioethicists, Tom L. Beauchamp and James F. Childress.

The principle of respect for autonomy--concordant with the experience of oncology physicians and molecular biologists in their daily work?

BACKGROUND: This article presents results from a qualitative empirical investigation of how Danish oncology physicians and Danish molecular biologists experience the principle of respect for autonomy in their daily work. METHODS: This study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company. RESULTS: We found that that molecular biologists consider the principle of respect for autonomy as a negative obligation, where the informed consent of patients or research subjects should be respected. Furthermore, molecular biologists believe that very sick patients are constraint by the circumstances to a certain choice. However, in contrast to molecular biologists, oncology physicians experience the principle of respect for autonomy as a positive obligation, where the physician in dialogue with the patient performs a medical prognosis based on the patient's wishes and ideas, mutual understanding and respect. Oncology physicians believe that they have a positive obligation to adjust to the level of the patient when providing information making sure that the patient understands. Oncology physicians experience situations where the principle of respect for autonomy does not apply because the patient is in a difficult situation. CONCLUSION: In this study we explore the moral views and attitudes of oncology physicians and molecular biologists and compare these views with bioethical theories of the American bioethicists Tom L. Beauchamp & James F. Childress and the Danish philosophers Jakob Rendtorff & Peter Kemp. This study shows that essential parts of the two bioethical theories are reflected in the daily work of Danish oncology physicians and Danish molecular biologists. However, the study also explores dimensions where the theories can be developed further to be concordant with biomedical practice. The hope is that this study enhances the understanding of the principle of respect for autonomy and the way it is practiced.

Empirical investigation of the ethical reasoning of physicians and molecular biologists - the importance of the four principles of biomedical ethics.

BACKGROUND: This study presents an empirical investigation of the ethical reasoning and ethical issues at stake in the daily work of physicians and molecular biologists in Denmark. The aim of this study was to test empirically whether there is a difference in ethical considerations and principles between Danish physicians and Danish molecular biologists, and whether the bioethical principles of the American bioethicists Tom L. Beauchamp and James F. Childress are applicable to these groups. METHOD: This study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company. RESULTS: In this sample, the authors found that oncology physicians and molecular biologists employed in a private biopharmaceutical company have the specific principle of beneficence in mind in their daily work. Both groups are motivated to help sick patients. According to the study, molecular biologists explicitly consider nonmaleficence in relation to the environment, the researchers' own health, and animal models; and only implicitly in relation to patients or human subjects. In contrast, considerations of nonmaleficence by oncology physicians relate to patients or human subjects. Physicians and molecular biologists both consider the principle of respect for autonomy as a negative obligation in the sense that informed consent of patients should be respected. However, in contrast to molecular biologists, physicians experience the principle of respect for autonomy as a positive obligation as the physician, in dialogue with the patient, offers a medical prognosis based upon the patients wishes and ideas, mutual understanding, and respect. Finally, this study discloses utilitarian characteristics in the overall conception of justice as conceived by oncology physicians and molecular biologists from the private biopharmaceutical company. Molecular biologists employed at a public university are, in this study, concerned with allocation, however, they do not propose a specific theory of justice. CONCLUSION: This study demonstrates that each of the four bioethical principles of the American bioethicists Tom L. Beauchamp & James F. Childress - respect for autonomy, beneficence, nonmaleficence and justice - are reflected in the daily work of physicians and molecular biologists in Denmark. Consequently, these principles are applicable in the Danish biomedical setting.

Using empirical research to formulate normative ethical principles in biomedicine.

Bioethical research has tended to focus on theoretical discussion of the principles on which the analysis of ethical issues in biomedicine should be based. But this discussion often seems remote from biomedical practice where researchers and physicians confront ethical problems. On the other hand, published empirical research on the ethical reasoning of health care professionals offer only descriptions of how physicians and nurses actually reason ethically. The question remains whether these descriptions have any normative implications for nurses and physicians? In this article, we illustrate an approach that integrates empirical research into the formulation of normative ethical principles using the moral-philosophical method of Wide Reflective Equilibrium (WRE). The research method discussed in this article was developed in connection with the project 'Bioethics in Theory and Practice'. The purpose of this project is to investigate ethical reasoning in biomedical practice in Denmark empirically. In this article, we take the research method as our point of departure, but we exclusively discuss the theoretical framework of the method, not its empirical results. We argue that the descriptive phenomenological hermeneutical method developed by Lindseth and Norberg (2004) and Pedersen (1999) can be combined with the theory of WRE to arrive at a decision procedure and thus a foundation for the formulation of normative ethical principles. This could provide health care professionals and biomedical researchers with normative principles about how to analyse, reason and act in ethically difficult situations in their practice. We also show how to use existing bioethical principles as inspiration for interpreting the empirical findings of qualitative studies. This may help researchers design their own empirical studies in the field of ethics.

Nanomedicine: techniques, potentials, and ethical implications.

Nanotechnology is concerned with materials and systems whose structures and components exhibit novel physical, chemical, and biological properties due to their nanoscale size. This paper focuses on what is known as nanomedicine, referring to the application of nanotechnology to medicine. We consider the use and potentials of emerging nanoscience techniques in medicine such as nanosurgery, tissue engineering, and targeted drug delivery, and we discuss the ethical questions that these techniques raise. The ethical considerations involved in nanomedicine are related to risk assessment in general, somatic-cell versus germline-cell therapy, the enhancement of human capabilities, research into human embryonic stem cells and the toxicity, uncontrolled function and self-assembly of nanoparticles. The ethical considerations associated with the application of nanotechnology to medicine have not been greatly discussed. This paper aims to balance clear ethical discussion and sound science and so provide nanotechnologists and biotechnologists with tools to assess ethical problems in nanomedicine.