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"Bioethics Legal issues."
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Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study
Background
The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients.
Methods
An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line
BRCA1/2
mutations had improved progression-free survival prognosis. Mechanisms to communicate
BRCA
results were evaluated, because these findings may be beneficial to patients and their families.
Results
Communicating individual
BRCA
results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual
BRCA
results to patients. Communicating the aggregate
BRCA
result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account.
Conclusion
This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results.
Trial registration
This study was registered in the NCT Clinical Trial Registry under
NCT00866697
on March 19, 2009, following approval from participating ethics committees (Additional file
1
).
Journal Article
The hunger strike in prison: bioethical and medico-legal insights arising from a recent opinion of the Italian national bioethics committee
This contribution addresses some bioethical and medico-legal issues of the opinion formulated by the Italian National Bioethics Committee (CNB) in response to the dilemma between the State’s duty to protect the life and health of the prisoner entrusted to its care and the prisoner’s right to exercise his freedom of expression. The prisoner hunger strike is a form of protest frequently encountered in prison and it is a form of communication but also a language used by the prisoner in order to provoke changes in the prison condition. There are no rules in the prison regulations, nor in the laws governing the legal status of prisoners, that allow the conscious will of the capable and informed subject to be opposed and forced nutrition to be carried out. However, this can in no manner make therapeutic abandonment legitimate: the medical doctor should promote every action to support the patient. In the recent opinion formulated by the CNB it was remarked how self-determination is a central concept in human rights and refers to an individual’s ability to make autonomous and free decisions about his or her life and body.
Journal Article
Ethics, Guidelines, Standards, and Policy: Telemedicine, COVID-19, and Broadening the Ethical Scope
The coronavirus crisis is causing considerable disruption and anguish. However, the COVID-19 pandemic and consequent explosion of telehealth services also provide an unparalleled opportunity to consider ethical, legal, and social issues (ELSI) beyond immediate needs. Ethicists, informaticians, and others can learn from experience, and evaluate information technology practices and evidence on which to base policy and standards, identify significant values and issues, and revise ethical guidelines. This paper builds on professional organizations’ guidelines and ELSI scholarship to develop emerging concerns illuminated by current experience. Four ethical themes characterized previous literature: quality of care and the doctor–patient relationship, access, consent, and privacy. More attention is needed to these and to expanding the scope of ethical analysis to include health information technologies. An applied ethics approach to ELSI would addresses context-specific issues and the relationships between people and technologies, and facilitate effective and ethical institutionalization of telehealth and other health information technologies.
Journal Article
Bioethical and Legal Issues in 3D Bioprinting
Bioethical and legal issues of three-dimensional (3D) bioprinting as the emerging field of biotechnology have not yet been widely discussed among bioethicists around the world, including Russia. The scope of 3D bioprinting includes not only the issues of the advanced technologies of human tissues and organs printing but also raises a whole layer of interdisciplinary problems of modern science, technology, bioethics, and philosophy. This article addresses the ethical and legal issues of bioprinting of artificial human organs.
Journal Article
How should China set ethical guardrails for medical research?
‘Ethics first’ reform in China significantly changes the governance framework for the research of emerging technologies. The misapplication of human genome editing technology reflects the urgent need to reform the governance framework. Strengthening ethics governance in medical research has become a consensus in China, where legal and ethical reforms are proceeding in parallel. The protection of human dignity, the prevention of biosafety risks, as well as the regulation of technological crimes are at the core of the legal system, which has been embodied in numerous fundamental legislations following the CRISPR-babies incident. Establishing a national ethics committee to coordinate ethics governance, and reinforcing ethics review and external oversight are significant steps in ethical reform. Essentially, ethics governance requires implementing the basic concept of ‘ethics first’, focusing on forward-looking and preventive governance rather than delayed intervention, while maintaining openness and collaboration.
Journal Article
Global bioethics at UNESCO: in defence of the Universal Declaration on Bioethics and Human Rights
The Universal Declaration on Bioethics and Human Rights adopted by the United Nations Educational, Scientific, and Cultural Organisation (UNESCO) on 19 October 2005 is an important step in the search for global minimum standards in biomedical research and clinical practice. As a member of UNESCO International Bioethics Committee, I participated in the drafting of this document. Drawing on this experience, the principal features of the Declaration are outlined, before responding to two general charges that have been levelled at UNESCO’s bioethical activities and at this particular document, are outlined. One criticism is to the effect that UNESCO is exceeding its mandate by drafting such bioethical instruments—in particular, the charge is that it is trespassing on a topic that lies in the responsibility of the World Health Organization. The second criticism is that UNESCO’s reliance on international human rights norms is inappropriate.
Journal Article
Sustainability principle for the ethics of healthcare resource allocation
We propose a principle of sustainability to complement established principles used for justifying healthcare resource allocation. We argue that the application of established principles of equal treatment, need, prognosis and cost-effectiveness gives rise to what we call negative dynamics: a gradual depletion of the value possible to generate through healthcare. These principles should therefore be complemented by a sustainability principle, making the prospect of negative dynamics a further factor to consider, and possibly outweigh considerations highlighted by the other principles. We demonstrate how this principle may take different forms, and show that a commitment to sustainability is supported by considerations internal to the ethical principles already guiding healthcare resource allocation. We also consider two objections. The first of these, we argue, is either based on implausible assumptions or begs the question, whereas the second can be adequately accommodated by the principle we propose.
Journal Article
Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review
Three-dimensional bioprinting is a rapidly evolving technology that holds the promise of addressing the increasing demand for organs, tissues, and personalized medicine. By employing computer-aided design and manufacturing processes, 3D bioprinting allows for the precise deposition of living cells, biomaterials, and biochemicals to create functional human tissues and organs. The potential applications of this technology are vast, including drug testing and development, disease modeling, regenerative medicine, and ultimately, organ transplantation. However, as with any groundbreaking technology, 3D bioprinting presents several ethical, legal, and regulatory concerns that warrant careful consideration. As the technology progresses towards clinical applications, it is essential to address these challenges and establish appropriate frameworks to guide the responsible development of 3D bioprinting. This article, utilizing the Arksey and O’Malley scoping review model, is designed to scrutinize the bioethical implications, legal and regulatory challenges, and medico-legal issues that are intertwined with this rapidly evolving technology.
Journal Article
Audio and panoramic video recording in the operating room: legal and ethical perspectives
IntroductionThe idea of video recording (VR) in the operating room (OR) with panoramic cameras and microphones is a new concept that is changing the approach to medical activities in the OR. However, VR in the OR has brought up many concerns regarding patient privacy and has highlighted legal and ethical issues that were never previously exposed.AimTo review the literature concerning these aspects and provide a better ethical and legal understanding of the new challenges concerning VR in the OR.ConclusionsThere is a disparity between the two main legal models concerning VR in the OR, namely the European legal system (General Data Protection Regulation (GDPR)) and the American legal framework (Health Insurance Portability and Accountability Act (HIPAA)). This difference mainly deals with two distinct bioethical paradigms: GDPR places a strong emphasis on protecting patients’ privacy to improve the public health system, whereas HIPAA indicates the need to generate protocols to safeguard the risks connected to medical activity and patient privacy. Following from this point, we may argue that, at the ethical and bioethical level, GDPR and HIPAA depend mainly on two different ethical models: a perspective based on moral acquaintances and weak proceduralism, respectively. It is worth noting the importance of developing additional guidelines concerning different world regions to avoid the ethical problems that may emerge when simply applying a foreign paradigm to a very different culture.
Journal Article