Personalized oncology, ethics and adherence to NCCN guidelines.

Successful personalized oncology today depends on clinicians taking advantage of the extensive, evidence-based information provided by the National Comprehensive Cancer Network (NCCN) Guidelines, which arguably represent the most important advance in cancer care occurring in the last many decades. Personalized oncology also demands that clinicians present guideline information to each patient in a thorough, comprehendible and unbiased manner. Finally, the patient's ability to process that information for shared decision-making about whether an intervention is consistent with their personal preferences, goals and values is perhaps the most important ingredient in truly personalized oncology care. Here, the ethics of sometimes transgressing from the NCCN guidelines with the aim of more personalized care is discussed.

[Situation-precise medicine : Ethical comments on the debate around precision medicine]. / Lebenslagenpräzise Medizin : Ethische Anmerkungen zur Debatte um Präzisionsmedizin.

The label "precision medicine" appears to have the status of a "moral high-value word". Moral high-value words possess an ambivalent dialectic of light and dark. On the one hand, precision medicine promises an individual diagnosis and treatment of severe diseases focussed on the ill person with reduction of undesired side effects as far as possible. On the other hand, the label "precision medicine" rapidly leads to a gradual devaluation of everything that only seems "not precise", "vague" or simply "generally just unspecific". Precision medicine therefore nearly automatically promotes their prioritization and preference in the distribution of scarce resources, which is simultaneously associated with a deprioritization or inferiority in the distribution of scarce resources for the "not so valuable". As a further communicative weak point the limited understanding of "precision" catches the eye: precision medicine is often associated with technological high-performance medicine, which often reacts to a clear (severe) disease picture; however, many courses of diseases are still in an unclear stage or in a situation where there are clearly no (longer) perspectives for recovery and curative measures are no longer medically indicated. This article takes up on three ethical aspects, which should play an essential role in the debate on precision medicine: the uppermost criterion in the distribution of scarce resources, the relevance for patients as the uppermost aim of medical treatment and that of the patient-relevant inner understanding of the quality of life or well-being of patients.

Generative artificial intelligence and the personalization of health professional education: A narrative review.

This narrative review examined the intersection of generative artificial intelligence (GAI) and the personalization of health professional education (PHE). This review aims to the elucidate the current condition of GAI technologies and their particular uses in the field of PHE. Data were extracted and analyzed from studies focusing on the demographics and professional development preferences of healthcare workers, the competencies required for personalized precision medicine, and the current and potential applications of artificial intelligence (AI) in PHE. The review also addressed the ethical implications of AI implementation in this context. Findings indicated a gender-balanced healthcare workforce with a predisposition toward continuous professional development and digital tool utilization. A need for a comprehensive educational framework was identified to include a spectrum of skills crucial for precision medicine, emphasizing the importance of patient involvement and bioethics. AI was found to enhance educational experiences and research in PHE, with an increasing trend in AI applications, particularly in surgical education since 2018. Ethical challenges associated with AI integration in PHE were highlighted, with an emphasis on the need for ethical design and diverse development teams. Core concepts in AI research were established, with a spotlight on emerging areas such as data science and learning analytics. The application of AI in PHE was recognized for its current benefits and potential for future advancements, with a call for ethical vigilance. GAI holds significant promise for personalizing PHE, with an identified need for ethical frameworks and diverse developer teams to address bias and equity in educational AI applications.

The way towards ethical anesthesia care: no aim - no game - no fame or blame?

PURPOSE OF REVIEW: This review explores the intricacies of ethical anesthesia, exploring the necessity for precision anesthesia and its impact on patient-reported outcomes. The primary objective is to advocate for a defined aim, promoting the implementation of rules and feedback systems. The ultimate goal is to enhance precision anesthesia care, ensuring patient safety through the implementation of a teamwork and the integration of feedback mechanisms. RECENT FINDINGS: Recent strategies in the field of anesthesia have evolved from intraoperative monitorization to a wider perioperative patient-centered precision care. Nonetheless, implementing this approach encounters significant obstacles. The article explores the evidence supporting the need for a defined aim and applicable rules for precision anesthesia's effectiveness. The implementation of the safety culture is underlined. The review delves into the teamwork description with structured feedback systems. SUMMARY: Anesthesia is a multifaceted discipline that involves various stakeholders. The primary focus is delivering personalized precision care. This review underscores the importance of establishing clear aims, defined rules, and fostering effective and well tolerated teamwork with accurate feedback for improving patient-reported outcomes. The Safe Brain Initiative approach, emphasizing algorithmic monitoring and systematic follow-up, is crucial in implementing a fundamental and standardized reporting approach within patient-centered anesthesia care practice.

The ethics of precision health.

In this paper, I defend an account of the ethics of precision medicine that can explain both its possibilities and limits. Creating a new conceptual and normative model of the ethics of precision health can ensure that good medicine is also excellent and that excellent medicine is also good by providing a resource to scientists and clinicians. First, I propose a new conceptual analysis of precision health. I argue that precision health is defined primarily by targeted medical interventions and not by stratification, as others have asserted. Next, I argue that failure to be adequately responsive to this conceptual analysis explains common ethical abuses in the field. Third, I argue that this conceptual analysis can also pave the way for future research heretofore overlooked. Thus, we can limit abuses in precision health research and care while at the same time opening new avenues to help historically oppressed communities.

Ethical considerations in elderly patients with acute coronary syndrome.

Acute coronary syndrome (ACS) is one of the main causes of mortality and morbidity in the elderly. The prevalence of ACS increases with age and patients with advanced age have some co-morbidities that require an individualized approach, which includes a comprehensive geriatric assessment. Ageism is a matter of great concern. In this scenario, some ethical conflicts may arise which should be anticipated, considered, and solved. Clinicians will need to prioritize and allocate resources, to avoid futility/proportionality, which is not always easy to assess in these patients. This review aims to summarize the evidence regarding ethical conflicts that may arise in the management of patients with ACS and advanced age. We will discuss how to choose the best option (which frequently is not the only one) with the lowest risk for harm, considering and respecting the patients' decision. The four basic principles of bioethics (beneficence, non-maleficence, autonomy, and justice) are thoroughly reviewed, and discussed, regarding their role in the decision making process.

Beyond inclusion: Enacting team equity in precision medicine research.

PURPOSE: To identify meanings of and challenges to enacting equitable diversification of genomics research, and specifically precision medicine research (PMR), teams. METHODS: We conducted in-depth interviews with 102 individuals involved in three U.S.-based precision medicine research consortia and conducted over 400 observation hours of their working group meetings, consortium-wide meetings, and conference presentations. We also reviewed published reports on genomic workforce diversity (WFD), particularly those relevant to the PMR community. RESULTS: Our study finds that many PMR teams encounter challenges as they strive to achieve equitable diversification on scientific teams. Interviewees articulated that underrepresented team members were often hired to increase the study's capacity to recruit diverse research participants, but are limited to on-the-ground staff positions with little influence over study design. We find existing hierarchies and power structures in the academic research ecosystem compound challenges for equitable diversification. CONCLUSION: Our results suggest that meaningful diversification of PMR teams will only be possible when team equity is prioritized as a core value in academic research communities.

Basic principles of biobanking: from biological samples to precision medicine for patients.

The term "biobanking" is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research.

Application of the community dialogues method to identify ethical values and priorities related to pharmacogenomics.

Given the expansion of genetics in medicine, there is a growing need to develop approaches to engage patients in understanding how genetics affects their health. Various qualitative methods have been applied to gain a deeper understanding of patient perspectives in topics related to genetics. Community dialogues (CD) are a bi-directional research method that invites community members to discuss a pertinent, challenging topic over the course of a multi-week period and the community members openly discuss their positions on the topic. Authors discuss the first application of the CD method to the topic of pharmacogenetics testing. Additional CD are needed to engage diverse participant populations on this topic to improve genetics literacy, enhance physician engagement and drive policy change.

Ancestry matters: Building inclusivity into preclinical study design.

Human cell lines (CLs) are key assets for biomedicine but lack ancestral diversity. Here, we explore why genetic diversity among cell-based models is essential for making preclinical research more equitable and widely translatable. We lay out practical actions that can be taken to improve inclusivity in study design.

My Data, My Choice? - German Patient Organizations' Attitudes towards Big Data-Driven Approaches in Personalized Medicine. An Empirical-Ethical Study.

Personalized medicine (PM) operates with biological data to optimize therapy or prevention and to achieve cost reduction. Associated data may consist of large variations of informational subtypes e.g. genetic characteristics and their epigenetic modifications, biomarkers or even individual lifestyle factors. Present innovations in the field of information technology have already enabled the procession of increasingly large amounts of such data ('volume') from various sources ('variety') and varying quality in terms of data accuracy ('veracity') to facilitate the generation and analyzation of messy data sets within a short and highly efficient time period ('velocity') to provide insights into previously unknown connections and correlations between different items ('value'). As such developments are characteristics of Big Data approaches, Big Data itself has become an important catchphrase that is closely linked to the emerging foundations and approaches of PM. However, as ethical concerns have been pointed out by experts in the debate already, moral concerns by stakeholders such as patient organizations (POs) need to be reflected in this context as well. We used an empirical-ethical approach including a website-analysis and 27 telephone-interviews for gaining in-depth insight into German POs' perspectives on PM and Big Data. Our results show that not all POs are stakeholders in the same way. Comparing the perspectives and political engagement of the minority of POs that is currently actively involved in research around PM and Big Data-driven research led to four stakeholder sub-classifications: 'mediators' support research projects through facilitating researcher's access to the patient community while simultaneously selecting projects they preferably support while 'cooperators' tend to contribute more directly to research projects by providing and implemeting patient perspectives. 'Financers' provide financial resources. 'Independents' keep control over their collected samples and associated patient-related information with a strong interest in making autonomous decisions about its scientific use. A more detailed terminology for the involvement of POs as stakeholders facilitates the adressing of their aims and goals. Based on our results, the 'independents' subgroup is a promising candidate for future collaborations in scientific research. Additionally, we identified gaps in PO's knowledge about PM and Big Data. Based on these findings, approaches can be developed to increase data and statistical literacy. This way, the full potential of stakeholder involvement of POs can be made accessible in discourses around PM and Big Data.

Ethics of Pharma Clinical Trials in the Era of Precision Oncology.

Pharmaceutical industry clinical trials are ethically problematic: human research subjects are being used as a means to the end of demonstrating statistically significant efficacy of novel anticancer agents to achieve regulatory registration and marketing approval. Randomized controlled trial design is inequitable since control arm patients are denied access to the postulated best treatment. Most pharma studies do not provide clinically meaningful benefit of increased overall survival and enhanced quality of life (QOL) to cohorts and are not reliably generalizable to real-world patients. Precision oncology now enables prospective identification of patients expressing a specific cancer biomarker to determine their particular eligibility for evaluation of efficiency of molecular-targeted treatments. A patient-centered approach, collecting prospective real-world data in large populations, could provide real-world evidence of cost-effective, sustained clinical benefits of survival and QOL, while preserving the ethical beneficent compact between patient and doctor.

Transparency, trust, and community welfare: towards a precision public health ethics framework for the genomics era.

Infectious disease control is experiencing a paradigm shift, as pathogen sequencing technologies and digital applications are increasingly implemented for control of diseases such as tuberculosis, Ebola, and COVID-19. A new ethical framework should be a critical part of this emerging paradigm to ensure that the benefit of precision public health interventions based on advances in genomics research is not outweighed by the risks they pose to individuals, families, and vulnerable segments of the population. We suggest that the ethical framework guiding practice in this domain combines standard precepts from public health ethics with emerging ethics principles from precision medicine.

Perspectives on Precision Medicine in a Tribally Managed Primary Care Setting.

BACKGROUND: Precision medicine (PM) research and clinical application is moving forward at a rapid pace. To ensure ethical inclusion of all populations in PM, in-depth understanding of diverse communities' views of PM research and PM implementation is necessary. METHODS: Semi-structured interviews were conducted to explore perspectives on PM in a tribally managed healthcare organization. Thematic analysis was used to analyze data from 46 interviews. RESULTS: Participants described gains in diagnostic efficiency, risk identification for preventable disease, and the advancement of population-specific biomedical research as key benefits of PM. Concerns expressed related to privacy risks associated with data-sharing, overpromising on PM, and managing patient expectations related to PM. Stakeholders encouraged PM implementation to be preceded by health education activities that leverage a range of communication strategies. CONCLUSION: Perspectives described in this study may aid in and should be considered prior to implementation of PM in this and other healthcare systems, especially those serving diverse populations.

Consent and Privacy in the Era of Precision Medicine and Biobanking Genomic Data.

"Big Data represents a challenge that points to the need for collective and political approaches to self-protection rather than solely individual, atomistic approaches."- Anita Allen, "Protecting One's Own Privacy in a Big Data Economy".

Responsible use of organoids in precision medicine: the need for active participant involvement.

Organoids are three-dimensional multicellular structures grown in vitro from stem cells and which recapitulate some organ function. They are derivatives of living tissue that can be stored in biobanks for a multitude of research purposes. Biobank research on organoids derived from patients is highly promising for precision medicine, which aims to target treatment to individual patients. The dominant approach for protecting the interests of biobank participants emphasizes broad consent in combination with privacy protection and ex ante (predictive) ethics review. In this paradigm, participants are positioned as passive donors; however, organoid biobanking for precision medicine purposes raises challenges that we believe cannot be adequately addressed without more ongoing involvement of patient-participants. In this Spotlight, we argue why a shift from passive donation towards more active involvement is particularly crucial for biobank research on organoids aimed at precision medicine, and suggest some approaches appropriate to this context.