BMC Medical Ethics最新文献

Background: The diagnosis of chronic lymphocytic leukaemia (CLL) is often fortuitous. Stage A patients do not experience severe symptoms and therefore do not require initial treatment. Instead, they are placed under active surveillance in order to track disease deterioration over time. Around half of these patients will never need treatment. Diagnostic disclosure of Stage A CLL thus leads to a great deal of uncertainty. Accordingly, stage A patients' lives are sometimes more impacted by their diagnosis than by the disease itself. This study aimed to outline the ethical issues surrounding the diagnosis of potentially indolent CLL in stage A patients under active surveillance in France by investigating their experiences, needs, expectations and self-perceptions.

Methods: We co-constructed an online questionnaire with the French leukaemia and lymphomas patient association ELLyE. Comprising 46 closed, semi-closed and semi-open questions, it focused on stage A patients' experiences regarding their diagnosis and active surveillance, their encounters with medical professionals, as well as the support they received from family members, friends, non-medical healthcare professionals, and patient associations. We conducted a descriptive analysis to examine the results.

Results: Of the 235 participants included in the study, 46% were women. Mean age was 66 years old. All had been diagnosed between 1982 and 2021 (median year of diagnosis was 2013). Almost three-quarters (72.8%) of the sample did not consider themselves as sick. Two-thirds (66.8%) reported feeling uncertain about their disease progression and the feeling of a constant threat hanging over them. Patients recently diagnosed (i.e., < 5 years) were more likely to experience anxiety, anguish and powerlessness related to this uncertainty than patients diagnosed more than ten years previously. Many participants did not wish for more frequent or longer follow-up consultations with hospital-based specialists. Moreover, some wished to distance themselves as much as possible from anything related to cancer care and to live their lives as normally as possible.

Conclusions: Our study highlights that the difficulties patients with stage A CLL encounter tend to remain invisible because of limited interactions with medical professionals. Greater acknowledgment and understanding of these difficulties by these professionals are needed in order to adequately address different needs.

Background: The expansion of newborn bloodspot screening (NBS) programs through genomic sequencing is proposed as a way to revolutionise infant and lifelong healthcare. But for all its promise, profound ethical challenges arise too. Robust analysis of these ethical challenges, which include technological and commercial imperatives, as well as balancing individual rights with communal goods, first necessitates clarity as to which ethical approach is best suited to considering the use of genomics in NBS.

Methods: We use normative ethical analysis to provide a critical comparison of three ethical approaches to the expansion of NBS that shape debates over the implementation of genomic newborn screening (gNBS): liberal individualism, public health ethics, and genomic healthcare as a human right.

Results: While these approaches often overlap in practice, their distinct priorities illuminate tensions between individual autonomy, collective welfare, and rights-based claims to genomic information and attendant healthcare. We argue that public health ethics should be the primary ethical approach for gNBS. Yet, none of the three approaches are individually sufficient to fully address the ethical complexities involved. This is because each approach sheds useful light on distinct benefits and limitations of gNBS.

Conclusions: While rigorous evidence-gathering to inform the ethical and societal impacts of gNBS is critical, this must be accompanied by - and interpreted through - normative ethical analysis that clearly articulates the values and tensions at stake. Overall, ethical implementation of gNBS requires a policy approach that (i) adopts public health ethics for programme design, (ii) operationalises select human-rights claims in accordance with established screening principles, and (iii) embeds liberal protections against state or parental overreach.

Background: Ethical regulation of biomedical research is essential to safeguard the rights and well-being of participants. In Ecuador, Research Ethics Committees (RECs) have undergone progressive growth. This study describes and evaluates the performance of the RECs of Ecuador using the first standardized registry of approved research studies implemented by the Ministry of Public Health.

Methods: An observational, descriptive, and retrospective study was conducted using administrative records corresponding to the first year of implementation of the First Standardized Registry of Approved Research Studies (September 2021-October 2022). All functional RECs and approved research projects were included, characterizing variables related to geographical distribution, institutional affiliation, researcher profiles, study type, review modality, response times, and protocol follow-up.

Results: A total of 957 projects approved by 21 RECs were evaluated. Of these, 52% were concentrated in Quito, and 62% were affiliated with higher education institutions. Most studies were observational (96%), with a predominance in Medicine and Nursing (63%), followed by Psychology (15%) and Sociology (10%). Geographical distribution revealed a high concentration in Azuay (52%) and Pichincha (43%). Only 3% of the projects had a unique identification code, 40% involved vulnerable populations, and 9% used biological samples. The average waiting time to obtain a resolution was 31 days (95% CI: 28.5-34.2).

Conclusions: Despite regulatory advancements and the implementation of the First Standardized Registry of Approved Research Studies, challenges persist in terms of decentralization, operational efficiency, and follow-up. Optimizing the regulatory framework, strengthening RECs training, and fostering public-private collaboration are crucial to consolidating a robust and adaptable ethical system capable of addressing emerging challenges.

Background: Accelerated clinical trials for drugs and vaccines during global health crises allow for rapid access but pose research ethics and integrity challenges. Understanding these challenges is crucial for preserving research participants' safety and supporting research fairness and trustworthiness. This study aims to explore the research ethics and research integrity challenges associated with the acceleration of clinical trials.

Methods: This qualitative interview study used semi-structured online interviews with key stakeholders in the regulation, design, implementation, and publication of clinical trials as professionals (i.e. trial experts from academia, pharmaceutical companies, non-governmental organizations and national and international regulatory authorities and publishers) recruited using purposive sampling. Interviews were conducted online from April to July of 2023. Transcripts were thematically analysed using deductive and inductive coding through MAXQDA software.

Results: The main challenges identified were: amplified familiar challenges related to participant recruitment and informed consent; lack of guidance for, and pressure on, ethics and scientific review processes; missing strategies and ambiguous responsibilities in public communication; and poor collaboration, coordination and competition for research resources and supportive structures among research groups Recommendations included: greater engagement with patients throughout the accelerated clinical trial process from design to implementation; providing Research Ethics Committees with specific training on accelerated trials; promoting transparent public communication; fostering international collaboration; and shifting from an industry-centred to a people-centred acceleration.

Conclusion: These findings highlight the need for systemic changes in the conduct of accelerated clinical trials, including the openness of clinical research and international coordination to address ethical and integrity issues, ensuring scientific rigor and public trust and promoting justice.

Background: Medical social workers' (MedSWs) roles and responsibilities expanded during the COVID-19 pandemic. They experienced larger caseloads, restrictive protocols, new policies, and work outside of their professional scope, despite limited access to resources, support, or hazard compensation. As a result, MedSWs faced complex ethical situations, which they had to address in accordance with the profession's guiding principles.

Methods: We conducted qualitative semi-structured interviews with 54 MedSWs about their professional experiences during the pandemic and used the National Association of Social Worker's Code of Ethics (service, social justice, dignity and worth of the person, importance of human relationships, integrity, and competence) as a deductive coding guide to describe MedSWs' navigation of and responsiveness to ethical situations across healthcare settings. We defined ethical situations as threats to values and ethical actions as attempts to resolve the threat in a way that aligns with professional standards. Our methodology was informed and documented via the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist.

Results: From MedSWs' interviews, we identified six major ethical situations that aligned with the six values and ethical principles in the Code: inadequate addressing of patients' social determinants of health by healthcare institutions (service), social injustices negatively impacting patients' and providers' healthcare experiences (social justice), de-prioritization of patients' wishes in high stakes situations (dignity and worth of the person), social isolation and related distress resulting from social distancing policies (importance of human relationships), encroachment on social workers' scope of practice boundaries (integrity), and lack of preparedness among social workers for emergency COVID-19 situations (competence). We also identified several ethical actions, aligning with the six ethical principles, that MedSWs took to address these situations.

Conclusion: The ethical situations and actions that MedSWs discussed in this qualitative study align closely with the experiences of other healthcare workers during the pandemic. Despite uncertain situations, MedSWs relied on their innate understanding of social work principles to guide ad hoc decision-making. Results from this analysis indicate the need for more robust administrative and institutional support structures that would allow MedSWs to practice self-care, maintain their scope of practice boundaries, and access additional emergency preparedness training.

Background: On January 1st, 2023, Shenzhen became the first city to legalize living wills in China. However, less was known about the readiness of healthcare professionals (HCPs) to implement Article 78 of the Shenzhen Special Economic Zone Medical Regulations. Our team aimed to timely examine the HCPs' readiness in Shenzhen, including their knowledge, attitude and confidence as well as associated factors.

Methods: A cross-sectional study was conducted among 685 doctors and nurses across 16 hospitals using convenience sampling between February and March 2023 in Shenzhen, China. A validated, self-designed electronic questionnaire consisting of 22 items was used to assess knowledge, attitude, confidence, and related factors. The scale-level content validity index (S-CVI) for these three dimensions was 94.4%, 96.7%, and 93.3%, respectively. The internal consistency reliability (Cronbach's α) for the three dimensions was 0.693, 0.944, and 0.890, respectively.

Results: Only 315 participants (46.0%) demonstrated adequate knowledge (score ≥ 9), with an average correct rate of 65.4%. Most participants had a positive attitude (644/685, 94.0%), and 596 (87.0%) scored ≥ 16 on confidence. However, many lacked confidence in validating living wills (350/685, 51.1%), mitigating legal risks (322/685, 47.0%), and adhering to ethical principles (161/685, 23.5%). HCPs who had cared for terminally ill patients were more likely to have better knowledge (OR = 1.391, 95% CI: 1.013-1.910), attitude (OR = 2.564, 95% CI: 1.316-4.997), and confidence (OR = 1.703, 95% CI: 1.086-2.670). Those with a bachelor's (OR = 3.348, 95% CI: 1.613-6.951) or master's degree (OR = 2.645, 95% CI: 1.080-6.477) showed more positive attitudes. Prior training improved confidence (OR = 3.035, 95% CI: 1.080-8.529). Most participants preferred doctors (556/685, 81.17%), family members (513/685, 74.89%), and lawyers (511/685, 74.6%) to discuss living wills, while fewer preferred nurses (321/685, 46.86%) or social workers (241/685, 35.18%).

Conclusion: HCPs generally supported living wills but lacked legal and ethical confidence for implementation. Targeted training integrating medical, legal, ethical, and cultural components is urgently needed to promote patient autonomy and support policy implementation in Shenzhen.