BMC Medical Ethics最新文献

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.

Background: Medical gaslighting- a phenomenon where healthcare professionals dismiss or minimize patients' symptoms- has garnered increasing attention due to its potential to cause significant harm to patients. This study aims to examine the ethical ramifications and implications of medical gaslighting, and explore how patients interpret and experience interactions affected by medical gaslighting.

Methods: We conducted two narrative interviews with fourteen participants. The first interview was conducted 2-3 days after discharge from hospitalization, and the second was carried out a month later. We then interpreted their stories through bioethical lenses.

Results: Data analysis yielded two main themes: (1) Pain dismissal and minimization; (2) Delayed or missed diagnoses- as subjectively perceived by interviewees. Using a principlist approach, we argue that medical gaslighting constitutes an obstacle to respect for patient autonomy and jeopardizes proper actualization of beneficence. Participants frequently described feeling dismissed, especially when presenting with complex or non-visible symptoms.

Conclusions: Medical gaslighting appears to be a common and impactful experience that contributes to psychological distress and reduces trust in the medical system, potentially delaying diagnosis and treatment. Healthcare institutions must prioritize training on implicit bias, communication skills, and patient-centered care to mitigate these harmful interactions. Future research should further explore structural contributors and develop interventions to foster more validating clinical environments. We propose some practical implications for eradicating medical gaslighting based on our findings.

Background: Over 300 million individuals worldwide live with Atopic Dermatitis and Psoriasis, which are among the most common chronic inflammatory skin diseases. Multimodal biomarkers are currently being developed using large-scale data and artificial intelligence to allow for more targeted prediction and to improve treatment of patients with Atopic Dermatitis/Psoriasis. Although this promises enormous benefits for patients, it comes with critical challenges. This article offers an in-depth analysis of the ethical challenges in research and application of data-driven biomarkers in chronic inflammatory skin disease, which, as recent work shows, has not yet been explored in depth.

Methods: We conducted an interview study with 28 members of the BIOMarkers in Atopic Dermatitis and Psoriasis consortium including multiple stakeholder groups involved in biomarker research and application following the COREQ checklist. The interviews were analysed and interpreted theme-oriented using an updated grounded theory approach.

Results: The interviews revealed interconnected ethical challenges described by a wide range of stakeholders involved in biomarker research. Our analysis identified two broad categories of ethical challenges - disease-related and biomarker-related issues - from which three cross-cutting themes emerged: multiple forms of harm, multiple injustices, and multiple uncertainties. Disease-related challenges include covert psycho-socio-physical dimensions of harm and suffering in Atopic Dermatitis/Psoriasis, quality of life impacts, trial-and-error approaches, and communication and expectation management in clinical practice. Biomarker-related challenges range from big data use with multiple biases in the different data-sets, stratification of patients into subgroups, to invasiveness of diagnostic measures, multiple uncertainties and expectation management in science. This article also provides stakeholder suggestions for mitigating harm associated with Atopic Dermatitis/Psoriasis and biomarker use to inform policy development.

Conclusions: The identification of the many ethical challenges uncovered in the interviews and the nuanced view of harm, intersecting injustices including epistemic injustice, and the multiple uncertainties provide crucial considerations for evaluating the risks and benefits of biomarker research and application in healthcare. These insights should inform policy development for data/AI-driven biomarker use for Atopic Dermatitis/Psoriasis and support research practice, public health interventions, and clinical practice to develop and apply medical innovations that are ethically responsible.

Background: Truth-telling is the process by which relevant medical information is disclosed to the patient to enable them to make informed decisions about their healthcare. It serves multiple aims; first, it is essential to adequately informed consent; second, it respects patients' rights to self-determination, third, it fulfills practitioners' ethical obligations; and fourth, it promotes trust between patients and practitioners. In Saudi Arabia, research suggests that patients support truth-telling, prefer a more collaborative role in decision-making, and want to be involved in difficult decisions at the end-of-life. However, evidence also finds a disparity between the preferences of patients and their relatives, with family members favoring concealment of information to honor and protect patients. The perspectives of Saudi physicians, and the challenges they encounter when faced with these oft-contrasting preferences is not as well explored.

Methods: This research is a qualitative phenomenological study that utilizes a semi-structured interview technique and interview guide. Through thematic analysis of 7 in-person interviews with senior Saudi physicians, this qualitative study attempts to understand the experiences of practitioners who routinely encounter truth-telling dilemmas, particularly in the face of strong family opposition.

Results: Study participants identified family requests for concealment as significant ethical challenges in their practice. They reported experiencing moral conflict between the ethical duty of truth-telling and the cultural norms of a family-based Saudi society that favor concealment.

Conclusions: Although some participants held firm in upholding the ethical duty of truth-telling, others agreed to conceal information. Most participants, however, tried to find a compromise between these contrasting commitments by relying on their own personal experiences and professional judgements.