BMC Medical Ethics最新文献

{"title":"Ethical self-efficacy among healthcare professionals caring for people with dementia: a brief pre- and post-report on the CARE intervention.","authors":"Frederik Schou-Juul, Lucca-Mathilde Thorup Ferm, Simon Kinch, Sofie Smedegaard Skov, Christian Ritz, Sigurd Lauridsen","doi":"10.1186/s12910-024-01106-z","DOIUrl":"10.1186/s12910-024-01106-z","url":null,"abstract":"<p><strong>Background: </strong>Interventions targeting healthcare professionals' confidence in managing ethical issues in dementia care are limited despite documented positive effects of educational programs on staff knowledge and self-efficacy. However, inconsistencies in the literature regarding the impact of educational programs underscore the need for targeted interventions. The CARE intervention, specifically designed to enhance confidence in ethical decision-making, aims to address this gap. This study evaluates the effectiveness of the CARE intervention in enhancing the ethical self-efficacy of healthcare professionals caring for people with dementia, particularly those with initially low levels of self-efficacy.</p><p><strong>Methods: </strong>Using a non-experimental pre-post evaluation design, the CARE intervention was administered to healthcare professionals (n = 86), measuring ethical self-efficacy pre-and post-intervention. We hypothesized significant differences in ethical self-efficacy mean scores pre- and post-intervention for all participants, particularly those with low pre-measurement scores, whom we expected to benefit most from the intervention. Statistical analysis included paired t-tests and Wilcoxon tests for the low pre-measurement subgroup analysis.</p><p><strong>Results: </strong>While no significant change was observed in the entire sample, participants with low initial self-efficacy showed a statistically significant improvement post-intervention.</p><p><strong>Conclusions: </strong>The CARE intervention holds promise in improving ethical self-efficacy among healthcare professionals with initial low confidence levels. Targeted interventions are essential in addressing confidence gaps in managing ethical challenges in dementia care, with implications for professional well-being and quality of care. Further research should explore long-term effects and expand sample size to enhance generalizability and sustainability of findings.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"109"},"PeriodicalIF":3.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care.","authors":"Loren G Marino, Katherine E Boguszewski, Haley F Stephens, Julia F Taylor","doi":"10.1186/s12910-024-01107-y","DOIUrl":"10.1186/s12910-024-01107-y","url":null,"abstract":"<p><strong>Background: </strong>Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments.</p><p><strong>Methods: </strong>Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed.</p><p><strong>Results: </strong>Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning).</p><p><strong>Conclusions: </strong>For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"108"},"PeriodicalIF":3.0,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinicians' roles and necessary levels of understanding in the use of artificial intelligence: A qualitative interview study with German medical students.","authors":"F Funer, S Tinnemeyer, W Liedtke, S Salloch","doi":"10.1186/s12910-024-01109-w","DOIUrl":"10.1186/s12910-024-01109-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Artificial intelligence-driven Clinical Decision Support Systems (AI-CDSS) are being increasingly introduced into various domains of health care for diagnostic, prognostic, therapeutic and other purposes. A significant part of the discourse on ethically appropriate conditions relate to the levels of understanding and explicability needed for ensuring responsible clinical decision-making when using AI-CDSS. Empirical evidence on stakeholders' viewpoints on these issues is scarce so far. The present study complements the empirical-ethical body of research by, on the one hand, investigating the requirements for understanding and explicability in depth with regard to the rationale behind them. On the other hand, it surveys medical students at the end of their studies as stakeholders, of whom little data is available so far, but for whom AI-CDSS will be an important part of their medical practice.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Fifteen semi-structured qualitative interviews (each lasting an average of 56 min) were conducted with German medical students to investigate their perspectives and attitudes on the use of AI-CDSS. The problem-centred interviews draw on two hypothetical case vignettes of AI-CDSS employed in nephrology and surgery. Interviewees' perceptions and convictions of their own clinical role and responsibilities in dealing with AI-CDSS were elicited as well as viewpoints on explicability as well as the necessary level of understanding and competencies needed on the clinicians' side. The qualitative data were analysed according to key principles of qualitative content analysis (Kuckartz).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In response to the central question about the necessary understanding of AI-CDSS tools and the emergence of their outputs as well as the reasons for the requirements placed on them, two types of argumentation could be differentiated inductively from the interviewees' statements: the first type, the clinician as a systemic trustee (or \"the one relying\"), highlights that there needs to be empirical evidence and adequate approval processes that guarantee minimised harm and a clinical benefit from the employment of an AI-CDSS. Based on proof of these requirements, the use of an AI-CDSS would be appropriate, as according to \"the one relying\", clinicians should choose those measures that statistically cause the least harm. The second type, the clinician as an individual expert (or \"the one controlling\"), sets higher prerequisites that go beyond ensuring empirical evidence and adequate approval processes. These higher prerequisites relate to the clinician's necessary level of competence and understanding of how a specific AI-CDSS works and how to use it properly in order to evaluate its outputs and to mitigate potential risks for the individual patient. Both types are unified in their high esteem of evidence-based clinical practice and the need to communicate with the patient on the use of medical","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"107"},"PeriodicalIF":3.0,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457475/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Practices and attitudes of herbalists regarding informed consent in Uganda: a qualitative study.","authors":"Sumayiya Nalubega, Paul Kutyabami, Adelline Twimukye, David Kaawa-Mafigiri, Nelson K Sewankambo","doi":"10.1186/s12910-024-01104-1","DOIUrl":"10.1186/s12910-024-01104-1","url":null,"abstract":"<p><strong>Background: </strong>Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent.</p><p><strong>Methods: </strong>To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were conducted. The data were analyzed thematically using NVivo version 12 software.</p><p><strong>Results: </strong>Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics were less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine.</p><p><strong>Conclusion: </strong>This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists' practices and attitudes toward informed consent.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"106"},"PeriodicalIF":3.0,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11451237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Speculation fit for a king? Medical announcements from the British royal family and the recurring ethical complexities of personal privacy and public commentary from physicians.","authors":"Alexander Smith, Dinesh Bhugra, Antonio Ventriglio, Michael Liebrenz","doi":"10.1186/s12910-024-01105-0","DOIUrl":"10.1186/s12910-024-01105-0","url":null,"abstract":"<p><p>This article explores the ethical complexities of openly-expressed medical commentary using recent cancer diagnoses within the British monarchy as illustrative cases. Specifically, it examines tensions between public interest, personal privacy, and professional standards, underlining the adverse implications of conjectural discourse, alongside the role of physicians in enhancing wider medical understanding.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"105"},"PeriodicalIF":3.0,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11451130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethical concerns in caring for persons with anorexia nervosa: content analysis of a series of documentations from ethics consultations.","authors":"Anna Lisa Westermair, Stella Reiter-Theil, Sebastian Wäscher, Manuel Trachsel","doi":"10.1186/s12910-024-01101-4","DOIUrl":"10.1186/s12910-024-01101-4","url":null,"abstract":"<p><strong>Background: </strong>Caring for patients with anorexia nervosa (AN) is associated with high levels of moral distress among healthcare professionals. The main moral conflict has been posited to be between applying coercion to prevent serious complications such as premature death and accepting treatment refusals. However, empirical evidence on this topic is scarce.</p><p><strong>Methods: </strong>We identified all 19 documentations of ethics consultations (ECs) in the context of AN from one clinical ethics support service in Switzerland. These documentations were coded with a sequential deductive-inductive approach and the code system was interpreted in a case-based manner. Here, we present findings on patient characteristics and ethical concerns.</p><p><strong>Findings: </strong>The ECs typically concerned an intensely pretreated, extremely underweight AN patient endangering herself by refusing the proposed treatment. In addition to the justifiability of coercion, frequent ethical concerns were whether further coerced treatment aimed at weight gain would be ineffective or even harmful, evidencing uncertainty about beneficence and non-maleficence and a conflict between these principles. Discussed options included harm reduction (e.g. psychotherapy without weight gain requirements) and palliation (e.g. initiating end-of-life care), the appropriateness of which were ethical concerns in themselves. Overall, nine different types of conflicts between or uncertainties regarding ethical principles were identified with a median of eight per case.</p><p><strong>Conclusions: </strong>Ethical concerns in caring for persons with AN are diverse and complex. To deal with uncertainty about and conflict between respect for autonomy, beneficence and non-maleficence, healthcare professionals consider non-curative approaches. However, currently, uncertainty around general justifiability, eligibility criteria, and concrete protocols hinders their adoption.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"102"},"PeriodicalIF":3.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142360679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Moral distress and protective work environment for healthcare workers during public health emergencies.","authors":"K Bondjers, Alve K Glad, H Wøien, T Wentzel-Larsen, D Atar, S K Reitan, L A Rosseland, J A Zwart, G Dyb, S Ø Stensland","doi":"10.1186/s12910-024-01098-w","DOIUrl":"10.1186/s12910-024-01098-w","url":null,"abstract":"<p><strong>Background: </strong>Public health emergencies, such as the Covid-19 pandemic, put great pressure on healthcare workers (HCW) across the world, possibly increasing the risk of experiencing ethically challenging situations (ECS). Whereas experiencing ECS as a HCW in such situations is likely unavoidable, mitigation of their adverse effects (e.g., moral distress) is necessary to reduce the risk of long-term negative consequences. One possible route of mitigation of these effects is via work environmental factors.</p><p><strong>Objectives: </strong>The current study aimed to examine: [1] risk factors associated with ECS among HCW [2], intensity of moral distress associated with ECS across various occupational factors (i.e., profession, degree of exposure to patients with Covid-19), and [3] the impact of work environmental factors on this association, in a sample of HCW during the pandemic.</p><p><strong>Methods: </strong>We employed multiple logistic and linear regression to self-report data from 977 HCWs at four Norwegian hospitals responding to a survey at the fourth wave of the pandemic.</p><p><strong>Results: </strong>About half of HCW in this study had experienced ECS during the pandemic, and levels of moral distress associated with such were higher than in previous studies using similar assessment methods. Younger age, female sex, geographical work area (mid-north of Norway), and profession (nurse) were all associated with higher odds (range of OR: 1.30-2.59) of experiencing ECS, as were direct contact with patients with Covid-19. Among those participants who reported that they had experienced ECS during the pandemic, moral distress levels when recalling those situations were moderate (Mean 5.7 on a 0-10 scale). Men reported somewhat lower intensity of moral distress (partial eta squared; ηp² = 0.02). Reporting a manageable workload (ηp² = 0.02), and greater opportunity to work according to best practice (ηp² = 0.02), were associated with lower levels of moral distress.</p><p><strong>Conclusions: </strong>Our findings suggest that moral distress could potentially be mitigated on an organizational level, particularly by focusing on ensuring a manageable workload, and an ability to work according to best practice. To build sustainable healthcare systems robust enough to withstand future public health emergencies, healthcare organizations should implement measures to facilitate these aspects of HCWs' work environment.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"103"},"PeriodicalIF":3.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142360680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The ethical requirement of explainability for AI-DSS in healthcare: a systematic review of reasons.","authors":"Nils Freyer, Dominik Groß, Myriam Lipprandt","doi":"10.1186/s12910-024-01103-2","DOIUrl":"10.1186/s12910-024-01103-2","url":null,"abstract":"<p><strong>Background: </strong>Despite continuous performance improvements, especially in clinical contexts, a major challenge of Artificial Intelligence based Decision Support Systems (AI-DSS) remains their degree of epistemic opacity. The conditions of and the solutions for the justified use of the occasionally unexplainable technology in healthcare are an active field of research. In March 2024, the European Union agreed upon the Artificial Intelligence Act (AIA), requiring medical AI-DSS to be ad-hoc explainable or to use post-hoc explainability methods. The ethical debate does not seem to settle on this requirement yet. This systematic review aims to outline and categorize the positions and arguments in the ethical debate.</p><p><strong>Methods: </strong>We conducted a literature search on PubMed, BASE, and Scopus for English-speaking scientific peer-reviewed publications from 2016 to 2024. The inclusion criterion was to give explicit requirements of explainability for AI-DSS in healthcare and reason for it. Non-domain-specific documents, as well as surveys, reviews, and meta-analyses were excluded. The ethical requirements for explainability outlined in the documents were qualitatively analyzed with respect to arguments for the requirement of explainability and the required level of explainability.</p><p><strong>Results: </strong>The literature search resulted in 1662 documents; 44 documents were included in the review after eligibility screening of the remaining full texts. Our analysis showed that 17 records argue in favor of the requirement of explainable AI methods (xAI) or ad-hoc explainable models, providing 9 categories of arguments. The other 27 records argued against a general requirement, providing 11 categories of arguments. Also, we found that 14 works advocate the need for context-dependent levels of explainability, as opposed to 30 documents, arguing for context-independent, absolute standards.</p><p><strong>Conclusions: </strong>The systematic review of reasons shows no clear agreement on the requirement of post-hoc explainability methods or ad-hoc explainable models for AI-DSS in healthcare. The arguments found in the debate were referenced and responded to from different perspectives, demonstrating an interactive discourse. Policymakers and researchers should watch the development of the debate closely. Conversely, ethicists should be well informed by empirical and technical research, given the frequency of advancements in the field.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"104"},"PeriodicalIF":3.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142360681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Researchers experience and views on participants' comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study.","authors":"Dorothy Maxwell Kazembe, Yimtubezinash Woldeamanuel, Solomon Mequanente Abay","doi":"10.1186/s12910-024-01100-5","DOIUrl":"10.1186/s12910-024-01100-5","url":null,"abstract":"<p><strong>Background: </strong>Informed consent is the cornerstone of research ethics. One of its goals is that participants enter research with an understanding of what their participation entails. This paper is a study on how researchers understand the informed consent process. Previous studies have looked at this topic from a research participant perspective. However, few studies focus on the perspectives of the researchers. Therefore, this is an important paper that highlights an important issue (informed consent) from the perspective of those who administer it during research.</p><p><strong>Methods: </strong>In-depth interviews were conducted with 18 researchers from 3 different research centers in Malawi working in clinical trials. The data was analyzed using open code utilizing the thematic approach to qualitative data.</p><p><strong>Results: </strong>This study identified that researchers have good awareness of the role of informed consent, how important it is for participants to understand the given information and ways to adjust their practice accordingly when obtaining it in order to enhance participant understanding. According to the research staff, most participants do not really understand all the concepts of the study at the initial visit, they gain more understanding during subsequent visits. It was emphasized that the best method of facilitating informed consent is reading the informed consent to the participant, thus a face-to-face conversation. Long and complex informed consent was identified as one of the barriers to participant understanding of the informed consent. Shortening the informed consent form and having additional conversation with the participants was suggested as one way of improving participant comprehension.</p><p><strong>Conclusion: </strong>Most of the participants understand much of the information during subsequent visits as you keep reminding them since informed consent is an ongoing process. Existing relationship or trust between a participant and a researcher, may influence participants' decision and misguide their understanding on the purpose of the study. Adequate time should be allocated to informed consent discussions. Shortening the informed consent forms and having additional conversations with potential participants may help improve their understanding.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"101"},"PeriodicalIF":3.0,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11438391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142332786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing.","authors":"Emilia Giannella, Josep Miquel Bauça, Simona Gabriella Di Santo, Stefano Brunelli, Elisabetta Costa, Sergio Di Fonzo, Francesca Romana Fusco, Antonio Perre, Valerio Pisani, Giorgia Presicce, Francesca Spanedda, Giorgio Scivoletto, Rita Formisano, Maria Grazia Grasso, Stefano Paolucci, Domenico De Angelis, Giulia Sancesario","doi":"10.1186/s12910-024-01102-3","DOIUrl":"10.1186/s12910-024-01102-3","url":null,"abstract":"<p><strong>Background: </strong>The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong.</p><p><strong>Methods: </strong>We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024.</p><p><strong>Results: </strong>We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%).</p><p><strong>Conclusions: </strong>Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"25 1","pages":"100"},"PeriodicalIF":3.0,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11437646/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142332785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}