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.

IF 3 1区 哲学 Q1 ETHICS BMC Medical Ethics Pub Date : 2024-09-27 DOI:10.1186/s12910-024-01102-3
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
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Abstract

Background: 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.

Methods: 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.

Results: 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%).

Conclusions: 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.

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生物库、数字健康和隐私:1410 名志愿者和神经病患者对数据和生物样本使用限制、结果返还和共享的选择。
背景:人工智能、数据科学和数字医疗的日益普及凸显了数据和生物样本收集的作用,从而引发了对其使用和传播的法律和伦理问题的关注。此外,生物银行的扩展,从基本的冷冻标本收集到今天的标本和相关数据的虚拟生物银行,给医疗保健系统带来了革命性的潜力,特别是在神经系统疾病领域,因为中枢神经系统无法进入,需要非侵入性的调查方法。知情同意(IC)被认为是所有研究和标本采集中的强制性规定,必须特别考虑到对所使用的生物材料和数据所属个人的伦理尊重:我们评估了神经系统疾病患者(NP)和健康志愿者(HV)对向生物库捐赠生物样本用于未来神经系统疾病研究的态度,以及根据《通用数据保护条例》(GDPR)的要求对数据使用的限制。研究共涉及 1454 名受试者,其中包括 502 名高血压患者和 952 名非高血压患者,这些受试者于 2020 年至 2024 年期间在罗马圣露西亚基金会 IRCCS 征募:我们发现:(i) 几乎所有受试者都同意参与生物库(ii)和授权基因研究(HV = 99.1%;NP = 98.3%);关于结果的返还,(iii) 我们发现 NP 和 HV 之间存在显著的统计学差异,后者倾向于不被告知潜在的结果(HV = 43%;NP = 11.3%;P 结论:同意为研究目的捐赠材料对于使用人类来源生物材料的生物库和生物医学研究至关重要。在此,我们表明,即使研究和科学进步的益处得到认可,高危人群和非高危人群对参与神经病学生物库的选择也会有所不同。NP 对获知可能的结果有浓厚的兴趣,但限制样本的共享,这凸显了他们对更大的个人利益或相对利益的看法;而 HV 则倾向于广泛传播和共享数据,但不希望获得结果的回报,他们更倾向于为社会和知识带来可能的利益。研究结果表明,有必要按照《信息权保护条例》(GDPR)和捐献者的具体要求,谨慎管理生物库中收集的生物材料和数据。
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来源期刊
BMC Medical Ethics
BMC Medical Ethics MEDICAL ETHICS-
CiteScore
5.20
自引率
7.40%
发文量
108
审稿时长
>12 weeks
期刊介绍: BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.
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