Clinical Neurochemistry Unit and Biobank, IRCCS Santa Lucia Foundation, via Ardeatina 354, Rome, Italy.
European Center for Brain Research, via del Fosso del Fiorano, Rome, Italy.
BMC Med Ethics. 2024 Sep 27;25(1):100. doi: 10.1186/s12910-024-01102-3.
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.
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.
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%).
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.
人工智能、数据科学和数字健康的日益普及凸显了数据和生物样本采集的作用，因此引发了关于其使用和传播的法律和伦理问题。此外，生物库的扩展，从基本的冷冻标本采集到今天存在的标本和相关数据的虚拟生物库，为医疗保健系统带来了革命性的潜力，特别是在神经疾病领域，因为中枢神经系统难以接近，需要非侵入性的研究方法。知情同意（IC）被认为是所有研究和标本采集的强制性要求，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。
我们评估了神经疾病患者（NP）和健康志愿者（HV）对捐赠生物样本用于未来神经疾病研究的态度，以及对数据使用的限制，这与一般数据保护条例（GDPR）的要求有关。这项研究共涉及 1454 名受试者，包括 2020 年至 2024 年在罗马圣卢西亚基金会 IRCCS 招募的 502 名 HV 和 952 名 NP。
我们发现：（i）几乎所有的受试者都同意参与生物库（ii）和授权进行基因研究（HV=99.1%；NP=98.3%）；关于结果的回报，（iii）我们发现 NP 和 HV 之间存在统计学上的显著差异，后者更倾向于不被告知潜在的结果（HV=43%；NP=11.3%；p<0.0001）；（iv）一小部分人限制了在欧盟（EU）内部的共享（HV=4.6%；NP=6.6%），而患者更不愿意将其转移到欧盟之外（HV=7.4%；NP=10.7%；p=0.05）；（v）几乎所有的患者都同意将电子病历中的其他健康数据用于研究目的（98.9%）。
为研究目的捐赠材料的同意对于使用人类来源的生物材料进行生物库和生物医学研究至关重要。在这里，我们表明，HV 和 NP 之间在参与神经生物库方面的选择可能不同，即使研究和科学进步的好处是公认的。NP 对可能的结果有强烈的知情意愿，但限制了样本的共享，突出了个体或相对受益的感知，而 HV 则更喜欢广泛的传播和数据共享，但不希望得到结果的回报，有利于社会和知识的潜在受益。结果强调了需要根据 GDPR 和捐赠者的具体要求，谨慎管理生物库中收集的生物材料和数据。
