Improving the Practice of Obtaining Informed Consent for Biobanking in Clinical Settings.

IF 1.2 4区 生物学 Q4 CELL BIOLOGY
Biopreservation and Biobanking Pub Date : 2023-10-01 Epub Date: 2022-09-29 DOI:10.1089/bio.2021.0158
Laura Arregui Egido, María Villalobos-Quesada
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引用次数: 1

Abstract

Background: Biobanks form key research support infrastructures that ensure the highest sample quality for scientific research. Their activity must align closely and proportionally to the interests of researchers, donors, and society. Informed consent (IC) is a central tool to guarantee the protection of donors' rights and interests. Aim: This study aimed to analyze the challenges of obtaining IC for biobanking in clinical settings and ways to improve this process. Methods: Biobank Bellvitge University Hospital HUB-ICO-IDIBELL in Barcelona received 8671 IC forms between 2017 and 2020. The mistakes that caused IC forms to be rejected by the Biobank were analyzed. In addition, interventions aimed at physicians to improve the IC process were evaluated through a calculation of the relative risk (RR). Finally, physicians who submitted samples to the Biobank, most of whom are involved in research activities, were surveyed about the barriers to collecting IC and how to improve this process. Results: During 2017-2020, 19.6% of IC forms were rejected. The most relevant cause of rejection was the use of outdated IC forms, followed by missing patient information or mistakes having been made by the physician. Evaluation of the rejection rates before and after interventions to improve the IC process suggests significant improvement (27.7% before interventions (January 2017-May 2018) compared to 9.6% after interventions (February-December 2020), RR 0.4 95% CI 0.34-0.47; p < 0.0001). According to the physicians, the most important barrier to collecting IC is the time constraint, and they consider digitalization as a viable solution. Conclusions: Our research offers a view of the less well-understood practical challenges that physicians and biobanks face when collecting IC in clinical settings. It suggests that, despite multiple challenges, continuous monitoring, training, and information programs for physicians are key to optimizing the IC process in clinical settings.

改进临床环境中获得生物库知情同意的实践。
背景:生物库构成了关键的研究支持基础设施,确保科学研究的最高样本质量。他们的活动必须与研究人员、捐赠者和社会的利益密切相关。知情同意是保障捐赠者权益的核心工具。目的:本研究旨在分析在临床环境中获得生物库IC的挑战以及改进这一过程的方法。方法:2017年至2020年间,巴塞罗那的Biobank Bellvitge大学医院HUB-ICO-IDIBELL收到了8671份IC表格。分析了导致IC表单被生物库拒绝的错误。此外,通过计算相对风险(RR)来评估旨在改善IC过程的针对医生的干预措施。最后,向生物库提交样本的医生(其中大多数参与研究活动)被调查了收集IC的障碍以及如何改进这一过程。结果:2017-2020年期间,19.6%的IC表格被拒绝。排异反应最相关的原因是使用了过时的IC表格,其次是患者信息缺失或医生犯了错误。对改善IC过程的干预前后排异率的评估表明,与干预后的9.6%(2020年2月至12月)相比,干预前的排异率有显著改善(干预前为27.7%(2017年1月至2018年5月),RR 0.4 95%CI 0.34-0.47;p 结论:我们的研究为医生和生物库在临床环境中收集IC时面临的不太为人所知的实际挑战提供了一个视角。它表明,尽管面临多重挑战,但医生的持续监测、培训和信息计划是优化临床环境中IC流程的关键。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Biopreservation and Biobanking
Biopreservation and Biobanking CELL BIOLOGY-MEDICAL LABORATORY TECHNOLOGY
CiteScore
3.30
自引率
12.50%
发文量
114
审稿时长
6-12 weeks
期刊介绍: Biopreservation and Biobanking is the first journal to provide a unifying forum for the peer-reviewed communication of recent advances in the emerging and evolving field of biospecimen procurement, processing, preservation and banking, distribution, and use. The Journal publishes a range of original articles focusing on current challenges and problems in biopreservation, and advances in methods to address these issues related to the processing of macromolecules, cells, and tissues for research. In a new section dedicated to Emerging Markets and Technologies, the Journal highlights the emergence of new markets and technologies that are either adopting or disrupting the biobank framework as they imprint on society. The solutions presented here are anticipated to help drive innovation within the biobank community. Biopreservation and Biobanking also explores the ethical, legal, and societal considerations surrounding biobanking and biorepository operation. Ideas and practical solutions relevant to improved quality, efficiency, and sustainability of repositories, and relating to their management, operation and oversight are discussed as well.
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