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储存生物样本和生物库的结果返还:沙特阿拉伯生物医学研究人员的观点。

Returning Results of Stored Biological Samples and Biobanks: Perspectives of Saudi Arabian Biomedical Researchers.

机构信息

King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia.

King Saud bin Abdulaziz University for Health Sciences (KSAU-HS), Riyadh, Saudi Arabia.

出版信息

Biopreserv Biobank. 2020 Oct;18(5):395-402. doi: 10.1089/bio.2020.0002. Epub 2020 Jul 20.

DOI:10.1089/bio.2020.0002
PMID:32706976
Abstract

Scientific medical research involving human samples often leads to improved diagnosis, the discovery of treatment modalities, or the identification of possible risk factors for many diseases. Some findings, including incidental findings, may be important to donors, and some may require intervention. This study aimed to explore the perspectives of health care professionals in their use of stored biological samples for biomedical research regarding the concept of the research results and the challenges of informing donors regarding the results. This qualitative study involved 19 medical researchers doing research with stored biological samples and biobanks. The data were gathered during face-to-face interviews in English using a semistructured interview technique. The participants provided rich and illuminating experiences, framed in the following themes: the professional duty of researchers to return the research results and the right of donors to know; factors affecting informing donors of results (e.g., severity of disease; impact of the provided information; reliability of the research results; and donor approval); challenges to physically returning the results; and the nature of the informed consent, as well as the elements required in the informed consent documentation. Although the majority of researchers agree on the importance of returning research results, some have contradictory views such as that returning research results is not the researcher's responsibility. The study results also support the view that a number of elements should be included in the informed consent, such as the intention of informing the donors of the results as well as the benefits and risks.

摘要

科学医学研究涉及人体样本,往往能改善诊断、发现治疗方法,或确定许多疾病的可能风险因素。一些发现,包括偶然发现,可能对供体很重要,有些发现可能需要干预。本研究旨在探讨医疗保健专业人员在使用储存的生物样本进行生物医学研究时对研究结果概念的看法,以及告知供体研究结果所面临的挑战。这是一项定性研究,涉及 19 名从事储存生物样本和生物库研究的医学研究人员。数据是通过面对面的英语访谈,采用半结构化访谈技术收集的。参与者提供了丰富而有启发性的经验,其内容框架如下:研究人员归还研究结果的专业职责和供体知情的权利;影响告知供体结果的因素(例如,疾病的严重程度;提供的信息的影响;研究结果的可靠性;以及供体的同意);实际归还结果的挑战;以及知情同意的性质,以及知情同意文件中需要包含的要素。尽管大多数研究人员都同意归还研究结果的重要性,但也有一些人持有矛盾的观点,例如归还研究结果不是研究人员的责任。研究结果还支持这样一种观点,即知情同意书应包含一些要素,如告知供体结果的意图以及获益和风险。

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Returning Results of Stored Biological Samples and Biobanks: Perspectives of Saudi Arabian Biomedical Researchers.储存生物样本和生物库的结果返还:沙特阿拉伯生物医学研究人员的观点。
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引用本文的文献

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Return of individual research results from genomic research: A systematic review of stakeholder perspectives.基因组研究中个体研究结果的返还:利益相关者观点的系统评价。
PLoS One. 2021 Nov 8;16(11):e0258646. doi: 10.1371/journal.pone.0258646. eCollection 2021.
2
To disclose, or not to disclose? Perspectives of clinical genomics professionals toward returning incidental findings from genomic research.是否披露?临床基因组学专业人员对从基因组研究中返还偶然发现的观点。
BMC Med Ethics. 2021 Jul 27;22(1):101. doi: 10.1186/s12910-021-00670-y.
3
Knowledge, perceptions and attitude of Egyptian physicians towards biobanking issues.
埃及医生对生物银行问题的知识、看法和态度。
PLoS One. 2021 Mar 26;16(3):e0248401. doi: 10.1371/journal.pone.0248401. eCollection 2021.