Eisenhauer Elizabeth R, Tait Alan R, Rieh Soo Young, Arslanian-Engoren Cynthia M
1 University of Michigan, Ann Arbor, MI, USA.
Clin Nurs Res. 2019 Jan;28(1):30-51. doi: 10.1177/1054773817722690. Epub 2017 Jul 26.
Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants' level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants' understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.
护士越来越多地被要求在生物样本库研究中获得参与者的同意。生物样本库给知情同意增加了独特的复杂性。本系统评价的目的是评估参与者对在为研究捐赠生物样本所特有的知情同意过程中所呈现信息的理解程度。采用系统评价和Meta分析的首选报告项目（PRISMA）指南进行该评价。检索了PubMed、EMBASE、CINAHL、PsycINFO、Scopus、Web of Science和ProQuest书目数据库。结果表明，生物样本库特有的知情同意要素理解不足。大多数研究的作者或资金与生物样本库有关。只有一项研究披露并评估了参与者对道德风险的理解。增加披露、价值观澄清以及通过多种方式呈现信息可能有助于理解。有必要通过使用标准化工具、定义以及鼓励生物样本库行业以外关于知情选择的研究来提高生物样本库研究知情同意的质量。
