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Traditional and Electronic Informed Consent for Biobanking: A Survey of U.S. Biobanks

机译:传统和电子知情同意的生物银行:对美国生物银行的调查

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Biobanks face unique challenges obtaining consent from biospecimen contributors. Electronic consent (e-consent) presents one option for streamlining the biobank consent process, and improving contributor understanding of consent information. An e-mail survey was conducted to establish the extent of current biobank e-consent and interest in future use of e-consent. A total of 235 biobanks were surveyed and 65 (28%) responded with a fully completed survey. Few of these 65 biobanks (8%) reported using e-consent; however, the majority (75%) were interested in e-consent. Many (48%) biobanks were in discussions with institutional stakeholders about using e-consent in the future. Anticipated benefits of e-consent included improved efficiency and increased enrollment. Perceived barriers to e-consent adoption included lack of funding, issues with human subjects approval, and factors affecting user uptake (e.g., computer literacy). Biobanks using e-consent reported cost, technology issues, and difficulty training staff as barriers to e-consent adoption. Traditional consenting methods (e.g., face-to-face, phone, and mail) continued to be used at biobanks reporting use of e-consent. The survey results suggest strong interest in e-consent among U.S. biobanks, and a need to consider a range of implementation issues, including user preferences and receptivity; institutional and technical support; integration with clinical data networks; electronic signature capture; and what type of e-consent to implement. Biobanks will need evidence-based guidance for purposes of addressing these issues, so that e-consent processes enhance efficiency, as well as contributor receptivity, understanding, and trust.
机译:获得生物样本提供者的同意,生物库面临着独特的挑战。电子同意书(电子同意书)提供了一种简化生物库同意书流程并提高贡献者对同意书信息的理解的选择。进行了电子邮件调查,以确定当前生物库电子同意的程度以及对电子同意未来使用的兴趣。总共对235个生物库进行了调查,其中65个(28%)进行了完整的调查。在这65个生物库中,很少有人报告使用电子同意书(占8%)。但是,大多数(75%)对电子同意书感兴趣。许多(48%)生物库正在与机构利益相关方讨论未来使用电子同意书的问题。电子同意书的预期收益包括提高效率和增加注册人数。电子同意采用的感知障碍包括资金不足,人类受试者批准问题以及影响用户使用的因素(例如计算机素养)。使用电子同意书的生物库报告了成本,技术问题和人员培训困难,这是采用电子同意书的障碍。在报告使用电子同意的生物银行中,传统的同意方法(例如面对面,电话和邮件)继续被使用。调查结果表明,美国生物银行对电子同意书非常感兴趣,并且需要考虑一系列实施问题,包括用户的偏好和接受度;机构和技术支持;与临床数据网络集成;电子签名捕获;以及实施哪种类型的电子同意书。为了解决这些问题,生物库将需要基于证据的指导,以便电子同意流程可以提高效率,并有助于参与者的接受,理解和信任。

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