...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Biopreservation and biobanking >Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic
【24h】

Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic

机译：在门诊心脏病学诊所中遗址生物发展的同意研究临床过程建模

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Introduction: Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our goal was to develop an electronic self-consenting workflow that mimicked clinical services. Specifically, we tested a research consent process for the biobanking of remnant clinical samples that relies solely on clinical resources in a busy outpatient practice. Materials and Methods: The Biorepositories Core Resource (BCR) unit initiated a new enterprise-wide biobanking infrastructure for consenting patients, termed Biospecimen Use for Research-Related Investigations and Translational Objectives (BURRITO). BURRITO is modeled after an established clinical process called Terms and Conditions of Service (TACOS). The TACOS requires patients to annually review printed documentation and self-consent electronically for clinical services. BURRITO also requires patients to review printed documentation and self-consent with eSign to opt-in for remnant biospecimen banking, but patients must complete this process only once. We captured eSign for consents directly into the EMR without research staff. Results: Patients reviewed the IRB-approved documents and self-consented during their cardiology clinic visit. At checkout, their participation preferences were electronically documented by clinic staff. During a 6-month period, 123 patients agreed to donate. After a review of process, a second 3-month period identified 202 patients agreeing to donate. BURRITO did not require face-to-face interactions with research staff, used a "no-paper" eSign for consent, and created discrete fields in the clinical EMR of the patient's preference. Conclusions: BURRITO electronically documents informed consent using an EMR functionality and the least amount of clinical and research resources. Our results show promise for developing institutionally adopted processes, which could leverage existing clinical workflows for universal research consenting and scalability.
机译：简介：传统上通过与研究人员的面对面互动以及签署机构审查委员会（IRB）批准的印刷表格来获得知情同意。电子签名（伊斯群）经常用于电子医疗记录（EMR），以便在患者审查印刷文件后同意临床服务。我们的目标是开发一种电子自我同意的工作流程，模仿临床服务。具体而言，我们测试了对残留临床样本的生物库的研究同意过程，这些方法仅依赖于繁忙的门诊实践中的临床资源。材料和方法：生物数据库核心资源（BCR）单位发起了一种新的企业宽的生物管理基础设施，用于同意患者，被称为生物开发用途，用于研究相关的调查和翻译目标（卷饼）。卷饼在既定的临床过程之后建模，称为服务条款和条件（炸玉米饼）。炸玉米饼要求患者每年审查印刷文件和自我同意，以电子方式用于临床服务。 Burrito还要求患者审查印刷文件和自同意的伊罗族来选择遗留生物起草银行，但患者必须只完成一次这个过程。我们捕获了伊尊，直接在没有研究人员的EMR中。结果：患者在心脏病学诊所访问期间审查了IRB批准的文件并自我同意。结账时，他们的参与偏好被诊所员工以电子方式记录。在6个月期间，123名患者同意捐赠。在对过程审查后，第二个3个月期间确定了202名患者，同意捐赠。卷饼不需要与研究人员面对面的互动，在患者偏好的临床EMR中使用了“无纸”伊斯级，并在临床EMR中创造了离散领域。结论：Burrito以电子方式通过EMR功能和最少量的临床和研究资源提供了知情同意。我们的结果表明，建立制度通过的流程，可以利用现有的临床工作流，以实现普遍研究同意和可扩展性。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号