SHARE: Simplifying Human Subject Data Sharing for Alcohol Researchers

分享：简化酒精研究人员的人类受试者数据共享

• 批准号: 10259585
• 负责人: Niina M. Haas
• 金额: $ 96.43万
• 依托单位: BRIGHTOUTCOME INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259585
• 关键词: Address; Alcohols; Applications Grants; Automation; Budgets; Code; Collection; Comb animal structure; Complex; Computer Assisted; Consumption; Data; Data Collection; Development; Evaluation; Face; Funding; Goals; Hand; Health; Human; Information Technology; International; Interview; Knowledge; Language; Libraries; Manuals; Maps; Measures; Mental Health; Modernization; National Institute of Mental Health; National Institute on Alcohol Abuse and Alcoholism; Performance; Phase; Pilot Projects; Policies; Preparation; Procedures; Process; Randomized; Research; Research Personnel; Research Project Grants; Resources; Rest; Site; Surveys; Technical Expertise; Technology; Time; Translational Research; United States National Institutes of Health; Validation; Vision; Work; alcohol research; archive data; archived data; cost; data access; data archive; data dictionary; data harmonization; data quality; data sharing; data standards; data submission; design; electronic data; experience; flexibility; human subject; improved; programs; prototype; recruit; repository; research study; standard measure; tool; usability; user-friendly

Abstract The National Institute of Mental Health (NIMH) Data Archive (NDA) collects and shares de-identified human subjects data from hundreds of NIH-funded research projects across many mental health-related scientific domains with qualified researchers. A new NDA repository is created for the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) and will serve as the portal for NIAAA-related data submissions and access. The NIAAA data-sharing policy (NOT-AA-19-020) released in July of 2019, requires that— beginning in 2019—all NIAAA grant applications involving human subjects must include plans for the submission of study data to NIAAADA. The first wave of submission to NIAAADA is expected in January of 2021. Many obstacles exist for alcohol researchers to comply with this policy, especially for those with limited budget and information technology support. To submit the study data, researchers have to comb through large and complex NDA data definition files, often filled with inconsistencies and inaccuracies, to find the measure items that they need, and then map their data to the right fields in the right format in a given data template. This process often requires researchers to manipulate their data by-hand or with complicated scripts, and is error prone, time-consuming, and requires certain technical skills. Our ultimate goal is to provide a nearly-automated process for the submission of alcohol research data into the NIAAADA so that the data submission can be performed accurately and efficiently by alcohol researchers with minimum IT knowledge and resources. We propose to develop and validate the Share HumAn REsearch (SHARE) platform to address the unmet need for assisting alcohol researchers with the submission of study data to NIAAADA. SHARE does so by offering the SHARE Measure Library of pre-defined standard measures that are already mapped to NDA data dictionaries. Alcohol researchers need to only select the measures that they want to use for their studies and let SHARE do the rest for data submission to NIAAADA. Phase II aims include: 1) Platform and measure development. In Phase II we will continue using a user-centric design process and the latest e-technologies to develop SHARE, and we will extend to 200 measures in both English and Spanish (when available). 2) Pilot evaluation. There will be 4 NIAAADA submission waves during the two-year Phase II period. We plan to align both Aim 1 and Aim 2 activities to these 4 submission waves and recruit five projects in each wave to compare the performance of SHARE vs. NDA. A total of 20 pilot projects will be recruited and randomized to use either SHARE or NDA for NIAAADA submission. The time and cost for data preparation and submission will be tracked, and the accuracy of submitted data assessed. We hypothesize that compared to NDA, SHARE will perform significantly better in terms of reduced time and cost improved data accuracy.

摘要 国家精神卫生研究所（NIMH）数据档案（NDA）收集和分享去身份化的人类 这些数据来自NIH资助的数百个研究项目，涉及许多与心理健康相关的科学领域。 与合格的研究人员领域。为国家酒精研究所创建了一个新的NDA存储库 滥用和酗酒数据档案（NIAAADA），并将作为NIAAA相关数据提交的门户网站 和访问。2019年7月发布的NIAAA数据共享政策（NOT-AA-19-020）要求- 从2019年开始，所有涉及人类受试者的NIAAA资助申请必须包括 向NIAAADA提交研究数据。第一波向NIAAADA提交的申请预计将于2021年1月提交。 酒精研究人员遵守这一政策存在许多障碍，特别是对于那些预算有限的人 和信息技术支持。为了提交研究数据，研究人员必须梳理大型和 复杂的NDA数据定义文件，通常充满了不一致和不准确的地方，以查找度量项 然后将他们的数据映射到给定数据模板中正确格式的正确字段。这 这一过程通常需要研究人员手工或使用复杂的脚本来操作数据， 容易，耗时，并需要一定的技术技能。我们的最终目标是提供一个近乎自动化的 向NIAAADA提交酒精研究数据的过程，以便数据提交可以 由酒精研究人员以最少的IT知识和资源准确有效地执行。 我们建议开发和验证共享人类研究（SHARE）平台，以解决未满足的问题。 需要协助酒精研究人员向NIAAADA提交研究数据。SHARE通过以下方式实现 提供已映射到NDA数据的预定义标准度量的SHARE度量库 字典酒精研究人员只需要选择他们想要用于研究的措施， 让SHARE完成其余的数据提交给NIAAADA。 第二阶段的目标包括：1）平台和措施的制定。在第二阶段，我们将继续使用以用户为中心的 设计过程和最新的电子技术来开发SHARE，我们将在两个方面扩展到200个措施 英文和西班牙文（如有）。2)试点评价。期间将有4次NIAAADA提交浪潮 第二阶段为期两年。我们计划将目标1和目标2活动与这4个提交波相结合 并在每一波中招募五个项目来比较SHARE与NDA的表现。共20名飞行员 将招募并随机分配项目，以使用SHARE或NDA提交NIAAADA。的时间和 将跟踪数据编制和提交的费用，并评估所提交数据的准确性。我们 假设与NDA相比，SHARE在减少时间和成本方面的表现明显更好 提高数据准确性。