Woolley J Patrick, Kirby Emily, Leslie Josh, Jeanson Francis, Cabili Moran N, Rushton Gregory, Hazard James G, Ladas Vagelis, Veal Colin D, Gibson Spencer J, Tassé Anne-Marie, Dyke Stephanie O M, Gaff Clara, Thorogood Adrian, Knoppers Bartha Maria, Wilbanks John, Brookes Anthony J
1Harris Manchester College, University of Oxford, Mansfield Road, Oxford, OX1 3TD UK.
2Public Population Project in Genomics and Society (P3G), McGill University and Genome Quebec Innovation Centre, 740 Dr Penfield Avenue, Suite 5104, Montreal, QC H3A 0G1 Canada.
NPJ Genom Med. 2018 Jul 23;3:17. doi: 10.1038/s41525-018-0057-4. eCollection 2018.
Given the data-rich nature of modern biomedical research, there is a pressing need for a systematic, structured, computer-readable way to capture, communicate, and manage sharing rules that apply to biomedical resources. This is essential for responsible recording, versioning, communication, querying, and actioning of resource sharing plans. However, lack of a common "information model" for rules and conditions that govern the sharing of materials, methods, software, data, and knowledge creates a fundamental barrier. Without this, it can be virtually impossible for Research Ethics Committees (RECs), Institutional Review Boards (IRBs), Data Access Committees (DACs), biobanks, and end users to confidently track, manage, and interpret applicable legal and ethical requirements. This raises costs and burdens of data stewardship and decreases efficient and responsible access to data, biospecimens, and other resources. To address this, the GA4GH and IRDiRC organizations sponsored the creation of the Automatable Discovery and Access Matrix (ADA-M, read simply as "Adam"). ADA-M is a comprehensive information model that provides the basis for producing structured metadata "Profiles" of regulatory conditions, thereby enabling efficient application of those conditions across regulatory spheres. Widespread use of ADA-M will aid researchers in globally searching and prescreening potential data and/or biospecimen resources for compatibility with their research plans in a responsible and efficient manner, increasing likelihood of timely DAC approvals while also significantly reducing time and effort DACs, RECs, and IRBs spend evaluating resource requests and research proposals. Extensive online documentation, software support, video guides, and an Application Programming Interface (API) for ADA-M have been made available.
鉴于现代生物医学研究数据丰富的特性,迫切需要一种系统、结构化且计算机可读的方式来捕获、传达和管理适用于生物医学资源的共享规则。这对于资源共享计划的负责任记录、版本控制、沟通、查询和执行至关重要。然而,对于管理材料、方法、软件、数据和知识共享的规则和条件,缺乏通用的“信息模型”构成了一个基本障碍。没有这个模型,研究伦理委员会(REC)、机构审查委员会(IRB)、数据访问委员会(DAC)、生物样本库和最终用户几乎不可能自信地跟踪、管理和解释适用的法律和伦理要求。这增加了数据管理的成本和负担,并降低了对数据、生物样本和其他资源的高效且负责任的访问。为了解决这个问题,全球基因组与健康联盟(GA4GH)和国际罕见病研究协作网(IRDiRC)组织赞助创建了可自动化发现与访问矩阵(ADA-M,简称为“亚当”)。ADA-M是一个全面的信息模型,为生成监管条件的结构化元数据“简档”提供了基础,从而能够在各个监管领域高效应用这些条件。广泛使用ADA-M将有助于研究人员以负责任和高效的方式在全球范围内搜索和预筛选潜在的数据和/或生物样本资源,以使其与研究计划兼容,提高DAC及时批准的可能性,同时还能显著减少DACs、RECs和IRBs在评估资源请求和研究提案上花费的时间和精力。目前已经提供了关于ADA-M的大量在线文档、软件支持、视频指南以及应用程序编程接口(API)。