Mee Blanaid, Gaffney Eoin, Glynn Sharon A, Donatello Simona, Carroll Paul, Connolly Elizabeth, Garrigle Sarah Mc, Boyle Terry, Flannery Delia, Sullivan Francis J, McCormick Paul, Griffin Mairead, Muldoon Cian, Fay Joanna, O'Grady Tony, Kay Elaine, Eustace Joe, Burke Louise, Sheikh Asim A, Finn Stephen, Flavin Richard, Giles Francis J
1 St. James's Hospital , Dublin, Ireland .
Biopreserv Biobank. 2013 Feb;11(1):3-11. doi: 10.1089/bio.2012.0028.
Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents-Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups-Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.
爱尔兰生物样本库信托基金（BIT）成立于2004年，旨在促进和发展爱尔兰生物样本库网络，以造福患者、研究人员、产业界和经济。该网络于2008年从两家医院生物样本库起步，目前由爱尔兰四大主要癌症医院的生物样本库组成。圣詹姆斯医院（SJH）生物样本库负责协调该网络。基于国际生物和环境样本库协会（ISBER）及美国国立癌症研究所（NCI）指南的程序在整个网络中实现了标准化。政策和文件——患者同意政策、患者信息表、生物样本库同意书、样本和数据访问政策（SAP）以及样本申请表已经（经过充分讨论）达成一致，供各医院使用。文中概述了文件编制和提交审核的最佳顺序。参与的生物样本库达成共识后，SJH生物样本库会与研究和伦理委员会、数据保护专员办公室、国家癌症登记处（NCR）、患者权益倡导组织、研究人员及其他利益相关者进行联络。NCR通过独特的生物样本库代码从其数据库为研究人员提供去标识化数据。讨论的伦理、法律和社会问题（ELSI）包括在整个网络中引入前瞻性同意以及向患者反馈重大研究结果。在每次将患者样本纳入新项目时，363名患者中只有4人选择被再次联系并重新获得同意。经过多学科讨论后决定，研究结果将不会反馈给患者。SAP以几个国际网络的模式为蓝本。爱尔兰生物样本库隶属于国际生物样本库组织——大理石拱门国际工作组、ISBER和欧洲生物样本库与生物分子资源研究基础设施（ESBB）。爱尔兰政府仍在商讨如何在全国范围内为生物样本库提供资金并付诸实施。与此同时，BIT利用一切机会在活动和媒体中宣传生物样本库的益处。
