审查与保证.ppt

September 20, 2001 Melody Lin, Ph.D. H:\NWU-Chicago, IL\Effective Compliance Audits Assurances审查与保证 Melody Lin, Ph.D. Deputy Director, OHRP Director, OIA 人类研究保护办公室副主任 国际合作办公室主任 2003年3月 中国北京 Objectives目标 Assurance 保证 Audits 审核 Lesson learned 取得的经验 Institutional Assurances机构保证 Assurances 保证 “Each institution engaged in research which is covered by this policy and which is conducted or supported by a Federal Department or Agency shall provide written assurance ... that it will comply with the requirements set forth in this policy.“ [45 CFR 46.103(a)] 受本规定管理，联邦政府部门或机构从事或接受其资助进行研究活动的每一个机构都必须提供书面保证…保证其将遵守本规定之要求。 [45 CFR 46.103(a)] Approved by OHRP 得到人类研究保护办公室的批准 Assurances 保证 The institution must certify that the research has been reviewed and approved by an IRB. 机构必须证明研究已经过伦理审查委员会的审查并获得批准。 [45 CFR 46.103(b)] Submitted to funding agency 提交给资助机构 Assurances 保证 What is an Institutional Assurance? 什么是机构保证 Documentation of institutional commitment to comply with the Common Rule 机构陈诺遵守共同准则的书面文件 Principal method of compliance oversight 主要遵从方法的监管 New OHRP Federalwide Assurance 新的OHRP联邦范围内的保证 Assurances保证 Required from each institution “engaged” in the research 每一个“从事”研究的机构都需要 See OHRP guidance on when institutions are engaged in research: 有关参与研究的OHRP指南参见一下网页： /humansubjects/assurance/engage.htm OHRP Federalwide AssuranceOHRP的联邦范围保证 All Institutions Eligible 所有机构都符合条件 Web-Based 以网络为基础 IRB Registration 伦理审查委员会注册 Rely on own institutional IRB, other institutional IRB, commercial IRB 依靠本机构的IRB, 其他机构的IRB以及商业IRB。 OHRP Federalwide AssuranceOHRP联邦范围保证 No OHRP review of individual applications, protocols, consent documents OHRP不评审单独申请、设计书、同意文件 Recommended completion of OHRP Assurance Training Modules (not considered education training) 建议完成OHRP保证培训课程（不被认为是教育培训） OHRP Federalwide AssuranceOHRP联邦范围保证 Education Training 教育培训 Initial Continuing Education 起始于连续教育 IRB Chair, Members, Staff 伦理审查委员会主席、成员、职员 Investigators 研究人员 OHRP Federalwide AssuranceOHRP联邦范围保证 Educatio