IRB:合作和外部研究

Collaborative studies are those in which each of the institutions involved are significantly engaged in the 研究, usually by means of local investigators carrying out 研究 每个研究地点的活动. 如果研究不涉及员工的外部 institutions collecting data from participants, obtaining informed consent, or being involved as members of the 研究 team, then the work is probably not a collaborative 研究. 同样，如果上海州立大学的研究人员将询问其他机构的员工 to pass along recruitment information to prospective participants this, al一个, does 不构成合作研究.

For collaborations that involve both 菠菜网lol正规平台 investigators and external investigators, different approaches may be used to obtain approval depending on how the 研究 将进行. 每个调查员都可以独立地获得批准 their respective IRBs or 一个 institution can agree to be the reviewing IRB; a reliance 在后一种情况下，协议成立.

In addition to the expectations outlined below for various circumstances, you may also need to obtain ancillary agreements depending on the type of data or materials 机构间共享. 协议，如数据使用协议(dua)和材料 转让协议(mta)由 上海外国语大学研究基金. 但是，IRB办公室可能会在适用的情况下指导您联系研究基金会 an IRB reliance agreement process between intuitions can be pursued separately from 可能需要的任何附加协议.

菠菜网lol正规平台调查员与外部IRB批准 

菠菜网lol正规平台 IRB接受外部机构的IRB批准 联邦保险(FWA) 只要审查的IRB愿意签订一份信赖协议.  我们参与 in reliance agreements for all review types, including administrative reviews of exempt 研究. 

IRB Mentor User Guide for 菠菜网lol正规平台 Investigators Relying on an External IRB Approval (required 阅读)[pdf]
Follow the instructions and steps outlined in this document for registering your external IRB approval within our online submission system (IRB Mentor) to allow the 菠菜网lol正规平台 IRB 办公室与审查IRB启动信任协议. 的链接 IRB导师网站，请访问我们的 提交页面.

所需文件

Most of these elements will be required within the IRB Mentor system and you will 在您提供所需信息之前，我们无法提交您的请求. If we receive initial communication from an external IRB, it is still your responsibility 通过IRB Mentor系统提供以下信息. 

  1. 审查内部审查委员会的姓名、职务和联系方式.
  2. The name, title, contact details of the signatory official for the reviewing institution.
  3.  审核内部审查委员会的FWA号码.
  4. 审核IRB分配给协议的跟踪号.
  5. 审查委员会的研究批准信. 如果外部IRB不愿意 to approve a protocol until a reliance agreement is established, you are responsible 提交除批准通知以外的所有其他文件.
  6. The IRB application, outlining the methods and procedures of the 研究, which lists 你作为研究人员的一部分.
  7. 同意文件(如适用).
  8. 数据仪器，如适用.
  9. Any site-specific forms required by the reviewing IRB and/or the reliance agreement 外部IRB希望使用的格式. 信赖协议的形式是典型的 称为机构授权协议(IAA). 如果审查IRB 不提供表格，我们会提供我们自己的吗.
  10.  Be prepared to explain how 菠菜网lol正规平台 is involved in the 研究, whether subjects will be recruited on campus (if so, provide the recruitment materials), whether data will be collected on campus, and what kind of information will be shared with external 团队成员.

确认通知

The 菠菜网lol正规平台 IRB Office will contact the reviewing IRB to establish a reliance agreement 一旦我们收到你的提交. 您将收到一封电子邮件，您可以开始 只有在信赖协议建立之后才学习. 确认的时间框架 will depend on whether the external IRB is willing to serve as the IRB of record and 他们多快能提供签署的协议. 我们建议您联系 reviewing IRB ahead of time to confirm their cooperation and to determine a timeline 用于签署信赖协议. 如果我们不能建立信任 agreement, the 菠菜网lol正规平台 IRB will conduct its own review and you will be asked to provide 通过IRB导师系统完成菠菜网lol正规平台申请.

菠菜网lol正规平台 IRB批准的外部人员研究

菠菜网lol正规平台调查人员可以在他们的申请中列出外部人员. 然而, 菠菜网lol正规平台招生委员会不对外部人员的合规性承担责任. Instead, external personnel should contact their IRB, either to coordinate a reliance agreement with the 菠菜网lol正规平台 IRB as the IRB of record or to have their IRB conduct a separate 审查他们的活动. 外部人员谁没有支持的一个 external IRB and have not established a contract with 菠菜网lol正规平台 should not receive access 个体识别主体的信息.  菠菜网lol正规平台的调查人员受到鼓励 to be judicious about who they add as part of the 研究 personnel, as responsibility for compliance rests with the 菠菜网lol正规平台 PI in the event that external personal do not have 外部审计委员会的支持.

涉及人类受试者的国际研究

菠菜网lol正规平台 IRB没有 recognize informal agreements between 菠菜网lol正规平台 investigators and 国际合作者. IRB没有授予许可的权力 to conduct 研究 that relies on the support of non-US institutions or personnel to access human subjects or their identifying information unless a formal arrangement 已经就位了.  菠菜网lol正规平台调查人员可以选择只接收去识别数据 from 国际合作者 (thus eliminating the involvement of human subjects in the 活动 of 菠菜网lol正规平台 affiliates) or they must pursue a formal agreement via the CSU Chancellor's Office if they wish to rely on international institutional support 访问主题或其识别信息. 联系 合规办公室 获取关于达成一项csu级别协议的信息.

For international 研究 where local institutional support is not needed, 菠菜网lol正规平台 investigators are responsible for determining what kinds of permissions are needed from the country where the human subjects 研究 将进行 and for providing documentation 通知内部审核委员会本地的要求已经得到满足. 权限可能包括 (but are not limited to) formal applications via the country’s embassy or regulatory authority, a local ethics review, as well as the fulfillment of all applicable local 隐私法.

In addition, investigators traveling abroad should review the information and expectations 关于国际旅行提供上 合规办公室网站.

在上海大学进行非合作研究的外部调查员

Non-菠菜网lol正规平台 investigators who wish to conduct human subjects 研究 at San Jose State University should seek IRB approval from their home institution, and be prepared to 向任何提出要求的人提供IRB批准的证据. 菠菜网lol正规平台 IRB没有 provide review services or evaluate 研究 projects conducted by external investigators. The 菠菜网lol正规平台 IRB will not provide you with an acknowledgment regarding your 研究, and we will not take responsibility for or provide institutional support for your 研究 活动.

Campus departments and staff are not obligated to assist you with your 研究 活动, including the recruitment of subjects or the release of student directory information. 校园社区的合作完全是自愿的. IRB办公室不会 assist you with recruitment, the acquisition of secondary data, or referrals to 菠菜网lol正规平台 人事或办公室. 菠菜网lol正规平台人员的自愿合作并不意味着菠菜网lol正规平台 支持你的研究.