IRB审核流程

一旦你提交了材料, your application will be sent out for review which will be conducted by one or more members of the Northwest IRB Committee. IRB review considers only whether the study meets the requirements for ethical research outlined by OHRP, 而不是研究问题或方法的质量. 审稿人人数, 复习时间长度, and complexity of review will depend upon which application was submitted:

• Exempt IRB applications involving adult subjects are typically reviewed by one committee member; initial review is usually completed within one week of 提交.
• Exempt IRB applications involving child subjects are typically reviewed by 2-3 committee members, at least one of which has expertise in research with children; initial review is usually completed within one week of 提交.
• Expedited IRB applications are typically reviewed by 2-3 committee members and initial reviews are usually completed within 1-2 weeks of 提交. 快速审查程序不因受试者年龄而异, though expedited projects with child subjects will include at least one member with expertise in research with children.
• Full IRB applications are reviewed and discussed by the full committee during a physical meeting (or, 在极端情况下, 虚拟会议). This meeting requires attendance of at least 50% of committee members and must include a 首位 IRB成员出席. 完整的IRB审查通常在提交的一个月内完成.

审查委员会的决定和重新提交

一旦西北IRB审查了你的申请, a decision will be made regarding whether your project can be approved in its current form. If your project is approved, you will be contacted through email by the chair of the Northwest IRB. The chair will provide you an IRB approval code and an approval letter signed by the chair and stating the terms of your approval.

It is common for reviewers to ask for revisions to your 程序 or materials prior to granting approval. 在这些情况下, the chair will contact you through email and explain any revisions to be made prior to approving your project for data collection. These changes can usually be made through a reply email with procedural questions answered and/or new versions of documents submitted.

在某些罕见的情况下, a full IRB application may be denied by the IRB committee based on its high risk of subject harm. If you think your project may have a high chance of harming subjects and would like to discuss it, 请联络西北税务局(IRBNWMS@wolaipei.com)，然后提交申请.

IRB批准后协议变更

有时, unexpected issues or problems arise that require the protocols and 程序 of a research project to be changed after the project has begun. It is important to understand that IRB approval is only granted to a project in the state that it was submitted and reviewed by the Northwest IRB committee. 

If any changes to protocol or 程序 are made following IRB approval, 首席研究员必须提交一份 协议变更表   透过西北税务局电邮地址(IRBNWMS@wolaipei.com). 表单提交后, it will be reviewed at same level at which the initial IRB application was reviewed. Note that some protocol changes may require your project to undergo an entirely new review if the protocol leads to higher subject risk or if your project no longer fits under the exempt or expedited category it was originally approved under.

当作出决定时, the chair of the Northwest IRB will contact you through email notifying you of approval to continue with the new protocol or requesting changes to the protocol.

无法使用更新后的协议收集数据, 程序, 或表格，直到获得IRB对协议变更的批准. 

Common examples of protocol changes you might need to submit for approval include (but are not limited to):

• 增加新的主要研究人员, 教师顾问, 或者其他可以接触到参与者和数据的研究人员.
• 增加新的调查问题/问卷, or changing the wording or presentation of existing survey questions/questionnaires.
• 改变进行面对面研究的地点, 或者改变地点的各个方面(例如.g.允许比原计划更大的团体参与).
• 改变项目执行的方式(e).g., an in-person study which needs to shift to online data collection 程序).
• Changes to 程序 or materials due to unforeseen circumstances that have arisen during data collection (e.g., adding a procedure requiring subjects to turn their phones off prior to participation).
• Collecting additional subjects significantly beyond that planned in the original IRB application.

继续复习

在获得初步批准后, most projects do not require continuing review or notice of project completion unless a protocol change must be approved:

• Exempt projects do not require any further information following IRB approval unless a protocol change occurs.
• By default, expedited projects do not require further information following approval. 然而, the IRB may request continued review and status reports for expedited projects deemed in need of special oversight.
• 需要全面审查的项目必须继续进行审查.

如果您的项目需要持续审查, the review process will be outlined in the approval letter you receive for your project. 要完成持续审查，您必须提交一份 IRB状态报告   项目批准后一年内的表格. Keep in mind that the one year timeline is the maximum allowed for a continued review, and the Northwest IRB may determine and require continued review under a shorter timeline.

如果您的状态报告在一年内未提交批准, IRB主席将通过电子邮件与您联系，要求您提供状态报告. 如果一个没有提交在一个星期内的电子邮件联系, the project will be 关闭d and you will not be allowed further time for data collection without submitting a new IRB review application.