IRB Review Process

Once your materials are submitted, 您的申请将被发送给西北IRB委员会的一名或多名成员进行审查. IRB审查只考虑该研究是否符合OHRP概述的伦理研究要求, not the quality of the research questions or methodologies. The number of reviewers, length of review time, 审查的复杂程度将取决于提交的申请:

• Exempt IRB applications involving adult subjects are typically reviewed by one committee member; initial review is usually completed within one week of submission.
• 涉及儿童主题的豁免IRB申请通常由2-3名委员会成员审查, at least one of which has expertise in research with children; initial review is usually completed within one week of submission.
• 快速IRB申请通常由2-3名委员会成员审查，初步审查通常在提交的1-2周内完成. The expedited review process does not vary based on subject age, 虽然与儿童有关的加速项目将包括至少一名具有儿童研究专业知识的成员.
• 完整的IRB申请由全体委员会在实际会议(或会议期间)进行审查和讨论, in extreme circumstances, a virtual meeting). 该会议要求至少50%的委员会成员出席，并必须包括一名 non-scientist IRB member in attendance. Full IRB reviews are usually completed within one month of submission.

IRB Decisions and Re-Submission

Once the Northwest IRB has reviewed your application, 将决定你的项目是否能以目前的形式获得批准. 如果您的项目被批准，西北IRB主席将通过电子邮件与您联系. 主席将向您提供IRB批准代码和由主席签署的批准信，并说明您的批准条款.

审稿人在批准之前要求修改您的程序或材料是很常见的. In these cases, 主席将通过电子邮件与您联系，并解释在批准您的项目进行数据收集之前需要进行的任何修改. 这些更改通常可以通过回复电子邮件进行，其中包含已回答的程序问题和/或提交的文件的新版本.

In certain rare cases, 一个完整的IRB申请可能会被IRB委员会基于其高风险的主体损害拒绝. 如果你认为你的项目可能有很高的机会伤害科目，并想讨论它, please contact the Northwest IRB (IRBNWMS@zheeer.com) prior to submitting your application.

Protocol Changes After IRB Approval

Sometimes, 在研究项目开始后，出现了意想不到的问题或问题，需要改变研究项目的协议和程序. 重要的是要明白，IRB批准只授予在西北IRB委员会提交和审查的状态下的项目. 

如果在审核委员会批准后对协议或程序进行了任何更改, the principal investigator must submit a Protocol Change Form   through the Northwest IRB email address (IRBNWMS@zheeer.com). Once the form is submitted, 它将在审查最初的内部审查委员会申请的同一级别上进行审查. 请注意，如果协议导致更高的主题风险，或者如果您的项目不再符合最初批准的豁免或加急类别，则某些协议变更可能要求您的项目经历全新的审查.

When a decision is reached, 西北IRB主席将通过电子邮件与您联系，通知您批准继续使用新方案或要求更改方案.

Data cannot be collected using updated protocols, procedures, or forms until IRB approval of the protocol change has been obtained. 

您可能需要提交批准的协议更改的常见示例包括(但不限于):

• Adding new principal investigators, faculty advisors, or other researchers who will have access to participants and data.
• Adding new survey questions/questionnaires, 或更改现有调查问题/问卷的措辞或呈现方式.
• Changing the location in which an in-person study will be conducted, or changing aspects of the location (e.g., allowing larger groups to participate than was originally planned).
• Changing the modality by which the project is conducted (e.g.(需要转向在线数据收集程序的面对面研究).
• 由于在数据收集过程中出现的不可预见的情况而导致程序或材料的更改(例如.g.增加了一个程序，要求受试者在参与前关掉手机)。.
• 收集远远超出原始IRB应用程序计划的额外主题.

Continuing Review

After receiving initial approval, 大多数项目不需要持续审查或项目完成通知，除非必须批准协议变更:

• 豁免项目在IRB批准后不需要任何进一步的信息，除非协议发生变化.
• 默认情况下，加急项目在批准后不需要进一步的信息. However, 内部审查委员会可要求对被认为需要特别监督的加急项目继续进行审查并提供状态报告.
• Projects requiring a full review must undergo continued review.

If your project requires continued review, 审查过程将在您收到的项目批准信中概述. To complete a continued review, you must submit an IRB Status Report   form within one year of the approval of your project. 请记住，一年的时间是允许继续审查的最长时间, 西北IRB可能会决定并要求在更短的时间内继续进行审查.

If your status report is not submitted within one year of approval, the IRB chair will contact you through email to request a status report. If one is not submitted within one week of email contact, 该项目将被关闭，如果不提交新的审查委员会审查申请，您将不允许有更多的时间收集数据.