Submitting Your IRB Application

All IRB应用程序s are to be submitted electronically. 调查人员被要求 完成 Electronic Submission Form，附上他们的 IRB应用程序 and click "Submit Proposal" at the bottom of the form. 

Other required supporting documents—including the 知情同意书, copies of all questionnaires and data collection instruments and any other supporting documentation—should be attached to an email and sent to irb@0759e.net.

All files should be submitted as Microsoft Word files unless the documentation is only available in another format (e.g., PDF).

Overview of Application Submission Process

注意: 而 student investigators can prepare their IRB应用程序 以及支持文件, they are not authorized to electronically submit their IRB应用程序. 在回顾 the student researcher's IRB应用程序 以及支持文件, the student's faculty advisor must upload the application on the student's behalf.  指导老师 must be listed in the IRB应用程序 and informed consent form.

1. 调查员准备 IRB应用程序.

2. 调查员完成 Electronic Submission Form, attaches the IRB应用程序, and clicks "Submit Proposal" at the bottom of the form. 

3. Investigator emails all required supporting documents—including the 知情同意书, copies of all questionnaires and data collection instruments and any other supporting 文档 irb@0759e.net.
   

4. IRB Coordinator notifies researcher (via email) that materials have been received, and provides the investigator with the protocol number associated with the IRB应用程序. This protocol number is to be used in all correspondence related to the application.

5. The IRB应用程序 and all supporting documents go to the IRB Chair, who determines 审查的类型(例如.g., 免除, expedited or full).
   
   
6. Subsequent to the review, the IRB应用程序 以及支持文件 will be returned to the investigator with any comments, requests for clarifications, and/or suggested edits provided by the reviewing IRB committee members. 调查员会 be asked to return the materials highlighting any revisions made and providing responses to the reviewing IRB committee members' comments.

7. When the reviewing IRB committee members are satisfied with the revisions and/or clarifications, the IRB Chair will send the investigator a final, clean copy of the IRB应用程序 以及支持文件. The IRB Chair will then issue an approval letter along with any initialed, date-stamped informed consent/verbal assent forms.

The IRB seeks to be as timely and responsive to review requests as possible. 而 the IRB is typically able to review an application within five business days, it may take up to two weeks to review an application depending on the classification. If your application requires the IRB to convene for a full-board IRB review, your application 以及支持文件 must be received at least one week before the next scheduled 会议. 看到 Meeting Schedule and Submission Deadlines 欲知详情.

Submission of an Amendment to an Approved IRB Protocol

Plans to deviate from the approved protocol and/or supporting documents must be submitted to the IRB as an amendment request and approved by the IRB prior to the implementation of any changes, regardless of how 小, except 1) where necessary to eliminate apparent immediate hazards to the subjects and 2) 小 changes to IRB protocols classified as 免除 如下:

• editorial or administrative revisions to consent documents or other study documents
• adding non-sensitive questions to a survey or interview or revising current questions
• increasing or decreasing number of participants, unless you are adding a new participant 人口

Amendment requests should be emailed to the IRB Chair. 邮件应该总结 the proposed changes, and the most recently approved IRB protocol should be attached with the proposed changes outlined using track-changes. The Chair will determine whether or not the proposed changes require additional review by the IRB.