Humans Subjects Research - Institutional Review Board (IRB)

菠菜网lol正规平台 has transiti一个d from an email 提交 system for studies involving human subjects to a cloud-based 提交 and review system called IRB Mentor. 我们现在 通过IRB导师接受提交. Starting June 1st, 2023 new study protocols must be submitted via IRB Mentor. 新 study 提交s will no longer be accepted 通过电子邮件 after this date.  

For IRB Mentor 提交 information, including how to manage pre-IRB Mentor approved 研究，请访问我们的 提交页面. View the information under the "Managing Pre-Mentor IRB Submissions" heading at the bottom of the page for information on your pre-Mentor IRB protocol.

菠菜网lol正规平台研究人员:入门

  • 我的项目需要评审吗? 使用我们的 排除决定工作表[pdf] to determine whether your work needs to be submitted to the IRB Office for review. This involves determining whether the work meets the federal definitions for "research" 和"人类受试者"." If, after using this worksheet, you determine that your work does not need to be submitted for review, please keep the worksheet for your records. This worksheet does not need to be submitted to our office and you do not need confirmation from our office to proceed with work that is excluded.

  • 访问我们的 帮助和指导页面 for videos and related educational documents, to understand review types and associated timelines, and to familiarize yourself with common application problems and ways to 避免这些问题.

  • 访问我们的 表格及文件 page to download informed consent templates and other forms or informational documents.

  • 确保你已经完成了一个 培训课程 if you are a faculty or staff member submitting your own protocol or supervising 学生的研究. The training is also recommended but not mandatory for students. Refresher 培训课程s are currently required every five years.

  • 查看我们的 提交页面 to get acquainted with the IRB Mentor 提交 system and to access user guides on how to accomplish various 提交s in Mentor. 

Steps for Submitting Your Protocol for IRB Review

You may not begin ANY recruitment, enrollment, or data collection until you have received a formal approval letter from the 菠菜网lol正规平台 IRB, regardless of the review type associated 提交后. This includes submitting any formal requests for the use of secondary data. If data are collected prior to receiving IRB approval, you may not use that 你的研究数据. The IRB does not retroactively issue approval.

  1. When submitting a new study refer to our 内部审查委员会提交资料核对表[pdf] 查看所需项目的摘要.

  2. 去我们的 提交页面 for instructions on how to access IRB Mentor. 确保阅读相关用户 guides for navigating the Mentor system before you log in.

  3. Once you have completed your IRB application within IRB Mentor and uploaded all required supplemental documentation, you will submit your study by electronically signing the 提交. If you are a student, you will be prompted to identify your faculty supervisor 作为提交过程的一部分. Once you sign your 提交, your faculty supervisor will be notified by an automated email to review and approve your 提交 before 它被交付给IRB. Your faculty supervisor may require edits before accepting 应用程序. If your faculty supervisor does not accept the 提交, it will 而不是寄到IRB办公室.

  4. Check IRB Mentor for any status updates.

    The IRB Office will contact you with any questions, comments, request for revisions, 或者担心你的提交. Once a study has been determined to meet federal, state, and institutional criteria for approval, you will receive an approval letter 通过电子邮件. The research team will then be able to begin subject recruitment, enrollment, 数据收集.

注册外部IRB批准

菠菜网lol正规平台 investigators with an external IRB approval should visit our 合作和外部研究页面 for details on what will be needed to register their external IRB approval within the IRB Mentor system in order to allow the IRB office to initiate a reliance agreement 与审查IRB.

Post-Approval指导

All post approval reporting is handled via the IRB Mentor system. 这包括: modifications to an approved protocol, reporting incidents and study deviations, continuing review renewals or study status check-ins, and study closures.

For information on how to file these post approval reports please visit our 提交页面 复习我们的 IRB Mentor User Guide for Post-Approval Reporting [pdf].