The IRB reviews all activities that meet the federal definition of human research or clinical investigation. See the Human Research determination worksheet for more information.
Use the following resources to prepare a new study submission:
New Submission Checklist
Checklist of documents and information needed to submit a new study.
Submit a New Study: Quick Guide
High-level, step-by-step guide on how to create and submit a new study.
Submit a New Study: Detailed Guide
Detailed step-by-step guide on how to create and submit a new study.
- Submit a Determination Form: Quick Guide
High-level, step-by-step guide on how to create and submit a determination request for not human research projects.
- Submit a JIT Study: Quick Guide
A step-by-step guide on how to submit a Just-in-Time Submission in ETHOS.
Guide for Students and Advisors
Step-by-step guide for student investigators and their advisors.
- Protocol Development Series
Recorded discussions of the essential elements, core components, and development process of a research protocol.
- Protocol Formatting
A step-by-step guide for copy-pasting text into the Toolkit protocol templates.
- HRPP Scientific Assessment Submission Guide - CTR Portal
A step-by-step guide for protocols that require HRPP scientific assessment through the CTR Portal.
- HRPP Scientific Assessment Submission Guide - ETHOS
A step-by-step guide for protocols that require HRPP scientific assessment through ETHOS.
- What to Expect after Submitting to the IRB
Explanation of the IRB process once a submission is received by the IRB.
Step-by-step guide on how to add funding to a submission in ETHOS.
How to Withdraw or Discard a Submission: Quick Guide
High-level, step-by-step guide on how to withdraw or discard a submission.
We also recommend reviewing the following documents from the Human Research Protection Program (HRPP) Toolkit Library:
- Investigator Manual
Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota.
Pre-Review (HRP-301, Worksheet)
Used by IRB staff who are conducting screening of submission materials.
Criteria for Approval (HRP-314, Worksheet)
Used by IRB members who are reviewing research protocols that have been submitted.