The IRB reviews all activities that meet the federal definition of human research or clinical investigation. See the Human Research Determination Worksheet (HRP-310) for more information.
Resources
Use the following resources to prepare a new study submission:
- New Study Submission Checklist
Checklist of documents and information needed to submit a new study.
- Create and Submit a Determination Form
High-level, step-by-step guide on how to create and submit a determination request for not human research projects.
- Create and Submit a New Study: Detailed Guide
Detailed step-by-step guide on how to create and submit a new study.
- ETHOS Guide for Students and Advisors
Step-by-step guide for student investigators and their advisors.
- FAQ for Investigators with a Dual Appointment at Minneapolis VA and the University of Minnesota – IRB
Frequently asked questions for investigators holding a dual appointment at the Minneapolis VA and the University of Minnesota.
- Transferred Study Submission Checklist
Step-by-step guide for investigators who will transfer an active study from an external IRB to UMN IRB for oversight.
- Copy-Paste Protocol Templates
A step-by-step guide for copy-pasting text into the Toolkit protocol templates.
- How to Submit HRPP Facilitated Scientific Assessment in ETHOS
A job aid 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.
- Adding Funding Information to your Submission in ETHOS
Step-by-step guide on how to add funding to a submission in ETHOS.
- How to Withdraw or Discard a Submission
High-level, step-by-step guide on how to withdraw or discard a submission.
- How to Copy an ETHOS Submission
Step-by-step guide on how to copy an ETHOS submission.
We also recommend reviewing the following documents from the Human Research Protection Program (HRPP) Toolkit Library:
- HRP-103: Investigator Manual
Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota.
- HRP-301: Pre-Review Worksheet
Used by IRB staff who are conducting screening of submission materials.
- HRP-314: Criteria for Approval Worksheet
Used by IRB members who are reviewing research protocols that have been submitted.