New Study

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.
   
• 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.