New Study

The IRB reviews all activities that meet the federal definition of human research or clinical investigation. See the Human Research determination worksheet (download) 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.

• Create and Submit a Just-in-Time Submission
  A step-by-step guide on how to submit a Just-in-Time Submission in ETHOS.

• 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.

• HRPP Protocol Development Series
  Recorded discussions of the essential elements, core components, and development process of a research protocol.

• 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.

We also recommend reviewing the following documents from the Human Research Protection Program (HRPP) Toolkit Library:

• Investigator Manual (download)
  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 - download)
  Used by IRB staff who are conducting screening of submission materials.

• Criteria for Approval (HRP-314, Worksheet - download)
  Used by IRB members who are reviewing research protocols that have been submitted.