University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
612-626-5654

Institutional Review Board homeIRB


Forms

The launch of ETHOS on March 27, 2017 will significantly impact how you submit protocols to the IRB. We recommend that researchers wait until March 27th to submit new applications in ETHOS. This will save researchers time overall as those submitting new studies outside of ETHOS will have to complete additional steps during the migration process.

Submitting forms

New applications

All new applications to the IRB must be submitted in ETHOS, effective March 27, 2017. If researchers want to submit a new study in the old process, researchers must do so by 4:30 p.m. on March 24th. Any new studies submitted after 4:30 p.m. on March 24th will be sent back.

Existing applications

Changes or reports on studies active or submitted to the IRB prior to March 27, 2017, must still be made using legacy forms including the Change in Protocol, Add/Remove/Change Personnel, Add/Remove Funding, and the Report Form. (See below.)These forms should be submitted to irb@umn.edu until further notice.

Continuing review

For non-ETHOS studies requiring continuing review, follow the steps provided to you in the continuing review notification.

Legacy forms (non-ETHOS)

These legacy forms are used after the initial application has been approved and should only be used for studies that were not submitted in ETHOS.

Download

When to use

Updated

Change in Protocol Changes to the approved project must be requested and approved before implementation. This includes:
  • making changes to study procedures or amending the protocol
  • closing study to accrual
  • changing recruitment strategy, inclusion/exclusion criteria or modifying IRB approved recruitment materials
  • updating consent form
  • notifying the IRB of an update or revised Investigator Brochure
Aug 2015
Add/Remove/Change Personnel When adding/changing or removing a principal investigator, co-investigator or other study personnel Jan 2016
Add/Remove Funding When adding or removing funding associated with a project Jan 2015
Report Form Use this form to report events, including Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO), which fit the definition of promptly reportable events. The IRB defines “prompt” to be within five business days of discovery of the event. See the Reporting Unanticipated Problems webpage for additional guidance. May 2015
IRB Study Document Request To request copies of documents or correspondence associated with IRB record Nov 2012
Continuing Review of Non-ETHOS studies (in eResearch Central) Until notified otherwise, non-ETHOS studies: Submit prior to deadline indicated in the notice for renewal (expedited and full committee review of medical and social applications)
Study Inactivation Request Form Submit this form to request inactivation of IRB approval. Submit only after all study related activities/interventions have been completed. Sep 2014
Continuing Review Event Reporting Template for tracking and reporting adverse events that do NOT meet the threshold for prompt reporting to the IRB. These events must be reported at continuing review or when requesting study inactivation.
Non-UPIRTSO AE Log Template
Non-UPIRTSO AE Log Template - Multi-page

Templates

Consent, assent, information sheets, HIPAA and protocol templates are commonly included with applications.