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Institutional Review Board (IRB)
The Essentia Health Institutional Review Board (IRB) reviews and evaluates proposed and ongoing human subjects research projects at Essentia Health to protect the rights and welfare of participants.
IRB Authority & Purpose
The IRB ensures research participants take part voluntarily and with safeguards from unnecessary or inappropriate risks in place. The IRB has also been designated to function as the privacy board under HIPAA requirements.
IRB Review of Research
The IRB tracks the progress of every Essentia research project, even before participant recruiting takes place. At least once a year, the IRB reevaluates each project and works with the principal investigator and other sources to make modifications, if needed, to safeguard participants.
IRB Membership
The Essentia Health IRB will include:
- At least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by Essentia Health
- At least one member whose primary concerns are in scientific areas
- At least one member whose primary concerns are in nonscientific areas
- At least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution
The Essentia IRB will:
- Ensure that the membership is not composed of entirely men or entirely women
- Disallow member participation in the initial or continuing review of any project the member has a conflicting interest in, except to provide information requested by the IRB
Federal Regulatory Guides for IRB
Federal regulations guide the Essentia Health IRB composition, operation, and responsibilities for human research participant protection processes. The Department of Health & Human Services (HHS) Office for Human Rights Protections (OHRP) oversees IRB operations and the Food and Drug Administration (FDA) enforces regulations for the use of experimental drugs and devices.
Federalwide Assurance
Through its Federalwide Assurance (FWA), Essentia Health pledges to comply with the Protection of Human Subjects (45 CFR part 46) regulations.
- FWA is a binding agreement between HHS and Essentia Health and is updated and renegotiated at regular intervals.
- Essentia Health FWA#: FWA00000635
- Verify Essentia Health's FWA
IRB Submission Deadlines
For consideration on the Essentia Health IRB agenda, complete IRB submissions in iRIS at least 14 days before the meeting date. IRB staff recommend submitting well before the 14-day deadline to ensure your submission is complete.
Essentia IRB Meeting Dates
The Essentia IRB meets monthly but reserves the right to cancel meetings if there are no submissions requiring full board review and/or if quorum cannot be met. The meeting dates and the corresponding submission due dates are listed below:
| IRB Meeting Date | Submissions Due Date |
|---|---|
| January 10, 2024 | December 27, 2023 |
| February 14, 2024 | January 31, 2024 |
| March 13, 2024 | February 28, 2024 |
| April 10, 2024 | March 27, 2024 |
| May 8, 2024 | April 24, 2024 |
| June 12, 2024 | May 29, 2024 |
| July 10. 2024 | June 26, 2024 |
| August 14, 2024 | July 31, 2024 |
| September 11, 2024 | August 28, 2024 |
| October 9, 2024 | September 25, 2024 |
| November 13, 2024 | October 30, 2024 |
| December 11, 2024 | November 27, 2024 |
Deadline:
The complete submission must be in the iRIS Administrative Pre-Review queue 14 days before (Submissions Due Date) the intended IRB Meeting Date for consideration on that agenda. FCOI surveys and/or management plans must be complete before IRB review. If FCOI surveys and/or management plans are not complete at least 7 days before the IRB meeting date, the submission will be deferred.
NOTE: If a submission does not qualify as complete on the Submissions Due Date it may not be considered at the corresponding IRB meeting. IRB staff recommend submitting prior to the Submissions Due Date and using pre-review checklists to ensure the submission is complete.
Contact Us
Learn more about the institutional review board (IRB). Call 218-576-0711. Email the IRB.