Avera Institutional Review Board Guidance Documents, Ethical Codes and Resources
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Avera Institutional Review Board Guidance Documents, Ethical Codes and Resources

Application Submission

Take advantage of our online portal for submission and review of initial, renewal and revisions of IRB applications. If you’re submitting new documents for the first time, please contact the Department of Human Subjects Protection/IRB for a username and password at irb@avera.org or 605-322-4706. You can also call that number with any questions about submitting an application.

Does My Project Need IRB Review?

The Avera IRB is required to review and approve all research involving human subjects. This document is intended to help you determine if your project is research, and therefore requires IRB Approval.

You have two options for submitting your research proposal:

  • Option 1: If you think that your project is indeed research involving human subjects or a clinical investigation, fill out a formal IRB application and submit your project in the TOPAZ System for IRB review. You'll need to also submit all relevant documents within this electronic IRB system. Upon conducting its preliminary review, the IRB will confirm that it meets the definition and the review will move forward. If you don't already have a username and password to this electronic system, please email the IRB office.
  • Option 2: If not human subjects research, or you are not sure and would like the Avera IRB to make a determination, fill out the HRP-100: Human Subject Research Determination Form and email this completed form and your protocol or project summary, and any other relevant supporting documents (i.e., consent forms, grant, etc.) to IRB@Avera.org for formal determination. If further IRB approval isn't necessary, you will be emailed back the IRB Determination stating that IRB determined the project may proceed without review. You should receive an IRB response within 10 business days.

Nursing Student Research Projects

Nurses, faculty and nursing students seeking to conduct research, quality improvement projects or evidence-based practice projects must work with an Avera Mckennan nursing leader.

Prior to implementation the project or study will require approval from the Nursing Research Committee. Please email jill.rye@avera.org.

Research Resources

The following is a list of resources available to assist in developing a research project:

    Recommended Online Resources

    • Clinicaltrials.gov – includes a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world that is sponsored by the National Institutes of Health
    • Office for Human Research Protections – provides leadership in the protection of the rights, welfare and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services
    • National Institutes of Health – supports scientific studies that turn discovery into health as the nation’s medical research agency
    • U.S. Food and Drug Administration – provides information about medical product safety and the approval process, including FDA information sheets for IRBs, clinical investigators and sponsors

    Ethical Codes

    Institutional Review Boards are guided by the ethical principles applied to all research involving humans as subjects. For more information on ethical codes, view the:

    Avera Institutional Review Board

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