IRB Resources

Application Submission

Take advantage of our online portal for submission and review of initial, renewal and revisions of Institutional Review Board (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. To help you determine if your project is research, and therefore requires IRB approval, review this document (pdf).

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 Forms and Resources

The following are resources available to assist you with your project.

Develop a Research Project

Waiver Applications (doc)
Assent Template (doc)
Informed Consent Template (Common Rule compliant) (doc)
IRB Corrective And Preventive Action Form (doc)
Protocol Template (doc)
Parental Permission for Research Participation (doc)
Genetic Information Nondiscrimination Act (GINA) Guidance (pdf)

Avera IRB Procedures

Standard Operating Procedures Table of Contents (pdf)

Research Conflict of Interest Policy (pdf)

Responding to Allegations of Research Misconduct Policy (pdf)

100 – Authority and Purpose (pdf)
101 – Activities Requiring IRB Review and Approval (pdf)
102 – SOP Maintenance (pdf)
103 – IRB Member and Staff Training and Education (pdf)
104 – Management of IRB Personnel (pdf)
105 – Conflict of Interest (pdf)
106 – Signature Authority (pdf)
200 – Composition of the Board (pdf)
201 – Management of the Board (pdf)
202 – Duties of IRB Members (pdf)
300 – Submission Requirements for IRB Review (pdf)
301 – IRB Meeting Administration (pdf)
302 – Administrative Review and Distribution of IRB Materials (pdf)
303 – Document Management, Retention and Archiving (pdf)
304 – Guests at IRB Meetings (pdf)
400 – Exempt Review (pdf)
401 – Expedited Review (pdf)
402 – Initial Review – Criteria for IRB Approval (pdf)
403 – Amendments (pdf)
404 – Continuing Review and Annual Check-In (pdf)
405 – Closing a Research Study (pdf)
406 – IRB Meeting Determinations (pdf)
407 – Protocol Deviations and Noncompliance (pdf)
409 – Suspension and Termination (pdf)
410 – Event Reporting (pdf)
411 – Investigational Drug or Device (pdf)
413 – Emergency Use of a Test Article (pdf)
414 – International Research (pdf)
500 – Pregnant Women, Unborn Babies and Neonates (pdf)
501 – Categories of Research (pdf)
502 – Research Involving Persons with Impaired Decision-making Capacity (pdf)
503 – Research with Children (pdf)
504 – Research with Prisoners (pdf)
505 – Humanitarian Use Device HUD (pdf)
506 – Expanded Access (Single Patient, Compassionate Use) (pdf)
600 – Communications (pdf)
601 – Reliance Agreements (IAAs), Single IRB (sIRB) and Cooperative Research (pdf)
700 – Informed Consent (pdf)
701 – Waiver of Informed Consent (pdf)
702 – Documentation of Informed Consent (pdf)
703 – Assent and Waiver of Assent (pdf)
800 – IRB Required PI Actions (pdf)
801 – Conflict of Interest (PI) (pdf)
900 – Quality Assurance/Quality Improvement Program (pdf)