IRB QI Self-Certification Decision Tool

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About the IRB QI Self-Certification Decision Tool

The IRB QI Self-Certification Decision Tool is a mechanism that allows study teams to make the decision about whether their project constitutes human subjects research or whether it is quality improvement (QI) or program evaluation (PE), such that IRB review and oversight is not required.

Allowing institutions and Institutional Review Boards (IRBs) to redistribute this decision-making process empowers study teams to move forward with their quality improvement or program evaluation projects more rapidly, and enables the IRBs to focus their time on projects that truly require IRB review and oversight.

Using the tool, study teams can provide certification that their project does not require IRB review and oversight, and this documentation can be provided to journals, conferences, funders, and others as needed.

Who should use this toolkit?

This toolkit is intended for administrators in human subject protection programs, including IRBs, at academic institutions that conduct a significant amount of QI, PE, and human subjects research.

What does the toolkit contain?

This toolkit provides practical steps for institutions and IRBs to develop and implement a QI Self-Certification Decision Tool. Additionally, it contains a flowchart/decision tree of the specific questions and outcomes that could be included in the IRB QI Self-Certification Tool, as well as a link to the tool itself.

Development of this toolkit

The IRB QI Self-Certification Toolkit was developed by IRB administrators (Project Leader: Gretchen Anding) at the University of Wisconsin-Madison School of Medicine & Public Health, Health Sciences IRBs Office.

This project was supported by the University of Wisconsin School of Medicine and Public Health’s Health Innovation Program (HIP), the Wisconsin Partnership Program, and the Community-Academic Partnerships core of the University of Wisconsin Institute for Clinical and Translational Research (UW ICTR), grant 9 U54 TR000021 from the National Center for Advancing Translational Sciences (previously grant 1 UL1 RR025011 from the National Center for Research Resources). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or other funders.

Toolkit Citation

Anding G. IRB QI Self-Certification Decision Toolkit. University of Wisconsin – Madison Health Sciences IRB Office, UW Health Innovation Program; 2015. Available at:

About the Developer

Gretchen Anding, MA is the Senior IRB Manager in the Research Compliance Office at Stanford University. Gretchen was the first Human Research Protections Coordinator at Aspirus-Wausau Hospital. She was then hired as the Minimal Risk IRB Manager for the Health Sciences IRBs Office and subsequently promoted to Assistant Director. Gretchen oversees the office’s protocol review core, along with maintaining her role as the administrator for the Minimal Risk IRB. Her professional interests include the shifting landscape of privacy and confidentiality protections for human subjects research data, biospecimen research ethics and improving the efficiency of the IRB review process.