INSTITUTIONAL REVIEW BOARD (IRB)

How to complete the IRB QA/QI/Program Evaluation Self-Certification Tool

Clicking the link at the bottom of this page will direct you to a survey asking for the following information which will allow you to determine if your project requires IRB review.

Note: This tool is not designed to determine all cases when a project falls outside of the IRB’s purview. This tool is only for determining if a project is Quality Improvement or Program Evaluation that does not include a research component requiring IRB review.

A completed self-certification does not constitute the UCF IRB’s review, approval, or exemption of a project. Please ensure accuracy of your responses. If this project is selected for a random audit as part of UCF’s post-approval monitoring program, you may be contacted for further information.

Additional guidance for certain questions can be found below.

If the results of this tool indicate that IRB review is not required, a copy of the results will be emailed to the UCF email address you list below. Print a copy of the results to use for your program, publishing, or presentation requirements.

Q1: Is the project intended to improve or to evaluate the practice or process within a particular institution or a specific program?

If the intention upon designing and conducting the project is to improve or evaluate a specific or individual practice/program or across several units within a larger practice/program, then the answer should be “Yes.”

Q2: Will Protected Health Information (PHI) be accessed for this project?

If yes, you will need permission from the institution/practice’s privacy officer to access the PHI. In general, if you are an employee and conducting this project as part of clinical operations, use of PHI for QA/QI or Program Evaluation purposes will fall under the practice’s privacy notice. If you are not an employee, you may need a business associate agreement, a waiver of HIPPA authorization from the practice’s privacy office, or you may be provided with de-identified data instead of access to PHI. The study team is responsible for obtaining permission for accessing PHI.

Q3: Are the results of this QI/QA project or program evaluation intended to produce generalizable knowledge?

The focus of this question is to evaluate the primary intent and design of the project. Features of generalizable research include but are not limited to:
- Testing a hypothesis
- Randomization of subjects
- Comparison of case vs. control
- Observational research
- Comparative effectiveness research.
If a QI/QA project or a program evaluation is designed for one entity (one department, one unit, one business, etc.), it is typically not designed to contribute to generalizable knowledge.

Intent to publish or present the findings may allow others to benefit from the findings. However, publishing or presenting findings does not necessarily mean the project will generate generalizable knowledge. The publication or presentation should indicate the project is QI or program evaluation and does not constitute human subjects research. This can be included as a statement in the abstract or in the publication or presentation title.

The key question for the IRB is what the primary intent of the project is from the outset. If the primary intent of the project is not generalizability (e.g., it is program evaluation/practice improvement related to a specific initiative) OR the project is not designed in a way that the findings would be generalizable (i.e., limitations to project design), then the answer to this question is “No”.

If the answer to this question is “Yes,” IRB review is likely required.

Q4: Will the project involve testing an experimental drug, device (including medical software or assays), or biologic?

This Self-Determination Tool is based on the definition of research pursuant to the Common Rule (45 CFR 46.102(d)). The purpose of this question is to determine whether federal regulations beyond the Common Rule, such as FDA regulations, need to be applied to a project. If the answer to this question is “Yes,” IRB review is likely required.

Q5: Has the project received funding (e.g. federal, industry) to be conducted as a human subjects research study?

The purpose of this question is to determine whether the project has received funding to be conducted as a research study. If you are unsure, consider contacting your funding’s program officer to determine whether there is requirement for a specific level of IRB review and oversight. If the funding source considers the project to constitute human subjects research, this IRB QI/Program Evaluation Self-Determination Tool is not appropriate; an IRB application should be submitted in Huron.

Q6: Is this a multi-site project (e.g. there is a coordinating or lead center, more than one site participating, and/or a study-wide protocol)?

This question is intended to determine whether the project is limited to local activities or whether multiple sites are conducting the same activities. The latter is an indication that the results may be generalizable. If multiple institutions are conducting the activities, it’s less likely that the outcomes will be used for quality improvement or program evaluation at the local institution. As a result, for multi-site projects, this IRB QI/QA/Program Evaluation Self-Determination Tool is not appropriate; an IRB application should be submitted in Huron.

Other Information

Principal Investigator (PI)’s Name
PI UCF e-mail address
Department or College through which the project will be conducted
PI Type (Nursing DNP, FIRE or FIRE + Student, Faculty or Staff Member)
Full Project Title:
Project Type (Quality Assessment/Improvement or Program Evaluation)
Brief Project Description
Name of the institution/practice where QI/QA project or program evaluation will take place

Click to access the tool: https://ucf.qualtrics.com/jfe/form/SV_do1R0NqvzxiWqYS

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

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