How to complete the ED/SBS Self-Certification Tool
- Name of Project Lead/Investigator
- Title of Project
- Brief Description of Project/Goals
- School/College/Center through which the project will be conducted
This information is important for documentation purposes, as the tool, based on responses to the questions, could produce a certification that the project does not constitute research requiring IRB review. This certification can be saved and printed for your records.
Q1: 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 and not, for example, quality improvement or program evaluation. If you are unsure, consider contacting your program officer for the funding or funding entity to determine whether the funding source requires 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-Certification Tool is not a sufficient indicator of whether IRB review is required. If the answer to this question is “Yes,” IRB review may be required. Please contact the IRB Office for additional guidance.
Q2: Is this a multi-site project (e.g. more than one site participating)?
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/Program Evaluation Self-Certification Tool is not a sufficient indicator of whether IRB review is required. If the answer to this question is “Yes,” IRB review may be required. Note that, in some cases, UW personnel work with a community partner on a local QI/program evaluation project; in these instances, a “not research” determination may still be applicable. In this case, please contact the ED/SBS IRB Office for additional guidance.
Q3: Is this a systematic investigation designed with the intent to contribute to generalizable knowledge (e.g. testing a hypothesis; randomization of subjects; comparison of case vs. control; observational research; and/or comparative effectiveness research)?
The focus of this question is to evaluate the primary intent and design of the project.
Simply publishing or presenting the results of a QI project does not make it research. The key question 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”.
The design of the project plays a key role in determining intent. If the project is standardized using systematic research methodologies with strong external validity in order to obtain reproducible results, then it would be considered research. If the intended outcome is simply to report on what happened at the institution/program, this does not indicate research design or intent as it may or may not be generalizable outside of the institution
Q4: Will the results of the project be published, presented or disseminated outside of the institution conducting it?
The purpose of this question is to determine whether, at the outset of the project, the intention is to disseminate results outside of the institution or program conducting the project. If there is no intention for disseminating results outside of the institution or program conducting the project, the answer should be “No”. Lack of dissemination of information is generally a strong indicator that a project does not constitute research. If there is a potential for results to be disseminated outside of the institution or program conducting the project, then the answer is “Yes”. Note that program evaluation and QI projects can be published or presented as such, but they cannot be described as research studies.
Q5: Will the project occur regardless of whether individuals conducting it may benefit professionally from it?
If the project is being done primarily to bolster one’s own scientific career path and advance his/her program of research, then “No” should be selected in response to this question. In contrast, if someone is required to complete a project for their job, or mandated to conduct a program evaluation by a funding agency, this indicates that the project would have to be conducted regardless of any professional benefit and in this case, the answer to this question would be, “Yes”.
The question is not focusing solely on whether an individual will professionally benefit, but rather whether they would conduct the project regardless of the potential for professional benefit.
Q6: Is the project intended to improve or evaluate the practice or process within a particular institution or a specific program?
If the intention upon designing and conducting the project is not to improve or evaluate a specific practice/program, then the answer should be “No” which indicates research intent and IRB review is likely required.
This question is also trying to identify the specificity of a project, hence the use of “particular institution” or “specific program”. If it is being conducted in a multi-site context with a common protocol across sites, then the results could be generalizable and thus constitute research. In this case, the answer should be “No” which indicates research intent and IRB review is likely required.
- “STOP HERE. Certification is not valid. IRB review is likely required. Access the ED/SBS IRB’s website for guidance.”
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. Please contact the ED/SBS IRB Office for additional assistance.
- “The project appears to constitute QI and/or Program Evaluation and IRB review is not required because, in accordance with federal regulations, your project does not constitute research as defined under 45 CFR 46.102(l)”
This result means that the questions were answered in such a way that the project does not constitute research requiring IRB review and oversight. In this case, please print a copy of the certification to to save with your files. If publishing or presenting the results of this project in future, please ensure it is not classified or identified as a research study. If the project changes in any way that might affect the intent or design, please complete the IRB QI/Program Evaluation Self-Certification Tool again to ensure that IRB review is still not required. Finally, the ED/SBS IRB Office does not maintain, review or support copies of your responses. A completed certification is not equivalent to the ED/SBS IRB’s approval or exemption of a project.
NOTE: If you are required by UW-Madison policy, an outside entity, or a publisher to obtain a formal IRB determination, then the certification the tool provides will not suffice. Instead, an IRB application will need to be submitted in order to receive a formal IRB determination that the project falls outside of the federal definition of research. This is generally true for access to academic records or the requirements outlined by FERPA. For example, if the Registrar’s office or an outside entity (e.g. Department of Public Instruction) wanted a formal IRB determination, then, as stated above, an IRB application would need to be submitted in order to receive a formal determination from the IRB that the project falls outside of the federal definition of research.