The University of Wisconsin-Madison IRB developed an online quality improvement/program evaluation self-certification tool that helps project leaders determine whether their projects qualify as research.
The following are some questions and items on the tool:
- List the project title.
- Write a brief description of project/goals.
- Will the project involve testing an experimental drug, device (including medical software or assays), or biologic?
- Has the project received funding (e.g. federal, industry) to be conducted as a human subjects research study?
- Is this a multisite project (e.g. there is a coordinating or lead center, more than one site participating, and/or a study-wide protocol)?
- 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, comparative effectiveness research, or comparable criteria in alternative research paradigms)?
- Will the results of the project be published, presented, or disseminated outside of the institution conducting it?
To view the self-certification tool, visit: http://bit.ly/2p5HQOF.
The University of Wisconsin-Madison IRB developed an online quality improvement/program evaluation self-certification tool that helps project leaders determine whether their projects qualify as research.
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