UC IRB process for SoTL
Given the nature of the research and the possible involvement of students and colleagues, it is important to proceed in an ethical manner. The researcher must ensure that the human subjects are protected and the research questions are valid and useful questions to ask. The IRB process is designed to address these ethical considerations. This can be a confusing process, and the IRB office is available for consultation and guidance.
The first steps in the IRB process are to ask two questions 1) Is it research and 2) Does it involve human subjects.
Each institution answers these two questions based on federal guidelines and how the institution’s IRB interprets these guidelines.
1. Is it research?
The Federal Guidelines:
From the Belmont Report Section B issued by the Department of Health, Education and Safety- Research is an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that subject.
From 45 Code of Federal Regulations (CFR) article 46.102 on PROTECTION OF HUMAN SUBJECTS: Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The determination is very dependent on the concept of generalizable knowledge.
Generalizable knowledge might include information presented to a broader audience or published with the intent of drawing scientific conclusions or increasing the body of scientific knowledge. This would not typically describe projects that are intended solely for internal assessment purposes, such as quality improvement/assurance, and program evaluations.
2. Does it involve Human Subjects?
From “DOING RIGHT & NAVIGATING THE IRB REVIEW PROCESS FOR SOTL” CET&L workshop presented by Beth Faller 2016-04-14
If you have …, then probably yes:
If you have …, then probably no:
Not Human Subjects Research Determination
Even if researchers believe that their SoTL project does not fall within the definition of “research” or “human subjects” described above, they will likely want to complete a “Not Human Subjects Research Determination.” This is an abbreviated process in which an IRB representative confirms that the project does not fall within UC’s definition of human subjects research. The SoTL researcher receives documentation in the form of an official letter stating that the IRB reviewed the proposal and the work does not require IRB oversight. The SoTL researcher will then have the most flexibility to publish or present their findings.
Other resources are available through CET&L’s Blackboard group to support SoTL researchers.
To join, visit this link and complete the request form.
UC IRB Website link: http://researchcompliance.uc.edu/HRPP/IRB/IRBOverview.aspx