Below is a copy of the content in an email sent to a UNCC IRB "Research and Economic Development" staff member:
The Loraine Genome Visualization Lab would like to start some usability research for product improvement with the potential for using our results in publishable research in the future.
We are trying to understand how these goals would work with IRB approval requirements. It seems to be that if we ever want to analyze and publish any data we collected from users interacting with our software, we would need to submit for IRB approval up-front?
Is this accurate? Would we have to submit a complete protocol with materials for IRB approval for usability studies if we think there is a potential to generate generalizable, publishable research?
Here is the response I received from "Research and Economic Development" at UNCC:
If you will conduct Research with Human Subjects, you do need IRB approval up-front.
Generally, with user studies, the initial IRB protocol defines all of the procedures for the planned user study. This includes all of the study materials. After this user study is conducted, you then submit a Modification to the protocol if/when you design another user study. Just like an initial approval, a Modification must be approved before you conduct any of the Research.
So, I think it depends on what you mean by "complete protocol." You do need to submit a complete protocol and all study materials for the specific user study you want to conduct. But you don't need to have all of the details for a series of user studies if each subsequent user study is developed and designed based on the results from the previous user study. This is why the IRB process allows for Modifications. You can submit a Modification for each subsequent user study.
If the intent is to conduct Research, IRB approval is needed. Generally, the goal is to conduct a study that will result in generalizable knowledge. The findings may not result in this but when designing a study, this is the goal.
Here is the Research definition.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Below is a copy of the content in an email sent to a UNCC IRB "Research and Economic Development" staff member:
Here is the response I received from "Research and Economic Development" at UNCC: