Do quality assurance projects need to be submitted to the IRB?
The answer to this question is not a simple one. As previously stated, in order for a project to be considered research, it must be “a systematic investigation designed to develop or contribute to generalizable knowledge.” Many quality assurance activities involve a systematic investigation of human subjects, but they may not be developing or contributing to generalizable knowledge. Instead, they are designed only to assess effectiveness of a specific program, practice, or service at single site. For example, a quality assurance project may ask CMH staff to answer questions about certain practices in order to determine if these practices are being done consistently throughout the Hospital. This project is not developing or contributing to generalizable knowledge – that is, the results are only being used to improve internal processes. As such, this project is not “research” and would not require IRB approval. However, if the results from a quality assurance project may be shared with o
