An Institutional Review Board (IRB) relies on a specific understanding of what constitutes a research activity to determine whether a project requires its review and oversight. Generally, an activity is considered research if it is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. For example, a survey designed to understand patient satisfaction with a new treatment protocol, with the intent of publishing the results and informing future protocols, would typically fall under this definition.
The importance of clarifying what constitutes research for IRB purposes cannot be overstated. This definition ensures that studies involving human subjects are ethically sound and adhere to federal regulations. Furthermore, understanding the boundaries of this definition provides clarity to investigators, enabling them to determine when they must seek IRB approval. Historically, the establishment of these definitions stemmed from ethical breaches in research, necessitating a formalized system for safeguarding participant rights and welfare.