What is “research” as defined by federal regulations?

The definition of "research" as specified by federal regulations emphasizes the importance of generalizable knowledge. This implies that research is not merely a collection of data or an informal inquiry, but rather a structured investigation aimed at systematically generating findings that can be applied broadly beyond the specific circumstances of the study. The focus on contributing to generalizable knowledge means that the research outcomes should ideally inform further studies or public understanding of a particular field.

This definition aligns with the regulatory framework that governs human subjects research, which ensures that studies adhere to ethical standards and promote the welfare of participants. By aiming to produce findings that have relevance and application beyond the narrow context of the research itself, this definition establishes a clear boundary around what constitutes research in order to protect participants and ensure rigor in scientific inquiry.

In comparison, the other choices fall short of this comprehensive definition. An informal analysis or a unique inquiry centered on just one participant do not meet the criteria of being designed to contribute broadly to knowledge. Similarly, a study that does not require IRB oversight reflects scenarios outside the regulatory definition of research involving human subjects, thus lacking the necessary attributes of generalizable knowledge generation.