What is the first question to ask in deciding if a project is non-exempt human subjects research under the Common Rule?

To determine whether a project qualifies as non-exempt human subjects research under the Common Rule, the initial step is to assess whether the project meets the definition of research. This involves understanding whether the activity is designed to develop or contribute to generalizable knowledge. Research is defined broadly, and knowing if an activity falls under this category is crucial because only activities that meet the research definition can further lead to questions about human subjects' involvement and the applicable regulations.

Once you establish that a project is indeed research, it becomes necessary to identify if it involves human subjects, as this will determine the next layer of regulatory scrutiny. The correct question helps to clarify that the status of the project as research is foundational before moving forward with additional considerations related to human subjects and regulatory exemptions. This systematic approach ensures compliance with ethical guidelines and regulations governing human research.