Under what circumstances does research with human subjects typically require IRB approval?

Research involving human subjects typically requires Institutional Review Board (IRB) approval when it includes experimental studies that involve interaction with individuals. This includes any research that collects data through direct engagement with participants, such as interviews, surveys, or physical interventions. The IRB's primary role is to ensure that ethical standards are upheld, safeguarding the rights and welfare of participants involved in research.

When participants are actively engaged, there are potential risks related to privacy, consent, and the possibility of physical or psychological impacts. Therefore, obtaining IRB approval is essential to assess and manage these risks appropriately.

In contrast, studies involving only observational data might not require IRB approval, especially if no identifiable private information is collected, as they may not interact with or impose any risk on individuals. Research with no funding does not automatically exempt a study from requiring IRB review, nor does focusing solely on educational programs eliminate the need for approval if human subjects are involved. In all cases, the fundamental aspect is whether human interactions are a part of the research process, which is why the emphasis lies on experimental studies involving direct interaction.