D03 - PLENARY: What Counts as a Direct Benefit of Research?

The concepts of “direct benefit” and the “prospect of direct benefit” are central to research ethics and IRB review. These judgments play a key role in risk-benefit assessments and are especially important when determining whether vulnerable populations—such as children or individuals unable to consent—should be included in research. But what exactly qualifies as a direct benefit? How certain must IRBs be that participants will actually benefit? For example, must an investigational therapy demonstrate prior evidence of efficacy before it can be considered likely to provide direct benefit? How much evidence is enough? How should IRBs evaluate interventions primarily designed to assess safety or efficacy? Additionally, routine benefits like payment or access to free services are often excluded from being recognized as direct benefits—what justifies this distinction, and is it still appropriate? This session will explore these complex questions and provide guidance on applying the concept of direct benefit in research oversight.