prospect of direct benefit

Prospect of direct benefit refers to the potential for a positive outcome (e.g., cure of disease, pain relief, increased mobility) for the individual participant resulting from the research intervention or procedure being studied. The relationship between the anticipated direct benefit and the risk or potential harm should be at least as favorable for the proposed intervention as for any available alternatives. The prospect of direct benefit does not mean proven clinical effectiveness; however, there must be sufficient evidence based on appropriate animal, preclinical, and/or other clinical data to support the potential for benefit from the intervention or procedure.