From: Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis
a. A serious threat to the prospective participant requires immediate intervention; | |
b. Either no standard efficacious care exists or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care; | |
c. Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant; | |
d. The prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project; | |
e. Third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and | |
f. No relevant prior directive by the participant is known to exist. |