any research that involves any of the following:
1) sponsored by the VA
2) being conducted by or under the direction of any salaried or without compensation employee of the VA during official duty time or in connection with VA responsibilities
3) being conducted at a VA facility
4) recruiting subjects at the VA or using the VA records to identify or contact subjects for research
5) funded or managed by the VA or the Foundation for Advancing Veterans Health Research
pertains to the fetus, means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. Once a fetus is viable it is a premature infant.
See also:ANIMAL: a violation of the standards promulgated by the AWA or assurances required by federal agencies.
HUMAN: a departure (generally intentional on the part of the investigator) from the approved study protocol, and occurs without prior IRB approval that:
1) has the potential to cause harm or increase the risk of harm to one or more research participants or
2) has the potential to damage the scientific integrity of the data collected for the study; or
3) impacts a subject's safety, rights, or welfare.