Adverse Events - Example


Study subjects in medical research seem to be developing stomachaches
from the study medication at a higher rate than was expected. With the
higher incidence of the stomachaches, the best recommendation on how to
handle this problem would be for the researcher to investigate a solution
to the problem (look into an antidote, change the time the medication is
taken, take medication with foods, etc.). The researcher can then present
a change in the consent document and, perhaps protocol, to the IRB for