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 review.