All clinical studies for medical devices are conducted with the best intention to benefit humans. Based on this week’s lecture, Dr. Simon mentioned that each subject should be informed with a consent form about any reasonably foreseeable risks or discomforts, but we all know that unfortunate results can occur from time to time. Does anybody have information about what kind of results could shut down a clinical study?

and if a clinical study is shut down, who will be the responsible party for not doing the proper due deligance prior to the study (i.e. IRB or the manufacturer)?