Human-subject Research


Compelling uncertainty whether the standard of care treatment or the research treatment is the most likely to benefit the patient. A research protocol ends when the data demonstrate conclusively the superiority of one treatment over the other treatment. 



New (including revisions on previously established) interventions intended to improve patient outcome and/or institutional efficiency.  Innovation should be conducted and assessed as research. 


Therapeutic Misconception

When research participants enroll in protocols with the expectation – perhaps informed and willful, perhaps misinformed by a referring physician or by a research recruiter – that they will receive treatment expected to be beneficial to them.