Human-subject Research

Equipoise

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. 

 

Innovation 

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.