Sham controls can be integral to CV device trials, providing a unique way to overcome the placebo effect, but they also present an ethical minefield of concerns that merit close consideration, a new ...

Recruitment is generally the first contact between researchers and prospective participants (whether through paper-based or online announcements, media communications, or face-to-face interactions) ...

Federal regulations at 45 CFR 46.102 item (j), define minimal risk as "... the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than ...