Introduction

There is no substitute for personal interaction in determining comprehension, giving reassurance, and helping participants to develop trust in the IC process. The IC process includes human interactions where the participants, based on their unique set of values, make a personal commitment involving significant trust in the investigator and the institution. This is not a calculation or a "sale". No external criteria - no matter how objectively defined or applied - can substitute for what is fundamentally a subjective decision. The decision whether or not to participate is entirely the participant's. Any attempt by the RTM to influence that decision is misguided.