Introduction

A PI does not decide to engage in clinical research lightly. The work is not easy, and the PI must be highly motivated to carry a project through to completion. Enthusiasm for one's research is good, but if it prejudices or coerces a participant into enrolling, the IC process is corrupted. Particularly in trials of new therapies or interventions, the PI designing the IC process, and the RTM presenting it to the prospective participant, must scrupulously guard against suggesting any benefit in excess of that objectively defined at the time of protocol approval. Motivation comes in many forms and can be direct or indirect, altruistic or self serving. For instance, a sponsor's contribution to the PI's research account in response to additional enrollment of participants in a study can be construed as an inducement to enroll inappropriate participants. There should be no pressure in the research process on participants, the RTM or the PI.