Introduction

The set of skills discussed in this section are less about transferring knowledge and more about defining a relationship. Participants make the decision to volunteer in research based on both understanding the facts and applying them subjectively to themselves. The RTM assisting in consent procedures can unintentionally influence the subjective part of the decision making process for the participant.

The RTM interacting with a research participant in an IC process must be aware that a statement of voluntary consent is necessary, but not necessarily adequate. The RTM should guard against the possibility of indirect, unintentional coercion. Other factors may inappropriately influence the Participant's decision, including fear of disappointing one of the RTM with whom the participant has a personal or clinical relationship; perceived lack of a therapeutic alternative; as a way to cover the costs of health care; a desire for research compensation; etc. It is the responsibility of the RTM to understand why the participant chooses to volunteer, and to be clear that the reasons are appropriate. Does the participant feel as comfortable saying, "No" as saying, "Yes"?

Below are two video clips. The first video demonstrates the impact of PI/RTM's willingness to coerce the potential participant. The second video demonstrates the PI/RTM's ability to recognize that the potential participant can be coerced and does not take advantage of this.