INSTRUCTIONS
An APN in a nurse-run inner-city family practice clinic is trying to decide whether to recruit from her patient population of Black, economically disadvantaged patients for a Phase III obesity randomized clinical trial. The aim of the trial is to evaluate a new medication that showed promise in Phase I and Phase II trials. Subjects will be assigned randomly to receive either the new medication and support plus exercise sessions or a placebo and support plus exercise sessions (Grace, 2018, p. 201).
Prepare
Answer the following questions:
1. What should the APN consider as she decides whether to recruit her patients for the obesity control trial related to each of the three guiding principles for research?
2. How is the legal definition of a child in your state (Texas) —and the regulations in U.S. Department of Health and Human Services, 48 FR 9818 46.408 governing research with children—relevant if the APN decides to recruit teenagers for the trial?
3. What else should the APN consider if she is asked for advice from a parent or guardian about enrolling their teenager in this study?
