As the scope of clinical research is broadened to
include more community-based sites, there will be
a greater reliance on local clinicians to deliver care in
support of the research intervention as well as to
monitor participant compliance and response to
treatment. This expansion has implications for the
roles of nurses coordinating studies in these sites as
well as for nurses providing the care to research
participants who may or may not have formal training
in research implementation and human subject
protection. It has been suggested18 that as clinical care
moves from the hospital setting to community-based
settings, threats to patient safety shift from being
treatment-related to being diagnosis-related. Greater
reliance must be placed on adherence to therapy as
opposed to direct delivery and oversight of care. This
parallels the shift in treatment implementation
responsibility from the care provider team to the
patient in ambulatory settings, and has implications
for the clinical research nurse’s role in promotion of
adherence to an experimental protocol as well as the
prevention of adverse events.