The invisible hand in clinical research: the study coordinator's critical role in human subjects protection.

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically.1 The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research.2 Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent,3 that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships4 that one can more fully define and understand the challenges of protecting subjects in research. Study coordinators are at the center of the clinical research enterprise. In collaboration with principal investigators, they assist with protocol development, write consent forms, recruit subjects, explain the study to and obtain consent from subjects, coordinate with relevant hospital/clinic units, collect and maintain clinical data, and serve as the main contact person for subjects during a trial. One recent survey identified 128 different activities performed by study coordinators.5 Studies have shown that adding a coordinator to a research team significantly improves subject recruitment numbers,6 enhances subject retention,7 and increases general study efficiency.8 Much of study coordinators' added efficiency is a result of their central position in clinical research activities. They see themselves as interpreters or liaisons, especially in their relationships with principal investigators and subjects, representing the study to subjects and subjects to fellow researchers, clinical staff, and to relevant institutional and external (e.g., federal government, financial sponsor) actors. Each relationship may require a different role, but more commonly, the study coordinator position requires that one relationship encompass several roles. Of particular interest is how clinical study coordinators reconcile the roles of caregiver and researcher. Some reports focus on study coordinators' successful combination of these two roles,9 while others emphasize their inherent incompatibility.10 Despite literature that chronicles their skills and efficiencies, surprisingly little systematic information is available regarding the impact of the study coordinator on the protection of human subjects. In fact, when study coordinators have been in the limelight, it has often been as objects of rebuke. For example, approximately 19 percent of investigators receiving FDA warning letters in 2000, and more than 37 percent in 2001, were cited for failing to supervise their trials.11 In an anecdotal analysis of twenty of these incidents, almost half of the investigators blamed study coordinators for their citations.12