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

0 ver the past decade, the number of clinical trials registered with the Food and Drug Administra- tion (FDA) has increased dramatically. ’ The business of clinical research has become more diverse, in-volving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and con-tract research organizations. This growth has been accompanied by increasing concerns about the ethical con-duct 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. How-ever, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nu-anced issues related to recruitment and retention of subjects, and to the process of informed consent: 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 pro-tecting subjects in research. Study coordinators are at the center of the clinical re-search 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 hospitalklinic units, col-lect and maintain clinical data, and serve as the main contact person for subjects during a trial. One recent survey identi-fied 128 different activities performed by study coordinators? Studies have shown that adding a coordinator to a research team significantly improves subject recruitment numbers,6 en-hances subject retention, ’ and increasesgeneral study effiaenq? Much of study coordinators ’ added efficiency is a result of their central position in clinical research activities. The