Clinicians or Researchers, Patients or Participants: Exploring Human Subject Protection When Clinical Research Is Conducted in Non-academic Settings

Abstract

Background: Clinical research is increasingly conducted in private physicians’ offices, clinics, community hospitals, local institutes, and independent research centers. The migration of research into this non-academic environment has brought new cadres of researchers into the clinical research enterprise and broadened the pool of potential research participants. This study was designed to explore how clinical investigators and research coordinators protect human subjects and ensure research integrity when conducting clinical research in non-academic settings. Methods: We employed a qualitative research design employing semistructured interviews that took place between October 2010 and September 2012. The sample of 80 participants from across the United States included 38 clinicians and 42 research coordinators, most of whom had been involved in clinical research for more than 5 years and nearly all of whom reported their patient base included a sizable rural population. With the aid of a research management tool, Atlas-Ti, the data were coded and organized into themes that could be compared and contrasted. Results: Findings suggest that clinicians conduct clinical research because such research is perceived as beneficial for both the patient and the practice. Findings also suggest that clinicians do not perceive firm distinctions between the roles of clinician and researcher, nor do they perceive firm distinctions between the goals of research and the goals of clinical care. Rather, most of the clinicians and coordinators in this study viewed trial participation as a means of providing optimal care for the individual patient. Conclusions: Findings suggest that the current processes and protocols employed in non-academic research settings may not achieve optimal protection of human subjects. More research is needed in order to more fully understand how a combination of factors, including the financing of research, recruitment practices, and the blurred distinctions between research and treatment, may undermine the optimal protection of human subjects.