DESCRIPTION (provided by the applicant): Research integrity, and its' corollary research misconduct, have been topics for debate and discussion in research and policy arenas for the past twenty years. Research misconduct is a serious violation of the fundamental principle that scientists should be truthful and fair in the conduct of research and the dissemination of research results. As clinical trials in biomedical research have evolved into the accepted method for evaluating the efficacy and effectiveness of health care interventions, the scientific work of these trials has become increasingly complex and requires a number of research workers to implement studies. One particularly important individual in this collaborative research enterprise is the research coordinator (RC), who is responsible for the coordination of the clinical trial and monitoring day-to-day implementation of the protocols for the trial. RCs hold a unique position in clinical trials management, and can be expected to be aware of and even influence the scientific integrity with which the research is conceptualized, implemented, and the findings disseminated. Yet, we know very little about their values, beliefs, practices and experiences related to scientific integrity and misconduct (SM). The purpose of this study is to conduct a national survey of clinical research coordinators in order to describe a) their beliefs and values about scientific misconduct, b) their perceptions of factors in their institution that could influence scientific misconduct, c) their estimation of the prevalence of specific types of misconduct in their environment, d) their awareness of actual misconduct that has occurred, e) their beliefs about how they would report an instance of scientific misconduct, and f) their perceptions of behavioral influences on scientific misconduct. In addition, RCs who are aware of an actual incident of SM will respond to 8 open-ended questions at the end of the SMQ-R and describe their experiences. This study employs a cross-sectional design. The Scientific Misconduct Survey-Revised (SMQ-R) will be sent to a random selection of 3,500 research coordinators from two mailing lists obtained from the Association of Clinical Research Professionals, and the Center for Clinical Research Practice, as well as a network of RCs in private practice, which are engaged in research coordination. Both quantitative and qualitative analytical procedures will be used to analyze data from this study to provide a comprehensive picture of the perceptions, beliefs, and actual experiences of research coordinators related to scientific misconduct.
|Effective start/end date||8/15/03 → 7/31/06|
- National Institutes of Health: $145,000.00