The purpose of this study was to conduct a national survey of clinical research coordinators (RCs) to describe their beliefs and experiences with Scientific Misconduct (SM). The Scientific Misconduct Questionnaire-revised was completed by 820 RCs, the majority of whom were female (95.4%), Caucasian (92.2%), RNs (62.2%) and certified in clinical research (79.4%), with a mean age of 46. The mean number of studies for which RCs enrolled subjects was 5, while the mean number of studies they were responsible for following (but not enrolling) subjects in was 7. The most common SM types reported were violations of subject enrollment (42.7%) and protocols (48.9) but most described the frequency of these violations as seldom. Only 200 (19.1%) indicated that coercion of potential subjects occurred. One-fourth (24.1%) indicated that pressure from sponsors to engage in unethical practices occurred, but very infrequently. In spite of the low frequency of SM, 42.1% (n=345) indicated that they were concerned about the amount of SM. RCs believed chances for getting caught for SM were high (67.4%) and penalties would be severe (73.9%). Two-thirds (67.6%) indicated that if someone engaged in SM and was reported, they were very likely to be disciplined; however, 10.7 % indicated that the discipline would depend on the person’s position. When asked what a typical RC would do if they were aware that an investigator violated rules for research integrity, 9.5% believed a typical RC would do nothing, 37.3% would express disapproval to the PI but not report it, 26.6% would ask the investigator to report themselves and report it if not, and 24.6% would report the PI to appropriate authorities. Although the actual prevalence of SM in this study is similar to previous reports, these findings provide more information about the actual scope of misconduct and actions taken by RCs when aware of SM.
Session #1211 - Scientific Inquiry
The 29th Annual MNRS Research Conference (April 1-4, 2005)