Learning Objective #1: Identify the most prevalent forms of scientific misconduct reported by research coordinators

Learning Objective #2: Describe how the reports of research coordinators about scientific misconduct are handled and how this affects their future actions

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The purpose of this study was to conduct a national survey of clinical research coordinators in order to describe their beliefs, attitudes about and experiences with SM. To date, 256 eligible RCs completed the SMQ-R, 54(21.1%) indicated awareness of SM occurrences within the last year and 56 described an actual occurrence. The mean number of studies for which RCs were responsible for enrolling subjects was 5.18 (sd=5.42), while the mean number of studies for which respondents were responsible for following (but not enrolling) subjects was 6.95 (sd=8.63). The most prevalent SM types reported were violations of protocols for procedures (84.4%) and subject enrollment (74.5%), but most described the frequency of these violations as seldom. Twenty percent indicated that coercion of potential subjects occurred. One-fourth (24.6%) indicated that pressure from sponsors to engage in unethical practices occurred; 44.7% indicated that they were concerned about the amount of SM. RCs believed chances for getting caught for SM were high (73.0%) and penalties would be severe (77.3%). Two-thirds (67.6%) indicated that if someone engaged in SM and was reported at their institution, then they were very likely to be disciplined; however, 12.1% indicated that the likelihood of discipline would depend on the person's position (investigator or staff). At least 25% of respondents identified the following as strong influences on SM: funding pressures, need for recognition, need for publication, insufficient involvement or low interest of PI, and intensity of protocols for which RC was responsible. The number of protocols for which the RC was responsible was described as having some influence by 57.1% and a strong influence by 24.2% of respondents.