In this national survey of scientific misconduct research coordinators (RCs) who indicated they had knowledge of a specific instance of misconduct were asked to answer twelve open ended questions about the instance. These questions focused on the instance, actions taken, whether the incidence was reported and to whom, what the outcome was, and how they would handle scientific misconduct if it occurred again. 178 participants (19.1% of overall sample) responded, 57% of whom worked in an academic medical center, 80% held certification in clinical research, 62% were nurses by discipline, and 74.5 % held a baccalaureate or higher degree. Responses were transcribed verbatim and analyzed using content analysis. Two investigators along with two doctoral students read the first 56 responses and developed a list of preliminary codes, followed by two members of the research team coding each of the responses independently and then meeting to resolve any differences. Findings indicate there are different types of scientific misconduct occurring with falsifying data the most common, followed by inclusion/exclusion criteria violations. At times, the nature of the misconduct was such that the RCs perceived it to be a patient safety concern. Other misconduct included informed consent violations, coercion, protocol violations, personal financial gain, untrained personnel and lack of IRB approval. Most often the person committing the scientific misconduct was the principal investigator (57%). To whom the incident was reported to varied greatly and appeared to be influenced by the structure of the organization. The outcomes of reporting an incident varied greatly with the violator being fired or disciplined (24%) most common followed the person reporting the incident being fired (9%). This is the first national survey of RCs who validated previous reports of the prevalence of SM, but also provided descriptions of precipitating factors and consequences as well.
Session #1211 - Scientific Inquiry
The 29th Annual MNRS Research Conference (April 1-4, 2005)