Academic Surgeons' Knowledge of Food and Drug Administration Regulations for Clinical Trials

Objectives: To identify knowledge levels of academic surgeons about Food and Drug Administration (FDA) and Institutional Review Board (IRB) regulations for clinical research and to determine whether being a member in an IRB, conducting or participating in clinical trials, or being a member in surgical societies affected knowledge levels. Design: Survey of surgical department faculty members in 20 universities. Results: Sixty-five responses were received from 14 sites. Overall mean (±SEM) correct score was 6.7±0.2 of a possible 20 points. The best predictor of overall score was being a primary investigator of a clinical trial ( P P ≤.02). The total mean score of members of the Surgical Infection Society (8.2±0.5) was significantly higher ( P Conclusions: Knowledge deficits exist in the academic surgical community about the role and requirements of the FDA and local IRBs for conducting clinical research. Further study is required to determine the reasons for this deficit and to identify appropriate interventions. Arch Surg. 1997;132:94-98