ACADEMIC SURGEONS KNOWLEDGE OF FOOD-AND-DRUG-ADMINISTRATION REGULATIONS FOR CLINICAL-TRIALS

Objectives: To identify knowledge levels of academic surgeons about Fo od and Drug Administration (FDA) and Institutional Review Board (IRB) regulations for clinical research and to determine whether being a mem ber in an IRB, conducting or participating in clinical trials, or bein g a member in surgical societies affected knowledge levels. Design: Su rvey of surgical department faculty members in 20 universities. Result s: 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 pred ictor of overall score was being a primary investigator of a clinical trial (P<.001), followed by being or having been a member of an IRB (P less than or equal to.02). The total mean score of members of the Sur gical Infection Society (8.2+/-0.5) was significantly higher (P<.001) than that of nonmembers (6.1+/-0.2), a phenomenon not observed with ot her surgical societies, In certain hypothetical clinical scenarios, al l respondents were mistakenly willing to conduct clinical trials witho ut obtaining appropriate approval from the FDA. Four (22%) of 18 IRB m ember respondents and 16 (25%) of the 65 respondents were willing to c onduct human research without appropriate approval from patients, the IRB, or both. Conclusions: Knowledge deficits exist in the academic su rgical community about the role and requirements of the FDA and local IRBs for conducting clinical research. Further study is required to de termine the reasons for this deficit and to identify appropriate inter ventions.