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January 1997

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

Author Affiliations

From the Department of Surgery, University of Medicine and Dentistry of New Jersey—New Jersey Medical School, Newark. Dr Waymack is now in private practice in Frederick, Md.

Arch Surg. 1997;132(1):94-98. doi:10.1001/archsurg.1997.01430250096020

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<.001), followed by being or having been a member of an IRB (P≤.02). The total mean score of members of the Surgical Infection Society (8.2±0.5) was significantly higher (P<.001) than that of nonmembers (6.1±0.2), a phenomenon not observed with other surgical societies. In certain hypothetical clinical scenarios, all respondents were mistakenly willing to conduct clinical trials without obtaining appropriate approval from the FDA. Four (22%) of 18 IRB member respondents and 16 (25%) of the 65 respondents were willing to conduct human research without appropriate approval from patients, the IRB, or both.

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

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