Ethics review and clinical trials

Abstract

1involved comparison of conventional two-dimensional videoendoscopic imaging with a threedimensional imaging display. The study looked at the influence of each imaging system on the performance of laparoscopic cholecystectomy. The rationale for the study was the absence of objective data showing benefit of three-dimensional imaging systems on clinical practice. Primary study endpoints were execution times and errors made: presumably the investigators believed that operative time and surgical errors might differ with the technique. Nevertheless, Hanna and colleagues state that “ethics approval was not influenced by the study allocation”. This short-sighted assumption ignores the alternative hypothesis that patient allocation might alter clinical outcome and runs against the principles of ethics review We believe that research ethics committees have an essential role in not only promoting the principles of the Declaration of Helsinki (1964), but also ensuring the scientific rigour and validity of the proposed research. 2,3