The effect of study type on research ethics committees’ queries in medical studies

Abstract

Background: Medical research involving human subjects must be evaluated by a research ethics committee (REC) before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant. Methods: The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies with other invasive interventions, studies with non-invasive physical procedures, and non-physical procedures only. Results: In clinical drug trials, the REC posed queries more frequently about the risk–benefit ratio and less frequently about study methods and participant-related issues in comparison with other study types. Relative to other studies, those with non-physical procedures were subject to more frequent queries related to reliability of the study methodology and to data protection and confidentiality. Most of the queries focused on the recruitment process. Conclusions: The emphasis on risk–benefit evaluation in clinical drug trials may arise from RECs’ concern that clinical drug trials are most often conducted on patients and may involve new chemical entities with limited safety data. The relative scarcity of method queries in relation to clinical drug trials may indicate high scientific quality of industry-sponsored research, whereas the elevated percentage of these queries in investigator-initiated studies with non-physical procedures may suggest a need for better scientific education of independent clinical investigators.