Reporting of Informed Consent and Ethics Committee Approval in Clinical Trials

Abstract

CONTEXT: To determine whether journals have improved their disclosure of ethical protections in clinical trials. METHODS: Comparison of clinical trials published before and after 1997 (July 1995 to December 1996 and January 1998 to June 1999) in Annals of Internal Medicine, BMJ, JAMA, The Lancet, and The New England Journal of Medicine. Sixty articles per journal per period were randomly selected and assessed for rate of reporting on informed consent and on ethics committee approval. RESULTS: Informed consent was not described in 79 articles (26%) published before 1997 vs 53 (18%) published after 1997 (P =.01), and ethics committee approval was not mentioned in 93 (31%) before 1997 vs 54 (18%) after 1997 (P