Compliance of Clinical Trial Consent Forms with International Guidelines: Analysis of Deficiencies

Abstract

To study whether clinical trial consent forms comply with international guidelines, the deficiencies of 71 clinical trial consent forms reviewed by the Center for Drug Evaluation in Taiwan were analyzed. Two hundred and twenty seven deficiencies in 15 categories were found. The most frequent deficiency was inadequate description of the worldwide regulatory status of the study drug, which was not specifically required by the international guidelines. The second most frequent deficiency was inadequate information regarding the person to contact in case of an emergency. It was concluded that consent forms, in general, do comply with international guidelines. However, the quality and hence, the protection of clinical trial subjects, can be further improved by monitoring deficiencies not required by the international guidelines but deemed significant.