Compliance of Clinical Trial Consent Forms with International Guidelines: Analysis of Deficiencies
- PDF / 239,194 Bytes
- 3 Pages / 504 x 719.759 pts Page_size
- 81 Downloads / 183 Views
Drug Informarion Journal, Vol. 36, pp. 17-19, 2002 Printed in the USA. All rights reserved.
Copyright 0 2002 Drug Information Association Inc.
COMPLIANCE OF CLINICAL TRIAL CONSENT FORMS WITH INTERNATIONAL GUIDELINES: ANALYSIS OF DEFICIENCIES YEONG-LIANG LJN,MD, CHIA-HSINHUANG,MD, CHIH-LIULIN, MD, AND BEY-LIING MAU, MD, PHD Medical Reviewers, Center for Drug Evaluation, Taipei, Taiwan
To study whether clinical trial consent forms comply with international guidelines, the deficiencies of 71 clinical trial consent f o r m reviewed by the Centerfor 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 signifcant. Key Words: Clinical trial; Deficiency; Consent form; Guideline; Compliance
INTRODUCTION
number of elements that must be disclosed in the written informed consent documents, certain inadequacies can render informed consent documents unsatisfactory. The aim of the present study is to examine whether clinical trial consent forms comply with international guidelines such as the Declaration of Helsinki and those of the International Conference of Harmonization (ICH) by analyzing the deficiencies in those forms. While the study focuses on the mandated elements in these guidelines, deficiencies deemed significant for local regulatory approval are also analyzed.
FOR ALL RESEARCH, the ethical conduct of a clinical mal is of prime importance. Ethical regulations that govern clinical research have, therefore, focused on the informed consent process as a means of protecting potentially vulnerable research subjects from physical and psychological harm (1,2). These regulations use informed consent documents to achieve full disclosure of relevant information, including the nature of the research and risks to research participation. Several recent studies have demonstrated that although regulations are being followed, informed consent documents have become increasingly MATERIALS AND METHODS unreadable, lengthy, and uninformative(3,4,5). Although no definite answers exist on the In Taiwan, approximately 200 clinical trials are conducted every year. About 50% of these are pre-New Drug Application (NDA) Reprint address: Yeong-Liang Lin, MD, Center for 50% are trials done for local registrials and Drug Evaluation, lF, No 15-1, Sec 1, Hangjou S Road, tration purposes (6). The Center for Drug Taipei, Taiwan 100. E-mail: [email protected]. 17 Downloaded from dij.sagepub.com at CARLETON UNIV on May 7, 2015
Y-L
Data Loading...
