title: Ethical considerations in clinical trials: a critique of the ICH-GCP guideline.
abstract: This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form.
authors.affiliation: Faculty of Law, University of Malaya, 50603, Kuala Lumpur, Malaysia. kaursh@um.edu.my.
authors.forename: Sharon
authors.initials: S
authors.lastname: Kaur
authors.forename: Choong Yeow
authors.initials: CY
authors.lastname: Choy
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005060:Europe; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D007564:Japan; D010043:Outcome and Process Assessment, Health Care / Q000379:methods; D014481:United States