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Ethical Considerations in Clinical Trials: A Critique of the ICH ‐ GCP G uideline
Author(s) -
Kaur Sharon,
Choy Choong Yeow
Publication year - 2014
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/dewb.12004
Subject(s) - engineering ethics , guideline , clinical trial , medicine , political science , law , engineering , pathology
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 G uideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH ‐ GCP G uideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH ‐ GCP G uideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH ‐ GCP G uideline in its present form.