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. (shrink)

The practice of medicine—and especially the patient-doctor relationship—has seen exceptional shifts in ethical standards of care over the past few years, which by and large originate in occidental countries and are then extrapolated worldwide. However, this phenomenon is blind to the fact that an ethical practice of medicine remains hugely dependent on prevailing cultural and societal expectations of the community in which it serves. One model aiming to conceptualise the dichotomous efforts for global standardisation of medical care against differing sociocultural (...) expectations is the individualism-collectivism model, with the ‘West’ being seen as individualistic and the ‘East’ being seen as collectivistic. This has been used by many academics to explain differences in approach towards ethical practice on key concepts such as informed consent and patient autonomy. However, I argue that this characterisation is incomplete and lacks nuance into the complexities surrounding cross-cultural ethics in practice, and I propose an alternative model based on the ethics of clinical care in Hong Kong, China. Core ethical principles need not be culture-bound—indeed, their very existence mandates for them to be universal and non-derogable—but instead cultural alignment occurs in the particular implementation of these principles, insofar as they respect the general spirit of contemporary ethical standards. (shrink)

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 theICH‐GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existingICH‐GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles (...) outlined in theICH‐GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of theICH‐GCP Guideline in its present form. (shrink)