Abstract

Objective: The human genetic resources are the base of innovative research in the field of life science and technology nowadays. The concrete practice of informed consent is of great significance in reasonable protection of human genetic resources. The aim of this study was to compare the common ground and difference of informed consent between the collection, preservation and utilization of human genetic resources for the purpose of scientific research and such activities in clinical care and clinical trial, and discusses how to reflect and provide for informed consent in the legislation of human genetic resources. Material and Methods: The relevant Chinese laws and regulations since 1993 and Regulations on the Administration of Human Genetic Resources (Submission for Review) was collected and compared. And the practical dilemma of informed consent was analyzed from the perspective of ethics, law and social implications. Results: Informed consent in the human genetic resources collection, preservation and research and development activities has demonstrated different characteristics on the aspects of the subject of informed consent, informed contents and re-consent etc., which are also the very dilemma confronted by the practice of informed consent in the human genetic resources protection. Conclusion: The reasonable provision in human genetic resources-related legislation on informed consent should take into account both the human dignity and Self-Determination and the particularity of human genetic resources and social and natural human attributes.

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