University of Sussex
Browse
Book Chapter- China Reg Def March 2017.pdf (607.94 kB)

The regulatory situation for clinical stem cell research in China

Download (607.94 kB)
chapter
posted on 2023-06-09, 06:25 authored by Achim Rosemann, Xinqing Zhang, Suli Sui, Adrian ElyAdrian Ely, Margaret Sleeboom-FaulknerMargaret Sleeboom-Faulkner
This chapter reviews the regulatory situation for clinical stem cell research in the People’s Republic of China since the early 2000s. The paper is structured in four parts. Part I examines the regulatory conditions for the donation of human gametes and embryos and their use in basic and preclinical research. This involves an overview of China’s regulatory rules for assisted reproductive technologies (ART) and its approach to the governance of human embryonic stem cell (hESC) research. Part II offers a summary of the regulatory and legal instruments that govern clinical trials and other forms of human subjects research in China. These instruments, most of which have been launched in the 1990s and early 2000s, do not specifically address stem cell research, but they influence clinical stem cell research as horizontal regulatory rules. Part III focuses more specifically to the regulation of clinical stem cell research and applications, including the regulation of experimental (for-profit) interventions with stem cells that do not classify as clinical trials or systematic forms of clinical research. This part documents the formation of a regulatory approach for clinical stem cell applications since the mid-2000s, which was still ongoing at the time of writing. The conclusions discuss open questions and the repercussions of China’s regulatory approach for stem cell research for domestic researchers, clinicians, and corporations in China, as well as for international clinical and corporate collaborations.

Funding

Bionetworking in Asia - A social science approach to international collaboration, informal exchanges, and responsible innovation in the life sciences; G0812; EUROPEAN UNION; 283219

Bionetworking in Asia - International collaboration, exchange, and responsible innovation in the life sciences; G0750; ESRC-ECONOMIC & SOCIAL RESEARCH COUNCIL; ES/I018107/1

History

Publication status

  • Published

File Version

  • Accepted version

Publisher

Springer

Volume

6

Pages

327.0

Book title

Safety, ethics and regulations

Place of publication

Heidelberg and New York

ISBN

9783319591643

Series

Stem cells in clinical applications

Department affiliated with

  • Anthropology Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Editors

Achim Rosemann, Van Pham Phuc

Legacy Posted Date

2017-05-26

First Open Access (FOA) Date

2021-10-22

First Compliant Deposit (FCD) Date

2016-09-01

Usage metrics

    University of Sussex (Publications)

    Categories

    No categories selected

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC