title: From global bioethics to ethical governance of biomedical research collaborations.
abstract: One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved.
authors.affiliation: Department of Anthropology, University of Copenhagen, Øster Farimagsgade 5, 1353 Copenhagen, Denmark. Electronic address: ayo.wahlberg@anthro.ku.dk.
authors.forename: Ayo
authors.initials: A
authors.lastname: Wahlberg
authors.affiliation: Institute for History of Medicine and Science Studies, University of Luebeck, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Rehmann-Sutter
authors.affiliation: Department of Anthropology, University of Sussex, United Kingdom.
authors.forename: Margaret
authors.initials: M
authors.lastname: Sleeboom-Faulkner
authors.affiliation: Reproductive and Genetic Hospital, CITIC-Xiangya, Changsha, PR China.
authors.forename: Guangxiu
authors.initials: G
authors.lastname: Lu
authors.affiliation: Horst-Görtz-Institute, Charité Medical University, Berlin, Germany.
authors.forename: Ole
authors.initials: O
authors.lastname: Döring
authors.affiliation: Centre for Medical Ethics, Peking University Health Science Centre, Beijing, PR China.
authors.forename: Yali
authors.initials: Y
authors.lastname: Cong
authors.affiliation: Department of Sociology, University of Lodz, Poland.
authors.forename: Alicja
authors.initials: A
authors.lastname: Laska-Formejster
authors.affiliation: Reproductive and Genetic Hospital, CITIC-Xiangya, Changsha, PR China.
authors.forename: Jing
authors.initials: J
authors.lastname: He
authors.affiliation: Asia Research Institute, National University of Singapore, Singapore.
authors.forename: Haidan
authors.initials: H
authors.lastname: Chen
authors.affiliation: Department of Political Science, University of Vienna, Austria and Kyung Hee University, Seoul, South Korea.
authors.forename: Herbert
authors.initials: H
authors.lastname: Gottweis
authors.affiliation: Department of Social Science, Health and Medicine, King's College London, United Kingdom.
authors.forename: Nikolas
authors.initials: N
authors.lastname: Rose
mesh_terms: D026688:Bioethical Issues / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002681:China; D026724:Ethical Review / Q000331:legislation & jurisprudence; D005060:Europe; D006801:Humans; D007391:International Cooperation; D007400:Interprofessional Relations / Q000941:ethics; D035844:Researcher-Subject Relations / Q000941:ethics
keywords: Ethical governance; Europe; Global bioethics; Informed consent; People's Republic of China; Regulation; Research collaboration