Governance of biomedical research – the perspective of international collaboration

Authors

DOI:

https://doi.org/10.18778/0208-600X.45.10

Keywords:

Global bioethics, ethical governance, regulation, research collaboration, informed consent, People’s Republic of China, Europa

Abstract

The issues addressed in the article concern international ethical standards of research, which are carried out in the field of life sciences. Thanks to the applications of the mapping method, key ethical challenges of international research have been distinguished and main currents in the critical verification of global ethics have been described. Moreover, the suggestion about tactics and its applications, which seems to be essential in our times according to the ethical challenges arising from the field of intercontinental biotechnological collaboration, have been made.

References

Abraham J., Reed T. (2003), Reshaping the Carcinogenic Risk Assessment of Medicines: International Harmonisation for Drug Safety, Industry/Regulator Efficiency or Both?, „Social Science and Medicine”, Vol. 57, No. 2, s. 195‒204. DOI: https://doi.org/10.1016/S0277-9536(02)00339-8

Alora T., Lumitao J. M. (2001), Beyond a Western Bioethics: Voices from the Developing World, University Press, Georgetown.

Angell M. (1997), The Ethics of Clinical Research in the Third World, „New England Journal of Medicine”, Vol. 337, No. 12, s. 847‒849. DOI: https://doi.org/10.1056/NEJM199709183371209

Bharadwaj A., Glasner P. (2009), Local Cells, Global Science: The Rise of Embryonic Stem Cell Research in India, Routledge, London. DOI: https://doi.org/10.4324/9780203891032

Bhutta Z. (2004), Standards of Care in Research Should Reflect Local Conditions and Not the Best Western Standards, „British Medical Journal”, Vol. 329, s. 1114‒1115. DOI: https://doi.org/10.1136/bmj.329.7475.1114

BIONET: Aims of BIONET (2006a), http://www.lse.ac.uk/researchAndExpertise/units/BIONET/about.htm, 22.02.2013.

BIONET: BIONET Partners (2006b), http://www.lse.ac.uk/researchAndExpertise/units/BIONET/partners.htm, 22.02.2013.

BIONET. Ethical Governance of Biological and Biomedical Research: Chinese-European Co-operation (2009), http://www.lse.ac.uk/researchAndExpertise/units/BIONET/Default.htm, 22.02.2012.

China Trials 2008 (2008), Global Clinical Development Summit, http://www.chinatrialsevent.com/, 22.02.2013.

Crane J. (2010), Adverse Events and Placebo Effects: African Scientists, HIV, and Ethics in the ‘Global Health Sciences’, „Social Studies of Science”, Vol. 40, No. 6, s. 843‒870. DOI: https://doi.org/10.1177/0306312710371145

De Vries R., Turner L., Orfali K., Bosk C. (eds.) (2007), The View from Here: Bioethics and the Social Sciences, Blackwell, Oxford.

De Costa A., D’Souza N., Krishnan S., Chhabra M. S., Shihaam I., Goswami K. (2004), Community Based Trials and Informed Consent in Rural North India, „Journal of Medical Ethics”, Vol. 30, s. 318‒323. DOI: https://doi.org/10.1136/jme.2002.001065

Geissler P. W., Kelly A., Imoukhuede B., Pool R. (2008), “He Is Now Like a Brother, I Can Even Give Him Some Blood” – Relational Ethics and Material Exchanges in a Malaria Vaccine “Trial Community” in The Gambia, „Social Science and Medicine”, Vol. 67, No. 5, s. 696‒707. DOI: https://doi.org/10.1016/j.socscimed.2008.02.004

Geissler P. W., Molyneux C. (eds.) (2011), Evidence, Ethos and Experiment. The Anthropology and History of Medical Research in Africa, Berghahn Books, Oxford. DOI: https://doi.org/10.26530/OAPEN_478050

Gottweis H. (red.) (2009), Biopolitics in Asia, „New Genetics and Society”, Vol. 28, No. 3. DOI: https://doi.org/10.1080/14636770903162411

Hall D. (1991), The Research Imperative and Bureaucratic Control: The Case of Clinical Research, „Social Science and Medicine”, Vol. 32, No. 3, s. 333‒342. DOI: https://doi.org/10.1016/0277-9536(91)90112-P

Jasanoff S. (2007), Designs on Nature. Science and Democracy in Europe and the United States, University Press, Princeton.

Łaska-Formejster A. (2010), Problemy i dylematy etyczne badań klinicznych w kontekście współpracy międzynarodowej: Europa ‒ Chiny, [w:] J. Kopka, G. Matuszak (red.), Problemy współczesnej demokracji i moralności, Wydawnictwo Uniwersytetu Łódzkiego, Łódź, s. 263‒279.

Łaska-Formejster A. (2012), Problemy i dylematy etyczne badań biomedycznych w kontekście realizacji projektu „BIONET”, [w:] J. Mariański, D. Walczak-Duraj (red.), Ład czy bezład moralny ‒ ku społeczeństwu bez moralności?, „Acta Universitatis Lodziensis”, Folia Sociologica 40, Wydawnictwo Uniwersytetu Łódzkiego, Łódź, s. 253‒273.

Molyneux C. S., Geissler P. W. (2008), Ethics and the Ethnography of Medical Research in Africa, „Social Science and Medicine”, Vol. 67, No. 5, s. 685‒695. DOI: https://doi.org/10.1016/j.socscimed.2008.02.023

Molyneux C. S., Wassenaar D. R., Peshu N., Marsh K. (2005), “Even if They Ask You to Stand by a Tree All Day, You Will Have to Do It (Laughter)!” – Community Voices on the Notion and Practice of Informed Consent for Biomedical Research in Developing Countries, „Social Science and Medicine”, Vol. 61, No. 2, s. 443‒454. DOI: https://doi.org/10.1016/j.socscimed.2004.12.003

Ong A., Chen N. (eds.) (2010), Asian Biotech: Ethics and Communities of Fate, Duke University Press, Durham. DOI: https://doi.org/10.1215/9780822393207

Participatory Governance and Institutional Innovation: The New Politics of Life, Summary Report of the PAGANINI Project (2007), University of Vienna, Vienna.

Petryna A. (2007), Clinical Trials Offshored: On Private Sector Science and Public Health, „BioSocieties”, Vol. 2, s. 21‒40. DOI: https://doi.org/10.1017/S1745855207005030

Petryna A. (2009), When Experiments Travel: Clinical Trials and the Global Search for Human Subjects, Princeton University Press, Princeton. DOI: https://doi.org/10.1515/9781400830824

Recommendations on Best Practice in the Ethical Governance of Sino-European Biological and Biomedical Research Collaborations (2010), BIONET Expert Group Report, London School of Economics, London, http://www2.lse.ac.uk/BIOS/research/BIONET/, 22.02.2013.

Regulations on Ethical Review of Biomedical Research Involving Human Subjects (2007), Ministry of Health, People’s Republic of China, Beijing.

Resnik D. (1998), The Ethics of HIV Research in Developing Nations, „Bioethics”, Vol. 12, No. 4, s. 286‒306. DOI: https://doi.org/10.1111/1467-8519.00118

Sleeboom-Faulkner M. (2009), Human Genetic Biobanks in Asia: Politics of Trust and Scientific Advancement, Routledge, London. DOI: https://doi.org/10.4324/9780203884607

Sleeboom-Faulkner M., Hwang S. (2012), Governance of Stem Cell Research: Public Participation and Decision-making in China, Japan, South Korea and Taiwan, „Social Studies of Science”, October, Vol. 42, s. 684‒708. doi: 10.1177/0306312712450939. DOI: https://doi.org/10.1177/0306312712450939

Sleeboom-Faulkner M. (ed.) (2010), Frameworks of Choice: Predictive and Genetic Testing in Asia, University of Amsterdam, Amsterdam. DOI: https://doi.org/10.5117/9789089641656

Sunder Rajan K. (2006), Biocapital: The Constitution of Postgenomic Life, Duke University Press, Durham. DOI: https://doi.org/10.1515/9780822388005

Tangwa G. B. (1996), Bioethics: An African Perspective, „Bioethics”, Vol. 10, No. 3, s. 183‒200. DOI: https://doi.org/10.1111/1467-8519.00020

Universal Declaration on Bioethics and Human Rights (2005), UNESCO, http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html, 22.02.2013.

Wahlberg A. (2012a), Emerging Biotechnology Trends, http://www.healthtechnica.com/blogsphere/2011/04/04/emerging-biotechnology-trends, 22.02.2013.

Wahlberg A. (2012b), Top 5 Strategies for Emerging Biotech Companies, http://www.bio.org/articles/top-5–strategies-emerging-biotech-companies-0, 22.02.2013.

Wahlberg A., Rehmann-Sutter Ch., Sleeboom-Faulkner M., Lu G., Döring O., Cong Y., Laska-Formejster A., He J., Chen H., Gottweis H., Rose N. [2013], From Global Bioethics to Ethical Governance of Biomedical Research Collaborations, „Social Science & Medicine”, Vol. 98, s. 293–300. DOI: https://doi.org/10.1016/j.socscimed.2013.03.041

Downloads

Published

2013-06-30

How to Cite

Łaska-Formejster, Alicja. 2013. “Governance of Biomedical Research – the Perspective of International Collaboration”. Acta Universitatis Lodziensis. Folia Sociologica, no. 45 (June): 147-61. https://doi.org/10.18778/0208-600X.45.10.