Ethical Dumping Behavior and Its Inducement and Avoidance Strategy
Wang Shuang1, Zhang Xinqing1, Zheng Xiaolan2, Huang Xiaoru2
1. School of Humanities and Social Sciences,Peking Union Medical College Chinese Acedamy of Medical Sciences, Beijing 100730,China; 2. School of Marxism Studies,University of Chinese Academy of Sciences,Beijing 100049,China
Abstract:With the cross-border development of clinical trials,the phenomenon of ethical dumping has brought huge challenges to international scientific and technological cooperation and ethical governance.Clarifying the status quo,connotation,and incentives of ethical dumping is essential for dealing with ethical dumping.By retrospecting typical medical ethics events,this paper clarifies the concept of ethical dumping and its constituent elements,and argues that ethical dumping is morally sensitive,cross-cultural and unequal.After a comprehensive and comparative analysis of the incentives for ethical dumping in high-income countries and low-to middle-income countries,it is believed that international research cooperation should enhance the awareness of mutually beneficial cooperation and strictly abide by relevant international norms and ethical standards.Low-and middle-income countries should strengthen the establishment of ethical standards,fully consider the safety of trials when accepting transnational cooperation,and avoid the occurrence of ethical dumping.
[1]THIERS F A,SINSKEY A J,BERNDT E R.Trends in the globalization of clinical trials[J].Nature reviews drug discovery,2008,7 (1):13-14. [2]DRAIN P K,ROBINE M,HOLMES K K,et al.Trial watch:global migration of clinical trials[J].Nature reviews drug discovery,2014,13 (3):166-167. [3]GLICKMAN S W,MCHUTCHISON J G,PETERSON E D,et al.Ethical and scientific implications of the globalization of clinical research[J].The New england journal of medicine,2009,360 (8):816-823. [4]U.S.National Library of Medicine.Trends,charts,and maps[EB/OL]. (2021-05-20)[2021-05-22].https://clinicaltrials.gov/ct2/resources/trends. [5]SILVA R E D,AMATO A A,GUILHEM D B,et al.Globalization of clinical trials:ethical and regulatory implications[J].International journal of clinical trials,2016,3 (1):1-8. [6]LONDON L.Ethical oversight of public health research:can rules and IRBs make a difference in developing countries[J].American journal of public health,2002,92 (7):1079-1084. [7]GILMAN R H,GARCIA H H.Ethics review procedures for research in developing countries:a basic presumption of guilt[J].Canadian medical association journal,2004,171 (3):248-249. [8]Germán N H,ROSEMARIE B.A survey in Mexico about ethics dumping in clinical research[J].BMC medical ethics,2019,20 (1):1-11. [9]邱仁宗.头颅移植:有哪些关口难以跨越[N].健康报,2017-12-22 (005). [10]MATHUR R,HAZAM R K,THAKUR K.When patients become guinea pigs-a fictitious case of ethics dumping based on real events[EB/OL]. (2017-03-01).http://trust-project.eu/wp-content/uploads/2016/03/Supplement-1_When-patients-become-guinea-pigs-final.pdf. [11]CORDIS.Reducing the risk of exporting non ethical practices to third countries[EB/OL]. (2015-03-25).https://cordis.europa.eu/programme/id/H2020_GARRI-6-2014. [12]周森,许小委.科研伦理倾销的概念辨析及其启示[J].科学管理研究,2019,37 (6):29-35. [13]周吉银,刘丹.伦理倾销对中国的危害与防范对策[J].中国医学伦理学,2019,32 (12):1511-1517. [14]陈化,葛行路,丛亚丽.涉及人的健康相关研究国际伦理准则[J].医学与哲学,2019,40 (18):75-81. [15]SCHROEDER D,COOK J,HIRSCH F,et al.Ethics dumping,case studies from north-south research collaborations[EB/OL]. (2017-12-01).https://link.springer.com/content/pdf/10.1007%2F978-3-319-64731-9.pdf.. [16]WEMOS.The globalization of clinical trials:testimonies from human subjects[EB/OL]. (2010-12-01).https://www.wemos.nl/wp-content/uploads/2016/07/Testimonies_Wemos.pdf. [17]WEMOS.Clinical trials realities in zimbabwe:dealing with possible unethical research[EB/OL]. (2015-05-01).https://www.wemos.nl/wp-content/uploads/2016/06/report-Clinical-Trials-Realities-in-Zimbabwe-Dealing-with-Possible-Unethical-Research.pdf. [18]DICKSON D.Calling into question clinical trials in developing countries[J].The lancet,2006,368 (9549):1761-1762. [19]SCHROEDER D,CHATFIELE K,MUTHUSWAMY V,et al.Ethics dumping-how not to do research in resource-poor settings[J].Academics stand against poverty,2020,1 (1):28-49. [20]NOVOA-HECKEL G,BERNABE R,LINARES J.Exportation of unethical practices to low and middle income countries in biomedical research[J].Revista de bioética y derecho,2017,40:167. [21]MACKLIN R.Bioethics,vulnerability,and protection[J].Bioethics,2003,17 (5/6):472-486. [22]SCHROEDER D,CHATFIELD K,MUTHUSWAMY V,et al.Ethics dumping-how not to do research in resource-poor settings[J].Academics stand against poverty,2020,1 (1):28-49. [23]WEIJER C.Protecting communities in research:philosophical and pragmatic challenges[J].Cambridge quarterly of healthcare ethics,1999,8 (4):501-513. [24]SCHROEDER D,CHATFIELD K,MUTHUSWAMY V,et al.Ethics dumping-how not to do research in resource-poor settings[J].Academics stand against poverty,2020,1 (1):28-49. [25]POGGE T.Justice[M]//BORCHERT D M.Encyclopedia of philosophy,Vol.4.Detroit:Macmillan Reference,2006. [26]SUGIGIMOTO C R,ROBINSON-GARCIA N,MURRAY D S,et al.Scientists have most impact when they're free to move[J].Nature news,2017,550 (7674):29. [27]SCHROEDER D,LUCAS J C,FENET S,et al.Ethics dumping-paradigmatic case studies;a report for trust[EB/OL]. (2016-10-27).http://clok.uclan.ac.uk/16039/1/TRUST-664771-Paradigmatic-Case-Studies-WP1-Final.pdf. [28]周森,许小委.科研伦理倾销的概念辨析及其启示[J].科学管理研究,2019,37 (6):29-35. [29]WORLD MEDICAL ASSOCIATION.World medical association declaration of helsinki:ethical principles for medical research involving human subjects[J].Jama,2013,310 (20):2191-2194. [30]CHATFIELD K,SCHROEDER D,GUANTAI A,et al.Preventing ethics dumping:the challenges for kenyan research ethics committees[J].Research ethics,2021,17 (1):23-44. [31]SCHAEFER G O,EMANUEL E J,WERTHEIMER A.The obligation to participate in biomedical research[J].Jama,2009,302 (1):67-72. [32]WEIGMANN K.The ethics of global clinical trials:in developing countries,participation in clinical trials is sometimes the only way to access medical treatment.What should be done to avoid exploitation of disadvantaged populations[J].EMBO reports,2015,16 (5):566-570. [33]GLICKMAN S W,MCHUTCHISON J G,PETERSON E D,et al.Ethical and scientific implications of the globalization of clinical research[J].The new england journal of medicine,2009,360 (8):816-823. [34]BIRTWISTLE H,FAIRNINGTION C.Clinical trials in developing countries are exploitative[EB/OL]. (2013-01-01).http://archive.debatingmatters.com/documents/DM_TopicGuidesClinicalTrials.pdf. [35]MATHUR R,HAZAM R K,THAKUR K.When patients become guinea pigs-a fictitious case of ethics dumping based on real events[EB/OL]. (2017-03-01).http://trust-project.eu/wp-content/uploads/2016/03/Supplement-1_When-patients-become-guinea-pigs-final.pdf. [36]BIRTWISTLE H,FAIRNINGTION C.Clinical trials in developing countries are exploitative[EB/OL]. (2017-03-01).http://archive.debatingmatters.com/documents/DM_TopicGuidesClinicalTrials.pdf. [37]MATHUR R,HAZAM R K,THAKUR K.When patients become guinea pigs-a fictitious case of ethics dumping based on real events[EB/OL]. (2017-03-01).http://trust-project.eu/wp-content/uploads/2016/03/Supplement-1_When-patients-become-guinea-pigs-final.pdf. [38]NDEBELE P,WASSENAAR D,BENATAR S,et al.Research ethics capacity building in sub-saharan africa:a review of NIH fogarty-funded programs 2000-2012[J].Journal of empirical research on human research ethics,2014,9 (2):24-40. [39]SILAIGWANA B,WASSENAAR D.Biomedical research ethics committees in sub-saharan Africa:a collective review of their structure,functioning,and outcomes[J].Journal of empirical research on human research ethics,2015,10 (2):169-184. [40]SCHROEDER D,CHATFIELD K,SINGH M,et al.Equitable research partnerships:a global code of conduct to counter ethics dumping[M].Cham,Switzerland:Springer nature,2019. [41]CHATFIELD K,SCHROEDER D,GUANTAI A,et al.Preventing ethics dumping:the challenges for Kenyan research ethics committees[J].Research ethics,2021,17 (1):23-44. [42]SCHROEDER D,COOK J,HIRSCH F,et al.Ethics dumping,case studies from north-south research collaborations[EB/OL]. (2017-12-01).https://link.springer.com/content/pdf/10.1007%2F978-3-319-64731-9.pdf. [43]WORLD MEDICAL ASSOCIATION.World medical association declaration of helsinki:ethical principles for medical research involving human subjects[J].Jama,2013,310 (20):2191-2194. [44]NOVOA-HECKEL,Germán,BERNABE,et al.Exportation of unethical practices to low and middle income countries in biomedical research.[J].Revista de bioética y derecho,2017,40:167. [45]WEIGMANN K.The ethics of global clinical trials:in developing countries,participation in clinical trials is sometimes the only way to access medical treatment.What should be done to avoid exploitation of disadvantaged populations[J].EMBO reports,2015,16 (5):566-570. [46]SCHROEDER D,COOK J,HIRSCH F,et al.Ethics dumping,case studies from north-south research collaborations[EB/OL]. (2017-12-01).https://link.springer.com/content/pdf/10.1007%2F978-3-319-64731-9.pdf. [47]South African San Institute.The san code of research ethics[EB/OL]. (2017-03-01).https://www.globalcodeofconduct.org/affiliated-codes/. [48]SCHROEDER D,LUCAS J C,FENET S,et al.Ethics dumping-paradigmatic case studies;a report for TRUST[EB/OL]. (2016-10-27).https://www.researchgate.net/publication/308985607_Ethics_Dumping_-_Paradigmatic_Case_Studies_a_report_for_TRUST. [49]National Health Council.Ministry of health resolution 466/12.Guidelines and regulatory standards for research involving human subjects[EB/OL]. (2013-06-13)〖2021-08-18]https://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf. [50]SILVA R E D,AMATO A A,GUILHEM D B,et al.Globalization of clinical trials:ethical and regulatory implications[J〗.International journal of clinical trials,2016,3 (1):1-8.