An International Collaborative Genetic Research Project Conducted in China

Abstract

In 1995, a research team from a renowned US university started collecting blood samples from villagers living in Anhui province, China, with the cooperation of local research institutes and the Chinese government. In 2000, the US university team was accused of violating research ethics principles by not adequately informing the participants about the research and not sharing benefits fairly. Subsequent investigations by American and Chinese media and authorities showed that the US research institute, its research personnel and a pharmaceutical company involved were benefiting substantially from the project, while the Chinese research participants and the government were not. Three levels of exploitation can be distinguished in this case: • the exploitation of local individual citizens as human research participants • the exploitation of the local scientific community in China • the exploitation of the country's national interest In order to avoid such exploitation, high-income countries as well as low-and middle-income countries should strengthen their institutional arrangements and improve their cooperation mechanisms, in order to ensure that both sides benefit equally from international science and technology cooperation.

Preventing ethics dumping: the challenges for Kenyan research ethics committees

“…6 While these governance issues are not limited to international collaborative research (Tindana et al, 2014), certain ventures between HICs and LMICs have highlighted the acute risks for exploitation of research participants in LMICs by HIC collaborators. For instance, Zhao and Zhang (2018) describe a controversial case where the export of thousands of human genetic samples gathered from China without adequate informed consent led to significant commercial benefits for a US company.…”

“…Typical examples of ethics dumping in international collaborative research include a group of three US-funded clinical trials with a placebo arm conducted in India, even though a standard of care treatment was available (Srinivasan et al, 2018); research on wild-caught, non-human primates in Kenya, which would have been prohibited in the home institution of the UK investigator (Chatfield and Morton, 2018); the export and profitable commercialisation of blood samples from China to the US without local benefit sharing (Zhao and Zhang, 2018); or the undertaking of highly ethically sensitive research by an international researcher without research ethics committee (REC) approval in Liberia (Tegli, 2018).…”

Ethical publication of research on genetics and genomics of biological material: guidelines and recommendations

“…As previously stated "research should refrain from taking either active or passive advantage of loopholes and weaknesses in the governance systems of another country in order to perform research that would be legally or ethically unacceptable in their own country [17]." Conflict between minorities and researchers were experienced by the San [18], and inappropriate use of samples of Chinese minorities [19], Native Americans [20], and other loose ethical practices in the African continent have been reported [21]. Active participation of indigenous peoples in drafting guidelines [22][23][24] and guidelines to empower native communities are a growing trend [24][25][26].…”

Development proposals of Human Research Protection Program

“…8 Currently, even in drug and medical device clinical trials initiated by sponsors for registration in China, providing compensation to human participants following damages is often difficult to accomplish. 9 For the other human research works initiated by sponsors and investigators, compensating human participants is even more difficult. 10 To better protect the safety and rights of human participants and in line with international ethical guidelines, China should nationally solve the problems; China should gradually establish the Human Research Protection Program on the foundation of an ethics committee, continuously explore its mode of operation, and effectively protect the safety and rights of human participants through facilitating communication and coordination among multiple departments to ensure a high quality of human research.…”