consent, authorship, Indigenous peoples, genetics/genomics, biobanking, malaria research, international collaboration, secondary use, gatekeepers, national research ethics committee
Over the past several years, there has been a global increase in the use of human biobanks for conducting biomedical research. International collaborations involving these biobanks are vital to expedite knowledge sharing and facilitate research development. However, sharing biological samples gives rise to a number of ethical concerns, including issues involving informed consent, ownership, confidentiality, commercialization, and public protection.1,2,3
In 2010, a group of researchers from a health agency in a high-income country proposed a collaborative research project to the Ministry of Health in a lower-income country. The research will investigate high endemic malaria rates and genetic susceptibility among Indigenous communities in the country and will involve collection of saliva, blood, and stool samples from the target population. The researchers planned to collect biological samples during mobile outreach clinic programs in which health care workers serve members of this population with a nomadic lifestyle. After a few rounds of changes, the National Research Ethics Committee within the Ministry of Health of the country approved the study protocol.
The researchers first approached the leader of this community and explained the study with the help of a mobile outreach health care worker who could speak the local language. The researchers also hired members of the medical staff from the mobile clinic (who also spoke the local language) as research assistants to help during the process of obtaining informed consent from the prospective study participants. The informed consent form for this research, drafted in English, explained that saliva, blood, and stool samples would be collected and stored for the current malaria research but also for future studies that might include developing a vaccine for malaria. Recognizing the potential value of this research, the community members consented to the research, which does not state any benefits beyond sharing findings with the Ministry of Health of the country.
Approximately 30,000 biological samples were collected within the 3-year study period. The collected biological samples were stored in one of the local government hospitals and later shipped to the high-income country for analysis and storage for future research. Years later, a research article was published in an internationally renowned journal showing an increased genetic susceptibility to SARS-CoV infection among Indigenous communities, especially within the study country. Researchers from that country were not involved in the analysis or publication.
Questions
What do you think about how the informed consent was obtained for this study? What, if any, recommendations would you have to promote an even more effective consent process for the study?
What should the National Research Ethics Committee require of the study to protect the Indigenous population?
In addition to sharing findings with the Ministry of Health, should the researchers be expected to return individual-level results to those from whom the samples were collected? What are some of the relevant factors that need to be considered before returning individual-level results?
In this study, who owns the samples, who should have a right of access to the samples, and what measures should be in place to protect ownership and access interests?
What is your opinion about the secondary use of the samples for nonmalaria research and publication of research findings without inclusion of the local researchers?
