By Sunnie Ning
In this blog post, I will continue exploring the ethical issues associated with conducting global vaccine trials.
To determine whether a research design has met the standard of care for the control group and provided informed consent, the proposed study typically must be reviewed by an ethics board. Some scholars have suggested that international studies must receive approval of ethics review boards from all countries involved. Others emphasize the importance of an independent review to minimize conflicts of interest and to ensure public accountability.
Review boards face different challenges depending on the country. For developing countries, institutional independence and quality of review can vary, and there are usually fewer resources available for such review. Review boards in developing countries might also feel pressured to let things slide for fears of losing research funding. For sponsor countries, the ethics review board may lack knowledge of local context, regulations, and standards of care. They are also less able to consider the local views of ethical issues.
An ethics review board in a developed country might come to a different conclusion than that of the host country. But there is no common procedure for adjudicating such conflicts. When the two disagree, the sponsor country’s ethical requirements often prevail. This can sabotage the collaborative partnership between the two countries. Such was the case in 2000, when a U.S. university team was accused of collecting blood from people in rural China for research purposes without a proper ethics review.
Fair Subject Selection
Historically, poor, uneducated, and stigmatized populations were usually targeted for high-risk research. Selecting target villages, tribes, or city neighborhoods for research participation can be difficult. On one hand, the selection of a vulnerable population might be especially scientifically salient. On the other hand, vulnerable populations are especially likely to be harmed or exploited in research. The Helsinki declaration states that research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. Despite this, debates on whether certain vulnerable populations are suitable as research subjects continue.
Pediatric clinical trials in developing countries highlight this conundrum. Clinical trials in children can be critical to developing age-specific, empirically-verified cures. This is especially important to developing countries, where infants and children make up a larger population. But since children cannot consent, they are vulnerable, and researchers should design studies especially carefully to avoid coercion and ensure safety. In one incident, the Nigerian government sued Pfizer for giving experimental antibiotics to 100 children with neither parental consent nor federal approval.
Benefit-sharing and post-trial access
Benefit-sharing is one of the important benchmarks for ethical research in developing countries. To avoid exploitation, researchers must make sure that the potential benefit to research participants and their society is proportionate to or greater than the risks. There are competing theories on how this can be achieved.
The traditional approach requires that when research shows an intervention to be effective, it should be made “reasonably available” to the host community. But the meaning of “reasonably available” can be ambiguous. In the COVID-19 context, this requirement has implications for price, volume, timing of delivery, and even intellectual property rights. Brazil, for example, is conducting trials on Sinovac’s vaccine in exchange for the right to produce 120 million doses.
Another approach to benefit-sharing suggests it should be achieved through a bargaining process between the research community and research sponsors. This is the view taken by the current Helsinki Declaration, which requires sponsors, researchers, and host country governments to “make provisions for post-trial access for all participants,” but does not specify any criteria for such post-trial access.
Others believe that sponsors should provide the best deal of benefits possible to the host country, given power and economic asymmetries. The benefits shared should not be limited to the benefits of the trial, but also include benefits such as overall healthcare structure improvements, or access to data collected over the course of the trial. Host country researchers are often denied access to samples and data collected in their countries, as was the case following the 2013-2016 Ebola outbreak.
Despite decades of experience and flourishing bioethics literature, the practice of conducting clinical trials in developing countries is still ethically contentious. COVID-19 vaccine trials will need to consider these ethics issues, as the decisions made in these trials will contribute to this debate.