As vaccines for the novel coronavirus get rolled out around the world, people have learned more about the process of developing a vaccine than ever before. Some of it has also been through experience, as thousands of people around the world have volunteered to receive the test vaccines still in vaccine trials.
Later this year, the first COVID-19 Human Infection Challenge Studies (HICS) is set to start in the U.K., where paid healthy volunteers will be infected with the virus in order to improve the efficacy of the existing vaccines. HICS involves intentionally infecting willful participants with pathogens in order to test the effectiveness of vaccines or antidotes, and to learn more about the organism’s natural history.
New research has suggested that healthy people volunteering to be infected with SARS-CoV-2, in order to help scientific advancements, should receive monetary compensation, if it is determined that these studies are otherwise ethical to proceed. In a study published in the American Journal of Bioethics, researchers assessed the ethics of paying participants to take part in so-called HICS. They also said that they don’t necessarily endorse the use of HICS for COVID-19, but asserted that participants should receive “substantial” payment.
“Our work was spurred by concerns that payment for SARS-CoV-2 HICS might require a novel ethical framework, which we ultimately determined to be unfounded,” said lead author Holly Fernandez Lynch from the University of Pennsylvania, adding that “payment for HICS participation should be treated like payment in other clinical studies involving healthy participants.”
Using this method for a disease that is potentially fatal and lacks a sureshot cure so far is ethically cloudy, and it cannot be ignored that offering money in exchange for participation might affect consent.
“High offers of payment are sometimes met with scrutiny and concern, but it can be ethically appropriate to offer substantial payment for research participation and we have to consider that low payment also raises significant ethical concerns,” said Lynch.
The area of vaccine development and testing is already fraught with enough concerns as it is. Recently, people in the Indian town of Bhopal were made to participate in the phase-3 trials of the homegrown Covaxin without any proper knowledge or even informed consent about the possible complications.
The American research team has developed a framework to ensure ethical assessments for payment in these studies that can be highly beneficial when it comes to developing and testing out vaccines. This framework is split into two parts. The first focuses on three main motives for payment: reimbursement (for out-of-pocket expenses), compensation (which includes payment for time, burden, inconvenience of isolating, etc.), and incentive (to broaden the range of individuals willing to consider participation).
The second part considers appropriate compensation in the event any harm occurs — ranging from injury to death.
The team laid emphasis on the trust factor in the process, noting that offering payment might adversely affect public trust in the exercise. They eventually concluded that it’s imperative to communicate both the scientific and ethical surety of such an exercise to the public.
“HICS can proceed only when strict research and ethical standards are satisfied,” said co-author Thomas Darton, from the Department of Infection, Immunity and Cardiovascular Disease at The University of Sheffield, “If the risks associated with these studies are unreasonable in relation to their potential benefits, payment for participation cannot help achieve ethical acceptability. But if the research is otherwise ethical, it doesn't become unethical simply because payment is offered.”
The team of researchers also considered if HICS in the case of COVID-19 could be uniquely dangerous when compared to other such clinical research, and thus merit higher payment, eventually deciding that the ethical concerns are similar across the board.
"Although certainly relevant to considerations regarding the ethical acceptability of HICS, including the importance of planning for research-related harm, heightened risks do not support adopting a novel framework for HICS payment as compared to other types of research," adds co-author Emily Largent, the Emanuel and Robert Hart Assistant Professor of Medical Ethics at the Perelman School of Medicine, University of Pennsylvania.
At this point, the team hasn’t come up with a specific amount that would be enough to compensate participants. “Stakeholders must take the final step between conceptual guidance and actual payment offers on their own,” the paper concludes. While this means that various sums of money could be justifiable, the framework developed by the researchers will help determine which figures are appropriate.
So far, whether or not people receive payment for volunteering in ongoing vaccine trials has depended on where they live. Participants are generally paid for their time and the trouble they take to reach the location for the trial, but care is taken to ensure there is no financial incentive for those volunteering to take part. So even if organisers could pay volunteers much more, they wouldn’t.
In the U.S, varying by the trial and its duration, it could be anywhere between a few hundred to a few thousand dollars. Volunteers at vaccine trials at the University of Oxford and Imperial College London in the U.K. were also promised between £190 (about $261) and £625 ($861) for their time, travel, and contribution. As per Indian regulations, volunteers are not paid any remuneration for participating in the trials, and receive only nominal amounts for food and travel when they visit the site.
The HICS researchers also find that the lack of such research when it comes to the Global South is a limitation when deciding on ethical payment guidelines that can be standardised across the world, since payment standards and guidelines differ in various countries.
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