Searching for a Cure: Challenge Trials

Leon Reilly

4th Year
CBC Monkstown Park

The corrupting influence of Covid-19 on global health and economy has been diagnosed: the IMF has stated that advanced economies will run a deficit of 11% GDP this year; the death rate will continue to rise, especially in poorer countries. The crisis will likely continue to fragment and disrupt the global economy as travel and social restrictions remain. Ultimately, then, until a vaccine has been found and widely applied, those restrictions will likely not be lifted. Given the scope of potential damage, a new weapon has been suggested to help fight in the war—Human Challenge Trials, where healthy volunteers are deliberately infected with Coronavirus as part of the approach for finding an effective vaccine and its safe dosage. On face, Challenge Trials seem ethically questionable: can volunteers truly consent to possible death or lifelong disability? We must, however, note the unique context this research is taking place in.

First, the current harms accruing due to Covid-19, in terms of lives lost and economic damage, are globally significant and will continue to grow until a vaccine is found and widely applied: vaccine development can be greatly expedited with Challenge Trials. Second, in poorer countries, where their industrial structure is largely built on labour-intensive activities, they will not be able to work from home and dodge the worst of the crisis; the virus will spread quickly. Further, poorer countries’ weaker health care systems will not be able to cope with the infected. Thirdly, the bulk of firms or organisations that can conduct human trials are almost exclusively based in the West. Given these three things, there are two reasons to believe that Human Challenge Trials are ethically just in a properly regulated environment, i.e. one in which volunteers are young, healthy, and properly informed to minimise risk. First, people can consent to dangerous activities. Currently, we allow people to undergo large risks to their health in exchange for more money; we allow people to work as soldiers, deep-sea divers, firefighters etc., because if undergoing the extra risk for more money to pay for an exotic holiday is what makes them happy, then who are we to judge? Even in cases which do not involve potentially coercive factors like money, we still allow people to undergo risk in order to do what makes them happy, e.g. we allow relatives to donate their organs to their family and allow volunteers to participate in drug trials. In the context of Challenge Trials, there is no monetary coercive incentive and the risk of death to young and healthy volunteers is very low. Beyond this, it is likely that everyone will eventually contract the virus, and so artificially giving volunteers the virus speeds up the inevitable in exchange for a vaccine or immunity against the virus. Further, given that most of the firms and organisations capable of doing Challenge Trials are in the West, which have ethical guidelines and considerations in place, the room for unethical practices is small. These do not categorically exclude the possibility of harm, but mitigate most of them.

Second, broader benefits. A more nuanced opponent view of Challenge Trials is that volunteers may consent to receive the virus, but can’t consent to all the potential effects of taking experimental vaccines and drugs, e.g. H1N1 (Swine Flu) vaccine receivers developed narcolepsy. The problem with this critique is not of factual inaccuracy but rather in weighing benefits against harms. Despite taking precautionary measures, it is possible that trial vaccines may give volunteers chronic disorders, e.g. narcolepsy, or cause death. But on balance, noting the context Challenge Trials take place in, Challenge Trials are still ethically justified. Why? Challenge Trials only require a small amount of people (about 100) and time to run effectively compared to traditional Phase III vaccine trials, which require far more people and time; the scope of potential harm to volunteers is hugely limited due to the numbers involved. Further, the benefits of developing a vaccine quickly are multifold, and most pronounced in the developing world as mentioned before.

Beyond a reduction in deaths and halting economic damage, it also allows for international oversight to be redirected on to despots who have seen opportunity in disaster to increase their power: Viktor Orban now rules by decree, Bolivia has postponed elections, India’s BJP are scapegoating muslims, and many regimes have used the pandemic as an excuse to silence critics. Ultimately, even if a few volunteers unfortunately suffer, on balance, the benefits a vaccine commands worldwide to potentially billions are incommensurable. Until the world recovers and can focus on other matters, these people will continue to live in shadows of abuse and neglect. We can bring them, and everyone else, into the light more rapidly through Challenge Trials.