While the world has long confronted the issue of human testing for vaccine trials, we know that this issue has taken on increased relevance in these days of the coronavirus and with the onset of human testing trials here in Israel, I welcome the chance to address this issue.
There are several core ethical and practical principles at play that guide us in establishing why human testing is both permissible under Jewish law, and vital, especially given the importance of this issue at this time and place. We should note from the outset, however, that this is a deep and complex topic that could fill volumes.
Indeed, there is likely no field of medicine that has had as extensive a positive impact on healthcare than the advent of effective vaccinations. That is, for all that there have been cases of vaccines having detrimental effects, when we look at the broader perspective of how vaccinations have changed the treatment of many deadly diseases — they have a tremendous positive value that cannot be underestimated.
Moreover, to address the concerns of potentially dangerous side effects in developing a new vaccine, researchers, in tandem with ethicists, have developed specific protocols for testing that are designed to promote optimal safety.
First, lab-based testing creates a hypothesis for how a patient will respond and the researchers then run modeling based on many relevant variables.
Testing then typically extends to live animals with similar relevant physiologies to humans, and only then is testing extended to three stages of human testing with each stage having a larger sample size. The concluding Phase 3 allows researchers to best understand what the impact of the vaccine would be on a general population.
Any attempt to skip phases or speed them up more than is acceptable can have direct safety implications, as well as impact on the overall value of the trial. Most problematic can be when external forces introduce economic or political equations intended to influence the nature of the testing. As such, every measure has to be put in place to ensure that testing is devoid of any such non-scientific influences and that no corners are cut along the way.
For every obvious reason, during a pandemic, time is a critical factor and there are ongoing pressures to work faster than might be ideal. While the scientific processes often cannot be sped up, bureaucratic and administrative steps can sometimes be accelerated. However, every attention must be paid to avoid the temptation to speed up the overall process as there is a very legitimate concern that acting in haste could have devastating effects for the long-term.
With these measures in place, and appreciating the scientific, social, and, indeed, moral value of producing a vaccine, the conclusion therefore must be that human testing cannot be a question of whether one can participate, but how one can participate.
The need to weigh the inherent risk versus the obvious benefits is an established principle in the worlds of halacha and ethics. That is, we know that one can endanger oneself if it is known that doing so will certainly save the lives of others. Indeed, this principle affects legislation in Israel, where certain dangers are acceptable if risking them means avoiding subjecting others to future dangers.
Two principles are, of course, at play in one’s decision to participate in a human vaccine trial. First, one must make every effort to ensure that no corners are being cut when it comes to optimal safety, and that sound and proven science is driving the process. Furthermore, one should confirm that only the minimum amount of testing is being done to achieve the desired results.
The second underlying factor before agreeing to be part of such a trial is a need for the potential participant to be privy to all relevant information to the decision — his or her decision to participate must be based on all the available science. It should go without saying that if information is withheld or if manipulative tactics are employed to convince a person to participate in the trial, the impetus to participate should be removed. That is, agreeing to participate must be conditional on the potential participant knowing all relevant facts, risks, potential outcomes, and so on.
These days, we know that the vast majority of mainstream public health experts acknowledge that the coronavirus is far more problematic than just some sort of advanced flu, in terms of mortality, long-term effects, its levels of contagion, and other key factors. The immediate importance of developing a vaccine is therefore just that critical and is necessarily a factor in assessing whether one may or should participate in human vaccine trials.
And indeed, once one recognizes the seriousness of this process, combined with its critical value for human society, we are left to conclude that participation in such trials is not just permitted, but also commendable, and, with God’s help, will contribute to creating the desired safe vaccine.