Phil Final Paper

Should we allow “human challenge” vaccine trials for COVID-19? Defend your
answer.

Covid-19 has had an immeasurable impact upon the way in which or society operates, but
could the extent to which it changed our lives have been minimised with the imposition of
‘human challenge’ vaccine trials, and would these have even made a difference? To speed
up the development of a COVID-19 vaccine, it had been suggested that the several stages of
gradual vaccine testing could be replaced with a human challenge trial (HCT) in which
volunteers would be deliberately infected with SARS-CoV-2 to test the potential efficacy of
the vaccines in being created (Tambornino & Lanzerath, 2020). To deliberately infect a
healthy human being with a deadly virus contradicts every ethical standard in medical
research, especially with no known treatment. But, could it have saved the lives of millions
of people?

Among the advantages of HCTs when contrasted to large field trials is that they can
generate the desired data much more quickly, they are far less expensive and they do not
require thousands (or more) of people to be research participants, normally only between
10 and 50 required (Solbakk et al., 2021). Many ethical dilemmas arise from these proposed
trials however. Which volunteer members of society do we subject to these trials; the
already disadvantaged, because they will suffer the net least or the perfectly healthy
because they are less likely to suffer severe side-effects. Does forcing this choice have
greater consequences surrounding future approaches to similar issues and who gets
prioritised. This paper will attempt to explore these issues and provide insight into the moral
problems that the controversial HCTs create, ultimately concluding whether they should be
allowed.

Before one can discuss the ethics behind who would be subject to the HCTs and their
repercussions, it must first be established whether or not these trials are ethical. Could it be
morally acceptable to expose human beings, even those who participate of their own
volition, to such a severe risk of sickness, side-effects and death, without any real treatment
available? Many people intuitively feel that the answer is ‘no’, because such trials would
take unfair advantage of, and even exploit the subjects (Bramble, 2020). Even many
proponents of these trials seem to be wholeheartedly against any “ethical exceptions or
shortcuts”, upholding the necessity of preserving “the priority of the individual principle”
(Solbakk et al., 2021). Variations of the principle are found in UNESCO’s Universal
Declaration on Bioethics and Human Rights and the Declaration of Helsinki, essentially
stating ‘the interests of the individual in trials, should always overrule the interests of
society’.

While adamantly defending these research ethics norms is commendable, when times of
crisis present themselves and the greater good is severely threatened (war, terror attacks,
public health threats etc.), deontological reasoning usually leaves the forefront of the public
conscience (Gordijn & Henk, 2021). It is then argued that due to institutional inertia,
violations of these norms become near impossible to redirect policies after these norm
infringements have been accepted by the wider population. However are these violations
completely unavoidable, or could individual interests still be prioritised? If volunteer
participants of an HCT had altruistic motivations for wanting to be involved, does it not
follow that there could be harmony between societal and individual interests within the
context of these trials? (Helgesson & Eriksson, 2008) If the subjects are fully cognisant of the
repercussions and willing to participate, why is there and issue? Counterpoints to this line of
thinking with regards to the flow on effects to, especially different socio-economic classes
within, society will be discussed later on, yet it does seem intuitive that the subjects agree,
everyone is happy.

Similarly the principle of proportionality; that potential societal benefits must outweigh
individual risk, would not necessarily be violated by these trials either (ibid.). Especially
considering the global events that have transpired in the last 18 months, the benefits of an
early, effective controlled infection study would easily outweigh the risk to the small group
of individuals. Nor would these HTCs unavoidably violate the right to informed consent,
amounting to state-sanctioned torture and violate basic human dignity (Gordijn & Henk,
2021). These principles appear very hostile towards human testing, as the preservation of
individual interests is paramount, yet to what end can this be the case. Is the interest of the
individual always to be prioritised no matter the context or the cost to others? Surely not.

Therefore it can be argued that HTCs do not in fact contradict nor infringe upon the norms
of research ethics, rather, especially in extreme circumstances, the two can coexist to
provide the best outcome for society.

Of course, it is easy to use this armchair philosophy to say: well isn’t it obvious that we
should use these trials, it’s a no-brainer? However, when considering the reality of who
exactly would be benefiting and suffering the most from these trials, a new set or ethical
questions present themselves. Who are the ones who should be selected to become
subjects for these trial; the rich, the poor, the healthy, the sick, those on the frontlines? All
of these suggestions come with their own moral issues. First, it must be answered whether
or not any volunteers should be allowed to take part in these trials (which was partially
explained in the first half of the paper)?

If it is perfectly acceptable to expose specific members of society (e.g. health workers) to a

certain level of ‘ex ante’ risk in order to maximise public safety and minimise the overall
harm from the virus, then surely it is legitimate to expose fully informed volunteers to a
similar level of risk in the context of encouraging research into the virus (Chappell & Singer,
2020). For instance, we do not stop firefighters from running into burning buildings,
relatives are permitted to donate organs, which could result in their death, and volunteers
can autonomously give their informed consent to take these risks (Eyal, Lipsitch & Smith,
2020). Given that these studies could prevent potentially millions of deaths, it appears
obvious that these comparisons can be made. Thus it makes sense to allow volunteers to
take part, should they so desire, given the others areas of work in which it is perfectly
acceptable.
The moral dilemma then becomes, which individuals are to be selected to participate in
these trials? Unfortunately it is highly likely that those who are from already disadvantaged
communities, will make up a large percentage of the candidates who volunteer, due to the
financial incentive (Bramble, 2020). What reason would an extremely privileged person have
to risk participating in the study, when they will reap the benefits regardless? While it may
be true that ‘high-risk’ individuals will likely suffer harsher consequences than most, by
educating the wider population as to the clear costs and benefits of participating, it should
assist in helping them to make informed, educated decisions. This cannot be a half-hearted
effort as many people will not be able to comprehend exactly what it is they are signing up
for. Of course it is not a flawless solution to the issue, there is no flawless solution to a
global pandemic, however the path with the least death seems like a logical path to take.

Despite the potential for the exploitation of individuals with lower socioeconomic standing,
on balance the risk of further infections and deaths outweighs this. Regulation of these
selections, whilst not a perfect solution, will assist in minimising the harm caused to the
already disadvantaged. Whilst not necessarily perfectly ethical in every aspect, the HTCs are
provide great benefit, and this cannot be understated.

While it may be especially easy to criticise the actions of governments whilst looking at their
decisions retrospectively, hindsight is 20/20. Given the knowledge we have now about how
long vaccine development took and death toll of over four million people, it is easier to
argue that HCTs may have certainly saved lives. We can never know if this were true,
however the contentious debate over these trials presents new challenges for governments
and scientists moving forward.

Given our experience with Covid-19, will we approach a similar future situation with the
solution being early HCTs? I think we should. While it may be very utilitarian, a global
pandemic could be thought of as a globally sized trolley problem. If millions of lives could be
saved by pulling a lever and switching the track to a few hundred who were to be subject to
this experimental testing, would you? While the two scenarios are not directly comparable
the similarity seems striking.

Despite the complex morality behind the choice of who is chosen for the testing it seems as
though if these trials could prevent the highly detrimental effects of a pandemic, as we have
all experienced, should we not do as much as possible to prevent it from happening again?
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