The current pandemic with the novel severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) has resulted in a major global health crisis.
1
This has put tremendous strain on healthcare systems around the world and naturally
raises issues concerning the allocation of scarce resources. It presents a clear and
urgent need for research into management of the disease in individuals and of the
epidemic in populations. Addressing this need around the world raises practical and
ethical issues for the scientific research community internationally.
There have been several recommendations addressing ethical issues which arise during
global health emergencies, including the current COVID-19 pandemic.
2-4
These partly serve to set guidance based on distributive justice to allocate limited
healthcare resources appropriately, and have been based on the relevant ethical principles
of justice, beneficence, utility, respect for persons, liberty, reciprocity and solidarity.
With regards to fair allocation of scarce resources during the COVID-19 outbreak,
recommendations have been made in line with the utilitarian approach of maximising
benefits and are based on four guiding principles: (1) maximising total benefits produced
by scarce resources, (2) treating equivalent cases equally, (3) promoting and rewarding
instrumental value (benefit to others) and (4) giving priority to the worst off.
5
More practical guidelines relating to critical care access have been set based on
urgency of medical need, the likelihood and duration of clinical benefit and the change
in quality of life.
6
Algorithms have been adopted to maximise patient safety and to direct the appropriate
use of resources in the event that they become scarce.
7
Recommendations have also been set to prioritise research in COVID-19-related work
with immediate and mid- to long-term priorities.
3,4
The immediate aims focus on accelerating research that can contribute to containing
the spread of this epidemic and helping those affected to receive optimal care. The
mid- to long-term priorities stemming from experience of this pandemic are to develop
global research platforms aiding preparedness for the next unforeseen epidemic and
to encourage research, development and equitable access, based on public health needs,
to diagnostics, therapeutics and vaccines.
4
The process of prioritisation to meet the above needs will result in reallocating
staff and resources towards COVID-19-related activities, which will naturally have
its pros and cons. The imperative for research must therefore be balanced by the need
to avoid unduly diverting resources, including personnel, equipment and healthcare
facilities, from other critical clinical and public health efforts.
2
Emphasis must also be put on the need to coordinate research within and between research
institutions as well as with government bodies to avoid overlapping protocols amidst
changing standards of care, which is particularly pertinent in settings where resources
are limited.
Despite the pressures that typically surround pandemics to implement treatments with
a promising rationale directly including research invitations, the research community
should assert the benefits of testing treatment hypotheses with methodological rigour.
8
This approach has arguably led to reliable improvements in treatment, for example,
demonstrating the ineffectiveness of hydroxychloroquine and benefits of dexamethasone
for patients with COVID-19.
9,10
While the investigators have used established methods such as randomised controlled
trials, they have chosen to expedite publication of the results before traditional
peer review, using press releases and preprint archives such as bioRxiv and medRxiv.
Many of the issues mentioned above will affect institutional review and medical ethics
boards (IRBs) and research ethics committees (RECs) around the world as they continue
to administer research governance during the health emergency. The majority of guidance
for IRBs during the COVID-19 pandemic have focused on the logistics of clinical trials,
with less focus on new study submissions during this outbreak.
11,12
IRBs and RECs are tasked with prioritising new study submissions and modifying ongoing
research activity while staying true to the ethical principles and international guidance
discussed above.
We therefore propose recommendations to guide research governance during the COVID-19
pandemic:
Review of new research study submissions may be expedited, but not compromised in
quality, particularly in relation to fair consent, the safety of study participants
and ensuring methodological validity to answer the scientific question asked. Scrutiny
should be applied to the publication strategy emphasising good publishing practice,
with the need for data transparency and peer review balanced against the benefit of
expediting knowledge of study results in a rapidly developing pandemic.
Research methodology should be assessed in the context of potentially stretched clinical
resources. The best designs will be conducive to the delivery of direct clinical care
and good designs will be complementary. Research that competes for resources such
as staff, protective equipment and hospital capacity should be carefully assessed
as described above, but may be justified in the immediate term to help contain the
pandemic and to help those affected to receive optimal care, for example, in the testing
of novel treatment and vaccines.
As the coronavirus pandemic develops, COVID-19 will come to sit among other medical
conditions in the clinical landscape. COVID-19-related research should be considered
alongside research into other conditions and evaluated on the same terms. In the short
term, research into COVID-19 is likely to be prioritised due to its clinical urgency
and the imperative to study the ongoing pandemic as it develops.
Research that was planned or ongoing before the pandemic may need to be reassessed
and formally reviewed, for example, in relation to risks to study participants, particularly
the impact on patients who are already suffering from life-threatening and, in some
settings, highly stigmatised disease, or to comply with public health control measures
such as social distancing requirements.