Case Studies

Case study
Group 1: Allocation of intravenous fluids during an outbreak of viral haemorrhagic fever

A deadly form of viral haemorrhagic fever has struck your community. The signs and symptoms of the disease include
high fever and increased susceptibility to bleeding. Manifestations in confirmed cases include low blood pressure
(hypotension), shock, vomiting and diarrhoea.
The capacity for laboratory diagnosis in your community is limited. The cause of the illness of some of the patients
admitted to your health care centre is, however, obvious: they have advanced symptoms, such as excessive bleeding,
high fever and shock. The diagnosis for other patients is less certain, as suspicion is based mainly on contact history and
more general symptoms. In view of the extent of the on-going outbreak, your health care centre is overwhelmed with
work.
Supportive care for patients is very limited, due to lack of resources. Although intravenous fluid therapy is known to be
useful in viral haemorrhagic fever to ensure adequate hydration while the immune system combats the virus, your health
care centre has insufficient intravenous sets to meet the growing demand, including for patients with other diseases. In
addition to supportive care and intravenous fluid therapy, you learn that the Ministry of Health has managed to secure
access to a very limited amount of treatment with an experimental medication. The quantities of this experimental
treatment are so limited that you expect that only about 2% of the patients at your health care centre could be given it,
should you decide to do so.
As health workers trained in epidemiology and ethics, you have been asked to prepare for a meeting on setting
guidelines for care during the outbreak. You must consider how you will prioritize access to intravenous fluids and
decide whether you will offer the unapproved treatment. If you do, you must decide how to allocate the limited stocks.
One of your concerns is to ensure that the allocation of resources demonstrates a high level of ethical consideration.
Prepare a statement explaining your preliminary basis for allocating resources. Make sure that you justify your responses
in the language of ethics.
For facilitators: If the group appears to bog down during the activity, you could ask them to reflect on some of the
following questions:
1. Who would you like to see sitting at the decision-making table with you, and how should decisions be taken?
2. Will you provide the experimental treatment? If so, will patients who receive the treatment also be eligible for
intravenous fluids? If so, how will you determine which patients of those receiving the treatment will also receive
intravenous fluids?
3. Will you take into consideration the demographic characteristics of the patients (e.g. age, health care
professional) in allocating treatment? If so, will the demographic characteristics used be different for access to
intravenous fluids and to the treatment (if you grant access)?
4. Will you use the concept of “need” in allocating resources? If so, Will you allow for consideration of how sick
the patient is?
5. Will you allow for consideration of how likely the patient is to survive?
6. Will you allow for consideration of evolving needs? If so, how will this be done?
7. In the case of intravenous fluids, will you allow for consideration of whether the patient was already receiving
care before implementation of the allocation policy?
8. What obligations does the health care centre have to patients who are not given intravenous fluids and/ or the
experimental treatment?
9. Will you allow patients who are not given access to treatment (e.g. an experimental drug) to challenge the
decision? If so, what process will be established for reviewing challenges?
10. Should the allocation policy be communicated to patients, families and the broader community? If so, how?
Other considerations
Group 2: Conducting a clinical trial during an outbreak of haemorrhagic fever

A deadly form of viral haemorrhagic fever has struck your community. The signs and symptoms of the disease include
high fever and greater susceptibility to bleeding. Manifestations in confirmed cases include low blood pressure
(hypotension), shock, vomiting and diarrhoea.
The laboratory diagnostic capacity in your community is limited. The cause of the illness of some of the patients
admitted to your health care centre is, however, obvious: they have advanced symptoms, such as excessive bleeding,
high fever and shock. The diagnosis for other patients is less certain, as suspicion is based mainly on contact history and
more general symptoms. In view of the extent of the on-going outbreak, your health care centre is overwhelmed with
work.
A few private firms and public organizations have rapidly come together to propose a clinical trial of an antiviral drug
that has been under development for a few years. Laboratory studies have shown good activity of the drug against the
virus that is affecting your community, but, while the safety and efficacy of the drug has been demonstrated in animals,
no studies have yet been performed in humans. The proposal is to test the drug immediately for efficacy in humans.
Your health care centre is approached by the consortium and asked to act as a centre for a clinical trial of the
experimental drug. They have requested your input as a potential co-investigator on the issues that should be discussed
in the study protocol. Your understanding is that, although the number of doses currently available is very limited,
manufacturing capacity could be rapidly scaled-up.
For facilitators: If the group appears to bog down during the activity, you might ask them to reflect on some of the
following questions:
1. What additional information might you want about the drug or research before your discussions?
2. What research designs would you consider? What methodological issues might you take into account?
3. Who will benefit from this study, and what benefits will they receive? Who may be harmed by this research and
how?
4. How might you consider recruiting patients into the trial?
5. What other information should be given to the participants when seeking their informed consent?
6. What contextual factors might affect the ability of patients to provide informed consent? What provisions and
adaptations might have to be considered to account for those factors?
7. How should the contextual factors be taken into consideration to ensure that the research is carried out
efficiently?
8. How might the trial affect patients who do not participate, either through choice or because they are ineligible?
How might any detrimental impacts be minimized?
9. What impact should the study be permitted to have on the role and duties of the health care personnel working
at your centre? Should the impact be communicated to patients and the community and, if so, how?
10. How will challenges that arise from the dual role of health care personnel and researcher be dealt with?
11. How will the findings be disseminated?
12. What are the consortium’s responsibilities towards trial participants and your community at the end of the trial?
13. How should you communicate with the community about the study?

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Case study

Group 1: Allocation of intravenous fluids during an outbreak of viral haemorrhagic fever

Group 2: Conducting a clinical trial during an outbreak of haemorrhagic fever

4. How might you consider recruiting patients into the trial?

11. How will the findings be disseminated?

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