CASE STUDY 1



Nick is a researcher at a pharmaceutical company, working in the vaccines division. He is part of a team that has developed an experimental vaccine that they hope will be effective in preventing infection with Ebola virus. This work has attracted lots of attention, both from the directors of the company and from international health organizations, in light of outbreaks of Ebola that are happening in Western Africa.


The director who oversees clinical trials for the company lays out a plan to test the vaccine in the outbreak zone. Research subjects will be randomly assigned to the experimental group (injected with the experimental vaccine) or the control group (injected with a placebo), without subjects or researchers knowing who is in which group until the conclusion of the study, and their health will be monitored over the course of the outbreaks. Because it is currently very expensive to produce the vaccine, the company wants to get as much clear data on whether the vaccine works as quickly as possible. Therefore, the clinical trials director stresses, no doses of the experimental vaccine will be distributed to patients outside the placebo-controlled trial. The process of getting official permission to conduct the study from local health authorities in West Africa is well underway, and the director says that if all goes well they will start recruiting subjects for the trial in a few weeks.


Nick is excited that the vaccine he helped develop may help people in the outbreak zone who might otherwise become sick with (and maybe even die from) Ebola. But he is a little worried that some African patients in the trial may think they are getting the vaccine when they are actually getting a placebo instead. Given how devastating the Ebola outbreak has been so far, and how wary people in the outbreak zone have been to come to the treatment facilities rather than hiding from health officials in their homes, Nick doesn’t want their clinical trial to make things worse for the people the vaccine is supposed to help. Then again, the director overseeing clinical trials has been doing this kind of research study for other vaccines the company makes — and he has much more authority within the company than Nick does.


Should Nick share his concerns about the placebo-controlled clinical trial of the vaccine with the director overseeing the trial? Why or why not?

 

Back to Case Study index

Discuss cases (using Canvas)

 

 

course home course information handouts assignments instructor information research links research ethics resources