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Case: Hepatitis Vaccine and the Military
Hepatitis E is a relatively uncommon for of hepatitis that is usually transmitted by exposure to the blood of persons with conditions like hepatitis B and C. Hepatitis E is not tested for in blood donations. There is reason to be concerned that military personnel, at time of war when injuries requiring transfusions are being suffered daily, that hepatitis E could result in substantial long term morbidity (illness).
A vaccine was recently developed for hepatitis E that required testing. When it was mentioned at an international military training program that this new vaccine was imminent and a clinical trial needed to be done, a senior office in the Nepalese army volunteered the entire army in exchange for a donation of military supplies. The US Army was delighted to follow up on this.
As the director of this research program for the US Army, you are designated to arrange and perform this trial.
Questions:
- What ethical considerations are paramount to you in designing this study?
- Is there additional information you would like to have before you agree to this study?
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Chapter 3
Quick Links
Ethics and Study Design
Introductory
Ethics Design
Appropriate Risk to Benefit Ratio
Selection of Subject Populations
Cases
Bibliography
Chapter 3 Download (PDF)
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