Question

Directions:

Carefully read and respond to each question. Please complete your responses using complete sentences. Your responses will be evaluated on the basis of content accuracy, clarity, correct usage of the English language, and demonstrated evidence of critical analysis.  

8.    An indigenous population of Inuit never exposed to tuberculosis (TB) is being considered for testing a new vaccination that has been shown to be fatal to some patients in similar populations unexposed to TB. What ethical considerations are relevant to a decision to test this vaccine in this population?

Answer 1

Clinical trials are an essential part of the product development pathway for TB vaccine development. Controlled human challenge models have been used in the vaccine development of malaria. But in case of TB we cannot deliberately infect human subjects with virulent mycobacterium tuberculosis for various ethical reasons.The testing of any new vaccine whether it is TB vaccine or any other ,there are some ethical challenges that need to be addressed.it include checking whether it would be considered appropriate if such trials are conducted in an indigenous population,where in the past such trials have lead to the death of the unexposed people from the similar community,where the new vaccine have been tried .Secondly the structure and process of ethical review and the roles and responsibilities of researchers and others in ensuring that trial results are available to the study population after the trial ends.Thirdly the provision of tuberculin skin test screening and preventive therapy to study participants.