12 Jun What boards or committees would you need
Question
For this discussion, imagine that you are a newly hired assistant professor at a teaching university and you wish to conduct a clinical trial examining the vaccine efficacy of a new, FDA-approved Ebola vaccine. You will be examining the immunological response in your study participants. Discuss the steps you would take as the principle investigator to get your study started, and address the following questions:
What paperwork would need to be submitted?
What boards or committees would you need to seek review and approval through?
What are some of the regulatory requirements for your study you would need to prepare and provide for?
Note: For this discussion, assume the vaccine has been through FDA trials and is approved for use in the general population: normal, healthy adults ages 18–65.
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