You are a member of the board at Florida Central IRB. You are reviewing a vaccine study for Zika2, a deadly infectious disease that has recently emerged in Florida and is spreading fast. The only clinical study discussed in the Investigator’s Brochure was conducted in Brazil, where Zika2 originated. It provides scientifically sound evidence that supports the proposed study. However, you have just learned that, because of the emergency situation in Brazil, the investigators made the decision to conduct their study without regulatory or ethics committee approval, in a vulnerable population, and without informed consent. The Brazilian manufacturer and investigators will not be involved in the proposed study. Time is of the essence. Will you vote to approve the study?

You have no other information to make your decision and no clever way to dodge it.
 
DO NOT PARTICIPATE IN THIS SURVEY UNLESS YOU ARE A CLINICAL RESEARCH PROFESSIONAL

* 1. Will you vote to approve the study?

* 2. If you would not approve the study, what action or information would you want before you would approve it?

* 3. Would your decision change if you knew no Brazilian study participants had been harmed?

* 4. Would your decision change if you knew the Brazilian manufacturer plans to distribute 10 million free doses of the new vaccine?

* 5. If you would vote "no," and your vote would be decisive in rejecting the study, how many lives would the study need to save to change your vote from "no" to "yes"?

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