You are a member of an IRB reviewing a study protocol for a new artificial heart that, if approved by the FDA, will likely save many lives. The study sponsor, a very small company, plans to test the device in patients who will probably die without the device. It cannot afford to test the device with an adequate sample size, so it proposes to increase the sample size with funds raised by auctioning off the right to participate. Any delay in approval will likely cost lives.

 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. How will you vote?

* 2. If you will vote for approval with condition(s), what would the most important condition be?

* 3. If you will vote to defer approval until certain issues and questions are resolved, what would they be, and what answers would you be looking for?

* 4. How did you vote and what was your reasoning?

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