Comment Re:The important bits (Score 1) 81
If you use your own team members as test subjects you can easily bypass regulatory agencies in the early parts of the research phase.
So long as you don't actually tell anyone outside of your research group about those experiments, and then lie to your insurance companies about what happened if there is an accident.
the research is the easy part, getting it through the regulatory agencies is the hard (and expensive) part.
For most of the $, it's hard to separate the two. Yes the FDA requires successful phase III and sometimes phase IV trials, Aren't those research? The actual paperwork for the FDA submission costs millions to prepare, but that's chump change compared to the rest of the costs.