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The poster above indicates that institutional IRB approval would cover things, but that can actually be a bit tricky depending on the regulatory board and the specific situation. For example, I am a member of our IBC (Institutional Biosafety Committee). We approve all scientific research done on our campus for safety reasons (chemical and biological). However, the legalities behind this are a bit unclear. The NIH and institution require this board, and you can't do research if you don't get our approval, but what is unclear is what would happen if something unfortunate occurred? Right now, we have legal backing from the institution which should cover all scenarios, but in speaking with said legal council, we are actually all personally liable for consequences from approvals we sign off on. Board members at other institutions have been personally sued, so there is precedent for this happening. However, with the backing of the University legal team it is much easier to swallow. It is difficult to see how Microryza will be able to replicate this without documenting full legal support.

I am not trying to be a Debbie Downer here, and I really like the concept. For most of your research topics this will not be an issue, but I would hate to hear how the entire organization got burned to the ground over some regulatory law suit, and I certainly would not like to see someone get harmed. Particularly since all of the hard work has already been done for you by other organizations. You just need to take advantage of it.

If handled correctly, this could actually be a marketing point for your organization over others. You would need to balance the headache of implementing these regulations against the real and perceived benefits, but I think folks would be much more confident in the process from an investigator or potential investor perspective if you implemented a transparent but rigorous system.



>You would need to balance the headache of implementing these regulations against the real and perceived benefits

This is why we can do this and get by because we are still a startup. :)

But yes you are absolutely right. We are currently pursuing more formal legal agreements with our partner schools, and this was a proactive move on our part when a lot of folks questioned the need for it. We belive strongly in integrity of science, it just won't be simple to shoehorn this new process into the machine that is big science today.




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