At the start of the covid epidemic in 2020, I had access to a lab and the know-how to make a nasal vaccine. I, and a few friends, tried to do this. We would only have made it for ourselves, and no one else, and shared the results with researchers. The lab -- which was just renting us equipment and bench space, not involved at all -- backed out when they were threatened by the FDA to lose government contracts for processing PCR test kits. What we were doing was not illegal, as clearly indicated by the regulators using other means available to them to shut it down.
I have family members suffering from Alzheimer's, with a probably genetic pre-disposition. Getting consent from someone who is already pretty far gone is questionable, but some who have not yet shown symptoms have expressed interest in signing pre-authorized directives in advance to permit these kinds of risky experimentation once they are clearly at the end of their good years. That is not legally possible under the FDA authorization laws & current regulations.
I have family members suffering from Alzheimer's, with a probably genetic pre-disposition. Getting consent from someone who is already pretty far gone is questionable, but some who have not yet shown symptoms have expressed interest in signing pre-authorized directives in advance to permit these kinds of risky experimentation once they are clearly at the end of their good years. That is not legally possible under the FDA authorization laws & current regulations.