The issue here is the lack of IRB (Institutional Review Board), and what looks like an intentional effort to conduct trials in a neighboring country to avoid that requirement.<p>An IRB is not run by the FDA. They are independent bodies affiliated with research organizations like universities. The use of IRBs grew in response to research done in Tuskegee and Nazi Germany, and has been the standard for decades. Rather than make an organization like the FDA screen all human subject studies, IRBs are empowered to review and manage studies instead.<p>So no one is saying this research study needs to monitored by the FDA -- that's not how it works. There are also international standards for IRBs, this isn't just an American concept.<p>The investigator is at SIU, which has plenty of experience managing IRB studies [1]. It does seem odd that they would set this study up in this way, unless everyone involved is an extreme libertarian trying to thumb their noses at the notion of ethical review and monitoring, or the researcher has had past conflicts with an IRB at SIU. I wonder how many at SIU are aware of this study and if they will distance themselves from the study or the researcher, if this gets more press.<p>[1] <a href="http://ospa.siu.edu/_common/documents/human-subjects-forms/hsc-guide-%205-4-2012.pdf" rel="nofollow">http://ospa.siu.edu/_common/documents/human-subjects-forms/h...</a>