L-Theanine Experiment (1 Month)
This website almost certainly violates FDA rules on human subject experimentation because it collects data on the effect of a drug on human subjects. I would stop working on this project until you have advisors (and lawyers) who have experience with regulatory oversight from the FDA. At the bare minimum you are going to need (a) procedures to gain <i>informed</i> consent from trial enrollees and (b) an Institutional Review Board (IRB) to sign off on your trial. Depending on the drug, you might also need an FDA waiver to conduct the trial.<p>The PhD student (Rob Wagner) listed in the about section should have had at least one course on the responsible conduct of research. This course is required for most (all?) scientists working under a training or research grant from the NIH. Design and implementation of clinical trials--along with the ethical and legal issues involves--is standard fare for these courses for precisely this reason!