The research going on at places like 23andMe is not the research that should be sending us into any kind of frenzy. If this research was not considered "human subjects" under the law, it's because the researchers could not identify the donors of the genetic material. What's more, it's quite clear that those donors freely volunteered, even paid, to participate in the research. This is not the time to get worked up about "unethical" research (which this was not).\n\nThe work done at 23andMe appears to comply with federal regulations, and it highlights the very reasonable standards that keep regulations from overstepping and hindering the ability to conduct effectively harmless research. If you want to get up in arms about the regulations not doing enough to protect subjects, then that attention is more rightly focused on other projects that do also follow the law. Consider, for example, the NIH's dbGaP (database of genotypic and phenotypic information). Genetics research funded by NIH is required to submit information to that database, and much of that comes from samples used secondarily originating from donors who did not consent to have their materials databased by the federal government. A review of their consent process is done by an IRB before the information is sent, but it does not require specific consent for dbGaP. Those samples, unlike the ones used by 23andMe, are linked to subject identities by the individual researchers submitting them.\n\nYes, the world of genetics research presents new challenges for research regulators, and it's moving faster than regulators can. But step back and consider 1) what are the things that we really need to be concerned about, and 2) what might be the unintended consequences of pushing regulation too far too fast.