1. 11. 45 CFR §46.306(a)(2)(B).
2. 21. Of course, these other risks are still subject to other 45 CFR 46 provisions, including that these other risks be “commensurate with risks that would be accepted by nonprisoner volunteers” (45 CFR §46.305(a)(3), and that, importantly, “risks to subjects are minimized….” (45 CFR §46.111(a)(1)).
3. 22. Id. (emphasis added).