Food and Drug Administration (FDA)

While an exemption request may not be the most expeditious way to meet the requirements of this rule, the regulation for Protection of Human Subjects, 28 CFR Part 46 §46.101(b)(1)-(6), defines categories of research involving human subjects that are exempt from its provisions. It is important to note that these exemptions do not apply to studies involving incarcerated persons, fetuses, pregnant women, or human in...