ABSTRACT
This document represents the agency’s current guidance on protection of human subjects of research. It is published as Level 2 guidance in accordance with the FDA “Good Guidance Practices.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. However, in many places throughout this document, a specific regulation is cited and the requirements of the regulation are reiterated. The regulations are enforceable.
