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Human Subjects Protection Resource Book

The Human Subjects Protection Resource Book synthesizes information currently available on the protection of human subjects in research, the continuing application of such information to new areas of endeavor, and ever-changing rules, regulations, and guidance.

This resource, to which the Oak Ridge Institute for Science and Education (ORISE) contributed, is for investigators, institutional review boards, research organizations, research subjects and others.

The book contains chapters that provide background information on the history and development of federal regulations; chapters that discuss procedural and substantive issues regarding the review and conduct of human subjects research; and chapters that are specific to one type of research (e.g., genetics, biological samples) or research in specific populations (e.g., international settings, children and workers).

The resource book was a joint project between the U.S. Department of Energy (DOE), the U.S. Department of Defense and the U.S. Department of Veterans Affairs.

Human Subject Protection Resource Book cover