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Federal Regulations and Guidance

Human Subjects Research

Title 45 Part 46 contains the relevant Federal Regulations regarding Human Subjects Research. The Office for Human Research Protection (OHRP) provides these regulations for reference purposes.

The OHRP also provides "Guidance". Guidance exists to assist in interpretation of regulations in some subject areas. Other subject areas may have partial guidance, or none at all.
Federal Regulation Policy and Guidance

Office for Human Research Protection Questions and Answers

Additional References

A. The Nuremberg Code

B. The Belmont Report

C. Federal Policy for the Protection of Human Subjects (Common Rule)

D. February 17, 1994 Memorandum on Human Subjects

E. FDA Regulations (21 CFR Part 50), Protection of Human Subjects

F. FDA Regulations (21 CFR Part 56), Institutional Review Boards

G. FDA Regulations (21 CFR Part 312), Investigational New Drug Application

H. FDA Regulations (21 CFR Part 812), Investigational Device Exemptions

I. Department of Education Information About the Protection of Human Subjects in Research

J. U.S. Department of Education (34 CFR Part 97), Protection of Human Subjects

K. U.S. Department of Justice (28 CFR Part 22), Confidentiality of Identifiable Research and Statistical Information

L. U.S. Department of Justice (28 CFR Part 512.11), Requirements for Research and Researchers

M. U.S. Department of Veterans Affairs (38 CFR 17.85) 85 - Treatment of Research-Related Injuries to Human Subjects