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Ethical Codes and Good Clinical Practices

Belmont Report

Released in 1978, this report expands on the Nuremberg Code. It is a statement of basic ethical principles and guidelines designed to help resolve the ethical problems in the conduct of research with human subjects.

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Declaration of Helsinki

This declaration, adopted by the World Medical Assembly in 1964, is a list of recommendations for the conduct of Biomedical research, emphasizing consideration for the welfare of subjects and patients.

Declaration of Helsinki

FDA’s Good Clinical Practice Guidance

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA.

Clinical Practice Guidance

Title 45 CFR 46: Protection of Human Subjects

Title 21 CFR 50: Protection of Human Subjects

Title 21 CFR : Institutional Review Boards

Comparison of FDA and HHS Human Subject Protection Regulations