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Milestone:
Hippocratic Oath 
[See text / Download PDF - 8KB]
[Compare the current principles of ethics of the American Medical Association]
[Compare a modernized version of the Oath]

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Milestone:
Nuremberg Code
[See text / Download PDF - 4KB]

Status:
International code of ethics

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Milestone:
International Code of Medical Ethics of the World Medical Assembly, including the Declaration of Geneva 
[See text / Download PDF - 8KB]

Status:
International code of professional ethics

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Milestone:
NIH Clinical Center policy 
Download PDF of human subject policy - 564KB]

Status:
Agency policy

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Milestone:
NIH Medical Board Document No.1
[Download NIH Clinical Center human subject policy- 249KB]

Status:
Agency policy

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Milestone:
Helsinki Declaration signed by U.S. (revised in 1975, 1983, 1989)
[See text / Download PDF - 8KB]

Status:
International ethical guidelines

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Milestone:
U.S. Surgeon General policy statement
["Clinical research and investigation involving human beings," Surgeon General, Public Health Service to the Heads of the Institutions Conducting Research with Public Health Service Grants]
[Download U.S. Surgeon General Policy PDF - 489KB]

Status:
U.S. policy

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Milestone:
National Research Act
[Title II, Public Law 93-348]
[Download PDF - 380KB]

Status:
U.S. Law

Description:
Regulations to be codified.
All research funded by DHEW to be reviewed by IRBs.

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Milestone:
Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research
[45 CFR 46]
[See text / Download PDF - 116KB]

Status:
U.S. Regulations

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Milestone:
Belmont Report (Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research), issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)
[See text / Download PDF - 32KB]

Status:
U.S. ethical guidelines

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Milestone:
FDA regulations revised.
Informed consent [21 CFR 50]
[See text / Download PDF - 72KB]

IRBs [21 CFR 56]
[See text / Download PDF - 72KB]

Status:
U.S. Regulations

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Milestone:
Common Federal Policy for the Protection of Human Subjects ("Common Rule")
[10 CFR 745]
[See text / Download PDF - 84KB]

Status:
U.S. Regulations

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Milestone:
National Bioethics Advisory Commission (NBAC)
[Download list of publications PDF - 192KB]

Status:
Series of ethical and policy reports

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Milestone:
FDA regulations revised.
[21 CFR 50.24]
[See text / Download PDF - 52KB]

Status:
U.S. Regulations

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Milestone:
International Conference on Harmonisation, Guideline E6: Good Clinical Practice, Consolidated Guideline
[Download PDF - 264KB]

Status:
International guidelines

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Milestone:
World Health Organization Operational guidelines for ethics committees that review biomedical research
[View webpage / Download PDF - 76KB]

Status:
International guidelines

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Milestone:
Best Pharmaceuticals for Children Act
Download PDF - 76KB]

Status:
U.S. Law

Description:
Provides six-month patent extension for manufacturers who conduct voluntary pediatric trials.

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