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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]
Status:
Code of professional ethics
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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
...
Milestone:
Common Federal Policy for the Protection of Human Subjects ("Common Rule")
[10 CFR 745]
[See text / Download PDF - 84KB]
Status:
U.S. Regulations
...
Milestone:
National Bioethics Advisory Commission (NBAC)
[Download list of publications PDF - 192KB]
Status:
Series of ethical and policy reports
...
Milestone:
FDA regulations revised.
[21 CFR 50.24]
[See text / Download PDF - 52KB]
Status:
U.S. Regulations
...
Milestone:
International Conference on Harmonisation, Guideline E6: Good Clinical Practice, Consolidated Guideline
[Download PDF - 264KB]
Status:
International guidelines
...
Milestone:
World Health Organization Operational guidelines for ethics committees that review biomedical research
[View webpage / Download PDF - 76KB]
Status:
International guidelines
...
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.
...
Description:
For applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on www.ClinicalTrials.gov.
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