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  1. Clinical Trials and Human Subject Protection

Good Clinical Practice Educational Materials

Useful References

  • Belmont Report
    Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978), the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects, 45 CFR part 46, in the late 1970s and early 1980s. In 1978, the Commission’s report "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" was published. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.
  • Bioethics Commissions - Papers
    Over the years, various U.S. bioethics commissions and councils have advised the President of the United States on ethical issues related to advances in biomedical science and technology. As a public resource, the Bioethics Research Library at Georgetown University compiled a list of these former national bioethics commissions and their reports, including, where available, downloadable copies of the reports. Materials produced by the various U.S. bioethics commissions in this archive are government documents and in the public domain. Please note the source as https://bioethicsarchive.georgetown.edu/pcbe/.
  • Comparison of FDA and HHS Regulations
    A chart comparing FDA's regulations for human subject protection with those of the Department of Health and Human Services. 
  • Critical Path Initiative
    The Critical Path Initiative (CPI), was launched in March 2004, as FDA's national strategy for transforming the way FDA-regulated medical products are developed, evaluated, and manufactured. The initiative carefully examined medical product development, and identified problems and potential solutions to the daunting task of ensuring that unprecedented breakthroughs in medical science are demonstrated to be safe and effective for patients as quickly and inexpensively as possible. Archived materials about the Critical Path Initiative includes the major report, "Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products."
  • E-Mail Messages
    Copies of e-mail messages (including the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account. These e-mail messages have been redacted to the extent permitted by the Freedom of Information Act.
  • FDA and Clinical Drug Trials: A Short History
  • GCP Training Information
  • International Compilation of Human Research Standards 
    The Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) maintains and updates this list of laws, regulations, and guidelines (collectively referred to as standards) that govern human subjects research in 130 countries, or which were developed by international and regional organizations. The most current version of the document is accessible at the link above.
  • Protecting America’s Health Through Human Drugs
    This FDA publication, originally titled From Test Tube to Patient: Improving Health Through Human Drugs, tells the story of new drug development in the United States. Articles discuss various aspects of drug development--from test tube to medicine cabinet. This is an excellent primer for learning about the drug development and approval process.


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