Major Events that Shaped the Current Guidelines for Protection of Human Subjects

  • Tuskeegee Syphillis Study

    In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called the "Tuskegee Study of Untreated Syphilis in the Negro Male." <a href='http://www.cdc.gov/tuskegee/timeline.htm' target="_blank">Read More</a> -
  • Period: to

    Major Events

  • Nazi Experiments During WWII

    During World War II, a number of German physicians conducted painful and often deadly experiments on thousands of concentration camp prisoners without their consent. <a href='http://www.ushmm.org/wlc/article.php?lang=en&ModuleId=10005168' target="_blank">Read More</a>
  • Human Radiation Experiments

    The US government sponsored several thousand human radiation experiments. <a href='http://www.hss.energy.gov/healthsafety/ohre/multimedia/film/index.html' target="_blank">Watch one of these!</a>
  • Nuremberg Doctors' Trial

    The individuals who conducted the Nazi experiments during WWII were tried separately form other war criminals because of their professional status as physicians and horrendous and unique nature of their crimes. they were found guilty of murder, torture and other atrocities
  • Nuremberg Code

    During the trial at Nuremberg, the judges codified fundamental ethical principles for the conduct of research<a href='http://ohsr.od.nih.gov/guidelines/nuremberg.html' target="_blank">Read More</a>
  • The Universal Declaration of Human Rights

    <a href='http://www.un.org/en/documents/udhr/' target="_blank" >Read More</a>This Declaration was adopted by the United Nations. It asserted the priniciple that eachhuman being was entitled to certain rights and fredoms.
  • NIH and Federal Policy

    NIH Produced the first US Federal policy for the protection of human participants. This policy provided a mechanism for prospective review of research by individuals who had no direct involvement or intellectual investment in the research. This system searved as the precednt for the IRB system.
  • Jewish Chromic Disease Hospital Study

  • Willowbrook Study

    1963 - 1966
  • Declaration of Helsinki

    <a href='http://www.wma.net/en/30publications/10policies/b3/index.html' target="_blank" >Read More</a>The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
    The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs.
  • Expose' of Tuskegee study

  • National Research Act

    National Research Act of 1974 required the Department of Healht, Educaiton and Welfare to codify its policy for the protection of human subjects into Federal regulations. Also the formation of the National Commission for the protections of human subjects of biomedical and behavioral research.
  • Belmont Report

    The National Commision for the Protection of Human Subjects of Biomedical and Behavioral Research wrote the Belmont Report. This report is the cornerstone document of ethical principles and regulations.
    Read More
  • Food and Drug Administration

    FDA establishes regualtions for clinical research. Code of Federal Regulations, Title 21, Part 50.
  • CIOMS Guidelines

    Read MoreThe Council for the International Organization of Medical Sciences published the International Ethics Guidelines for Biomedical Research Involving Human Subjects.
  • The Common Rule

    Read MoreFederal Policy
  • Radiation

    President Clinton creates Advisory Committee on Human Radiation Experiments.
  • National Bioethics Advisory Commission

    Read MoreNBAC is established.
  • OHRP

    Read MoreOHRP established. Continue to provide leadership in the area of Human Subjects research.