1931: Germany: “Guidelines for Human Experimentation”

Germany’s Ministry of the Interior issued “Guidelines for Human Experimentation”

  • Unambiguous informed consent is mandatory;
  • particular care must be taken when the subject is a child under 18;
  • exploitation of patients who poor, or socially disadvantaged is prohibited;
  • disclosure requirements — the purpose, justification, and the manner in which research will be carried out;
  • a statement that the subject has been provided with relevant information, then gave his consent;
  • risks and anticipated benefits must be proportionate;
  • experimental therapies must first be tested in animals;
  • human experiments should be avoided if obtainable by other means (i.e, laboratory tests and animal studies);
  • This law remained in effect throughout the Nazi regime — but was violated in its entirety.
    (The Nuremberg Code — A critique, 2011; ACHRE Report Ch. 2)