Ethical principles for research involving human subjects were first adopted by the World Medical Association in 1964 in Helsinki, hence giving rise to the "Declaration of Helsinki". Since that date, the guidance has been and still is being revised several times, in some areas fundamentally. The latest revision was approved by the 64th World Medical Association in Fortaleza, Brazil in October 2013. It still contains controversial points, such as research with placebos, despite the fact that a certified standard therapy is existent, as well as the rights of participants after a research survey.

The "Convention on Human Rights and Biomedicine" adopted in 1997 by the Council of Europe constitutes another influential international document governing research on human beings, although it still has to be ratified by Germany. This text also initially defines general rules for research on human subjects (Art. 16). The requirements include inter alia the lack of any alternative to the human experiment, a favourable risk/benefit balance and informed consent on the part of the person concerned. Art. 17 contains further provisions relating to research on subjects unable to give informed consent, including minors. The Convention on Human Rights and Biomedicine has met with sharp criticism in Germany. Critics see it as the precursor for a legal foundation justifying the - in their eyes unacceptable - research on persons unable to give informed consent. However, among ethicists and legal experts the opinion prevails that this far-reaching criticism is inaccurate. The Convention is supplemented by additional protocols dedicated to specific topics. The additional protocol on human research was adopted in 2005.