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Also known as the Declaration of Helsinki, the Helsinki Report is a cornerstone document on the ethics of human clinical research, developed by the World Medical Association (WMA) in 1964, with seven revisions, the latest and only official version of which can be found at the WMA’s website (http://www.wma.net/en/20activities/10ethics/10helsinki/index.html). It is one of the first major efforts of the medical community to regulate itself, and it built upon the previously developed Nuremberg Code of 1947. Major revisions were made in 1975, 2000, and most recently in 2013. The first revision was the Tokyo (1975) revision, the second was the Venice (1983), the third was the Hong Kong (1989), and the fourth was the Somerset West, South Africa, (1996) revision.

The first 700-word Declaration of Helsinki developed and corroborated the 10 principles that were first stated in the Nuremberg Code with the Declaration of Geneva, which was more geared toward the ethical duties of physicians.

The first major revision in 1975 doubled the length of the original document, ensuring that concern for the subject (the patient volunteer) must always come before the interests of science and of society. This revision also included the introduction of the requirement of an independent oversight committee for the clinical research project. This concept was adapted in the United States as the Institutional Review Board (IRB), and in other countries with similar equivalent ethics review committees.