The World Medical Association (WMA)[edit]
One potential explanation is that it derives its legitimacy from being an official declaration of the World Medical Association (WMA). This organization represents the largest global assembly of physicians, and consequently, it could be argued that the WMA is a credible and authoritative entity for issuing statements on behalf of the medical profession as a whole.[40]
However, a historical observation appears to challenge the notion that this explains the Declaration of Helsinki's authority. It can be argued that the Declaration was most widely accepted as an authoritative document during the period from the late 1970s (after the 1975 amendment had been widely promulgated) to the mid-to-late 1990s when increasing demands for changes to the Declaration began to emerge. Notably, this period was marked by significant internal unrest within the WMA. In the 1980s, a group of countries, known as the 'Toronto Group,' which included the UK, withdrew from the WMA due to persistent objections related to the South African Medical Association's failure to denounce apartheid. Historical events eventually led to the reconciliation of this division, and all the countries that had previously withdrawn had rejoined the WMA by 1995.[82]
1964: Original version. 18th Meeting, Helsinki
1975: First revision. 29th Meeting, Tokyo
1983: Second revision. 35th Meeting, Venice
1989: Third revision. 41st Meeting, Hong Kong
1996: Fourth revision. 48th Meeting, Somerset West (South Africa)
2000: Fifth revision. 52nd Meeting, Edinburgh
2002: First clarification, Washington
2004: Second clarification, Tokyo
2008: Sixth revision, 59th Meeting, Seoul
2013: Seventh revision, 64th Meeting, Fortaleza
[83]
2014: This was the 50th anniversary of declaration. To mark this special occasion, the WMA published "The World Medical Association Declaration of Helsinki: 1964-2014 50 Years of Evolution of Medical Research Ethics.".
2016: The Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks finally complemented the Declaration of Helsinki.
[83]
Informed consent
Medical ethics
Clinical trial
Human experimentation in the United States
Clinical Research
U.S. National Institutes of Health (NIH) - Protecting Human Subject Research Participants
Nuremberg Code
Declaration of Helsinki
Belmont Report
CIOMS
(GCP)