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 Historical events eventually led to the reconciliation of this division, and all the countries that had previously withdrawn had rejoined the WMA by 1995.[82]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

Studdert DM, Brennan TA (November 1998). . The Medical Journal of Australia. 169 (10): 545–8. doi:10.5694/j.1326-5377.1998.tb123406.x. PMID 9861913. S2CID 33885748.

"Clinical trials in developing countries: scientific and ethical issues"

McNeill PM (November 1998). . The Medical Journal of Australia. 169 (10): 509–10. doi:10.5694/j.1326-5377.1998.tb123394.x. PMID 9861904. S2CID 36042251.

"Should research ethics change at the border?"

Lurie P, Wolfe SM (July 1999). . The Western Journal of Medicine. 171 (1): 6. PMC 1305720. PMID 10483334.

"Proposed revisions to the Declaration of Helsinki. Paving the way for globalization in research"

Nuremberg Code

Declaration of Helsinki

Belmont Report

CIOMS

(GCP)

Good clinical practice

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

Code of Federal Regulations

Nuremberg Code

Declaration of Geneva 1948

Rickham, PP (1964). . British Medical Journal. 2 (5402): 177. doi:10.1136/bmj.2.5402.177. PMC 1816102. PMID 14150898.

"Human Experimentation. Code of Ethics of the World Medical Association. Declaration of Helsinki"

Shephard, DA (1976). . Canadian Medical Association Journal. 115 (12): 1191–2. PMC 1878977. PMID 1000449.

"The 1975 Declaration of Helsinki and consent"

Declaration of Helsinki: 1983 (Second revision)

Declaration of Helsinki: 2000 (Fifth revision, with footnotes from 2002, 2004)

Declaration of Helsinki: 2013 (Seventh revision - Current)

International ethical guidelines for biomedical research involving human subjects. 2002 CIOMS

WMA Medical Ethics Manual 2005

CIOMS

UNESCO: Universal declaration on bioethics and human rights. 2005

CFR Title 45 Public Welfare

CFR Title 45 Part 46 Protection of Human Subjects

Tri-Council Policy Statement: Ethical conduct for research involving humans (Canada)