Module 5 Presentations

05/07/2024

Declaration of Helsinki (1)

WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects It is not a legally binding instrument under international law.

1964, Helsinki

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1975, Tokyo

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1983, Venice

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1989, Hong Kong

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1996, Somerset West

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2000, Edinburgh

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2008, Seoul

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• 2013, Fortaleza (valid version)

"Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity”.

The Organisation for Professionals in Regulatory Affairs

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Declaration of Helsinki (2)

• Clinical trials must conform to accepted scientific principles and should be based on laboratory and animal experimentation

• Independent review of the Protocol

• Clinical trials conducted only by scientifically qualified persons

• Benefit to subject should exceed the risk

• Freely given Informed Consent required

The Organisation for Professionals in Regulatory Affairs

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