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Health Research Regulation

Two important codifications after 1947: Nuremberg Code and Helsinki Declaration.

Nuremberg Code 1947 (World War II)

After the Nuremberg trials, Nazi doctors were convicted of the crimes committed during human experiments on concentration camp prisoners. It attempted to give clear rules about what was legal and what was not when conducting human experiments.

It has no legal force and focuses on human rights of subjects. It is about voluntariness and consent.

- informed consent absolutely essential

- qualified researchers

- favourable risk/benefit ratio

- participants are free to stop any time

- prior animal study

- physical/mental injury should be avoided

- no expectation of death/disability

Helsinki Declaration 1964

A set of ethicals regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.

It is physician oriented and focuses on obligations of physician-investigators. The well-being of the subject should take precedence over the interests of science and society.

- written consent

- scientifically sound and robust research

- limited use of placebo especially if treatment is available

- greater access to benefits if research is concluded

- need to balance with potential benefits so as to decrease risk

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