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- Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.
- The experiment should aim at positive results for society that cannot be procured in some other way.
- It should be based on previous knowledge (e.g., an expectation derived from animal experiments) that justifies the experiment.
- The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries.
- It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.
- The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.
- Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks.
- The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.
- The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.
- Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.
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