Abstract
Chapter 17 addresses the legal effects of the requirement of proportionality. The outline is brief as the exact legal effects usually depend on domestic legislation. The question is legal effects are at hand when there is a disproportionate relationship between risks, burdens and potential benefits in biomedical research? Several possible consequences are outlined, such as breach of researchers duty of care and the responsibility for negligence, compensation for damage, criminal liability and prosecution. Does disproportionate risks and inadequate information about risks and benefits make the consent invalid?
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