Module 5 Presentations

19/07/2024

• Consent – Fundamental right to determine what is done with one’s own body. – Nuremburg Code/ Declaration of Helsinki – “Valid” consent: competent individual, voluntary agreement, adequately informed – Lack of consent - criminal assault - civil battery - negligence (failure to warn) - breach of rules of professional conduct and/or terms of employment Consent and Information

The Organisation for Professionals in Regulatory Affairs

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Consent and Information

• Requirement for consent applicable to both treatment and clinical trial contexts • Research without consent is unethical and constitutes battery and negligence ● Nazi experimentation during World War 2 ● Tuskegee syphilis study 1930-1972 ● Bristol and Alder Hey organ retention scandals

The Organisation for Professionals in Regulatory Affairs

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