Informed Consent

Definition

Consent given with full understanding of what is being agreed to, based on clear, comprehensive, and understandable information about data processing. Informed consent requires that individuals understand what data is collected, how it will be used, who it will be shared with, how long it's retained, what rights they have, and consequences of consenting or refusing. The information must be provided before consent is sought, in clear and plain language appropriate to the audience, accessible and easy to understand, specific about the processing, and sufficient for meaningful decision-making. Simply providing a privacy policy isn't enough—individuals must actually understand the material information. For consent to be informed, avoid legal jargon, use clear examples, highlight key points, layer information appropriately, and confirm understanding for high-risk processing. Informed consent respects individual autonomy by ensuring people make knowing choices about their data.

Applicable Laws & Regulations

  1. 1GDPR Article 4(11) - Consent must be informed
  2. 2GDPR Article 7(2) - Information requirements for consent
  3. 3Various medical research regulations - Informed consent standards

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