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Informed Consent; Comprehensive Concepts and Components eLearning Module

Informed Consent: Comprehensive Concepts and Components eLearning Module

This comprehensive module provides the key concepts of informed consent. It explains the components of a complete and appropriate consent form as specified by the International Conference on Harmonisation (ICH) and the US Food and Drug Administration (FDA), as well as guidance for the creation and appropriate wording of these components. It also includes a discussion on the benefits and concerns with electronic informed consent, and presents publications and projects that explore the use of eConsent.

Featured Topics
  • Determining When Informed Consent Is Necessary
  • Comprehension Guidelines
  • Overview of Elements of Consent
  • Writing the Introduction and Purpose Statement
  • Explaining Procedures
  • Explaining Risks and Benefits
  • Explaining Alternatives, Cost, and Compensation
  • Explaining Confidentiality and Subject Rights
  • Storage of Specimens
  • Contact Information, Consent Statements, and Signatures
  • Long Form versus Short Form, and Tips for Administering Consent
  • Changes to Informed Consent Under HIPAA

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