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Informed Consent: Comprehensive Concepts and Components


Overview

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.

This module takes an average of 3.5 hours to complete.

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

Who should attend?

This module is designed for professionals involved in:

  • Clinical research including research scientists, clinical research associates, study coordinators, clinical trial recruiters, principal investigators, and clinical study teams
  • Regulatory affairs

Learning objectives

Upon completion of this module, learners should be able to:

  • Define informed consent and identify the key characteristics of the process
  • Identify situations that would require informed consent, and exceptions to consent
  • Explain the proper methods of communicating with and gaining consent from various populations of potential study subjects
  • Explain the proper use of electronic consent, its benefits, and concerns with its use
  • Identify common problems with completed consent forms
  • Write a complete and appropriate consent form
  • Determine which consent form components are necessary based on the characteristics of the study and potential study subjects
  • Analyze completed consent forms for comprehensiveness, appropriateness, and accuracy
  • Describe the difference between short and long consent forms, and explain when each is appropriate
  • Summarize informed consent requirements under HIPAA

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