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Informed Consent: Comprehensive Concepts and Components

Review the essentials of informed consent to create clear, compliant forms, navigate electronic options, and apply best practices in real-world clinical trials.

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Overview

This module equips learners with a better understanding of informed consent, covering every essential component of a complete and compliant consent form as outlined by the ICH and FDA. Participants will gain practical guidance on crafting clear, effective consent language, explore the advantages and challenges of electronic informed consent, and examine real-world research and case studies highlighting the use of eConsent in modern clinical trials.

The module takes an average 4 hours to complete.

This eLearning module can be purchased individually or as part of the Clinical Trial Fundamentals eLearning Program or Clinical Trial Management Comprehensive eLearning Bundle. 

Featured topics

  • Introduction to informed consent
  • Exceptions to requirements for informed consent
  • Comprehension guidelines
  • 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
  • Tips for administering consent
  • Changes to informed consent under HIPPA

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
  • Clinical data managers
  • Clinical study teams

The content is also relevant for regulatory affairs team members at both sponsor and study sites.

Learning objectives

At the conclusion of this course, participants should be able to:

  • Recognize key aspects of the informed consent process, including procedures for securing consent and adherence to the Health Insurance Portability and Accountability Act (or, HIPAA) Privacy Rule.
  • Apply best practices for readability and comprehension when creating an informed consent document.
  • Differentiate between required and additional elements of informed consent.
  • Identify how and where the elements of informed consent are incorporated into a consent document.
  • Distinguish between the long form and short form consent document.

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