Informed Consent

Informed Consent

The moral and regulatory framework for informed consent is a vital structure for any clinical trial. This course follows a participant and research team through the informed consent process, examining the components of consent, guidance from regulatory organizations, the complexities of consent for vulnerable individuals, and the growing use of electronic consent to protect participants’ autonomy and conduct ethical, successful research.

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CEU Credits: 0.1
Course Code: ELM-972
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 04/15/2025

Curriculum for this course

Juls
Informed Consent Basics
Consent Elements and Requirements
Emergency and Rescue Scenarios
Special Considerations
ICH Guidelines
Consent vs. Assent
Secondary Consent: Representatives
Secondary Consent: Consent Addenda
Consent Clarity Caper!
eConsent
eConsent Regulations
The Consent Bridge
Developing The Consent Process
Developing Materials
Vulnerable Populations
Training Research Staff
Providing Study Information
Assessing Comprehension
Documenting Consent
Monitoring and Auditing the Consent Process
Considerations For Data Use After Study Completion
The Ongoing Journey
Test your Knowledge!
v1.1 Minor Update 01/27/2026 Sections referencing informed consent discussion, signatures, and witnesses augmented with supportive content, industry standard definitions added to glossary
v1.0 Course released on 10/28/2025

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