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Informed Consent 

The cornerstone of clinical research is the informed consent process.  History has taught both investigators and research participants many valuable lessons of the importance of informed consent. For historical milestones related to informed consent and humans subjects protection, refer to the GCP & HSP module. This module is divided into 4 required components (videos). Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.

At the conclusion of this module, learners will be able to:

  • Discuss the guiding principles of informed consent.
  • Discuss the essential elements of the informed consent document.
  • Discuss who is allowed to obtain the consent from a patient.
  • Discuss when consents will be obtained.
  • Discuss how decisional capacity can impact giving valid informed consent
  • Discuss the difference between consent and assent.
  • Discuss the assent process in pediatric clinical trials.
  • Discuss the process for obtaining informed consent from non-English speaking research participants.

Part 1

Part 2

Part 3

Part 4

Overview of Informed Consent (IC) & the IC Document (19 minutes)

IC Process (24 minutes) NOTE: For non-NIH staff please know where
to find/how to locate your IRB-approved IC documents.

Assent Process (7 minutes)

Consent Process for Non-English Speaking Subjects (6 minutes)

Part 1 handout


Part 3 handout

Part 4 handout

Resources Evaluation

 Office for Human Subject Protection (2010). OHRP: General Informed Consent Requirements. (18 minutes)

Last updated by Ness, Elizabeth (NIH/NCI) [E] on Jul 24, 2016