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:


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)