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 3 required videos and 1 recommended interactive training. 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 and regulatory requirements of the informed consent document.
- Discuss strategies to ensure participant-centered informed consent documents and discussions.
- 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.
| Required | ||||
|---|---|---|---|---|
Part 1 | Respecting Persons – From Basic Requirements to Embracing Participant-Centered Informed Consent (60 minutes – final 10 minutes is Q&A, this is optional) | Resources | Evaluation | |
Part 2 | Pediatric Assent (9 minutes) | |||
Part 3 (NIH Staff Only) | ||||
| Recommended | ||||
Participant-Centered Informed Consent Training (95 minutes) | ||||
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