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ACRP 2022

157 - Informed Consent for Research

Apr 25, 2022 12:45pm ‐ Apr 25, 2022 1:45pm

Expiration Date: May 31, 2024

Credits: None available.


This session addresses ACRP core competencies in Ethical and Participant Safety Considerations. Many education opportunities surrounding the topic of informed consent only address one element: the informed consent form. While the informed consent form is important, this neglects to teach research personnel about the informed consent discussion. This education gap is impactful, as the informed consent process is one of the most important periods of a participant's participation in a trial. However, participants tend to not understand crucial elements of informed consent (Thanh Tam et al., 2015). It is crucial for informed consent educational opportunities to focus on both the informed consent form as well as the informed consent discussion. In this session the audience will learn about elements of the informed consent form and also use the "questions method" (asking who, what, when, where, why, and how) to improve their informed consent discussions and increase subject understanding. In addition, this session will also walk through tricky consent scenarios. The audience should walk away with knowledge of the required elements of the informed consent form as well as increased confidence on how to complete an informed consent discussion that maximizes participant understanding. REFERENCE: Tam, Nguyen Thanh, et al. “Participants’ Understanding of Informed Consent in Clinical Trials over Three Decades: Systematic Review and Meta-Analysis.” Bulletin of the World Health Organization, vol. 93, no. 3, 2015, doi:10.2471/blt.14.141390.

Learning Objectives:
  • Define informed consent
  • List what elements should be included in the informed consent form
  • Confidently conduct a thorough informed consent discussion, increasing participant understanding


  • Catherine Barnes, CCRC, Personnel Development and Training Specialist, UNC Chapel Hill


  • 1.00 - ACRP Credits

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