The CITI Program is developing advanced content to provide a second level of training on different issues about informed consent. These modules in the Human Subjects Research (HSR) series explore contemporary consent issues and are designed to be taken after learners complete the basic informed consent module.
New Module - Consent in the 21st Century
A new module entitled Consent in the 21st Century is now available. This module is part of the Human Subjects Research (HSR) series and subscribing organizations may add it to their current offerings for no additional fee.
This module explores how technology has impacted the informed consent process in the 21st Century, especially electronic informed consent (eIC). This module covers technology and tools used in the recruitment and consent process, describes alternatives to paper-based informed consent forms, and explores confidentiality issues. This module reviews federal guidance concerning multimedia tools and eIC.
New Module – Consent Tools Used by Researchers
A new module entitled Consent Tools Used by Researchers is now available. This module is part of the Human Subjects Research (HSR) series and subscribing organizations may add it to their current offerings for no additional fee.
This module provides an overview of the potential barriers to informed consent and discusses strategies and tools that may be used to enhance and ensure research subjects’ understanding of study information, including subject capacity assessments, the teach-back approach, tools for child assent, use of framing and graphics, and video and multimedia presentations. This module discusses ways to present research information to subjects in several simple, practical, and inexpensive ways.
The new modules are primarily intended for Institutional Review Board (IRB)/ Research Ethics Board (REB)/ Independent Ethics Committee (IEC) members and administrators, as well as investigators, research team members, and others involved in consent processes. It is meant to complement informed consent content provided in the HSR and Good Clinical Practice (GCP) series. Specifically, this new content is for those involved in obtaining and recording informed consent (researchers and study coordinators), those reviewing informed consent processes and documents (IRB members and administrators), and those designing or conducting research projects where informed consent will be obtained or waived.