Home > News > Advanced Issues in Informed Consent: New Modules of Interest (March 2016)

Advanced Issues in Informed Consent: New Modules of Interest (March 2016)

The CITI Program is developing advanced content to provide a second level of training on different issues about informed consent. These modules 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 (March 2016)

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.

Description

The new content will provide the learner with advanced knowledge and training about the informed consent process, best practices, documentation, and current regulatory issues. Nine new modules will be announced over the coming months, exploring consent topics including non-English speakers, cultural competence, biobanking, incidental findings, therapeutic misconception, 21st century, tools used by researchers, non-traditional study designs and more.

New Module - Consent in the 21st Century (March 2016)

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.

Description

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 (March 2016)

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.

Description

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.

New Module - Consent and Subject Recruitment Challenges: Remuneration (August 2015)

A new module entitled Consent and Subject Recruitment Challenges: Remuneration 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.

Description

This module explores the types of remuneration in research, regulatory requirements regarding remuneration to research subjects, how to distinguish between remuneration and reimbursement, and strategies to reduce the potential for undue influence. It also identifies ways of disclosing remuneration plans in consent and advertising materials.

Audience

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.

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