New Module: Informed Consent and Incidental Findings in Research with Human Subjects
Concluding our year addressing advanced topics in informed consent in human subjects research, the CITI Program is proud to announce a new module entitled “Informed Consent and Incidental Findings in Research with Human Subjects.”
This module is intended to be taken after learners complete the basic informed consent module. As part of the Human Subjects Research (HSR)
series, subscribing organizations may add this module to their content offerings for no additional fee.
This module defines incidental findings (IFs) in human subjects research and covers how IFs should be managed in the informed consent process. It provides an overview of Institutional Review Board (IRB) and researcher responsibilities, as well as strategies for managing IFs in the consent process, including review of the research plan, IF management plan, and consent form language.
Other Advanced Informed Consent Modules
- Consent and Biobanks and Associated Databases
- Consent and Cultural Competence
- Consent and Subject Recruitment Challenges: Remuneration
- Consent and Subject Recruitment Challenges: Therapeutic Misconception (TM)
- Consent in the 21st Century
- Consent Tools Used by Researchers
- Consent With Subjects Who Do Not Speak English
This new module (and the other advanced informed consent modules) are primarily intended for IRB members and administrators, as well as investigators, research team members, and others involved in consent processes. The new modules are designed 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.
How to Proceed