Home > News > New Modules of Interest – Advanced Issues in Informed Consent (June 2016)

New Modules of Interest – Advanced Issues in Informed Consent (June 2016)

Continuing with our year addressing different areas of informed consent in human subjects research, the CITI Program is proud to announce advanced content on informed consent issues. These four new modules explore contemporary challenges and are designed to be taken after learners complete the basic informed consent module. As part of the Human Subjects Research (HSR) series, subscribing organizations may add these modules to their content offerings at no additional fee.

New Module - Consent and Biobanks and Associated Databases (June 2016)

A new module entitled Consent and Biobanks and Associated Databases 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

Biobanks are widely used in research and can be thought of as libraries of biospecimens – containing everything from blood, saliva, to tissue samples. The associated database is the organized collection of searchable data associated with the biobank. This module describes different consent approaches used for biobanks and associated databases, with reference to pertinent legal and ethical documents and regulatory requirements. Additionally, learners will review examples of key consent clauses (for example, linkage, return of research results and incidental findings, storage for future use, and access by researchers).

New Module - Consent and Cultural Competence (June 2016)

A new module entitled Consent and Cultural Competence 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

Cultural competence, as it applies to developing consent processes, obtaining consent, and evaluating the appropriateness of the consent processes is a focus of this module. The module describes strategies for enhancing understanding of research among diverse populations and communities during the consent process.

New Module - Consent and Subject Recruitment Challenges: Therapeutic Misconception (June 2016)

A new module entitled Consent and Subject Recruitment Challenges: Therapeutic Misconception (TM) 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 discusses therapeutic misconception and identifies potential strategies researchers and IRB members can use for reducing therapeutic misconception in the consent process. Also discussed are the related phenomena of therapeutic misestimation and therapeutic optimism.

New Module - Consent With Subjects Who Do Not Speak English (June 2016)

A new module entitled Consent With Subjects Who Do Not Speak English 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 focuses on the role that language plays in developing consent processes and obtaining consent in study populations that do not speak English. This module also covers challenges and strategies that researchers can use in the consent process, including the role of interpreters and the use of translations in obtaining consent and during the conduct of the study. The module concludes with a discussion of the federal regulations and guidance covering recruitment and consent for subjects who do not speak English with particular attention to the role of the IRB and the responsibilities of researchers.

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. 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.