Addressing Informed Consent Issues (Jul 2016)

Throughout this past year, the CITI Program has released new modules about topics associated with informed consent.

The new modules expand CITI Program’s informed consent content offerings for both the Human Subjects Research (HSR) and Good Clinical Practice (GCP) series. They are a second level (or expanded discussion) of informed consent with an emphasis on topics not covered in the basic modules. The modules are specifically intended for individuals responsible for obtaining and recording informed consent, reviewing informed consent processes and documents, and designing or conducting research projects where informed consent will be obtained or waived.

The authors of the modules reflect foremost experts in the field of human subjects research. Additionally, all modules went through the CITI Program's thorough review process, including external peer review.

Allowing organizations to choose which modules best meet their learners’ training needs helps connect learners with the most relevant training for them. Organizations may elect to use any of the modules to enhance existing learner groups. Consider adding some or all as a refresher series or as educational materials for training.

Consent and Biobanks and Associated Databases (Human Subjects Research, CITI Program)Consent and Biobanks and Associated Databases

Biobanks are widely used in research and can be thought of as libraries of biospecimens – containing everything from blood and 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 are presented examples of key consent clauses (for example, linkage, return of research results and incidental findings, storage for future use, and access by researchers).

Consent and Cultural Competence (Human Subjects Research, CITI Program)Consent and Cultural Competence

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.

Consent and Subject Recruitment Challenges: Remuneration (Human Subjects Research, CITI Program)Consent and Subject Recruitment Challenges: Remuneration

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.

Consent and Subject Recruitment Challenges: Therapeutic Misconception (TM) (Human Subjects Research, CITI Program)Consent and Subject Recruitment Challenges: Therapeutic Misconception (TM)

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.

Consent in the 21st Century (Human Subjects Research, CITI Program)Consent in the 21st Century

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.

Consent Tools Used by Researchers (Human Subjects Research, CITI Program)Consent Tools Used by Researchers

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.

Consent With Subjects Who Do Not Speak English (Human Subjects Research, CITI Program)Consent With Subjects Who Do Not Speak English

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.

Informed Consent and Incidental Findings inResearch with Human Subjects (Human Subjects Research, CITI Program)Informed Consent and Incidental Findings in Research with Human Subjects (Coming Soon)

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 and strategies for managing IFs in the consent process, including review of the research plan, IF management plan, and consent form language.


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.

For more information, please refer to the HSR Catalog (see "Additional Modules of Interest" on Page 12). Add these modules to your learner groups by contacting our Help Desk at or 888.529.5929.

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Last Updated: 09-Jan-2019 11:46 a.m. EST
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