History and Ethics of human subjects research CITI

Human Subjects Research (HSR) content is organized into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). They are intended for anyone involved in research studies with human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs). HSR Biomed and SBE courses are offered as Comprehensive and Foundation versions.

Comprehensive courses provide an expanded training covering not only major topical areas but also many concepts that are specific to types of research, roles in the protection of human subjects, and advanced modules on informed consent topics, vulnerable populations, stem cell research, phase I research, data and safety monitoring, big data research, mobile apps research, and disaster and conflict research.

Foundations courses provide foundational training covering major topic areas in human subjects protections.

This series also include refresher course options for both the Biomed and SBE tracks. Refresher courses provide retraining for individuals who have already completed a basic course. CITI Program offers a variety of refresher courses so learners can meet retraining requirements with fresh content.

Additional modules of interest within HSR allow for exploration of several important topics and may be selected to meet organizational needs.

HSR includes additional standalone courses for different specific roles including institutional/signatory officials, IRB chairs, public health researchers, and Certified IRB Professionals (CIPs) seeking recertification credit. Topic-focused mini-courses such as Single IRB (sIRB) Use and Administration, Clinical Trial Agreements, Phase I Research, and Community-Engaged Participatory Research, as well as a standalone revised Common Rule course that covers the regulatory updates to the Common Rule (45 CFR 46, Subpart A) are also available.

All HSR modules reflect the revised Common Rule (2018 Requirements). Upon request, a selection of HSR modules are available as legacy versions (reflecting the pre-2018 requirements).

These courses were written and peer-reviewed by experts.

Note: Organizations subscribing to HSR have access to all of the modules included in the courses below.

Demo of Informed Consent Case Videos:

Language Availability: English, Korean, Spanish, French

Suggested Audiences: Human Subject Protection Staff, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Administrators and Staff, IRB Chairs, Research Team Members, Researchers, Students

This course provides an expansive review of human subjects research topics for biomedical researchers.

This foundational course provides a focused introduction to the essential human subjects research topics for biomedical researc...

This course provides an expansive review of human subjects research topics for social-behavioral-educational researchers.

This foundational course provides a focused introduction to the essential human subjects research topics for social-behavioral-...

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical...

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical...

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical...

This course provides retraining on the HSR SBE Basic course and discusses core human subjects research topics for social-behavi...

This course provides retraining on the HSR SBE Basic course and discusses core human subjects research topics for social-behavi...

This course provides detailed training for current and future Institutional Review Board (IRB) chairs.

This course provides a foundational training for institutional/signatory officials on their roles and responsibilities as part of the human research protection program (HRPP).

Provides an overview of the structure and function of public health systems, differentiates research and practice, and reviews consent and ethical issues for public health researchers.

Comprehensive training covering the Final Rule updates to the Common Rule.

This course covers relying on a sIRB, serving as a sIRB of record, and authorization agreements.

Provides sites and investigators an overview of CTA development, negotiation, and execution.

Provides an introduction to phase I research and the protection of phase I research subjects.

Delivers introductory information to help researchers and community partners participate in research partnerships.

Provides foundational training for IRB members involved in the review of biomedical human subjects research.

Provides foundational training for IRB members involved in review of social-behavioral-educational human subjects research.

Provides foundational training for IRB members involved in the review of both biomedical and social-behavioral-educational huma...

This course provides advanced learners all the CIP approved modules on topics such as informed consent, U.S. Food and Drug Admi...

This course provides advanced learners a topic-focused course on IRB administration and 4 CE hours for CIP recertification.

This course provides advanced learners a topic-focused course on biomedical and U.S. Food and Drug Administration (FDA) researc...

This course provides advanced learners a topic-focused course on subject population and informed consent topics as well as 9 CE...

Basic HSR courses are suitable for all persons involved in research studies involving human subjects (for example, researchers and staff), or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs) and other members of organizational communities where research with human subjects occurs.

There are additional standalone courses that are intended for specific audiences such as institutional/signatory officials, IRB chairs, public health researchers, and Certified IRB Professionals (CIPs) seeking recertification credits. Additional standalone courses on IRB Administration and the Revised Common Rule are available. The Revised Common Rule course covers the regulatory updates to the Common Rule (45 CFR 46, Subpart A). Legacy versions of select basic and refresher modules are available for learners who need training on the pre-2018 requirements of the Common Rule. Legacy content must be requested by contacting CITI Program Support.

HSR courses are comprised of modules that include detailed content, images, supplemental materials (such as, case studies), and a quiz. Learners may complete the modules at their own pace. Each module varies in length, and learners may require different amounts of time to complete the module based on their familiarity and knowledge of the topic. In general, modules can take about 30 to 45 minutes to complete.

This series contains Basic and Refresher courses that are structured into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). These tracks contain different levels of review-- Compressive and Foundations.  The Foundations level provides a review of the core concepts of human subjects protections, while the Comprehensive level contains additional modules of interest that allow for exploration of several important topics and may be selected to meet organizational needs. Organizations may group these modules to form courses.

Additional courses that are intended for specific audiences such as institutional/signatory officials, IRB chairs, public health researchers, and Certified IRB Professionals (CIPs) seeking recertification credits are also available. HSR also includes a standalone Revised Common Rule course covering the regulatory updates to the Common Rule (2018 Requirements).

The Basic Biomed modules have three corresponding sets of refresher modules and the Basic SBE modules have two corresponding sets of refresher modules. These refresher modules are intended to provide learners with a review of core concepts. It is generally recommended that organizations select refresher module requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle specified by the organization (for example, Refresher Stage 1: 3 years after completion; Refresher Stage 2: 6 years after completion).

The CIP courses should be taken by independent learners who are seeking CIP continuing education (CE) credits for recertification.

There is no uniform standard regarding how frequently HSR training should occur. However, most organizations select a three-year cycle of retraining. HSR Refresher courses allow organizations an endless number of options when it comes to presenting content to meet their retraining needs, including different timings between basic and refresher course stages depending on the learner group.

Yes, CITI Program’s HSR training fulfills the human subjects research training requirements if the learner completes the basic modules for either the Biomed or SBE Comprehensive or Foundations courses.

CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs. You can also choose to use our recommended learner groups.

HSR covers the historical development of human subject protections, as well as current regulatory information and ethical issues. It also has additional modules on various topics related to human subject research protections, including cultural competence, advanced issues in informed consent, external IRBs, phase I research, stem cell research, and population-specific content.

HSR was developed and reviewed by human subject research experts to help organizations and individuals understand human subjects research protections. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for HSR training.

Yes, like all CITI Program educational materials, the modules that make up HSR can be customized to meet the specific needs of your organization. This includes selecting modules from other CITI Program subjects (for example, Good Clinical Practice, Responsible Conduct of Research, or Information Privacy and Security) when creating a learner group for HSR. Additional subscription charges may apply. We can work with your CITI Program designated admin to determine learner groups and courses for your organization.

Yes, advanced-level modules that meet the criteria in the Certified IRB Professional (CIP) recertification guidelines are eligible as accredited continuing education units for CIPs. These modules were approved by the Council for Certification of IRB Professionals (CCIP) as advanced-level and eligible for CIP CE credit. View CITI Program Advanced-Level Modules/Courses Eligible for CIP® Recertification Credit. for a list of approved modules.

The “Other Courses for Independent Learners” are meant to provide additional course options that meet the unique needs of independent learners.

• The IRB Member – Biomedical Focus course is meant for IRB members who review biomedical research.
• The IRB Member – Social-Behavioral-Educational Focus course is meant for IRB members who review social-behavioral-educational research.
• The IRB Member – Biomedical and Social-Behavioral-Educational Combined course is meant for IRB members who review biomedical and social-behavioral-educational research.

These courses are intended for independent learners only. For more information on customizing learner groups as part of an organization subscription, see the “Can learner groups include components from HSR and other subjects?” FAQ.

Yes. All CITI Program modules affected by revisions to the Common Rule were revised by the general compliance date (21 January 2019). These modules reflect the 2018 Requirements of the Common Rule (the Final Rule issued by the U.S. Department of Health and Human Services [HHS] at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" [the Common Rule] on 19 January 2017).

Prior to the general compliance date (21 January 2019), CITI Program modules reflected the pre-2018 requirements version of the Common Rule. CITI Program offers legacy content (upon request) that reflects the pre-2018 requirements of the Common Rule. Contact CITI Program Support for more information.

For more information, refer to support center article Current CITI Program Modules and the Final Revisions to the Common Rule.

Yes, CITI Program will notify administrators via email and post news articles on our website when courses are significantly revised or updated.