Human Subjects Research (HSR)

The HSR courses are suitable for all people involved in research with human participants or responsible for setting policies and procedures for such research, including IRB members and personnel. Other role-specific courses are intended for community research partners, IRB chairs, institutional/signatory officials, and individuals seeking CIP recertification credits.

Each course consists of various modules that learners complete at their own pace. In general, modules can take about 15 to 45 minutes to complete, depending on the topic.

The HSR series is organized into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). Each track is intended for anyone involved in research with human participants or responsible for setting policies and procedures for such research, including IRB members and personnel.

The Biomed and SBE Foundations courses provide foundational training covering core topics and concepts in the protection of research participants. OHRP’s Human Research Protection Foundational Training is also available as an option. The Biomed and SBE Comprehensive courses provide expanded training covering core topics and concepts, as well as advanced topics such as informed consent, vulnerable populations, stem cell research, phase I research, data and safety monitoring, big data research, mobile app research, and disaster and conflict research. Various Biomed and SBE refresher course options are available. Refresher courses provide retraining for individuals who have already completed a basic course.

The HSR series also includes standalone courses for specific roles and topics. Role-specific courses include Community Research Partner Training, Research Ethics for All (designed for community research partners with developmental disabilities), IRB Chair, and Institutional/Signatory Official. Topic-specific courses include OHRP’s Considerations for Reviewing Human Subjects Research and Participant-Centered Informed Consent Training, Essentials of Public Health Research, Single IRB Use and Administration, Clinical Trial Agreements, Phase I Research, Community-Engaged and Community-Based Participatory Research, and Revised Common Rule. Various courses are also available for Certified IRB Professionals (CIPs) seeking recertification credit.

There is no uniform standard regarding how frequently HSR training should occur. Most organizations select a three-year retraining cycle. Organizations have various options for retraining, including different timing between the basic and refresher course stages, depending on the learner group.

Yes, the Biomed and SBE Comprehensive and Foundations courses fulfill the human subjects research training requirements. OHRP’s Human Research Protection Foundational Training also fulfills the requirement.

CITI Program allows organizations to customize their learner groups, which means they can choose the modules their learners need to complete. We will work with you 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, you can select modules from other subject areas (for example, Good Clinical Practice, Responsible Conduct of Research, or Information Privacy and Security) when creating HSR learner groups. Additional subscription charges may apply.

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, the following courses are eligible for CME credits:

• HSR – Biomedical (Biomed) Comprehensive Course
• HSR – Social-Behavioral-Educational (SBE) Comprehensive Course
• HSR – Biomedical Refresher 1 Course
• HSR – Biomedical Refresher 2 Course
• HSR – Biomedical Refresher 3 Course
• HSR – Social-Behavioral-Educational Refresher 1 Course
• HSR – Social-Behavioral-Educational Refresher 2 Course
• IRB Chair Course
• Revised Common Rule

For more information on how to ensure CME credit availability for learners at your organization, contact Support.

Yes. All CITI Program modules affected by revisions to the Common Rule were revised by the general compliance date (January 21, 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 January, 19 2017).

Prior to the general compliance date (January 21, 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.

Yes, CITI Program is proud to host this OHRP training, free for organizations using our HSR series. Integrate this course into your organization’s training curriculum for tracking, documentation, and support in our LMS. If your organization currently subscribes to the HSR series, contact Support to add this new course for free.