Human Subjects Research (HSR)
HSR provides foundational training in human subjects research and includes the historical development of human subject protections, ethical issues, and current regulatory and guidance information.
Human Subjects Research (HSR) basic content is organized into two courses: 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). Additional modules of interest within HSR allow for exploration of several important topics and may be selected to meet organizational needs. HSR also includes additional standalone courses for institutional/signatory officials, IRB chairs, and public health researchers.
In preparation for the revised Common Rule to go into effect, HSR now includes the Revised Common Rule course -- a standalone course covering the Final Rule updates to the Common Rule. All Basic and Refresher level modules (except legacy versions) will be updated by the general compliance date (21 January 2019) to reflect the revised Common Rule. A selection of HSR modules are offered in legacy version (reflecting the pre-2018 revisions to the Common Rule) at both Basic and Refresher levels.
These courses were written and peer-reviewed by experts.
Language Availability: English, Korean
Suggested Audiences: Researchers, Research Team Members, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Chairs, IRB Administrators and Staff, Human Subject Protection Staff, Students
Biomedical (Biomed) Basic
Social-Behavioral-Educational (SBE) Basic
Legacy Biomedical (Biomed) Basic
Legacy Social-Behavioral-Educational (SBE) Basic
Biomedical (Biomed) Refresher 1
Biomedical (Biomed) Refresher 2
Biomedical (Biomed) Refresher 3
Social-Behavioral-Educational (SBE) Refresher 1
Social-Behavioral-Educational (SBE) Refresher 2
Legacy Biomedical (Biomed) Refresher
Legacy Social-Behavioral-Educational (SBE) Refresher
Who should take human subjects research training?
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 institutional/signatory officials, IRB chairs, and public health researchers. There is also an additional standalone IRB Administration course. In preparation for the Final Rule's implementation, HSR also includes a standalone Revised Common Rule course covering the Final Rule updates to the Common Rule. For learners who need training on the pre-2018 requirements of the Common Rule, HSR includes legacy versions of selected basic and refresher level options.
As an administrator setting up my organization, how should I select HSR modules for my learner groups?
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.
What different courses are offered in HSR?
HSR consists of content organized in two basic tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE). Additional modules of interest within HSR allow for exploration of several important topics and may be selected to meet organizational needs. Organizations may group these modules to form a basic Biomed or SBE course, or a course that combines the two tracks. Additional basic courses for institutional/signatory officials, IRB chairs, and public health researchers are also available. In preparation for the Final Rule's implementation, HSR also includes a standalone Revised Common Rule course covering the Final Rule updates to the Common Rule.
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 what was covered in the basic level modules. 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 at an interval specified by your organization (for example, [Refresher Stage 1: 3 years after completion; Refresher Stage 2: 6 years after completion).
How long does it take to complete an HSR course?
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.
Can learner groups include components from HSR and other subjects?
Yes, like all CITI Program educational materials, the modules that make up of 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.
What topics does HSR cover?
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.
How frequently should learners take HSR training?
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.
What are the advantages of CITI Program’s HSR training?
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.
Does HSR fulfill the human subjects training requirement?
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 track.
Can learners go back and review the basic module if they are taking a refresher course?
Yes, all refresher modules include a link back to the basic module for learners to review.
Are HSR courses eligible for continuing medical education credits?
Yes, the following courses are eligible for CME/CEU credits:
- HSR – Biomedical (Biomed) Basic Course
- HSR – Social-Behavioral-Educational (SBE) Basic 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
Click on the course name above for details. For more information on how to ensure CME/CEU availability for learners at your organization, contact firstname.lastname@example.org or 888.529.5929.
Will I be notified if this course is significantly revised or updated?
Yes, CITI Program will notify administrators via eBlast (email) and post announcements on our website when courses are significantly revised or updated.
Are HSR courses updated to the revised Common Rule (2018 requirements)?
Prior to the general compliance date (21 January 2019), CITI Program modules will reflect the current (pre-2018 requirements) Common Rule.
All CITI Program modules affected by revisions to the Common Rule will be revised by the general compliance date (21 January 2019) of the regulation to 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).
CITI Program will offer Legacy content that will reflect the pre-2018 requirements of the Common Rule.
For more information, refer to support center article Current CITI Program Modules and the Final Revisions to the Common Rule.