CITI HSR Training: Tracks & Renewal

CITI Human Subjects Research (HSR) training is the specific course track within the CITI Program catalog that institutions use to satisfy human-subjects-protection education requirements ahead of Institutional Review Board (IRB) protocol review. It is one of several CITI series — alongside Responsible Conduct of Research (RCR), Good Clinical Practice (GCP), and conflict-of-interest training — and this page covers it specifically: its two tracks, its course levels, what "completion" actually requires, and how renewal cycles are set. For CITI’s institutional model, subscription structure, and what CITI training does and doesn’t satisfy on its own, see the general CITI Program overview.

What the HSR Course Covers

The HSR series trains researchers and research staff on the ethical principles and regulatory requirements that govern research involving living human participants: the historical background (including the Belmont Report principles of respect for persons, beneficence, and justice), the U.S. federal Common Rule (45 CFR 46), informed consent requirements, privacy and confidentiality, and review-category mechanics (exempt, expedited, full board). Most U.S. institutions require anyone named as an investigator or key personnel on a human-subjects protocol to complete the relevant HSR course before the IRB will approve that protocol, and many require it before an IRB application can even be submitted.

Biomedical Track vs. Social-Behavioral-Educational (SBE) Track

CITI splits HSR training into two parallel tracks aimed at different research contexts:

Biomedical Research (Biomed) — oriented toward clinical trials, drug and device studies, specimen and genetic research, and other biomedical/clinical human-subjects work. Content leans toward FDA-regulated research, adverse-event and safety reporting, and biomedical-specific consent issues.
Social-Behavioral-Educational (SBE) — oriented toward survey, interview, observational, educational, and behavioral research. Content covers issues more specific to that context, such as qualitative-research confidentiality, internet-based research, and educational-setting consent.

Which track a researcher takes is a function of the research they actually do, not their department or degree — a biomedical-department researcher running a survey study would typically be assigned the SBE track for that protocol, and institutions with both types of research active often require some personnel to complete both. The institution’s IRB office or CITI institutional administrator sets the assignment, not the researcher, since it is usually tied to a required “group” the institution has configured in CITI for a given role or protocol type.

Course Levels: Foundations and Comprehensive

Within each track, CITI now organizes HSR content into course levels rather than a single fixed curriculum:

Foundations courses cover the core topics and concepts — the baseline most institutions require for general human-subjects involvement.
Comprehensive courses cover the same core content plus additional advanced topics (for example, international research, vulnerable populations, or research involving specific technologies), typically required for principal investigators or higher-risk protocol types.
Refresher courses (Biomed Refresher 1–3, SBE Refresher 1–2) are shorter retraining modules for people who have already completed a basic course and need to renew, rather than repeat the full initial curriculum.

Exactly which modules populate a given course — and whether a researcher sees Foundations, Comprehensive, or a custom mix — is configured by each subscribing institution’s CITI administrator, not fixed by CITI itself. This is why module counts and required content differ noticeably between institutions even though everyone is nominally taking “the CITI HSR course.”

Completion Requirements

A CITI course is organized into individual modules, each ending in a short quiz. Institutions commonly set a minimum passing score (an 80% aggregate score across required modules is a widely used institutional threshold, though CITI itself does not mandate a single figure — the requirement is set by the subscribing institution). Learners who don’t meet the threshold on a module can typically retake it. Once every required module in the assigned course group is passed, CITI generates a completion report and certificate, which the researcher’s institution (and, in many cases, the IRB system itself, if integrated) can verify directly through CITI rather than relying on a self-reported certificate.

Renewal and Refresher Cycles

This is the part most often described inconsistently, so it’s worth stating precisely: CITI itself does not impose a fixed expiration on HSR completion. CITI’s own program guidance states there is “no uniform standard regarding how frequently HSR training should occur,” while noting that most subscribing organizations select a three-year retraining cycle. The retraining interval that actually applies to a given researcher is an institutional policy decision, set by that institution’s IRB office or human-research-protections program, and enforced through the institution’s own tracking system — not through anything CITI enforces centrally. Commonly seen intervals across institutions range from one to three years, with three years being the most frequently reported default.

This is a different mechanism from the Public Health Service financial-conflict-of-interest training renewal requirement, which is federally mandated on a fixed four-year cycle under 42 CFR 50.604(f) regardless of institutional preference — see the general CITI Program guide for that distinction. HSR renewal, by contrast, is entirely institution-set.

Practically, this means a researcher moving between institutions, or checking whether a certificate is still valid for a new protocol, needs to check the receiving institution’s own policy rather than assume a fixed CITI expiration date applies everywhere.

How Institutions Use HSR Completion

Research-administration and IRB offices typically integrate CITI completion tracking with their protocol-submission system so that a protocol can’t move to review, or a new team member can’t be added to an active protocol, until CITI records show a current, non-expired HSR completion on file for that person and track. Because the underlying requirement (current training on file for anyone touching human-subjects work) is set locally, offices vary in how strictly and how far in advance they enforce it — some block submission outright, others allow conditional approval pending training completion within a grace period.

Frequently Asked Questions

Is CITI HSR training the same as IRB training?

They’re related but not identical. CITI HSR is the training content most institutions use to satisfy the education component of human-subjects research oversight; the IRB itself is the review body that approves protocols. Completing CITI HSR training is typically a prerequisite for IRB submission, not a substitute for IRB review.

Do I need both the Biomedical and SBE tracks?

Only if your research spans both contexts. Institutions generally assign the track (or both) based on the type of human-subjects research a protocol involves, not a researcher’s department.

How long does a CITI HSR certificate stay valid?

There is no fixed answer set by CITI — validity is an institutional policy decision. CITI’s own guidance says most organizations use a three-year cycle, but check your specific institution’s IRB office, since one- and two-year cycles are also used.

Can I use a CITI HSR certificate from a previous institution?

Many institutions accept a current, unexpired CITI completion report from another CITI-subscribing institution, sometimes via CITI’s transcript/affiliation transfer feature, but this is a local policy decision — confirm with the receiving institution’s IRB or research-compliance office before assuming reciprocity.

What’s the difference between Foundations and Comprehensive courses?

Foundations covers core human-subjects-protection topics; Comprehensive covers the same core content plus advanced topics and is more often required for principal investigators or higher-risk protocol types. Which one applies to you is set by your institution’s CITI configuration.

CITI Human Subjects Research (HSR) Training: Biomedical and SBE Tracks, Requirements, and Renewal