IRB Ready

CITI Training: What to Expect and How to Prepare

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CITI training is the human subjects protection education that most US institutions require before you submit an IRB application. The CITI Program (Collaborative Institutional Training Initiative) hosts the modules on behalf of institutions; you access them through your institution's single sign-on. If you have been told to "complete CITI before your first protocol submission," this post walks through what that actually involves.

What CITI is and why institutions require it

The requirement traces back to federal regulations under 45 CFR 46 and FDA guidance that require institutions to ensure research personnel are trained in human subjects protection. Most institutions satisfy the requirement through CITI because it provides standardized, externally tracked modules.

Your training certificate has an expiration date (typically three years) and must be current at the time of IRB submission. Every listed personnel on a protocol — PI, co-investigators, research assistants — needs a current certificate.

The two main tracks

The basic course you need as a student researcher is usually called "Human Subjects Protection" or "Social-Behavioral-Educational Researchers" (SBE). Biomedical researchers take the "Biomedical Researchers" track instead. The two tracks share a foundation of ethical principles and diverge in the details of risk and regulation relevant to each domain.

Your institution decides which track you take based on your role. When in doubt, email your IRB coordinator before you register — taking the wrong track means retaking modules.

What the modules cover

The SBE track typically includes modules on:

  • History and ethical principles (Nuremberg, Tuskegee, Belmont Report).
  • The federal regulations and definitions (Common Rule, human subjects, research).
  • Informed consent.
  • Privacy and confidentiality.
  • Assessing risk.
  • Research with vulnerable populations (children, prisoners, pregnant individuals, decisionally impaired adults).
  • Internet-based research.
  • Populations in research (international research, cultural competence).

The biomedical track adds FDA-regulated research, investigational drugs and devices, genetic research, and HIPAA considerations.

For deeper context on research ethics that goes beyond the CITI modules themselves, the Healthcare Theory & Research Course has structured curriculum content on research ethics that maps well to the CITI topics. Many students find it useful to read a broader ethics primer before working through CITI — the modules land better when the vocabulary is already familiar.

How long it takes

Budget 6 to 10 hours to complete the basic course, spread across several sittings. The modules are a mix of short readings and quizzes. You need a passing score (usually 80 percent aggregate) on the quizzes to earn the certificate. You can retake individual quiz items, so do not panic about a wrong answer.

Refresher courses for recertification are shorter — usually 2 to 3 hours.

How to actually learn the material

The temptation is to treat CITI as a compliance hurdle and click through. Resist that. The modules are the only structured human subjects protection education most researchers ever receive, and the material comes back on every protocol you ever write.

Three habits make it stick:

  • Take notes as you read. Every module has five to ten concepts you will cite in a protocol. Write them down.
  • Do the case studies seriously. They are the closest thing the course has to applied practice.
  • Connect the modules to your own study. When you reach the consent module, think about your consent form. When you reach the vulnerable populations module, ask whether your sample includes any.

Quizzes: the short strategy

The quizzes test recognition more than recall. Read the module first, then attempt the quiz. You can retake and the system averages your score. Look for keyword matching in the question stem — CITI questions are not tricky in wording, and the correct answer usually uses the module's exact language.

After you finish

Download your completion report as a PDF and save it somewhere you can find it again. Your institution's IRB system may auto-import it, but do not assume. When you submit a protocol, you will need to attach or reference the certificate for every listed person.

Set a calendar reminder for the recertification date. Expired training at the time of a continuing review is one of the most common reasons a protocol gets held up mid-study. Our protocol writing guide and amendments guide both assume current CITI certification for all personnel — if yours has lapsed, fix it before you file.

Conditional training

Some institutions require additional modules for specific study types: HIPAA for protected health information, Good Clinical Practice (GCP) for FDA-regulated work, Conflict of Interest for externally funded work, Responsible Conduct of Research (RCR) for federally funded work. Your IRB coordinator or training office will tell you which apply.

CITI is the floor, not the ceiling, of human subjects protection education. Treat it that way and the rest of the IRB process is easier.