Required Education

Investigators and staff engaged in human subjects research may complete any one of the following to meet the basic human research protections training requirement:

• CITI Basic course for Biomedical Researchers; or
• CITI Basic course for Social and Behavioral Researchers.

CITI offers two human subject research protection courses, one for researchers conducting biomedical research and one for researchers conducting social and behavioral research. You should choose the course that applies to the majority of your research.

Training is valid for a three-year period. Investigators and staff must renew their training certification before it expires by taking either a refresher course or retaking the full course. Members of the research team who have not completed human subject research protection training may not take part in aspects of the research that involve human subjects or their private identifiable data.

Investigators and staff engaged in a clinical investigation or an NIH-funded clinical trial are required to take Good Clinical Practice (GCP) training in addition to basic human research protections training.

Good Clinical Practice

Investigators and staff engaged in a clinical investigation or an NIH-funded clinical trial are required to take GCP training in addition to basic human research protections training.

If the research is a clinical investigation under FDA jurisdiction you must complete one of the following:

• GCP for Clinical Trials with Investigational Drugs and Biologics; or
• GCP for Clinical Trials with Investigational Medical Devices; or
• GCP for Clinical Trials with Investigational Drugs and Medical Devices; or
• GCP for Social and Behavioral Research (if the research is an NIH-funded clinical trial not subject to FDA jurisdiction).

If you are involved in the conduct of an NIH-funded clinical trial, you are required to be trained in GCP.  If you fail to maintain the training, you may lose funding.

Training is valid for a three-year period. Investigators and staff must renew their training certification before it expires by taking either a refresher course or retaking the full course. Members of the research team who have not completed human subject research protection training may not take part in aspects of the research that involve human subjects or their private identifiable data.

CIRTification

CIRTification human research protection training can be completed to satisfy the training requirement when the following conditions are satisfied:

• The researchers are NOT affiliated with a domestic institution, including UC Davis;
• The research involves only minimal risk;
• The training is conducted by a facilitator experienced in human research protections who has completed the basic CITI course for investigators and has current CITI certification or is otherwise approved by IRB;
• The facilitator and research personnel receiving training attend the entire training session and sign the CIRTification Completion Log;
• The facilitator signs the attestation on the CIRTification Completion Log; and
• The PI maintains a copy of the CIRTification Completion Log.

Click here to download the CIRTification training slides.

External Investigators

An external investigator submitting to UC Davis IRB for review under a reliance agreement may complete one of the following to meet the basic human research protections training requirement:

• The human subjects protection training required by the investigator’s home institution.
• UCD CITI human subjects protection training. External investigators may register with CITI, affiliate with UC Davis, and select the appropriate training course. Additional information about the accepted training courses can be found under the “Basic Human Research Training” and “Good Clinical Practice” tabs on this page.