TRAINING POLICY
Who: All personnel conducting human subjects research (HSR) with the Berkeley Lab (Including contractors & staff)
What: All personnel listed on an HSR protocol Must complete appropriate training in human subjects research requirements every 3 years.
When: Prior to being added to a human subjects protocol.
How: Follow this NEW step-by-step Guide
QUESTIONS? The complete Policy is currently being updated to match the new CITI offerings. The HARC Office is available to answer any questions, please email [email protected].
Training
The LBNL human subjects protection program currently requires recurring ethics training for all individuals conducting human subjects research in accordance with the DOE Order 443.1C.chg1. All protocol personnel are required to take the CITI ethics training course (details below) in the appropriate research focus. This must be renewed with a refresher course every three years.
1) LBNL Researchers: Access to the CITI program training site is provided by the Department of Energy (DOE) for researchers engaged in DOE supported and conducted HSR. Researchers at LBNL should choose a track from the HSR curriculum that aligns with their research focus and role on the study (Biomedical, Social/Behavioral, or Data only). All tracks require multiple modules, which can be taken all at once (approximately two hours) or taken over time. CITI will allow you to pause in the middle of a module and come back to it. To enter CITI , register with your email and a password. Here is a How-To Guide for navigating the website. When you have completed the courses, please send the downloadable pdf of your completion certificate to the HARC office ([email protected]) so that it can be uploaded into your HARP training profile. You will need to refresh this CITI training three years later by taking the refresher course. This is required because the ethical use of human research subjects is an evolving field, especially in the area of data protection, and it has been added as a requirement to the DOE Order 443.1C.chg1.
Note: Those researchers involved in the Million Veterans Project should choose the biomedical track, per VA recommendations.
2) Outside Researchers: If you are a member of a different institution and have previously taken a required IRB course, it is likely that your course will be considered equivalent to the CITI courses we require of our researchers. For example, CITI Human Subjects Protection training. If you have taken an equivalent course, please email the HARC office ([email protected]) to confirm whether it will be sufficient training to participate in research at LBNL. If your course is not found to be equivalent or you have not previously completed any human subjects research training, we will require you to take the same CITI course as the LBNL researchers (above) or an equivalent course such as OHRP's free foundational training.
Training Policy 2021 - UPDATE IN PROGRESS
NEW_08-2025_Human Subjects Training How-To Guide.docx
