UPDATED! 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 HARC Office is available to answer any questions, please email [email protected].
Training
The LBNL human subjects protection program currently requires ethical recurring ethics training for all researchers in this fieldindividuals conducting human subjects research in accordance with the DOE Order 443.1C.chg1. All protocol personnel are required to take one of the CITI ethics training course (details below) following training courses in the appropriate research focus. This must be renewed with a refresher course , when applicable. Refresher courses are required every three years. HSC members should take the IRB Member CITI course.
1)
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CITI Program: 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
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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
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once (approximately three hours) or taken
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over time. CITI will allow you to pause in the middle of a module and come back to it. To
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enter CITI , register with your email and a password.
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How-To Guide for navigating the website. When you have completed the
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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
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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
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the Million Veterans Project should choose the biomedical track, per VA recommendations.
2) OHRP's Foundational Training: This course is free to the public, and available on the Health & Human Services website - https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/human-research-protection-foundational-training/index.html Lessons 1 through 4 are the basic requirement for researchers. Lesson 5 is also required for IRB Members.
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 researchersLab's requirements. For example, CITI Human Subjects Protection or Responsible Conduct of Research trainingtraining from another institutional license. 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).3) Human Subjects Committee members: LBNL members of the Human Subjects Committee (our IRB) should take the CITI course for IRB members and administrative staff. Register under "Other DOE." Please remember to download your completion certificate or save the completion email you receive from CITI and forward it to the HARC staff, who can then load it into your HARP profile as proof of your ethics training. Refresher training will also be required every three years.complete one of the above courses or an equivalent course.
NEW_08-2025_Human Subjects Training How-To Guide.docx
