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 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 one of the following training courses in the appropriate research focus, when applicable. Refresher courses are required every three years.
1) 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 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 three 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. 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) 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 Lab's requirements. For example, CITI Human Subjects Protection training 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 complete one of the above courses or an equivalent course.
NEW_08-2025_Human Subjects Training How-To Guide.docx
Training
In June 2000 the National Institutes of Health Office of Extramural Research issued a requirement that all researchers conducting research involving human subjects with NIH funds must receive training on the protection of human subjects. Currently the Lab has a short on-line tutorial covering the main points which those researchers using human cell lines should take.
The short LBNL computer based training program on the protection of human subjects can be found at the Lab'straining site. Select the EHS 740 course,. The 20 question tutorial takes approximately 40 minutes to complete. Please direct any comments or questions about the tutorial to Dianna Bolt, [email protected]. Note that the EHS 740 course was updated on March 1, 2011 and all investigators and responsible protocol staff at LBNL who are involved in research with human subjects who took this course earlier must retake it. If a grant agency requires certification from you for human subjects protection training, after you have completed EH&S 740 contact the training office here at LBNL.
LBNL researchers may also take the CITI online human subjects protection training course. This is a course hosted by the University of Miami Collaborative IRB (Inst. Review Board) Training Initiatives on the ethical use of humans as research subjects. It has multiple modules, such as those on the history of human research subject use, consent form requirements, using vulnerable populations, etc.
In addition to the online tutorials, LBNL offers occasional seminars on ethical subjects of interest to researchers. The next seminar has not yet been scheduled. It will be posted here as soon as the details are known. The last offering was:
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