NEW TRAINING POLICY
Who: All personnel working in human subjects research with the Berkeley Lab (Including contractors & staff)
What: Updated Training Policy from the Human Subjects Committee (HSC) - All Personnel Working on a Human Subjects Research Protocol Must Complete appropriate CITI Training Every 3 Years.
When: Goes into effect on September 1st, with a flexible roll-out throughout the first year. When an existing study is due for continuing review, the new requirements will be applied. Flexibility can be granted in certain situations, but it will be expected that everyone is up to date within 1 calendar year.
Why: This update brings our program up to the more consistent standards that are upheld in many large institutions, including University of California. We understand that this may not be easy to adjust to immediately, and that is why our roll-out will be flexible based on the needs of our researchers.
QUESTIONS? The complete Policy is HERE. Administrator of the HSC, Kelsey Miller, is available to answer any questions about this new policy, please email [email protected].
Training
The LBNL human subjects protection program currently requires ethical training for all researchers in this field. 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. HSC members should take the IRB Member CITI course.
1) LBNL Researchers: The CITI program offers internationally recognized courses in the ethical use of human research subjects, with multiple courses covering a variety of areas. Researchers at LBNL should choose the Biomedical track, the Social & Behavioral track, or the Other Key Staff course depending on their research focus and role on the study. Both tracks offer multiple modules which can be taken all at one (a one to two hour commitment) or taken one at a 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 course, 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 short refresher course. This is required because the ethical use of human research subjects is an evolving field, especially in the area of data protection. Note: Those researchers involved in the Million Veterans Project should choose the biomedical track.
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 or Responsible Conduct of Research 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).
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.
Human Subjects Training How-To Guide.docx
