photo courtesy of © The Regents of the University of California, Lawrence Berkeley National Laboratory.
Berkeley Lab has a rich history of research engaging human participants beginning all the way back with our founder, John H. Lawrence, M.D., D.Sc., F.A.C.P, the Father of Nuclear Medicine. Our early work exploring the medical uses of radioactive isotopes and subatomic particles have lead to numerous discoveries that guide medical practice today! Learn more
Today, the Human Subjects Committee (HSC) is LBNL's IRB and meets typically once a month. The committee is made up of staff scientists and community members and considers any research at LBNL involving people or human tissues. Federal regulations concerning scientific research using human subjects may be found on the Office of Human Research Protection website and more information on the Department of Energy's human subjects protections can be found here.
Have a question? Email us at [email protected] or sign up for a timeslot at HARC OFFICE HOURS: Mondays, 2-3pm & Thursdays, 9-10am.
What's New for LBNL Investigators?
Human Subjects in Energy Technology and Policy Research - Symposium Report This comprehensive report is a highly recommended resource for researchers and IRB professionals. It highlights the importance of this research, best practices for writing protocols, focus points for the review of Modification of the Human Environment studies and examples of amazing research being performed across the DOE portfolio!
NEW HARC Help Desk! - email [email protected] or submit a ticket from our customer portal
NEW FORM! - submit use of Coded or De-identified human data/specimens for a faster Not Human Subjects Research (NHSR) determination
Need help finding translation/interpretation services? Ask about our Open PO with Accent on Languages for translation or interpretation services! Overview and pricing sheet, Email us for more information
Check out our updated and new Policies & Guidelines
Frequently Asked Questions
Does this project need review? Is it really human subjects research?
Any project that could fit the definition of human subjects research, is required by the newly edited DOE Order 443.1C to have a determination from the HARC Office, including work that is done by subcontractors on your behalf and the use of publicly available data about people or biospecimens from people. This Guidance for Determinations of Human Subjects Research can help you understand the process of making a determination. Not Human Subjects Research (NHSR) determination letters can be provided for researchers to use for journal publications, funding sources, or any other entity that requests one.
What are Berkeley Lab's FWA and IRB Numbers?
LBNL FWA #FWA00006253; IRB #IRB00006447
What criteria does the HSC use to evaluate and approve protocols?
All research projects evaluated by the Human Subjects Committee are reviewed for compliance with applicable local, state, and federal regulations. For Expedited and Full Board categorized studies, at a minimum the Common Rule Regulations would be applied, which include the § 1c.111 Criteria for IRB approval of research. For Exempt categories of research, the HSC applies our institutional policy at a minimum. To find out if there are any other specific requirements for your research, ask the HSC administrator at [email protected] or during HARC Office Hours.
Can I use cannabis in my research?
> Maybe! This is a growing area of research, so if you're considering this please reach out at the earliest point possible to the HARC Office and the Controlled Substances Program ([email protected]).
Specific Guidance for Human Terrain Mapping
If in the course of your research, questions about whether or not the data you are collecting could be used for human terrain mapping, please see the following documents for guidance:
If you will be receiving data that has been sufficiently de-identified, please use the following >HTM data assessment tool, which include a data security agreement template.
