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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
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people or human tissues. Federal regulations concerning scientific research using human subjects may be found on the Office of Human Research Protection
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Human/Animal Research Protocol Management System (HARP)
A note on COVID-19: If you currently have an active, HSC approved study involving human subjects and you find that to conduct your research in the near future you need to make modifications to the planned implementation of your study, please contact the HARC (Human and Animal Regulatory Committees) office at [email protected] to discuss this with the HSC administrator. All amendments will be fast tracked and can ideally be approved very quickly. If you need to completely halt the part of your study that involves human subject interaction, for the duration of the pandemic, there is no need to amend your protocol, although you might send an email to the HARC office to keep them informed. If you are considering studying the COVID-19 virus itself and its effect on the population, here is a link to some articles on the ethics of performing human subjects research among those experiencing a global health emergency that dwells on some special considerations for such situations.
What if you're working on COVID-19 and you and your group are completely new to research potentially involving human subjects/tissues/data? Best advice at this point is to call the HSC administrator, Kelsey Miller, (510 486 6005) or send an email ([email protected]). If you do so between 8 am and 5 pm M-F you will get a swift answer. Note, your research may be deemed to be not in need of human subjects protection oversight, or to need some review which can be done relatively swiftly. Please call or email to discuss.
The HARC office has an online database for managing human subjects protocols: the Human/Animal Research Protocol management system, or HARP. Researchers submitting new protocols or wanting to renew or amend already approved protocols must use the new system. If you are on an LBNL computer, and logged into anything (email, calendar, etc.) where you have already typed in your LDAP password, the HARP system can be accessed through our webpage using this link. If you are on a non-LBNL computer, you can get access from offsite either by logging on to your LBNL computer remotely, or through the use of Virtual Private Network (VPN) software, available to LBNL employees from the IT Division website. You may call the HARC office at x6005 or send email to [email protected] with any questions. This frequently asked questions document may be of some use to you.
All principle lead investigators and their responsible research staff named in the protocol must have an account on the HARP system. The HARC staff are currently setting up new accounts. Please send us all the information requested in this role and account information document to [email protected].
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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?
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?
If you are unsure whether a project meets the definition of human subjects research, please contact HARC for a determination. 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 will be provided for researchers to use for 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?
> Not quite yet. See this document from the University of California Office of the President on 7/24/2018 on the use of cannabis in federal research. This is an evolving field however, and things can change in the future.
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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.
