The 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 humans or human tissues. Federal regulations concerning scientific research using human subjects may be found on the Office of Human Research Protection.
Human/Animal Research Protocol Management System (HARP)
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].
There are several basic types of human subjects protocols. They are described in the next section. The HARP system will step you through the definitions and submission processes once you enter it.
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 your group is 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.
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.
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.
**Please note that the HARC office moved on May 30, 2019 if you need to send a paper item through the mail to the HARC office use the mailstop 26-0097. The office is physically located in 26-109.**
