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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 humans 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

What's New for LBNL Investigators?

Have a question? Sign up for HARC OFFICE HOURS: Mondays, 2-3pm & Thursdays, 9am-10am. Sign up for a time slot HERE

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.

Changes needed for 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:

  1. DOE Human Subjects Protection Order
  2. HTM or Not HTM Tool

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.**

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