Human subjects protocols at LBNL
Federal regulations require that research involving human subjects or human-derived data or tissues be reviewed by an Institutional Review Board. At Lawrence Berkeley National Laboratory the IRB is the Human Subjects Committee (HSC). Here is a copy of our charter and our federalwide assurance with the U.S. Department of Health and Human Services' Office of Human Research Protection (OHRP). Here is further guidance from the Dept. of Energy's Human Subjects Protection Program on the need for IRB/HSC review of energy use research that impacts human environments in any way. The HSC meets monthly to consider human subjects protocols, consent forms, recruitment flyers, etc. Researchers seeking approval of research involving humans and/or human-derived materials should begin the process well in advance of when such approval is needed for grant initiation or conducting research. It will be necessary to submit multiple forms for each type of protocol listed below. All protocol information must be submitted in the HARP system. Please complete all the information requested in this HARP Account Request Form for each person listed on the protocol, including the protocol lead investigator. All personnel who will be a part of the research must also submit the form and appropriate training certificates to be added to the protocol.
Not Human Subjects Research Determination
If you think your research may qualify as not human use or not research, please call or email the HARC office at 510-486-6005/harc@lbl.gov to discuss this with Kelsey Miller. All determinations of whether a project is Not Human Subjects Research should be made by HARC in conjunction with the HSC Chair. More details on the determination process are in our new guidance for NHSR determinations.
Exempt protocols
Some kinds of HSR may fall into a Common Rule Exempt category. These types of HSR projects still require submission of a protocol the HSC in order to meet DOE Order 443.1C.chg1 requirements. More information can be found on the Exempt HSR Page.
Non-exempt research
If the research you are planning to conduct at LBNL does not meet the qualifications of exempt research, and particularly, if it involves interaction with human subjects, you will be required to complete a full protocol. You must submit a detailed protocol outlining the nature of the research, recruitment of subjects, procedures to be used, storage of data, etc. In other words, you need full review of your protocol, your consent form(s), your recruitment flyer or letter, and any other materials relevant to protecting the health, safety, and confidentiality of your human subjects. Once all responsible personnel have accounts please enter the HARP system and proceed to follow instructions for submitting a full protocol. Please feel free to call or email the HARC office at x6005/[email protected] for any help you may need with this.
Full protocols can be reviewed in one of two ways by the HSC depending on the nature of the study, expedited review or full board review. If in your research you will be using human tissues or collecting data of any sort from identifiable sources, then you must complete the full protocol. Possible scenarios: 1) you will be conducting online surveys that contain possibly identifiable information, or are completed by individuals about their own perceptions or characteristics. 2) Or you may be conducting an energy study of low risk in subjects' homes or at their work, sampling air quality, or testing whether a new appliance works more efficiently. If these or similar scenarios describe your work, then your protocol may be judged by the HARC office and the Human Subjects Committee and its policies to qualify for expedited review. You will still need to file a non-exempt protocol in HARP, however the review process is usually accelerated as it does not require the entire committee. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an expedited protocol. Any questions should be directed to HARC office staff at x6005.
Important Elements of the Protocol
Maintaining confidentiality through proper data security is a priority for research conducted on human subjects. UC Berkeley campus' IRB (CPHS) website has a detailed policy on securing data. Please review this policy as you complete your protocol: Data Security . You may call the HARC office if you have any questions about this.
You will need to complete an informed consent form for prospective subjects to read and sign before they are part of the study. One concern with writing consent forms is that they should be written to be understandable by a potential subject with an 8th grade reading level. You may need more than one consent form for different populations you are studying. For example, if you have control and experimental subjects, the two study populations will need their own consent forms. If you are studying minors, they may need different consent forms pitched to different age groups. With minors you may also need to create assent forms for parents or guardians of the minors to read and sign. Consent forms cannot be created within the HARP system, but must be created as external documents, then uploaded into HARP. Please call/email the HARC office with any questions.
The LBNL Human Subjects Committee has worked out a checklist for items recommended for consent forms. This checklist, a standard outline, and two specific models are available below for LBNL researchers. Use the routine phlebotomy or blood draw consent form for any study involving a blood draw, or for general reference. The biomedical research consent form is for research involving complex medical procedures involving greater than minimal risk, such as PET or MRI scans.
You should also attach a copy of the California Medical Research Subject's Bill of Rights to your consent form.
- Consent form checklist
- Template consent form
- Routine phlebotomy/blood draw consent form model
- Biomedical procedures consent form model
- California Medical Research Subject's Bill of Rights
Collaborative research
Research with data from people is sometimes performed with collaborators. Depending on the role of the different collaborators, these projects have varying record keeping requirements. If you have any question about what is required for your collaborative work, please call HARC office staff at x6005. More Info on this Page
Working with another IRB: If you will be relying on the review of another designated IRB, please use the NOITR (Notice of Intent to Rely) path in the HARP system. Basically the study must be reviewed and approved by the other IRB first through their institutional system. Once the reviewing IRB has approved the complete application, you can submit the approved documentation in HARP. These Please call the HARC office staff at 510-486-6005 if you have any questions, or send them email at [email protected].
