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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/ 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 

Research involving pre-existing human data or tissues with no identifying information attached will typically be exempt from some of the requirements of full review.  If your study is considered human subject research, but in an exempt category, you must submit an exempt protocol in the HARP system. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an exempt protocol.

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. This can be quite a challenge if one is dealing with medical or scientific terminology, and a glossary of lay terminology can be useful in "translating" medical terms into more commonly used language. 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.

  1. Consent form checklist
  2. General consent form outline
  3. Routine phlebotomy/blood draw consent form model
  4. Biomedical procedures consent form model
  5. California Medical Research Subject's Bill of Rights

Collaborative research  

If your research involves receiving encoded samples from collaborators at other institutions, or at LBNL, such that the identity of the subject tissue donors is unknown to you and you will be returning tissues, or data to your collaborators at those institutions, and especially if any part of this information will be returned to the subjects, then you must submit your protocol through the HARP system to submit it as an Expedited Verification Assessment or EVA. You must also submit (upload into HARP) a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval.

Note: to avoid delays, if you have any question about whether your study qualifies as an EVA please call HARC office staff at x6005. New researchers and those submitting LBNL human subject protocols for the first time are advised to consult with HARC office staff before submitting protocols to HARP.

Working with another UC campus: If you will be relying on the review of another University of California's 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 UC's IRB first through their institutional system. Once the reviewing IRB has approved the complete application, you will be informed of this via the UCOP Reliance Registry system. Please call the HARC office staff at 510-486-6005 if you have any questions, or send them email at [email protected].

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