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Human/Animal Research Protocol Management System (HARP)
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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 form 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.
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There are several basic types of human subjects protocols. They are described below. The HARP system will step you through the definitions and submission processes once you enter it.
Exempt protocols Research involving pre-existing human data or tissues with no identifying information attached will typically be exempt from needing a full protocol. In fact, if tissues are obtained from a federally assured public tissue bank no review of any kind may be needed. If you think your research may qualify as not human use, please call the HARC office at 510/486-6005 to discuss this with Dianna Bolt. An exemption is needed then, if you do not already have a HARP account, please fill out this form and send it as an email attachment to [email protected]. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an exempt protocol.
Non-exempt research 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 process (see below). Possible scenarios: 1) you will be receiving encoded samples from collaborators at other institutions such that the identity of the subject tissue donors is unknown to you. If, however, 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 complete a full protocol. 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 be expeditable, but you will still need to file a non-exempt protocol in HARP. Fill out this form and send it as an email attachment to [email protected]. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an expedited protocol. Please note that you will need to upload into the HARP system a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval. Any questions should be directed to HARC office staff at x6005.
Full If the research you are planning to conduct at LBNL involves interaction with human subjects, then 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. If you and all of your responsible staff members do not already have an account on the HARP system, please fill out this form for all relevant personnel and send it as an email attachment to [email protected]. Once you have all needed accounts please enter the HARP system and proceed to follow instructions for submitting a full protocol. Please feel free to call the HARC office at x6005 for any help you may need with this.
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Collaborative and other non-exempt 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 Verfication 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.
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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 'paperwork' for the other UC's IRB must be done first and filed there. 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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