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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 linkIf 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. This is still a relatively new system and we appreciate your patience during our roll-out. You may call the HARC office at x5399 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].

Please note that to renew or amend an older protocol, you must first enter all the information in that old protocol as a new submission to the HARP system, including uploading as attached documents all consent forms, recruitment flyers, etc. In most cases the HARC staff will be able to accept this old version of the protocol for initiation within one or two days. Researchers should then proceed to use the HARP system to submit their renewal and/or amendment. That renewal or amendment submission will be treated as deemed necessary by the HARC staff, either treated as expeditable or taken to the full Human Subjects Committee for consideration at its next regularly scheduled meeting. Although this may seem like a major inconvenience, even a very complicated protocol can be fed into the HARP system and submitted for intitial acceptance in under an hour.The HARC staff believes that LBNL researchers will find the renewal process quick and easy.

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.

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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, that campus should send a copy of the signed NOITR you, which you will upload it with your submission in the HARP system. Please call HARC officer staff at 510/486-5399 if you have any questions, or send them email at [email protected].

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