Human/Animal Research Protocols system (HARP)
The HARC office uses an online database for managing animal use protocols: the Human/Animal Research Protocol management system, or HARP. If you are on an LBNL computer, and logged into anything (gmail, calendar, etc.) where you have already typed in your LDAP password, the HARP system can be accessed through opening a web page and typing in the url goapp/harp. Once on the HARP page, click the white 'login' in the upper right corner. You may send an email to [email protected] with any questions. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. The first few times you use the HARP protocol submission system it may be challenging, particularly with the concept of arms/groups where you can separate your different groups of animals by species or strain or experimental path.
All principle lead investigators and their protocol personnel must have accounts and profiles on the HARP system by HARC staff. Please complete all the information requested in this HARP Account Request Form for each person listed on the protocol, including the protocol lead investigator.
Reviews: Note that reviews of all new protocols and triennial renewals are done by the full AWRC at monthly convened meetings. Certain types of collaborative protocols and protocol modifications can be done via a different review process.
New Protocols
Researchers at Lawrence Berkeley National Laboratory who will be using animals in their research must create them in the HARP system, after having accounts and profiles created for themselves and all staff on the protocol. While a protocol coordinator may create a protocol, only the protocol lead investigator can submit it for consideration. The submission function is the equivalent of an electronic signature. Note that in lieu of departmental or division head signatures of the paper protocol, the HARC office has created a Divisional Verification Form that should be submitted to the researcher's division head, along with an account of the planned research, for review and signature. This form must be uploaded into the HARP system on the "Investigator's Assurance" page of the protocol, which is the last page before the final page.
Veterinary Pre-review
All new protocols will be subject to pre-review by the veterinarian. When a new protocol is submitted its state will change to "veterinary review" in HARP and an email will be sent to the veterinarian with a link to the protocol. The veterinarian will look at the protocol and either send it on to the HARC office or, more likely, make some review notes, suggest some changes, and return it to the researcher. When the latter happens, the protocol lead investigator, and co-lead investigator (if any), and the protocol coordinator (if any) will get an email with a link to the protocol. The suggested changes can be made, justifications can be given, etc., and the protocol can be re-submitted for veterinary review. This may be done a number of times until the veterinarian is satisfied that the protocol may move forward for Animal Welfare and Research Committee review. The vet will send the protocol in the HARP system to the HARC staff and they will put it on the agenda for the next monthly AWRC meeting.
AWRC Full Committee Review (FCR)
Committee members will review the protocol and may create reviewer notes where they ask questions, ask for justifications, or suggest changes to be made. Once the protocol has been considered at the meeting and voted on, within few days the researcher and staff will receive either an emailed letter of approval, or a letter requesting further changes be made, with a link to the protocol in HARP. If the protocol was approved pending clarification, the suggested changes and clarifications can be responded to and then the protocol can be resubmitted to the HARC office. Once again, the submission may only be done by the protocol lead investigator (PLI). In such cases the AWRC chair, or other designated person, may review the changes and either approve them or send the protocol back to the researcher for further revision. This can go back and forth until the AWRC chair or designated person is satisfied at which time the PLI and staff will receive a letter of approval.
If after a protocol has been reviewed by the committee and requested changes are such that the committee members agree they need to see it again, the PLI and staff will be informed of this by email letter, with changes listed, etc. Revisions must be made and the protocol resubmitted for further committee review.
Helpful Resources
Here is the the link for adding New Personnel: HARP Account Request Form
Here is a twelve page HARP manual that you might find useful in navigating around the HARP system.
If your study has multiple groups/arms with multiple experiments or variables, you might find it useful to use the old table from the paper form to lay out the size of your groups, sets, number of reps, etc.
If you will be breeding animals you may find this Breeding Colony Size Worksheet helpful in determining the numbers of animals you will need. Both these documents can be uploaded into the HARP system on the species information page, under 3.0
If you are entering the HARP system and filling out a protocol for the first time, please contact the AWRC administrator's office for help. Please email [email protected] with any questions.
