Researchers at Lawrence Berkeley National Laboratory who will be using animals in their research must complete a ten page animal protocol form, as well as the protocol personnel form, obtain the necessary signatures, and submit the protocol to the HARC office at least two weeks before the next scheduled AWRC meeting.  Researchers should submit the original plus 12 copies, with the Protocol Personnel form collated with the protocol.  It is rare, although not unknown, for a new protocol to receive complete approval the first time it is presented to the committee. Principal investigators will typically have to make a few minor, in some cases major, changes and resubmit the protocol to the committee. Submission of revisions should be made in a timely manner. Thus researchers should submit the protocol at least two months before they plan to begin their research. For first time researchers: if this is the first time you have ever filled out the LBNL animal use protocol form, please feel free to call Dianna Bolt (x6005) or Chris Byrne (x5507) with any questions.

Protocol form – rtf

Protocol Personnel Form (PPF) – rtf

Protocol Instructions

Once an animal use protocol has been approved, the principal investigator will receive an approval letter and copies of the signed protocol and protocol personnel forms. If the grant(s) supporting the research need certification of animal use approval, contact the HARC office. The HARC staff will send the certificate directly to the grant agency.

PROTOCOL RENEWALS

Federal law requires that animal use protocols be annually reviewed by the Institutional Animal Care and Use Committee (AWRC at LBNL). For the first two years following initial protocol approval, the researchers may submit the short, 2 page renewal form, as well as the protocol personnel form, detailing animal usage and any possible small changes in procedures used. A recent change to the short form requests that researchers include a copy of their lay abstract from the full protocol form. This is only to help committee members put the research in context when looking at the renewal form. In no case will a researcher be required to modify their lay abstract for a short form renewal. Every third year the protocol must be resubmitted in full.  Once again, the original of the renewal form and PPF as well as 12 copies (collated) should be submitted to the HARC office in a timely manner.

Note, failure to renew a protocol in a timely manner will result in any animal use under that protocol being suspended and, in extreme cases, may result in all of a researcher's animal use protocols being suspended.

Short renewal form – rtf

Full renewal form – rtf

Protocol personnel form

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It sometimes happens that researchers in the midst of conducting their experiments find they must make changes, large or small, to the planned course of procedures. Small changes would include changing an animal supplier, adding a new strain of mice to the study, changing a drug to be used to a very similar, but superior drug. For the purpose of these small changes, the HARC office supplies a one page form to be filled out in full and submitted to the AWRC two weeks before the next meeting, accompanied by any necessary documentation. For larger changes, such as the addition of a new experimental procedure or a change in hypothesis, researchers must submit a full protocol form, with changes from the original approved form highlighted in bold. If a researcher has any question as to whether their required modification is small or large, they should contact Dr. Jack Bartley (jcbartley@lbl.gov) , chair of the AWRC. The original plus twelve copies should be submitted to the HARC office two weeks prior to the next AWRC meeting.

Note that for the short modification form the HARC office has two versions.  The first version can be filled out online, then printed out, signed, and mailed in to the HARC office.  The second version can be printed out, filled out by hand or typewriter, signed, and mailed in.

Short Modification form - online version

Short Modification form - for printing out only

Full modification form

When researchers have completed the experiments listed in a given animal use protocol form and the study is at an end, the protocol should be discontinued. In the event that the study was never funded and no work involving animals ever took place, writing a memo or sending an email to the HARC office (dgbolt@lbl.gov or cebyrne@lbl.gov) requesting the protocol's discontinuation and stating that no animals were ever used is sufficient. However, if any animals were used under the protocol, then researchers should fill out the 4-5 page form below and submit it to the HARC office for consideration at the next AWRC meeting. The Animal Wefare and Research Committee is mainly focused on the outcome of the study, how many animals were used and of what type, and their final disposition. The committee would also like to see a list of publications flowing from the research, if this is possible. Any questions should be directed to either Dianna Bolt, dgbolt@lbl.gov, or to Jack Bartley, chair of the AWRC, jcbartley@lbl.gov.

Protocol Discontinuation Form

If principal investigators wish to add a new person or persons to their protocol personnel, they should fill out a new Protocol Personnel Form detailing the duties of the new person(s), have the new person(s) read the approved protocol and sign the new PPF, and submit the new PPF to the HARC office. This must be done before a new researcher begins work with the animals. In most cases, the new personnel can be approved by the AWRC staff. If researchers do not hear from the AWRC office within a few days, they should assume that the new personnel have been approved.

Protocol Personnel Form

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All animal research conducted at or in any way sponsored by LBNL must be carried out under an approved Animal Use Protocol. When animal use takes place off site, LBNL must ensure that researchers provide documentation showing that the animals or tissues will be used appropriately and that the animal derived material or data received at LBNL were obtained under an animal use protocol approved by an Institutional Animal Care and Use Committee (IACUC), analogous to the LBNL AWRC, covered by an Office of Laboratory Animal Welfare Assurance or other suitable ethical standards. There are several different types of collaborative research possible. A researcher may wish to conduct joint research with a colleague at a different institution. Or a researcher may wish to use tissues or data from a commercial laboratory. In some cases a researcher will be receiving archival or surplus tissues from an on- or off-site colleague. A fourth possibility is to ship live animals from LBNL to a colleague at another institution. If this last instance is the case, then please see the section on shipping animals below.

All these cases necessitate the approval of the LBNL Animal Welfare and Research Committee. Please download the form you need from the list below, which includes instructions about documentation needed, number of copies to submit to the HARC office, and renewal schedules. The instructions should answer most of your questions. If you have any further questions, please contact Dianna Bolt, x6005, dgbolt@lbl.gov, or Chris Byrne, x5507, cebyrne@lbl.gov.

Joint Research

Joint Research renewal

Use of a Commercial Laboratory

Use of a Commercial Laboratory renewal

Receiving Archival/Surplus Tissues

Researchers who will be using animals that will not be entered into the LBNL Animal Colony must use this form and submit it for review by the committee. If you plan to enter animals into the Colony, you must submit a Protocol and Protocol Personnel form to the Animal Welfare and Regulatory Committee for approval.

Facility Use Form

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Animals shipped from the LBNL Animal Colony to another institution must have this approved by the HARC office. The first document in the following list is the collaborative form which must be submitted to the HARC office (26-143) and approved before shipment can take place. The second document is a shipping checklist, which is not a required form, but included to help researchers determined that all necessary things have been done before their animals are shipped. Call the HARC office, 486-6005 or 486-5507 with any questions.

Shipping Document

Shipping Checklist

Along with submitting protocol forms for approval, it is the responsibility of researchers to make sure that the HARC office has a copy of all grant proposals listed on the protocol form. In many cases the Sponsored Projects Office at LBNL sends copies of grant proposals to the HARC office if research involving animals is planned. However, it is the responsibility of the researcher to make sure that the HARC office has a copy of each grant proposal for which animal use certification is needed. Please contact either Dianna Bolt 486-6005 or Chris Byrne 486-5507, to have the certificate mailed or faxed directly to the agency

The researcher should also supply the protocol's: lead investigator name, title and current approval number; and a short statement addressing whether the grant, if funded, will require changes in the procedures or animal use numbers of the protocol. Please note that the full approval number should be supplied; this number will be in the format ##N-#####-####. The middle four or five digits represents the protocol’s unchanging unique identification number and are not sufficient to convey the protocol’s approval status. The last four digits give the protocol’s expiration date in a year/month format; thus ‘0104’ would indicate that the approval expires on April 30, 2001.

See the Animal Welfare and Research Committee's certification instructions for more information.

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The ethical use of laboratory animals program has recently changed at LBNL. New researchers should go to the CITI training website registration page and register as an LBNL user. Then proceed to the login page and log in.

You will notice that there are several courses given. The one required by the Animal Welfare and Research Committee is the Lawrence Berkeley National Laboratory Working with the IACUC the last on the list. The courses on the use of specific animals in research: mice, rats, and dogs, are recommended, but not required. There is a certain overlap between modules of the different courses, but still much useful information can be obtained from these extra courses. The course for IACUC members need only be taken by new members of the Animal Welfare and Research Committee.

As you complete each module of the course you will be asked to take a short quiz. Please do so. Note that in scrolling down the screen during the quizzes, you must use the "mouse" attached to your computer. Using the down arrow key on your keyboard will result in chosen answers moving around. Please do not print out a competion report for each module.