EHSS
Health Services
Human and Animal Regulatory Committees:
Animal Welfare and Research Committee
- New Animal Use Protocols
- Renewals of Animal Use Protocols
- Modifications of Protocols
- Discontinuation of Animal Use Protocols
- Collaborations with other Researchers
- Facility Use only applications
- Shipping animals offsite
- Grant proposals: certification and the NIH vertebrate animal section
- Description of the Animal Colony
- Ethical Training for researchers at LBNL
- Animal Use Guidelines
- Frequently Asked Questions and AWRC charter documents
- Schedule of AWRC meetings
- Links to other useful sites
Animal Welfare and Research Committee
HARP
The HARC office has implemented a new online database for managing animal use protocols: the Human/Animal Research Protocol management system, or HARP. Researchers submitting new protocols, wanting to modify already approved protocols, or for the triennial renewals of existing protocol must use the new system. 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. 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. This is a brand new system and we appreciate your patience during our roll-out. You may call the HARC office at x5399 or send email to harc@lbl.gov with any questions. Here is a frequently asked questions document, which will no doubt be added to during the year, but meanwhile may be of some use to you. The first few times you use the HARP protocol submission system may be challenging, particularly with the concept of arms/groups where you may separate your different groups of animals by species or strain or experimental path. Here is an overview document that will help you navigate through the system.
All principle lead investigators and their protocol personnel 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 for each person listed on the protocol, including the protocol lead investigator, to harc@lbl.gov. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. This is a work in progress, so if you have any suggestions for additions or clarifications, please contact Dianna Bolt, dgbolt@lbl.gov, with your feedback.
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 Departmental Review Verification Document that should be submitted to the researcher's departmental head, along with an account of the planned research, for review and signature. A pdf file or similar can be uploaded into the HARP system on the "Investigator's Assurance" page of the protocol, which is the last page before the final page. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. This is a work in progress, so if you have any suggestions for additions or clarifications, please contact Dianna Bolt, dgbolt@lbl.gov, with your feedback. If you will be breeding animals you may find this Breeding Colony Size Worksheet helpful in determining the numbers of animals you will need.
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.
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.
If you are entering the HARP system and filling out a protocol for the first time,
please contact the HARC office for help. Please call x5399 with any questions.
Dianna Bolt, the AWRC administrator, may be available for an in office visit to
help get started.
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. While we are implementing the new HARP system, researchers may continue using the paper short renewal form until their protocol is up for triennial review.
Short renewal form – rtf
If your protocol is up for triennial renewal, then it must be entered into the HARP system. Please follow instructions given above for entering new protocols into HARP. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. This is a project in work, so if you have any suggestions for additions or clarifications, please contact Dianna Bolt, dgbolt@lbl.gov, with your feedback.
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. To amend or modify an older protocol, you must enter the protocol into the HARP system. On the first page, indicate that this is a triennial renewal (even if it is not). This will take you to a page where you will be asked for a summary of the research and animal numbers use. The last item on this page will ask you to upload an electronic copy of your previously approved protocol and a detailed description of the modifications you want to be made.Please make sure that this document is very specific about all needed changes: in numbers, species or strains, procedures, personnel and training, animal housing, extra health monitoring, etc. Once you have uploaded these documents, then proceed through the protocol entering the planned and ongoing work, including all the modifications you are asking for. Once this is all done, the PLI may submit the protocol. Such modifications must go through veterinary pre-review, so researchers must submit these modifications according to the schedule below for new protocols. The submission date is always two and one half weeks before the regularly scheduled monthly AWRC meeting. The Committee may ask researchers for revisions and resubmissions of requested modifications, even if changes seem minor. Please be aware that modifications may take up to two months or more for approval.
Follow instructions given above for New Protocols for details on entering your protocol into HARP. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. This is a project in work, so if you have any suggestions for additions or clarifications, please contact Dianna Bolt, dgbolt@lbl.gov, with your feedback.
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.
Note, if this protocol has been entered into the HARP system, then it will have to be closed out in HARP. On the HARP page for the protocol, scroll down until you see the New Renewal button near the bottom on the left. Click on this and on the first page fill out as requested, checking the appropriate button near the bottom, 6.0, that indicates that the protocol is to be terminated. You will then be taken to a screen asking for the information described above, about the outcome of the research, the final disposition of the animals, etc.
ADDITION OF NEW PERSONNEL TO A PROJECT
If principal investigators wish to add a new person or persons to their protocol personnel, and the protocol still exists only in paper form, then the PLI or the protocol coordinator 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.
If the protocol has been approved in HARP, then a modification will need to be created for this. On the approved protocol's page, scroll down until you see the "New Modification" button on the left hand side. Click on this to create a new modification, then edit it, then indicate that the change will be one in personnel, etc. Note that new personnel will need to have accounts and profiles created for them first. Have each such person fill out the account information document and send it to the HARC office, harc@lbl.gov, or MS 26R143.
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. See here for a more detailed explanation of the types of collaborative research. 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. A collaborative protocol will need to be created in HARP, with the collaborator's IACUC approved protocol or SOP and all relevant materials uploaded in electronic form into HARP. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. This is a project in work, so if you have any suggestions for additions or clarifications, please contact Dianna Bolt, dgbolt@lbl.gov, with your feedback. All relevant personnel must have accounts and profiles in HARP. Fill out a accounts and profiles document for the protocol lead investigator and any additional personnel necessary, such as the protocol coordinator, send it to the HARC office, and have accounts and profiles created. Once this has been done, enter the HARP system and click on the blue button on the left side of the screen for creating a new protocol. On the first page you will be asked what kind of protocol you are creating. Check the appropriate buttons for your type of collaboration. You will then be led through a set of screens asking all relevant information and with a place to upload your collaborator's materials. The PLI then should submit this to the HARC office, where it will be reviewed and scheduled for the next monthly AWRC meeting, if no changes are requested.
Note that previously approved collaborative protocols must also be entered into HARP. Contact the HARC office at harc@lbl.gov or x5399 with any questions.
Must be entered into the HARP system. Follow the above procedures for collaborative protocols.
Animals shipped from the LBNL Animal Colony to another institution must have this approved by the HARC office. They must be entered into the HARP system, with the appropriate "shipping" button selected on the first page. Researchers will then be led through a few screens where the relevant information needed for AWRC approval will be asked for. The PLI should submit the completed shipping protocol to the HARC office and wait for AWRC approval. This will normally only take a few days. Here is a twelve page HARP manual that you might find useful in navigating around the HARP system. This is a project in work, so if you have any suggestions for additions or clarifications, please contact Dianna Bolt, dgbolt@lbl.gov, with your feedback.
GRANT PROPOSALS: CERTIFICATION AND NIH VERTEBRATE ANIMAL SECTION
When certification of IACUC (Institutional Animal Care and Use Committee) review is requested: once your animal use protocol has been approved by the Animal Welfare and Research Committee (LBNL's ICAUC), researchers or their proposal specialists should fill in the certification request form and submit it along with a copy of the grant proposal to the HARC office (MS 26-143, electronic copies to harc@lbl.gov). The HARC office will perform a side by side review with the protocol and the grant proposal and if it appears that all live animal use as described in the grant proposal is covered by the LBNL animal use protocol, then the HARC office will issue a certificate. This certificate is sent to the principal investigator on the grant, investigator lead(s) on the protocol, the sponsored projects office, and anyone else indicated on the certification request form. The sponsored projects office will then send the document to the funding agency as required.
The glossary contains definitions for terms used in the form, as well as other information helpful to filling out the form. It may be the case that a given grant proposal describes work covered by more than one animal use protocol. The regular certification request form contains spaces to list 3 protocols. In rare cases where more than 3 protocols need to be listed, here is a second page of the form to list further protocols. Note that this is a new form and we welcome feedback on ease of use, understandability, etc.
Here is the flow chart which gives an over all view of the process. If you would like further documentation and instruction on this, here is a guidance document.
Note, if you need the AHU form (also known as the Human Subjects and/or Vertebrate Animal Use in Field Task/Work Proposals form) for a field task or work proposal, you can download the 2008-2009 version here. If you need the similar LDRD form you can download the 2009-2011 version here
For help on filling out the Vertebrate Animal Section of a grant proposal for the National Institutes of Health, see this 2012 fact sheet from the Office of Laboratory Animal Welfare.
DESCRIPTION OF THE ANIMAL COLONY FOR USE IN PROPOSALS
The Animal Care Facility (ACF) at LBNL will house the mice involved in this research. The ACF is a state-of-the-art facility with a soft-wall design that is easy to modify as research needs change and with filtration design that creates individual clean rooms. This allows a controlled environment that permits continuous visibility of the individual environmental units through freestanding vinyl wall bio-Bubble transparent enclosures. Each bio-Bubble provides a separate enclosure for each specific animal colony, special projects, procedures and quarantine rooms. A total of six bio-Bubbles are designated to hold animals with a total capacity of 3000 cages (current occupancy is at ~1300 cages). One bio-Bubble is set up as the procedure room and is equipped with an isoflurane-anesthesia machine, a CRi Maestro in-vivo fluorescence imaging station, and other basic molecular biology equipment (centrifuge, microscopes, incubator, etc). Another bio-Bubble houses the transgenic production facility. If necessary, mice will be obtained from the Jackson Laboratory, an LBNL-approved source. The LBNL ACF is accredited by the American Association for the Accreditation of Laboratory Animal Care International (AAALAC), and the animal laboratory staff at the ACF is devoted to full-time care of housed animals.
ETHICAL TRAINING FOR ANIMAL USE RESEARCHERS 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.
After you have completed the whole of the required course, please print out your completion report and mail it (via snail mail) to Dianna Bolt HARC office, 26RO143. It’s a good idea to also send email to her at dgbolt@lbl.gov to alert her that the completion report is in the mail. It is helpful to include the AWRC numbers of those protocols a research will be working under.
If you have any further questions, please contact Dianna Bolt, dgbolt@lbl.gov, for more information.
Guidelines and approved procedure descriptions for the use of laboratory animals at LBNL are in the electronic HARP system. Users entering protocols in HARP will have access to these when they check off the procedures they are planning to use on the Procedures Classification page. For example, if you are planning on performing blood draws on your animals, check the box next to "fluid collection, including blood" on the Procedures Classification page and continue through the protocol, when you come to the page for blood collection, the AWRC approved methods for collecting blood will be in a document you can view there.
There are also several publications in the HARC office that researchers may borrow or, in some cases, keep. Please contact Dianna Bolt (x6005) if you are interested in seeing any of the following:
- "Experimental Design and Statistics in Biomedical Research" from the Inst. for Lab. Animal Research (ILAR)
- "Immunization Procedures and Adjuvant Products," from the Inst. for Lab. Animal Research (ILAR)
- "Development of an Environmental Enrichment Program Utilizing Simple Strategies" from the Animal Wefare Information Center, Bulletin, Summer 2004.
- "Overcoming Challenges in Transporting Laboratory Animals," from ILAR
- "Public Health Service Policy on Human Care and Use of Laboratory Animals" from the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health
- "Guide for the Care and Use of Laboratory Animals" from the National Research Council
- "Animal Care Policies," an Animal Care Resource Guide, from the U.S. Dept. of Agriculture
- "Institutional Animal Care and Use Committee Guidebook," 2nd edition, from OLAW and the Applied Research Ethics National Association
- "Variables, Refinement and Environmental Enrichment for Rodents and Rabbits kept in Research Institutions," by Viktor & Annie Reinhardt, Animal Welfare Institute
- "Contemporary Topics for Animal Care Committees," Inst. for Lab. Animal Research (ILAR)
- "Cost of Caring: Recognizing Human Emotions in the Care of Laboratory Animals," from the American Assoc. for Laboratory Animal Science
- "Guidelines for the Welfare and Use of Animals in Cancer Research, from the British Journal of Cancer (2011) 102, 1555-1577
How are experimental animals protected at LBNL?
All care and use of experimental animals at Lawrence Berkeley National Laboratory follows protocols and guidelines approved by the Institutional Animal Care and Use Committee, known as the Animal Welfare and Research Committee. The AWRC follows the policies set by the Public Health Service's NIH Office of Laboratory Animal Welfare. See here, for a recent article published by OLAW on frequently asked questions about their policy.
Is the animal program at LBNL accredited? What is LBNL's asurance number?
The Berkeley Lab holds Assurance of Compliance #A3054-01 from the Public Health Service's NIH Office of Laboratory Animal Welfare, and is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC, International). We are currently AAALAC fully accredited through June of 2013. Our assurance of compliance with the Office of Laboratory Animal Welfare expires in December of 2014.
Can I obtain proof of the LBNL Animal program's AAALAC accreditation?>Yes.
Can I obtain a copy of the LBNL Assurance of Compliance with the Public Health Service policy on humane care and use of laboratory animals?
>Yes.
How about the Animal Welfare and Research Committee's charter?
>Here.
Does LBNL have a USDA permit?
>LBNL is exempt from USDA inspection because it is a registered federal facility. Here is a .pdf of our registration.
If I have concerns about the way research animals are being treated at LBNL, what should I do? Who should I contact?
>Consult the LBNL whistleblower policy on the investigation of concerns involving the care and use of laboratory animals.
SCHEDULE
OF ANIMAL WELFARE AND RESEARCH COMMITTEE
MEETINGS
and DEADLINES for 2012-2013
All meetings are held on Wednesdays from 9:00 am to noon in Building 977, room 248, unless otherwise indicated. The AWRC is now requiring veterinary pre-review of all new protocols, as well as those up for triennial renewal and those submitted for major modification. These protocols must all be submitted in the electronic protocol HARP system. Collaborative and shipping protocols must also be submitted through HARP. Until 2015, short form renewals, discontinuations, and facility use protocols may be submitted to the HARC office on paper. Short form renewals and collaborative and shipping protocols do not require veterinarian review and have a later due date.
| New/Modification/Triennial Renewal | Collab/Shipping/Non-triennial renewal | AWRC meeting |
| July 30, 2012 | August 8, 2012 | August 15, 2012 |
| September 3, 2012 | September 12, 2012 | Sept. 19, 2012 |
| October 1, 2012 | October 10, 2012 | Oct. 17, 2012 |
| November 5, 2012 | November 14, 2012 | Nov. 28, 2012 |
| December 3, 2012 | December 12, 2012 | Dec. 19, 2012 |
| January 2, 2013 | January 9, 2013 | Jan. 16, 2013 |
| February 4, 2013 | February 13, 2013 | Feb. 20, 2013 |
| March 4, 2013 | March 13, 2013 | March 20, 2013 |
| April 1, 2013 | April 10, 2013 | April 17, 2013 |
| April 29, 2013 | May 8, 2013 | May 15, 2013 |
| June 3, 2013 | June 12, 2013 | June 19, 2013 |
| July 1, 2013 | July 10, 2013 | July 15, 2013 |
Association for Assessment and Accreditation of Laboratory Animal Care: http://www.aaalac.org/
Veteran’s Administration Medical Research Service Animal Use Training site: http://www.wwla.org/
National Institutes of Health training site for laboratory animal users: http://www.nihtraining.com/oacu/accfLogin/
United States Dept. of Agriculture Animal and Plant Health Inspection Animal Care Policy Manual: http://www.aphis.usda.gov/ac/polman.html
Dept. of Agriculture Animal and Plant Health Inspection Service, Regulations: http://www.access.gpo.gov/nara/cfr/waisidx/9cfr2.html
Institutional and Animal Use Committees website: http://www.iacuc.org/
