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| THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE |
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FREQUENTLY ASKED QUESTIONS IACUC Protocol related questions An IACUC is an Institutional Animal Care and Use Committee. IACUCs are required by Federal law to oversee the humane care and treatment of laboratory animals. At UCSF the IACUC is appointed by the Executive Vice Chancellor. UCSF's IACUC was formerly known as the Committee on Animal Research (CAR). Ethical, regulatory, and policy mandates (including the USDA Animal Welfare Act (AWA), the USDA Animal Care Policies, the PHS Policy on Humane Care and Use of Laboratory Animals, the NIH Guide for the Care and Use of Laboratory Animals, and University of California policy) require that approval by a duly appointed Institutional Animal Care and Use Committee (IACUC) be granted before any research project using vertebrate animal subjects can be initiated. For more information, see About the IACUC. Do I need to submit an IACUC application? If you will conduct research on live animals, or on tissues collected from live animals, you must first submit an IACUC application for approval. All research conducted by UCSF faculty, students, and staff which uses animal subjects, regardless of the source of funding or even when no funds are involved, must have prior approval from the UCSF IACUC. Who is eligible to submit a protocol application? You are eligible to submit an IACUC application as a Principal Investigator if you have one of the following UCSF appointments:
In extraordinary circumstances the Dean may grant Principal Investigator status to others. Applicants for PI status should follow the procedures for completion of the Principal Investigator Status Request . The approved PI Status Request must be submitted to the IACUC office before the application process can begin. If you do not have Principal Investigator status according to the criteria listed above, you may still be listed as an Alternate Responsible Individual on an IACUC application. All I need is some blood, tissue, or antibodies. Do I need to submit a protocol? If only blood and tissue are required, investigators are strongly encouraged to obtain them from animals euthanized by other laboratories through the UCSF Tissue-Sharing Program. The IACUC office has an accessible database and we can assist you in locating the tissues you need. Please contact the IACUC office at 476-2197. In addition, there is a Mouser’s Listserve that you can subscribe to which gives you access directly to other users that may be able to provide tissues. A protocol is not required. If tissue sharing is not possible and animals must be euthanized for this purpose, an IACUC protocol must be submitted. A protocol must be submitted for the production of antibodies whether they are being generated by the investigator, by a UCSF Core Facility, or by an outside facility. I'm a new investigator. How do I start an IACUC application? Contact the IACUC Office a 476-2197 to set up a new PI account and to schedule an orientation to the RIO online system. How long does it take to get an IACUC application reviewed and approved? About 8-10 weeks. When a new application is submitted, it will first be pre-reviewed by a LARC veterinarian, an OEH&S consultant, and an IACUC administrative analyst. You will receive an e-mail with their comments for making revisions and instructions for resubmitting the application for Full Committee review. After the application has been reviewed by the Full Committee you will receive approval, or (more often) another e-mail requesting further revisions. The PI must respond to each of the Committee’s questions and make the relevant changes in the RIO protocol online. This response is reviewed by the IACUC Chair (or by the Full Committee again if the changes are substantial) for final approval. No work may begin until the protocol has been approved. Where can I get assistance with writing an IACUC application? For veterinary assistance, e.g., anesthesia, surgical procedures, analgesia, euthanasia, contact the Laboratory Animal Resource Center (LARC) at 476-9481. For general assistance, e.g. policy and procedures, contact the IACUC office at 476-2197. For technical assistance with the online application (RIO), contact riotechhelp@ucsf.edu or the IACUC office at 476-2197. Describe your technical problem very specifically when contacting riotechhelp@ucsf.edu. For what kinds of species do I need to have an approved IACUC protocol? All warm and cold-blooded vertebrates, both in the field and the laboratory, e.g., salamanders, fish, birds, mice, nonhuman primates, require IACUC protocol review. Who should be listed on a protocol? All faculty, staff, students and visiting scholars using animals must be listed on a protocol. New personnel must be added to a protocol prior to their use of laboratory animals. All personnel must have the required training as specified below. What training is required for new lab personnel?
For access to LARC animal facilities, personnel must also complete a Facility Orientation and the Rodent Online Barrier Training if using mice/rats in the Parnassus campus barrier (see below). Personnel who fail to complete these requirements may not work with or around experimental animals and are out of compliance. For further information about training, please email the IACUC training group at trainerIACUC@ucsf.edu What is scientific merit review and when is it required? Review and approval of scientific merit is required before the protocol can be assigned to an IACUC meeting agenda. The primary charge of the IACUC is to ensure the ethical and humane use of animals in research. Pursuant to that objective, all studies involving animals in research must be deemed scientifically meritorious. Several mechanisms are in place to ensure the latter objective. Scientific merit review may be conducted by the Principal Investigator’s Departmental Review Committee (DRC), the NIH or one of the other agencies on the IACUC List of Funding Agencies That Conduct Acceptable Scientific Merit Review. The IACUC reserves the right to request additional review of scientific merit. In such cases, the IACUC constitutes an ad hoc committee. This committee may be composed of members of the IACUC and/or peers within the research community who offer a particular area of expertise. Full Committee applications must include documentation of current scientific merit review and approval from one of the listed agencies or from the appropriate DRC. The IACUC will consider for approval only those applications that have been found to be scientifically meritorious by one of the described mechanisms. DRC Review: If a Departmental Review Committee provides the scientific merit review for your proposal, the PI must document this by submitting a form to the IACUC which includes signatures from a committee of 3 peers organized at the level of the department, division, research institute, or school. The DRC may use the Scientific Merit Review Form recommended by the IACUC, or an adaptation thereof, as long as three signatures are included. To obtain information on DRC application and review, contact your department. NIH Review: This review constitutes a committee of peers organized through external agencies such as the National Institutes of Health and the National Science Foundation. Submit documentation, e.g., current funding letter(s) for the relevant grant(s), or the summary statement if the grant is not yet funded. If neither is available, obtain DRC review and approval. IACUC List of Funding Agencies That Conduct Acceptable Scientific Merit Review: These are generally private foundations which conduct a rigorous review process. If you do not find your funding source on the list maintained in RIO, email is available in this section to notify the IACUC who will see that the funding source is added to the list of funding agencies. To propose adding a funding agency to the IACUC List of “Funding Agencies That Conduct Acceptable Scientific Merit Review”, send the agency name (and address, if available) by email to the IACUC office. Why is the Vertebrate Animals section of my grant application required? Federal regulations require comparison of IACUC protocols with the research grants that support them. If your protocol is new and is federally funded, you must provide this documentation when you submit the protocol. What is the Office of Laboratory Animal Welfare (OLAW) Assurance number for UCSF? A3400-01 When did UCSF become accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC)? June 14, 2004 How do I renew my current protocol? This is referred to as an Annual Review. Login to RIO (you must login as the PI or Alternate Responsible Individual).
Annual review applications (without concurrent modification) typically take less than 1 month to approve. Note: A full committee application must be submitted every 3 years, therefore after 2 consecutive Annual Reviews, a Full Committee application is required for the third renewal. NOTE: When a full committee renewal has been approved with a new approval number, you must transfer any existing animals to the new protocol (using LARC forms) and request new cage cards from the LARC Business Office.
How do new personnel get added to an animal protocol? The PI and/or Alternate Responsible individual on an animal protocol must submit a modification to the relevant protocol in RIO and make the necessary changes to the Contacts and Personnel section in the application. Be sure to complete administrative and/or functional roles for all personnel added to the animal protocol. If the person is new to UCSF or the PI’s lab, they must be added to the PI’s portfolio before they can be added to the protocol. New personnel on an animal study must complete all of the required training (i.e., online BRER class(es), species specific training, CDP Questionnaire, related facility orientation/training) and be added to a protocol and approved before beginning any live animal work. In the Mod Justification section of RIO include specific text indicating what personnel changes were made to the protocol (i.e., list specifically who was added and who was removed). If personnel changes are the only modification, check the little box labeled “Contacts and personnel changes only.” Once the add personnel modification is complete, the PI/Alternate Responsible must submit the modification by clicking on the “submit” button on the main page of the application. Personnel modifications are reviewed by designated reviewers. Approval takes approximately 1-1.5 weeks. How do I add or delete a location on my animal protocol? Location additions and deletions are made by submitting a modification in RIO. Once the PI/Alternate Responsible person has created a modification in RIO, select the “Mod Justification” link and specify which rooms are being added or deleted. Then select the Locations section in RIO. To add a location:
To delete a location: Once in the Locations section of RIO, hit the ‘Delete’ button next to the location you would like to delete from the protocol. Can I modify my protocol at the same time I request annual review? Yes. Once you are in the protocol
and have clicked on the What is the status of my protocol application? The status is displayed in RIO. If you need assistance please call the IACUC Office at 476-2197. Can I use expired drugs/fluids on my animals if it’s a terminal procedure? Under NO circumstances can you use expired drugs or fluids (including saline) on ANY live animals. If you would like to use expired medical materials (such as catheters) in terminal procedures you must fill out a request form and submit it to the IACUC for review. What is the Principal Investigator’s Certification? This form must be completed and signed by the Principal Investigator (PI) for new, modification and three-year renewal application. The PI’s signature certifies that s/he has read and agrees to all items on the form. The signed form must be mailed or faxed (502-7991) to the IACUC office to be included in the protocol on file in the IACUC office. Can I keep mice/rats in my lab overnight? No, not unless your protocol has listed the lab room number as “animal housing” AND the animal use area has been inspected and approved by IACUC Training & Compliance staff. If you would like this designation for your lab you must:
If my animals are housed in LARC facilities, how do I get access to that facility? Required training must be completed before facility access can be granted. In all facility cases, required training includes: online BRER class(es) and species-specific training (if <1 year experience working with the relevant species). Facility orientation and training are required for most areas, but vary per area. Please call trainerIACUC@ucsf.edu for specific facility/area training requirements. Once the necessary training is completed, a Proximity Application Form must be filled out (LARC Business Office). Signatures from the PI, facility trainers, animal user and IACUC Training and Compliance personnel are required on the form. How do I do obtain access to the Parnassus rodent facility (PSB)?
How do I get specialized training, such as tail vein injection or oral gavage training for mice? Contact the IACUC office by Why do Research Online and RIO (Research Information Online) have different information about my protocol? IACUC is using RIO only and is not updating information in Research Online*. For information about what is in your currently approved protocol, check the IACUC/LARC binder in your laboratory or login to RIO, find the protocol, click on “Documents” and select the most recent document in the list with “final” in the file name. This is the currently approved version of your protocol. *Research Online is still used for online trainings and for requests for a new username and password. |
Page Updated: May 12, 2008