IACUC FAQs

What kind of training is required by the IACUC?

IACUC Online Training Requirements

Online IACUC training may be required for all UC personnel listed on a UCSC IACUC application before the IACUC will give approval.

To complete the online training go to: https://www.citiprogram.org.

All personnel named on a Tissue Sample or an Observational (No Contact) protocol must complete the modules in the "Working with the IACUC, Basic Course (Course option A). All personnel named on a Full Use BiomedicalorNon-Biomedical(Contact) IACUC protocol must complete the modules in the "Laboratory Animal Welfare" course (Course option B or Course option C).

On a case by case basis, other courses may be required by the IACUC.

How do I get an IACUC verification letter?

If you need a letter verifying IACUC approval sent to a funding agency, please email the following information to iacuc@ucsc.edu.

  • PI/Co-res names and phone numbers

  • IACUC office code and protocol title

  • Grant title, if different from the above

  • The 8-digit OSP data-sheet SC# of the grant (available from your OSP analyst)

  • If you would like to have the verification letter submitted via email, please include the address of the funding agency, including a contact name.​

Please be aware that all conditions of approval must be met before a letter can be written.

What happens after I submit my research protocol?

Check you email on a regular basis, as the IACUC may have important information and questions regarding your application.

Respond promptly to these emails ensures that your application can receive approval as quickly as possible.

Make sure that all research personnel
have met the training requirements. Protocols cannot be approved until all research personnel have met the training requirements.

Upon approval, you will receive a confirmation email from the IACUC Coordinator with a copy of the approved protocol attached.

Why does the IACUC ask for animal numbers, and what is an acceptable answer?

The UC Santa Cruz IACUC biomedical form (non-biomedical form asks for similar justification) asks the following question: Justify the number of animals to be used, which should be the minimum number required to obtain statistically valid results. Indicate how you arrived at your calculations, and include justification for group size through a power analysis when possible. In this calculation, you should consider the number of animals produced in a production colony to achieve the necessary number of genetically appropriate individuals, if applicable. Note that all individuals from a production colony are counted against the total number of animals utilized.

This is due to federal requirements from the Animal Welfare Act, PHS Policy, and the Guide for the Care and Use of Laboratory Animals. These agencies ask for an approximate number of animals, for the minimum number required to obtain valid results, and whenever possible, and that the number of animals requested should be justified statistically.

Acceptable answers can be based on:

  • Power analysis
  • Citations from previous research with similar sample size, species, and methodology
  • Student to animal ratio in a teaching protocol
  • Statistics showing probability of success of experimental procedure or desired effect
  • Number needed to provide appropriate amount of specimen for in vitro studies
  • Estimation of variance, effect size, and statistical power for pilot studies
  • N=1 for feasibility studies

Please see sources and links below for further assistance.

Sources:
https://www.uvm.edu/iacuc/statjustification.pdf
http://iacuc.umc.edu/IACUCforExpInvesNov06.ppt
http://safetyservices.ucdavis.edu/article/rationale-numbers-and-species-protocols
http://iacuc.ucsf.edu/Policies/AnimalNumbersJustification.docx

Power analysis links:
http://www.biostathandbook.com/power.html
http://www.gpower.hhu.de/

What if I'm conducting research involving animals at a Foreign Institution?

There are many circumstances that involve partnerships between collaborating institutions or relationships between institutional animal care programs. Inter-institutional collaborations have the potential to create ambiguities. Therefore, it is imperative that institutions define their respective responsibilities. Institutions should have a formal written understanding (e.g., memorandum of understanding) that addresses responsibilities for animal care and use, ownership, and IACUC review and oversight. (Guide page 15).

Guidelines for doing research at a foreign institution:

  • If there are no grant funds coming from or through UCSC, and the animals are not owned by UCSC, and UCSC personnel are not directing the animal portion of the research, there may not be a requirement for UCSC IACUC review. If the animals are being housed in the foreign institution, they will be the responsibility of the foreign veterinary staff.

If UCSC will contract or subcontract with the foreign institution, then:

  • The contracted or subcontracted institution would have or obtain Foreign Animal Welfare Assurance with the US Office of Laboratory Animal Welfare (OLAW)

  • Following confirmation of a PHS assurance at the contracted or subcontracted institution, and the completion of a Memorandum of Understanding, UCSC IACUC will defer the review of the protocol activities and oversight of activities occurring at the institution to the institution.

Why do I get my lab inspected?

Federal regulations governing the use of animals in research require that the IACUC review and inspect the care and treatment of animals in all animal study areas at least once every six months. These inspections must be performed by at least two IACUC members. Study areas include any place where animals are housed for greater than 12 hours and where surgical manipulations are conducted.

As part of their oversight responsibilities, the IACUC has also initiated a policy for separate inspections of facilities and areas using animals outside of an approved UCSC housing area.

Is a medical screening required to conduct animal research?

Occupational Health Requirement

To obtain IACUC approval, all personnel listed on IACUC Use of Vertebrate Animal Subjects with Contact (i.e. Full Use form) must participate in the Occupational Health Surveillance System (OHSS). This program is administered by EH&S. For more info, please contact EH&S's Biosafety Officer directly (310)459-3542 or biosafety@ucsc.edu. Or go to the EH&S website.

Observational and Sample Protocols 

Submission of an Observation of Non-Human Vertebrates — No Contact  protocol application or a Use of Vertebrate Samples protocol application to the IACUC does not require completion of OHSS unless you are notified to do so by EH&S. Observation-Only or Vertebrate Sample applications will be reviewed by EH&S for health and safety concerns (biosafety, field safety, general safety, etc.) If additional information is necessary or medical surveillance is deemed appropriate, EH&S will contact the PI directly to request details.

Questions related to the risk assessment process for Observation Only or Vertebrate Sample protocols should be directed to biosafety@ucsc.edu.

What are the definitions and classification for animal pain or distress ?

Potential Pain/Distress

Procedures are classified according to the level of potential pain or distress that the animal may experience. If more than slight or momentary pain and distress could be caused by the procedure, then relief must be provided (pain class B). If relief cannot be provided (pain class C), there must be scientific justification for withholding of relief, the justification must be included in the animal use protocol, and must be approved by the IACUC. Additional information can be found in USDA Animal Care Resource Guide, Policy #11, Painful Procedures.

USDA Pain Codes

C - No Pain or Distress
D - Pain or Distress with Relief
E - Pain or Distress Without Relief

What are the attributes of major survival surgery and multiple survival surgery?

Multiple Major Survival Surgery: A major survival surgery penetrates and exposes the body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, craniotomy, joint replacement and limb amputation). Scientific justification is required in the animal use protocol if more than one major survival surgery is to be performed on an animal during the course of the protocol experiment.

What is food and fluid restriction?

General

Certain experimental paradigms require the use of food or water restriction in order to accomplish studies such as operant conditioning work. The IACUC is required to approve these restrictions to ensure they are scientifically justified, minimize the level of restriction, and have criteria in place to monitor the health of animals on these studies.

Specifics

Animal use protocols employing food or water restriction must provide the duration of restriction, level of restriction, and justification for the restriction as part of the protocol description. Furthermore, the early removal criteria must provide methods to assess the animal's health while on restriction. Typically this will require a frequent monitoring method such as daily weighing of the animal. Note that pre-surgical food restriction is detailed in the surgery procedure as part of the animal use protocol, and does not need specific justification.

What records do I need to maintain for animals on a protocol?

In addition to cage cards for all animals housed on a protocol, a post-operative record should be kept in the room where the animals are housed. Having the record in the room accomplishes several functions: 1) It explains the condition of the animals to animal care staff (a sedated animal may otherwise be thought to be ill), 2) It assures animal care staff and federal inspectors that the animal is being cared for, and 3) It informs animal care staff how recently the investigator has seen the animal; this knowledge helps them decide whether or not there is a need to contact the investigator to inform him or her of the present condition of the animal.

Although individual records are desirable, a composite post-operative record may be used for a group of rodents. Important information to include in the post-operative record is the animal's identification, surgical procedure summary, any therapeutics given including drugs, doses, and routes of administration, and the observation date and findings. After all wounds have healed and all sutures/wound clips have been removed, the post-operative record requires no further entries. When the study is completed, the record may either be kept by the investigator or discarded.

Is there any way to extend my approval period?

Federal regulations do not permit the IACUC to extend any approval periods. If a renewal protocol has not been processed and approved by the expiration date, the IACUC approval for the work will expire. Should IACUC approval expire, all activities involving the care and use of animals must cease immediately. Any activities conducted under the protocol after expiration will be in direct violation of federal regulations and institutional and IACUC policies.

Can I use expired drugs/fluids on my animals?

Under NO circumstances can you use expired drugs or fluids (including saline) on ANY live animals, even if it is a terminal procedure.

How do I get specialized training?

For specialized training, such as tail vein injection or oral gavage training for mice, please contact the campus veterinarian's office.

Campus Veterinarian:
831-459-3135
dcasper@ucsc.edu

When are IACUC inspections?

At least every six months, the IACUC conducts unannounced on-site inspections and evaluation of facilities and programs where vertebrate animals are housed and used.

The PHS Guide for the Care and Use of Laboratory Animals and regulations under the Animal Welfare Act are the main documents utilized by our IACUC in its evaluations.

Faculty who use animals should expect unannounced visits to their laboratories by a small group of IACUC members at approximately five-month intervals. In addition to looking at the research facilities and activities during the lab inspection, site visitors may discuss animal use procedures in the approved protocol(s) with staff and students.

Researchers can also expect
examination of research records, cage cards, drugs, and materials associated with animal care and use.

What are IACUC SOPs (Standard Operating Procedures)?

The UCSC IACUC standard operating procedures (SOPs) educate individuals on the proper and current techniques to ensure optimal animal care and welfare.

In addition, laboratories, research groups, or researchers working in the same area may wish to have a SOP approved for a specific procedure or practice. This provides consistency across the research group and creates a standard practice that is approved by the IACUC, and that can be incorporated by reference into multiple protocols, in lieu of repeating descriptions of identical procedures in multiple protocols.

The UCSC SOP on SOPs is the approved format for submitting a SOP for UCSC IACUC review.

Additional SOPs are available to UCSC investigators by request to iacuc@ucsc.edu such as:

  • Euthanasia of Laboratory Rodents
  • Reporting Adverse Events and Other Animal Welfare Concerns
  • Personnel – Who to name on IACUC Applications
  • PI Managed Housing – Procedure for securing approval to house animals outside of UCSC animal housing
  • Feed & Bedding Storage — Proper management of bulk feeds within storage rooms
  • Procedures for Handling Syringes, Needles, & Sharps

What if I need to keep animals outside of the UCSC animal facilities?

If your research requires that your lab or group needs to maintain or contain animals outside of the recognized UCSC Animal facilities which are staffed by animal care personnel, you will need to obtain prior permission for Investigator-Maintained Animals.

The PI Managed Housing SOP is relevant to animals which may be kept in an Investigator-managed or an Investigator-managed Study Area/Use Site. The SOP requires that the research group specifies the procedures for animal husbandry and housing site maintenance to be employed at the investigator-managed site, and helps to ensure that topics such as bedding, sanitation, temperature, and transportation are considered prior to initiation of a new site for animal care.

Definitions:

Investigator-managed Housing Area:Any investigator­ managed building, room, area, enclosure, orother containment site in which animals are housed for periods longer than 12 hours.

Investigator-managed Study Area/Use Site:Any investigator­ managed building, room, area, enclosure, or other containment site in which animals are taken for use (i.e. surgery, euthanasia, behavioral testing) on an IACUC approved protocol.

How do I conduct an 'alternatives' search?

Refer to the UC Davis Center for Animal Alternatives Information Website.

An alternatives search requires the following to be documented in your protocol:

  • Note names of databases searched and years covered by the search. (example: PubMed, 1966-2005) 

  • Note the date(s) on which you searched.

  • Describe what alternatives-related information you found, how you are integrating those alternative methods, procedures, or models into your protocol, as well as why you are not using others. This is sometimes referred to as the "narrative" or "search results" section.

One suggested method for those who are not familiar with searching alternatives, or who would simply like a standardized way of searching and documenting the search is to use the USDA Alternative Search Worksheet to guide your progress. A step by step walk through of the worksheet is included below.

Before beginning your search, we suggest the following steps:

  • Consider other possible animal or non-animal models (e.g., tissue culture, cell culture, fish, rats, etc.)

  • Consider your objectives and endpoints.

  • Note any drugs or compounds used in procedures. (e.g., anesthetics, analgesics, test compounds, etc.)

  • Note methods and procedures using animals, paying particular attention to those procedures that may cause pain or distress to the animal.

  • List any potential alternatives (all 3 Rs) of which you are aware. (e.g., alternate models, modified techniques, housing modifications, modified restraint, in vitro methods, computer simulations, etc.)

  • Develop a conceptual search strategy using the keywords and concepts you noted above. A search strategy is necessarily flexible, dependent both on the topic and on the database selected. If too many records are retrieved, additional relevant terms may make the results fewer and more useful; if too little is retrieved, fewer terms and a more conceptual approach may identify the relevant material. Use these terms and concepts as needed when searching in the following databases.

  • Database selection: Choose those that are appropriate for the area of study, keeping in mind type of protocol: Is the proposed study a research, teaching, or testing protocol? 

Worksheet Guide and Information

This worksheet is a tool used to 1) familiarize the principal investigator with the procedure; 2) identify keywords and concepts that are important in the development of a search strategy; and 3) aid in the selection of appropriate topical databases or other on-line resources. Although this worksheet will help, it is not designed as a replacement for communication between information providers, investigators, veterinarians, and IACUC members.

Searching for possible implementation of reduction and refinement to the study is essential. The use of analgesics and analgesia, the use of remote telemetry to increase the quality and quantity of data gathered, and humane endpoints for the animals are examples of refinements. Use of shared control groups, preliminary screening in non-animal systems, innovative statistical packages, or a consultation with a statistician are examples of reduction alternatives.

Because reduction and refinement aspects of alternatives are broad and often are addressed in the methods section of studies, the search at this point is really a comprehensive look at the field of study. Keywords and concepts from the area of research are used. This in turn addresses whether the protocol unnecessarily duplicates prior research. This approach will result in a basic understanding of the research area, including the literature published in the particular field, the techniques used, and the commonly used species.

Models:

Considering replacement requires that you address potential alternatives such as cell culture, tissue culture, models, simulations, etc. This is also where you might look for any alternate animal models lower on the phylogenetic scale —fish or invertebrates, for example— that would still give you the data you need. In addition considering non-animal and alternative animal-models, the proposed animal species should also be searched.

Objectives and Endpoints:

As often required for the protocol, write-up a complete description of the proposed use of animals, including a succinct outline of the scientific plan and direction of the experiment. When doing a keyword search, the database system searches for words that appear in the title, abstract, and descriptor fields of the citation. Because the painful part of the procedure may be described in the materials and methods sections, the search should focus on the experimental endpoint or objective, in most cases. Exceptions are when methodology papers are common in the field of study (i.e., skin irritation tests, antibody production). Humane endpoints, such as indicators of pain, or euthanasia can be searched to determine when the animal should be removed from the study. While endpoints are not easily searchable, they are worth considering when reviewing the search results.

Drugs or Compounds:

List specific names of drugs you may be using for your study or as anesthetics or analgesics. (i.e. halothane, rompun, buprenorphine, etc.). Remember to include the scientific and generic name of the drugs. If you are using other compounds in your study, included them when you search the literature for drugs that may conflict or have contraindications with your area of study.

Methods and Procedures:

Providing the methods and procedures used in your animal study protocol will assist in addressing issues of refinement alternatives, such as handling techniques, restraint techniques, injection techniques, surgical procedures, etc. Identify any painful procedures, along with drugs or methods that will be used to relieve the pain. The law defines a painful procedure as one that would "reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure was applied." If a procedure involves pain or distress, the PI must search for an alternative and, also, consult with the attending veterinarian.

Potential Alternatives:

Listing terms to describe any potential alternatives you are aware of, such as in vitro, tissue culture, alternative procedures or alternative animal models, etc. is helpful in conducting the refinement alternative aspect of the search. It is also helpful in determining potential search terms to use, since these are terms outside the specific area of study.

Search Strategy:

Keywords, concepts and database selection determine the ultimate search strategy. These keywords are those that will likely be found in the title, abstract, and descriptor fields of the citation. Use as many synonyms as possible, such as "cardiac" and "heart." Include acronyms and complete spellings (i.e., "GH" and "growth hormone"). Also include all possible spellings of words. For example, "anesthesia," "anesthetic," and "anaesthesia." Include words that make the study different from other studies. This will help detect unintentional duplication as well as limit the scope of the search if the number of citations from a broader search is more than 200. All potential alternatives should be included as keywords, whether or not the researcher believes they will be useful. Using the keywords selected from your notes, put together brief strings of words so that each search set covers a separate concept. For example, the first set might include words relating to the experimental outcome, and the second set will contain words relating to the animal model. Short and simple search sentences are preferred. Considering reduction and refinement requires a search similar to the typical literature review done in preparation for a new project or scientific publication. Keywords used will help determine if there is unintentional duplication, how many animals are necessary using the proposed model, appropriate anesthetics and analgesics, and any other method of minimizing pain and distress. Since much of the refinement and reduction information will be found in the materials and methods sections, it is important for the researcher to review some of the articles that may be of interest.

Many people make the mistake of putting the term ";alternatives" in the strategy and expect to find all possible alternatives. Because alternatives is a complex concept involving refinement, reduction and replacement, this term is best used only in those areas of study where larger amounts of research have been conducted on alternatives, such as in toxicology or education. They might also end up with ";alternatives" that have nothing to do with the 3Rs.

Considering replacement requires a search that should include keywords for potential alternatives such as "vitro," "culture," or "simulation." The word "alternative" may also be included here. The selected animal model, other species, and the word "model" will help retrieve animal and non-animal models as potential alternatives.

Search strategies for research, teaching, or testing protocols differ. For example, a teaching protocol might include keywords such as "teach," "educate," or "instruct," while a testing protocol could include"safety," ";efficacy," or "test".

NOTE: It is very important to realize that stringing together keywords on one line (i.e., dogs or cats and cardiac or thoracic and stent or device and alternative) does not create a proper search strategy and results in a poor search with inaccurate results. Boolean operators and individual database vagaries require familiarity or professional librarian assistance.

Database Selection:

The worksheet lists many of the most useful databases for biomedical research topics. Although there is some overlap in journals and other publications covered by the databases, each database is unique; each indexes a unique set of informational resources. Several of the core databases should be searched in order to conduct a comprehensive literature search. Keep in mind the type of protocol when choosing databases. An education protocol, for example, should include ERIC; a protocol involving testing toxic effects of compounds should include TOXNET and RTECS. There are many other specific databases available online — both free and subscription based.

Years of Coverage:

Years of coverage. When a database is chosen on CD-ROM, the World Wide Web, or on a multi-database system, the publication years covered are listed near the title of the database. The searcher should record the years included in the search based on database coverage or the years selected by the searcher within the search strategy (i.e., 1988-2005).

It is important to become familiar with the informational resources, databases, and services available at your institution in order to most effectively perform an alternatives search. The institution's librarian or information specialist can help with this and should be consulted.

Narrative Description:

A written narrative is required, one that evaluates the search results and assesses the alternative possibilities. It should support the decisions to both use and to not use available alternatives. Be sure to address refinement and reduction alternatives, not just replacement.

For additional information or assistance:

AltWeb  –  Alternatives news, information, and resources

AWIC  –  Sample searches, methods and guidelines, training and education, databases, organizations, and other resources that can assist in understanding alternatives, finding alternatives and completing the alternatives search.

UCDavis Center for Animal Alternatives Information

Other resources:

USDA/APHIS/AnimalCare
Animal Care Policy Manual
Policy #11 — Painful Procedures (page 24)
Policy #12 — Consideration of Alternatives to Painful/Distressful Procedures (page 26)

Alternatives and the AWA Brochure (PDF – AWIC)

Alternatives Search Tip Sheet PDF – NIH Library

The Principles of Humane Experimental Technique by Russell and Burch

What is an 'alternatives search'?

Requirement for Alternatives Searching

The US Animal Welfare Act (AWA) regulations (specifically the 1985 Amendment), require the principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions, and replacements.

The search for alternatives refers to the three Rs described in the book, The Principles of Humane Experimental Technique (1959) by Russell and Burch. The 3Rs are reduction in the number of animals used,refinement of techniques and procedures to reduce pain or distress, and replacement of animals with non-animal techniques or use of less-sentient species.

3Rs:

Refinement:
The use of analgesics and analgesia, the use of remote telemetry to increase the quality and quantity of data gathered, and humane endpoints for the animals are examples of refinements.
Reduction:
The use of shared control groups, preliminary screening in non-animal systems, innovative statistical packages or a consultation with a statistician are examples of reduction alternatives.
Replacement:
Alternatives such as in vitro, cell culture, tissue culture, models, computer simulations, etc. are examples of replacement. This is also where you might look for any alternate animal models lower on the phylogenetic scale (fish or invertebrates, for example), that would still give you the data you need.

Where do I search for 'alternatives'?

Databases

Free Bibliographic Resources
Research
Teaching
Testing

Proprietary Bibliographic Databases, check with your library for availability
Research
Teaching
Testing

Free Governmental, Regulatory and Organizational Databases
Research
Testing
Other resources, databases, and websites may be useful. The Animal Welfare Act regulations and policies allow for researchers to describe other methods and sources used to determine the availability of alternatives, though this should be secondary to the literature search.

Can you give me a copy of the most recent USDA certification?

UCSC's USDA certification number is 93-RR0439 and is effective through September 15, 2017; see USDA Registration document.

How do I report an adverse event?

All individuals participating in UCSC animal care and use activities are obligated to assure animal well-being for all animals engaged in such activities.  If an adverse event / unanticipated event occurs, then the individual having knowledge of the event is obligated to report, or assure a report of the adverse event / unanticipated outcome has been reported, to the UCSC IACUC. Refer to Adverse Event Report Form.