THE CARC APPLICATION AND REVIEW PROCESS

• Summary of the Process
• Choosing the Appropriate Application Form
• Directions for Completing and Submitting a CARC Application

Itemized Instructions for Filling Out the CARC Full Use Form

• Questions 1-9
• Questions 10a and 10b
• Question 11
• Question 12 and 13f
• Questions 15 - 21
• Question 12
• Questions 22 and 26
• Question 28

• Submitting the Form

Introduction

UCSC has legal and ethical obligations to review all proposed use of NON-HUMAN VERTEBRATE ANIMALS for RESEARCH AND EDUCATIONAL PURPOSES.

USE IS DEFINED AS:

• Use of living animals with contact at UCSC or at collaborating institutions
• Ordering or bringing animals, or animal materiel (samples) on campus
• Observing animals in the field without contact
• Altering animal environments

FORMS

OBSERVATION ONLY (NO CONTACT OR SIGNIFICANT ENVIRONMENTAL IMPACT)

Download "Application for Observation of Vertebrates (no contact)"

VERTEBRATE SAMPLES ONLY

Download "Application for Use of Vertebrate Samples. " (Note: Samples may require the form for use of live animals. If unsure, contact the CARC Office or co-chairs.)

USE OF LIVE ANIMALS

Download "Use of Live Vertebrate Subjects with Contact"

PROPOSING MODIFICATIONS TO AN EXISTING PROTOCOL

Download "Amendment Form"

 

IACUC (CARC) APPROVAL VERIFICATION LETTERS

If you need a letter verifying CARC approval to a funding agency, you must fill the corresponding item on the form and make arrangements in advance with the CARC office. Agencies usually require this letter within 60 days of their proposal due date. All conditions of approval must be met before a letter can be written. The CARC meets only quarterly, so please plan ahead.

Principal investigators (PIs) submitting applications are UCSC faculty members or academic research staff. Students may not be PIs and must have faculty sponsors.

PI Responsibility

PIs are responsible to ensure that collaborators, technicians, and students use animals according to the CARC-approved application and with respect for all applicable laws, regulations, and policies. While the PI has ultimate responsibility for compliance, CARC provides the necessary resources. Information can be obtained here, or from the CARC Office (see Contact Information).

To obtain CARC approval for a NEW OR RENEWAL RESEARCH proposal, certain UCSC personnel listed on the protocol must pass a web-based training program showing they understand federal laws and policies governing animal use. For more information go to Web Training Information.

New Activities

Related animal use may be covered with one application. Consult the CARC Office or co-chairs to see if this applies to your situation.

Summary of the Process:

Step 1: Submission of application to CARC coordinator electronically as an e-mail attachment saved in Rich Text Format (RTF). If submitted on deadline, your application will be reviewed at the next regularly scheduled meeting. If submitted after deadline, the committee may postpone review to a subsequent meeting.

Step 2: Initial review by the committee through publication on a website page accessible only to CARC members. The PI may be contacted with preliminary questions. A revision may be requested before review.

Step 3: Full committee review at a convened meeting, or, with permission of the entire committee, by one or more self-designated members. You will have the opportunity to have someone present to represent the protocol.

Step 4: The PI is notified of approval or other action and satisfies any conditions for approval. When approved, any grant funds may be released and a letter of verification is written to a funding agency upon PI request. Any conditions for approval must be fulfilled before the next regularly scheduled CARC meeting.

Follow-up Review:

Modifications

When any modification is anticipated, the PI should notify the CARC coordinator, who will consult with the co-chairs to determine whether the requested changes are significant enough to require a new application. If not, the PI downloads and completes the CARC amendment form, saves in RTF, and attaches the form to an e-mail to carc@ucsc.edu. The activity must proceed according to the approved application until the PI is notified in writing that the modification is approved.

Annual Updates

Activities utilizing live animals are subject to annual review, whether there are changes to propose or not. The PI is asked to return responses to questions in the body of a return e-mail. Any anticipated modifications should be proposed. Some modifications may require an amendment. The amendment form, can double as the annual update. Contact the CARC Office to determine whether an amendment is required. The annual update must be approved before the activity's anniversary, or a new application on a new form will have to be approved to resume animal use. The CARC Office endeavors to remind PIs and co-respondents of annual reporting requirements at least three months before activity anniversary. However, timely reporting is a PI responsibility and failure to receive a reminder does not release the PI from this resonsibility. PIs should contact the CARC Office if no update reminder has been received two months prior to activity anniversary.

Three-Year Renewal

However long the funding period, federal policies require that every activity utilizing live animals receive three-year review of a new application on the most recent form, incorporating all modifications after the original approval and any contemplated for the next three years. Applications prepared on older forms are returned to be redone on the latest form. The CARC Office endeavors to remind PIs and co-respondents of renewal application requirements at least three months before activity anniversary. However, timely reporting is a PI responsibility and failure to receive a reminder does not release the PI from this resonsibility. PIs should contact the CARC Office if no three-year renewal reminder has been received two months prior to activity anniversary.

Choosing the Appropriate Application Form.

There are four application forms to choose from. Clicking on any title below will take you to the page to download forms, thus it is best to determine which form(s) you will need before clicking:

1. Application for Use of Live Vertebrate Animal Subjects Involving Contact (Full Use Form)
   If there is to be any contact with any living vertebrate animal by any personnel whatsoever, or any alteration of animal environment(s) during observational work, this full-use form is required. The quantity of information required by federal sponsoring and regulatory agencies is reflected in the 28 items. Proposals involving observation of animals without alteration of animal environment(s), or use of postmortem animal tissues, require use of the corresponding short form below. If the activity requires use of both living vertebrates and their tissues, attach the second page or the next form for use of postmortem tissues, or be sure to respond to all questions on that page within the full use form.
   
2. Application for Use of Vertebrate samples
   If no living vertebrate is to be contacted at any point, use this two-page form. Samples activities are updated only if changes are proposed and are not reviewed annually.
   
3. Application for Observation (No Contact) of Live Vertebrate Animal Subjects
   If animals will only be observed from a distance, and no manipulation or disturbance of living or dead animals or their environments is planned, you should use this one-page form. Observational activities are updated only if changes are proposed and are not reviewed annually.
   
4. Activity Modification Form
   ALso called "amendmennt form", this form is required to request CARC approval of any proposed changes in site, personnel, permits, protocol, species, or animal numbers between annual updates. Changes must be approved before implementation. Changes determined by the CARC co-chairs to be significant will require a new application.
   

Directions for Completing and Submitting an Application

A separate application must be completed for each unrelated activity.

• Never use forms obtained previously for use of live animals. CARC forms change due to changing regulations and interpretations. Applications for use of live animals submitted on old forms will be returned to be redone on the latest form.
• Never change any question on a CARC form. For example, if your grant is for five years, do not change the questions asking for information for three years to reflect your five year grant; conversely, do not change "3 years" to "1 year," because you believe you will be finished in 1 year. Federal policy requires a new application every three years, regardless of the funding period. Request the animals you will need in the first three years only.
• Respond in boldface, lower-case "Times" font. Mark "X" before the correct response for multiple choice items.
• For "Yes/No" questions, delete the inappropriate response.
• Fill form completely but concisely in language that could be understood by a faculty member in a non-scientific discipline. Enter "N/A" where items are not applicable.
• Be consistent with your grant or contract application, but do not reference it or attach it to your application.
• Spell-check last, save in Rich Text Format (RTF), and submit from a campus computer as an attachment document to carc@ucsc.edu.

Itemized Guidelines for Completing the Full-Use Form:
(Only those items of general difficulty are covered)

0. Office box at top of page: The "CARC code" is an office code to help distinguish applications with long or similar titles in all intercampus correspondence, but not in correspondence with external agencies. The code consists of the first four letters of the PI's last name and the first letter of the first name, followed by the year and month of first submission, i.e., "Caspd99.03" The CARC Office will add the code and reformat your application for consistency with other applications to facilitate reading.

1. The title (and all information on this application) should match the information on your grant.

2. There is usually only one PI of record at CARC. That person is usually a member of the faculty or academic research staff at UC Santa Cruz and the investigator listed first on any grant. CARC will consider on a case-by-case basis allowing co-PIs in cases where the Office of Sponsored Projects lists two investigators as co-PIs on the proposal. In special circumstances, a non-UCSC PI may be approved. A student may not be a PI and must obtain faculty sponsorship. There should be only one co-respondent named on the application. Annual updates, three-year renewals, and proposed modifications will be accepted only from the PI and co-respondent named on the application.

4. If no grant with a specific end date is involved and it is difficult to estimate an end date (such as a class that is taught every spring quarter for the foreseeable future), specify "ongoing." If the activity is already in progress through a previous protocol, state "ongoing" as the estimated start date. However, if modifications are proposed in the renewal application, specify the date you wish to implement the modifications, and/or "ASAP."

5. An IACUC approval verification letter for a funding agency is usually due 30-60 days from the proposal due date. Occasionally, a funding agency does not require a letter, but merely the IACUC's NIH/OPRR Assurance identification number. CARC's number is A3859-01. Occasionally they require a protocol approval number. These are included on verification letters, or upon request by providing the OSP data sheet SC# in an e-mail to carc. PIs must obtain the SC# and all information necessary to write the letter from their OSP analyst; CARC does not contact the Office of Sponsored Projects for it. Information needed to write a verification letter includes the title of the grant, if different from the title of the CARC application, the OSP data sheet SC#, funding agency contact information: address, fax number, e-mail address, etc.. You may request from CARCan e-mail form to return with all information needed to write the letter by a request to carc@ucsc.edu.

7. Specify known, specific geographic sites, and also the widest possible geographic area, so that you will not have to amend your protocol if you need to add a site near a previously approved site.

8. "Collaboration" is defined as working on the same project with a PI at another institution. If the PI on a funding proposal is at UCSC, an application on a CARC form is required, even if the protocol has been approved at the collaborating institution. Ask the other institution to send or fax the approved application to the CARC Office.

9. (Part a) Include yourself as PI and a co-investigator who can respond on your behalf. Correspondence on the protocol will be accepted from the PI and designated co-respondent only. List all co-investigator(s) and all key personnel (research technicians, TAs, and graduate students) who will handle animals or animal tissues during the next three years of the tenure of this application. Personnel who never come in contact with animals or animal tissue should not be listed. Students and researchers who's names are yet unknown should be listed as "TBA." Their names, CVs, and qualificaitons for the particular activity must be provided to the CARC before contact with animals, and applicable personnel must pass the CARC website training course before they can be added to the protocol. Check with the CARC Office regarding the procedure for adding particular personnel. Some, such as undergraduate students and volunteers, may be added by merely proposing them on the annual update form or in an e-mail and do not require filing a formal amendment.

9. (Part d). Everyone listed on a protocol who will handle animals during the next three years, including the PI, must be qualified. General background of personnel who do not have CVs should be attached. The experience and training of all personnel, including the PI, IN THE PERFORMANCE OF THE PARTICULAR PROPOSED PROCEDURES must be explained in a brief narrative. In most cases, CVs and general information will need to be supplemented with more specific information. It is a PI responsibility to arrange for and describe how any additional training will be obtained prior to the onset of the project, including students in short-term projects and other technical assistants.

10. (Part a). No use of animals can be initiated without a clear statement of purpose as required by Item II of the "US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training":

"Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society."

As potential public information, this section especially should be written with sensitivity toward a reader with reservations regarding the scientific use of animals. Technical terms must be made understandable by a faculty member in a nonscience discipline. Technical text from your grant is not an acceptable substitute for a summary in nonscientific terms.

Please see Search Strategies for further information that will assist you to adequately address items 9a and 9b.

10. (Part b). The federal Animal Welfare Act [9 CFR 2.31 (d) iii] requires that:
"The IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirement: The principal investigator must provide written assurance that the activities do not unnecessarily duplicate previous experiments.

11. (Part a) Under the Animal Welfare Act, CARC members must be able to certify that the PI has adequately explained why the research design requires use of any animals at all and describe alternative approaches that have been considered. Examples would be in vitro embryo or cell cultures and computer models.

Further information on this item may be found under USDA Informational Requirements.

11. (Part b) Explain why the chosen species is optimal for the project and why animals of a lower phylogenetic class are not acceptable. Lower acquisition or maintenance costs cannot be used as a justification. Examples of acceptable justifications would be:

• All of the preliminary data has been collected in this species;
• The technologies have developed only in this species (e.g., transgenics);
• The only available reagents use this species;
• The species has properties similar to human properties in some important way;
• This species is the minimum size to do the indicated manipulations.

Further information on this item may be found under USDA Informational Requirements.

11. (Part c) Explain how you have chosen the number of animals proposed. Animal numbers must be justified as the minimum necessary to obtain scientifically valid results and are for the three-year period this application is in effect. They should be consistent with numbers cited in item 22.

Examples of nonstatistical factors in determining sample size would be:

• Animal availability (e.g., lack of information on a rare species, or a species of which there are few available in captivity)
• Need for a sample large enough to measure
• Ethical or animal welfare considerations
• Granting agency specifications

If applicable, animal numbers must be justified as the minimum necessary to obtain statistically valid results. To establish statistical validity, describe the outcome to be measured, the variance (either anticipated or based on previous experiments), the difference between experimental and control subjects that would be regarded as relevant, and the statistical tests that will be used to evaluate the data. It is recognized that not every animal enrolled in a project provides usable data and a modest surplus of animals may be requested to cover unforeseen problems. (You need not reproduce your power analysis here). Further information on this item may be found under USDA Informational Requirements. If, after reading this section, you are still unsure of the appropriate justification for the number of animals you plan to use, please contact the CARC Office, or consult a CARC co-chair.

12. Describe all methods and techniques proposed to be used on animals. Excerpts from the text of your grant may not be an acceptable substitute for a summary, since your description must be comprehensible to a faculty member in a non-science discipline. Do not mention any methods or techniques that will take place under a different IACUC's approved protocol. Any substance administered to the animals other than sedatives, anesthetics, and analgesics (listed under surgery) should be listed with the dose and route (IM, IP, SC, etc.). Anticipated side effects and monitoring not being provided under surgery should be provided here. Any anticipated impairment should be described, even if it will be subsequently corrected. For instance, a drug that renders the animal diabetic is considered to have induced an impairment, even though the investigator plans to fully correct the problem with insulin.

CARC has available upon request several standard operating procedures (SOPs) which may be useful in completing this Item.

13. (Part f). If animals are not acquired and transported through university channels, or if animals are wild (non-domesticated), describe how the animals are obtained and transported to a campus animal housing facility. Even if animals are only transported on campus, describe the method used and care provided to the animals while in transport. If non-domestic animals are to be trapped, describe the type of equipment to be used, duration of trapping, schedule for traps, duration of restraint, method and frequency of monitoring, signs of pain or distress to be watched for, potential for trapping non-target animals, disposition of trapped animals, etc.

15. If the animals are kept in any area more than 24 hours, that area must be approved as a satellite facility.

15 (Part a). If animals are kept in a lab for more than 12 hours, the area must be considered a study site subject to semiannual inspections.

19. The response to this question should be well-thought-out in order to assist the Animal Facility personnel in planning housing and care needs. It is essential to contact the facility before purchasing or ordering animals. Users of Long Marine Lab or other facilities are not required to fill this section.

20. If the protocol involves field work, contact EH&S specialist Jim Schoonover at X9-5182. He will ensure that precautions and requirements are met for using or transporting hazardous materials in animals (e.g., radioisotopes, carcinogens, toxic materials, or other hazardous and infectious agents). Describe any such agent(s)/hazards, amount to be used, route of administration, frequency of administration, route of excretion, anticipated deficit/adverse effects on treated animals, and monitoring protocol/schedule for affected animals. Describe precautions that will be followed to protect all personnel with animal contact, including animal-care staff. If special training of personnel is necessary, describe training specifics. Describe any special animal-care procedures required for the use of the hazard, such as masks, gloves, lab coats, respirators, autoclaving items, special/isolated animal housing. If none are required, so state. Contact EH&S specialist Jim Schoonover at X9-5182 for assistance if you are not sure.

21. Procedures on animals must be classified based upon pain or distress, and the appropriate use of pain-relieving drugs. CARC will determine final classification of procedures, and approval of applications are not dependent upon the results of classification

Most procedures, including administration of tranquilizers or chemical restraint, are Class D. Both Class D and E procedures require a literature search narrative in item 22 "to determine that there are no adequate alternatives to such procedures in the proposed activity that may cause more than momentary or slight pain or stress to animals." Classes of procedures must be claimed in items 23 & 24, even if the animal is to be euthanized. Euthanasia does not constitute a Class D procedure in-and-of itself. However, a terminal procedure, such as a terminal bleed on a rabbit, is considered a Class D procedure, even if the animal is anesthetized.

Class D, C, and E procedures are defined in item 21 of the Full Use Form. Animals must be claimed under the highest class involved at any point prior to euthanasia or release, except that euthanasia is not claimed as a Class D procedure.

22. A literature-search narrative is required for Class D and E procedures that describes the methods and sources used to determine that there are no adequate alternatives to procedures that may cause more than momentary or slight pain or stress to animals. (See Search Strategies to learn about the acquisition and documentation of information on alternatives.)

Further details on this item are found under USDA Informational Requirements.

The federal Animal Welfare Act [9 CFR 2.31 (d) ii] requires that:

1. "The IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirement: The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center, used to determine that alternatives were not available."

A USDA interpretation of the Act created new policy in 1998, when the USDA published the following: "Your narrative should be such that the CARC can readily assess whether the search topics were appropriate and whether the search was sufficiently thorough. Reduction, replacement, and refinement (the three R's) must be addressed, not just animal replacement. For more information on the three R's, go to http://carc.ucsc.edu/USDAinfo.html#alternative_methods

Please see Search Strategies for further information needed to adequately address this item.

26. Use of postmortem vertebrate tissues as other than animal food requires attachment of ONLY items on CARC's Application for Use of Vertebrate Samples that cover items not already covered on this full-use application.

28. Specify method of euthanasia. If by chemical means, specify dose (i.e. mg/kg) and route of administration. This must be consistent with the AVMA Panel on Euthanasia, Journal of Veterinary Medical Association (Vol. 202, No. 2, January 15, 1993, pages 229-249). This document may be accessed under Applicable Policies, Regulations and Guidelines. Also, you may consult with the campus veterinarian on specific recommendations by contacting carc, or the veterinarian directly. See "Animal Quarters" under "Physicial and Biological Sciences, division of."

Any persons named under (h.) or (i.) must have agreed to serve in the capacity indicated for this specific activity. The method of disposal (j.) must be approved. Even if you do not intend to euthanize animals at the completion of your project, a method of euthanasia should be listed in cases of emergency or inability to arrange for an alternative disposition. This item is never "N/A." At the very least, the AVMA guidelines must be cited. If animals are not to be euthanized, indicate their disposition, e.g., released near point of capture, transferred to another project/class (indicate which CARC project and investigator).

Submitting the Form:

Return the application from a UCSC computer as an e-mail ATTACHMENT saved in RTF. Do not return applications in the body of an email message. Be careful to NEVERsave your application in "TextEdit." This destroys all formatting and necessitates starting over on a new form. The application will be reviewed by the committee on a private page of the CARC website after possible preliminary consultation with you. Approved, reformatted applications are returned to PIs as attachments when all additions and corrections have been completed. PIs are asked to return this versioun of the approved application with their "PI Assurance." Upon receipt of the PI assurance, the CARC Office sends an approval notification and animal use may begin. The the PI must print, sign, date, and return the title page of the approved protocol to maintain approval.