ARC Applications | UCLA Research Safety & Animal Welfare Administration

What Requires ARC Approval, and What Does Not?

ARC review and approval is required for research and teaching activities that involve the use of live vertebrate animals. If a live vertebrate animal is required for any research or teaching purpose, including immediate euthanasia, the proposed care and use of that animal must be described and justified in a protocol submitted through the ARC Research Application Tracking System (RATS). Following initial ARC approval, any changes to the care or use of animals described in the approved protocol must be submitted to the ARC via an amendment application in RATS. Amendments must be approved before changes can be initiated.

The ARC encourages the sharing of animal tissues by UCLA investigators as a way of increasing benefits and minimizing the number of animals used. Investigators who want to use post-mortem tissue supplied by another investigator who has an approved protocol to conduct research using those animals do not need to submit a protocol. However, the following considerations must be addressed by investigators who wish to receive and use tissue derived from animal research conducted at UCLA:

Investigators who will receive tissues obtained from animals infected with biohazardous agents or treated with carcinogens, radioisotopes, or covered DNA must obtain appropriate prior approvals from EH&S, the relevant safety committee(s), and/or the Campus Veterinarian.
Investigators seeking to obtain tissues from USDA-regulated species should make arrangements through the Campus Veterinarian.
ARC approval is required if tissues or extracts, or tissue by-products, will be introduced into live animals. Further, the Campus Veterinarian should be consulted prior to initiating these activities so that appropriate measures may be instituted to avoid the spread of pathogens.
If modifications to an approved ARC protocol are required to accommodate the use or transfer of tissues, ARC review and approval of an amendment application describing those accommodations is required prior to implementation.
Live animals will not be transferred from the investigator providing the tissue to another investigator for the purpose of harvesting tissue.
Personnel who have contact with animal tissues must file a Medical History Questionnaire (MHQ) form on an annual basis.

Investigators who wish to share animal tissues with individuals outside UCLA must contact the UCLA Technology Development Group at UCLAMTA@tdg.ucla.edu to determine whether a Material Transfer Agreement (MTA) is needed to memorialize the terms of that transfer.

How Long Will My Application Take to Be Reviewed?

The length of time you can expect from submission to approval is dependent upon many factors, including the complexity of the application, the number and nature of changes proposed (if amending a previously approved protocol), the ARC's meeting schedule, and whether the application is eligible for review via Designated Member or must go to the Full Committee (see section entitled "The Review Process" below).

Turnaround times for new and renewal applications average approximately 6 weeks from submission to approval. For renewal applications, investigators are strongly encouraged to begin working on their applications as soon as possible after receiving their first (90-day) expiration reminder notice.

Amendment and continuation applications requesting significant changes (e.g., experimental design, animal number or species/strain) average approximately 5 weeks from submission to approval.

Amendment applications requesting minor/administrative changes (e.g., personnel, locations, funding) are generally approved within 7-10 days of submission, assuming no outstanding issues such as personnel who have not completed all ARC certification requirements or grant-protocol congruency issues (e.g., procedures described in the grant application that are not described in the protocol).

Continuation applications requesting no changes are generally ready for approval within 2 weeks of submission. However, in an effort to not penalize investigators who submit their applications early and who would otherwise lose a substantial amount of time from their current approval period, these applications are normally held for review until within 1 month of expiration.

Investigators with an urgent funding issue or who need ARC approval for experimental changes quickly should notify the staff in the ARC administrative office as soon as possible.

ARC Submission Deadlines

Applications must be submitted to the ARC no later than the submission deadline in order to be reviewed at the next Committee meeting. The ARC convenes twice per month, and the deadline for submission is 10 calendar days prior to a meeting. (Meeting times and deadlines are subject to change and will be promptly posted online if any changes are necessary.)

Online Protocol Submission (RATS)

For guidance in using the ARC's Research Application Tracking System (RATS), please refer to the RATS Help Center.

If you are a new investigator and have not yet submitted a protocol using RATS, please contact the ARC administrative office at (310) 206-6308 or arc@research.ucla.eduto activate your account.

Questions? Please contact the ARC administrative office at (310) 206-6308 or arc@research.ucla.edu if you have any questions.

Eligibility as Principal Investigator

To determine your eligibility to serve as Principal Investigator of a research protocol, please refer to UCLA Policy 900 (Principal Investigator Eligibility) or contact the ARC administrative office (310-206-6308). If the terms of Policy 900 are not met, faculty sponsorship or principal investigatorship by a UCLA employee with faculty appointment may be required.

Veterinary Consultation

Federal regulations require that the attending veterinarian or his/her designee be consulted when planning studies that may cause more than momentary of slight pain or distress to the animals. Veterinarian consultation is also required when planning research or procedural changes that may result in more than momentary or slight pain or distress to animals. This consultation is often conducted via the protocol pre-review process; however, you may also contact a DLAM Veterinarian to schedule a consultation.

Pre-Committee Review

For most new applications and submissions for triennial review, the ARC requires a pre-review prior to formal ARC review. This process is designed to address administrative and animal care issues, and to ensure completeness of your application, prior to Committee review.

A Pre-Committee Review must be completed and subsequent modifications made to your application prior to submission to the ARC. Early submission of your application for Pre-Committee Review is therefore strongly advised in order to meet the ARC submission deadlines. If recommended changes are not incorporated into the application, the principal investigator must provide explanations in the final application to be submitted to the ARC. If Pre-Committee Review comments are not incorporated or addressed in your application prior to submission to the ARC, the protocol will not be reviewed by the Committee, and your application will be returned to you.

The Review Process

Federal regulations allow for two types of review of animal use protocols: Full Committee Review (FCR) and Designated Member Review (DMR).

Full Committee Review (FCR): As its name suggests, the FCR process involves review of an application at a convened meeting with a quorum (majority of voting members) present. The Committee has the authority to approve, require modifications to secure approval, or withhold approval of an application. Any such decision is based on a majority vote of the members present.

Designated Member Review (DMR): The DMR process is somewhat more complicated. Briefly, a list of applications eligible for DMR is distributed to all ARC members, and any member can call for FCR of any application. If no member requests FCR, the Chair designates one or more reviewers who have the authority to approve the application or require modifications to secure approval. The Designated Reviewer does not have the authority to withhold approval of an application; any protocol with serious concerns will be presented to the Full Committee for discussion.

The DMR process is intended to allow the Committee to devote more time during convened meetings to protocols warranting greater discussion, such as proposals involving more invasive or more painful procedures. Protocols that involve minimal potential for pain/distress (e.g., euthanasia of animals for tissue harvest only) or that do not involve substantial modifications (e.g., continuation applications with no significant changes) are more likely to be reviewed through DMR. However, review through DMR is no less thorough than review through FCR.

Committee members are notified of applications eligible for DMR once per week. While this process can often allow a quicker turnaround time than FCR, DMR is not the same as the "expedited review" process permitted for review of certain human research proposals. It is also important to note that assignment to DMR does not guarantee that an application will not be referred to FCR.

Administrative Review: Amendment applications to existing protocols that involve certain changes not considered significant (e.g., addition of a new funding source, changes in personnel, use of a new vivarium housing location) can be reviewed administratively. Typically, the turnaround time for applications undergoing administrative review ranges from a few days to a week.

As always, please contact the ARC administrative office (x66308) with your questions or concerns about the review process, as well as appropriate timelines for processing applications prior to grant deadlines or lapse in ARC approval.

Review Fees

The ARC does not charge review fees for UCLA faculty, staff, and student animal research activities that occur on the campus or in field settings. A review fee will be assessed in the following cases:

When a CNSI Magnify company enters into a Sales and Services Agreement with UCLA for mouse or rat work in the UCLA animal facilities.
When a Doheny-UCLA faculty member proposes animal activities on the Doheny campus.

Rates
Initial and triennial review	$2,700
Amendment	no charge

Contact arc@research.ucla.edu if you have questions.

ARC Certification

The ARC requires that all personnel having direct contact with live vertebrate animals obtain ARC certification prior to initiating work with laboratory animals.

Supplemental Forms

Medical History Questionnaire (MHQ) Form
The UCLA Medical History Questionnaire for Investigators, Technicians, Students and All Others Exposed to Laboratory Animals must be completed by all investigators and personnel who are listed in an ARC protocol. In accordance with University Policy, completion of this form is mandatory for all personnel having contact with research animals or animal tissues and all personnel who have a security key card or key to enter the vivarium. Please note that the MHQ must be submitted on an ANNUAL basis.

Forms can be completed online via the MHQ Online website. If you have questions regarding the MHQ, please contact the Occupational Health Facility (OHF) at (310) 825-6771.

Medical History Questionnaire Waiver Form for Visitors
In lieu of submitting the Medical History Questionnaire (MHQ) form, visitors may complete the MHQ Waiver Form provided they: 1) are not UCLA faculty, staff or students and 2) will only have transient contact with animals or animal or human tissue for a period of time not to exceed 3 days. All others must complete the MHQ.

Registration of Transgenic Rodents (Institutional Biosafety Committee)
The NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules requires that all transgenic animals (excluding rodents) used, housed, or constructed at UCLA be registered with the UCLA Institutional Biosafety Committee (IBC).

Transgenic rodents require IBC registration if they are constructed at UCLA or off-site through a UCLA contract or are considered to be hazardous and require BSL2 or higher containment.

Additionally, breeding of two different transgenic rodent strains could also require IBC registration if the resulting strain contains more than one-half of an exogenous viral genome from a single family of viruses, OR if the parental rodent contains the following genetic modifications:

Incorporation of more than one-half the genome of an exogenous eukaryotic virus from a single family of viruses; or
Incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR)

Purchase or transfer of non-hazardous rodents is exempt from the NIH Guidelines and does not require IBC registration. Please refer to the NIH Guidelines or contact the IBC administrative office (x40262 or ibc@research.ucla.edu) for more information on which animals are exempt.

If IBC registration is needed, please submit a Biological Use Authorization (BUA) application through SafetyNet.

VA/UCLA Memorandum of Understanding (MOU)

The Memorandum of Understanding (MOU) Between VA Greater Los Angeles Healthcare System and University of California Los Angeles With Regard to Collaboration on the Use of Animals in Research defines the expectations of the VA and UCLA with regard to collaborations involving the use of animals in research, teaching, and testing, including the procedures for review of UCLA-sponsored research studies conducted at the VA, and VA-sponsored research studies conducted at UCLA.

Resources for Investigators

Research Using Vertebrate Animals

Developed by the National Institute of Allergy and Infectious Diseases (NIAID), the NIAID provides a step by step guide to the preparation of an application and covers such topics as considering alternatives, obtaining assurances and Institutional Animal Care and Use Committee (IACUC) approval, Just-In-Time processes, NIH review of animal subjects applications, grant awards, IACUC monitoring of awards, and reporting requirements. Although designed specifically for NIAID applicants, the information is relevant to any investigator submitting an application to the NIH for an activity involving animals.

The Office of Laboratory Animal Welfare (OLAW) offers a tutorial on the PHS Policy on Humane Care and Use of Laboratory Animals. The tutorial is for new animal care and use committee members, institutional administrators, investigators, animal care personnel, veterinarians, and others who are interested in learning about the PHS Policy.