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Overview
Research Using Vertebrate Animals
Research Using Invertebrate Animals
Fieldwork and Permits
Institutional Ownership, Stewardship and Transfer of Laboratory Animals
CMC-HMC IACUC Protocol Application Review Process
CMC-HMC Medical Monitoring Program for Vertebrate Animal Users
Questions?
Overview
At Claremont McKenna College (CMC), all research involving animals is carried out under strict ethical and legal standards to ensure humane care and responsible use. Projects using vertebrate animals must be reviewed and approved by the joint CMC-Harvey Mudd College Institutional Animal Care and Use Committee (IACUC). Work with invertebrates may require safety review. Faculty members conducting or supervising animal research in their laboratories are responsible for making sure all requirements are met.
Research Using Vertebrate Animals
CMC follows federal standards for animal care set by the Public Health Service, reflecting policies and recommendations of:
Any project using vertebrate animals (mammals, birds, reptiles, amphibians, or fish) at CMC must be approved in advance by the joint CMC-Harvey Mudd College Institutional Animal Care and Use Committee (IACUC). The principal investigator (PI) on such protocols must be a CMC faculty member. The PI is responsible for supervising all work with animals under their protocol and ensuring compliance with all applicable policies. Step-by-step information about applying for IACUC approval, required training, and safety is available at the links at the end of this document.
The United States Department of Agriculture (USDA) Animal Welfare Act (AWA) sets standards for most “warm-blooded” animals, but not for laboratory-bred rats (of the genus Rattus), mice (of the genus Mus), birds, or any “cold-blooded” species. CMC’s animal facilities only accommodate these non-USDA-regulated species.
In accordance with federal policies, our attending veterinarian has access to all IACUC-covered laboratory animals on campus and the authority to assess and treat, relieve pain, and/or euthanize these animals.
Research Using Invertebrate Animals
The IACUC does not regulate work with invertebrate species. However, researchers wishing to conduct research with invertebrates should discuss their plans with the CMC Environmental and Chemical Hygiene Officer before starting a project. Note that some invertebrate research may require review by the Institutional Biosafety Committee.
Fieldwork and Permits
Research that involves collecting animals, working with wildlife, or taking animal samples in the field may require state and/or federal permits. The PI must obtain the necessary permits, and for work with vertebrate animals, provide documentation of these permits to the IACUC.
Institutional Ownership, Stewardship and Transfer of Laboratory Animals
I. Policy Statement
Claremont McKenna College (CMC) asserts legal ownership and full regulatory stewardship of all laboratory animals acquired for use in research, teaching, or testing activities approved by the Institutional Animal Care and Use Committee (IACUC). CMC is responsible for ensuring the humane care and use of these animals in strict accordance with the Public Health Service (PHS) Policy, the Animal Welfare Act (AWA), and The Guide for the Care and Use of Laboratory Animals. Transfer of institutional ownership and liability for research animals shall occur only through formal, documented, and IACUC-approved mechanisms.
II. Scope and Authority
This policy applies to all CMC personnel, departments, and activities involving live vertebrate animals, regardless of funding source or location. The Dean of Faculty serves as the Institutional Official (IO) responsible for assuring compliance to OLAW. The Attending Veterinarian (AV) provides professional insight of animal health, housing, and welfare and must be consulted in all matters involving animal transport, housing exceptions, and inter-institutional transfers. The IACUC is delegated the authority to enforce this policy and approve all acquisition, use, housing, movement, and disposition protocols.
III. Acquisition and Commencement of Ownership
A. Procurement: All procurement of laboratory animals must be coordinated in advance with the Robert Day Sciences Center (RDSC) Vivarium Manager. This process facilitates IACUC oversight, health surveillance, and record keeping.
B. Commencement of Title: Institutional ownership and custodial liability commence upon physical delivery of the animals to the RDSC vivarium.
C. Control of Movement and Housing: All spaces where animals will be present for any period of time, including brief procedures, must be inspected and approved by the IACUC prior to use. No animal may be housed for more than twelve (12) hours outside the IACUC-approved RDSC vivarium animal housing rooms without explicit, prior approval from the IACUC in consultation with the Attending Veterinarian (AV).
IV. Inter-Institutional Transfer and Collaboration (Outbound)
A. Requirement for Material Transfer Agreement (MTA): All transfers of institutionally owned animals to external collaborators (academic, non-profit, or corporate entities) must be governed by a fully executed Material Transfer Agreement (MTA). The MTA must be negotiated and approved by CMC’s Office of Institutional Philanthropy and Sponsored Research.
B. Transfer of Ownership and Liability: Negotiation of the MTA will include specification of when legal title, physical ownership, and primary custodial liability transfer from CMC (Provider) to the Recipient Institution.
C. Indemnification and Intellectual Property (IP): The MTA must contain explicit clauses whereby the Recipient Institution assumes full custody and control and agrees to indemnify and hold the Institution harmless from any liabilities, damages, or losses arising from the Recipient’s care, use, or treatment of the animals. CMC shall retain all IP rights associated with the genetic material or inventions in the animals.
D. Compliance Vetting: Outbound transfers require:
1. An Animal Transfer Form submitted by the PI to the IACUC Chair and Vivarium Manager tracking the disposition.
2. Proof of the Recipient Institution’s current IACUC approval and OLAW PHS Assurance (if applicable).
3. A Certificate of Veterinary Inspection (CVI) signed by the Attending Veterinarian, confirming health status and compliance with destination regulations, must accompany the shipment.
V. Inter-Institutional Transfer and Collaboration (Inbound)
A. Coordination of shipment: All incoming animal transfers must be pre-approved by the IACUC and coordinated with the Vivarium Manager and the Attending Veterinarian. Incoming animals from a non-approved vendor may require quarantine.
B. Compliance vetting: The outbound institution must provide proof of current IACUC approval, health certification, and shipping documentation in compliance with USDA and OLAW standards.
C. Transfer of ownership and liability: Commencement of CMC ownership and husbandry liability will be determined by agreement with the outbound institution.
VI. Documentation and Record Retention
The IACUC and RDSC Vivarium Manager shall maintain all records related to animal acquisition, transfer, and disposition, including executed MTAs and CVIs, for a minimum period of three (3) years following final disposition.
CMC-HMC IACUC Protocol Application Review Process
1. The faculty member who is the Principal Investigator will complete and submit the protocol application and any appendices to the IACUC chair at least 6 weeks prior to the proposed activation date.
2. The IACUC chair or in case of conflict of interest, another member of the IACUC, will do a brief administrative pre-preview to ensure that all required parts of the application are submitted and determine next steps according to the following processes.
3. The protocol will also undergo a veterinary and Environmental and Chemical Hygiene pre-review before review by the IACUC, and you will be given an opportunity to consult with the veterinarian and/or Environmental and Chemical Hygiene Officer if there are any questions, concerns, or required revisions at that time.
4. Protocols or amendments to approved protocols may be subject to Designated Member Review (DMR) if they meet the following specifications, otherwise they will typically undergo Full Committee Review (FCR). Protocols that include procedures in pain category E will always undergo FCR. Amendments for certain minor changes may undergo Administrative Review only. The method of review and the outcome of that review must be documented in IACUC meeting minutes.
4.1 Protocols that may be subject to DMR are limited to:
- Change of Principal Investigator
- Change and/or addition of species that does not change the objective of the protocol, as long as they do not require new or revised permit conditions, Institutional Biosafety Committee review, or housing that involves significant changes such as caging or space that the IACUC has not previously approved. The PI must provide written documentation from the CMC or HMC biosafety official that the addition of the new species does not require IBC review.
- Addition of anesthesia, sedation, or analgesia that will improve animal well-being for procedures on an already-approved protocol.
- Addition of a procedure or substance that does not result in greater pain, distress or degree of invasiveness. Limited to pain categories C and D.
- Change of procedure that results in that procedure being less invasive or impactful to the animal. E.g., collecting a smaller volume of blood, reducing frequency of imaging, etc.
- Revised protocol application that underwent FCR and was returned for modifications to secure approval.
4.2 The DMR process is as follows:
- All members of the IACUC are given 3 business days to view the protocol application and call for FCR. If no member requests FCR, the protocol may be reviewed by one or more qualified members appointed by the chair.
- The DMR reviewer(s) will have 5 business days to review the protocol.
- DMR may result in approval, return for modifications to secure approval, or referral to FCR. DMR will not result in a rejection.
- If there is more than one designated reviewer, these reviewers must all review identical versions of the protocol, and they must be unanimous in any decision made. If they are not unanimous, the protocol will be referred to FCR.
4.3 The process for FCR is as follows:
- All committee members receive a copy of the protocol application to review at least 5 business days in advance of the meeting at which it is to be discussed.
- The IACUC chair designates a member to serve as the primary reviewer. This reviewer will briefly present the protocol to the committee at the meeting, and discuss any concerns or recommendations for modifications. Committee members have the opportunity to ask questions and/or share opinions.
- Protocol approval requires a quorum (>50% of the voting members of the IACUC) present at the meeting (“present” includes presence by teleconference).
- If the meeting has a quorum, a vote will be called and the protocol will be approved by majority vote of the members in attendance. Other possible outcomes include: return for modifications to secure approval (which may then be reviewed by FCR or DMR), or rejection.
4.4 Amendments to an approved protocol requesting minor administrative changes may undergo Administrative Review by the IACUC chair or, in the case of conflict of interest, another member of the IACUC, and in some cases in consultation with the veterinarian. These requests will be reviewed within 5 business days. Such changes are limited to:
- Change in personnel (addition, removal, or change in role), with verification of completion of required training by the Environmental & Chemical Safety Officer
- Change in personnel (addition, removal, or change in role), with verification of completion of required training by the Environmental & Chemical Safety Officer.
- Change in title.
- Increase in animal numbers for non-USDA-regulated species, provided the change is no more than 10% the approved number since the last IACUC protocol review.
- Change in source of animals. Veterinarian may be consulted.
- Change in animal strain/line. Veterinarian may be consulted.
- Change in location of housing and use. Veterinarian may be consulted. New locations must be inspected by the IACUC before use.
5. The PI will be notified of the outcome of the vote in writing, along with any required modifications or reasons for rejection.
CMC-HMC Medical Monitoring Program for Vertebrate Animal Users
The Public Health Service Policy on Humane Care and Use of Laboratory Animals requires that institutions receiving federal support for research involving vertebrate animals have a Medical Monitoring Program for personnel who either work in animal facilities or have substantial animal contact. In accordance with the National Research Council’s Guide for the Care and Use of Laboratory Animals and Occupational Health and Safety in the Care and Use of Research Animals and in compliance with OSHA’s Bloodborne Pathogens Standard (29 CFR 1910.1030) and OSHA’s Hazard Communication Standard (29 CFR 1910.1200), Claremont McKenna College has developed a Medical Monitoring Program for Vertebrate Animal Exposure (MMPVAE), and this program is shared with Harvey Mudd College vertebrate animal users. The purpose of the program is to ensure individuals are aware of possible hazards while working with or in the presence of laboratory animals. The program is designed to prevent, monitor, and reduce diseases transmitted from animals to man (zoonotic diseases), and provide education and training for personnel about zoonotic diseases, personal hygiene, and other related issues. Individuals who plan to work with laboratory animals are evaluated by an occupational health Physician Assistant with respect to the type and extent of his/her animal contact and are advised on the inherent risks involved with the animal research and the recommended medical services to provide a healthy and safe work environment. The MMPVAE coordinator is the CMC Environmental & Chemical Hygiene Officer (ECHO), who may be contacted with any questions at echo@cmc.edu.
Enrollment in the program is initiated by completing the MMPVAE risk assessment form and submitting it in a sealed envelope to the ECHO in the Robert Day Sciences Center (RDSC), room 038, or to the ECHO mailbox in the RDSC mailroom on the 3rd floor. The information provided on that form will be evaluated by a licensed Physician Assistant to determine any possible recommendations to the individual. For example, it may be suggested that the individual follow up with their personal physician for further evaluation, or it may be recommended that an individual use a respirator or other personal protective equipment during animal contact. Individuals may choose to accept or waive any or all recommendations. Regardless of any recommendations made, individuals may request further consultation with the assessing Physician Assistant.
Personal protective equipment (PPE) provides a physical barrier to potentially hazardous materials associated with working with animals. At no cost to faculty, staff, or students, departments will provide appropriate PPE which may include such items as gloves, lab coats, gowns, face shields or eye protection, masks. If the healthcare provider recommends use of a respirator, in accordance with OSHA 1910.134, The Claremont Colleges Services will provide respirator fit testing, training, and medical clearance at no cost to the faculty, staff member, or student.
Faculty, staff, students, and volunteers who have contact with vertebrate laboratory animals on campus are required to be enrolled in the CMC-HMC MMPVAE. Principal Investigators on IACUC protocols have the responsibility to ensure that all individuals working on their protocols are enrolled.
Faculty wishing to establish a classroom project or educational program with vertebrate animal contact must submit a description of the type of contact associated with their project or program to the ECHO. Based on the information provided, the ECHO and the Physician Assistant will determine whether individuals participating in these programs will be required to enroll in the MMPVAE.
MMPVAE enrollment forms and any associated documents will be maintained confidentially by the occupational health provider in compliance with HIPAA, and will not be shared with CMC or HMC except for fit-for-duty determinations. Records will be retained for the duration of employment/enrollment plus 30 years in compliance with OSHA recordkeeping requirements. The signed Authorization to Disclose Medical Information (on the MMPVAE enrollment form) is required for any release of medical review results to the MMPVAE coordinator.
All individuals are required to renew their enrollment every 3 years, or sooner if there is a change in health status, animal species contact, or research procedures, to maintain up to date assessment.
Questions?
Contact the IACUC Chair for help with planning your research or understanding the requirements.
Concerns about lab animal welfare or non-compliance can be reported to the IACUC chair directly, or anonymously at the Report a Concern webpage.
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