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Animal Welfare Assurance of Compliance
(RPH 8.1)

Printable version (Adobe Acrobat PDF)
Located Inside: Research Policy Handbook

Stanford University

Research Policy Handbook

Document 8.1

 

Title:

Animal Welfare Assurance of Compliance

Current version:

April 12, 2005

Classification:

Public Health Service (PHS) Assurance

Summary:

Provides assurance of Stanford compliance with PHS Policy on Humane Care and Use of Laboratory Animals. Includes description of Stanford policies and procedures for the Administrative Panel on Laboratory Animal Care (A-PLAC). Does not include Exhibits or Attachments.

This Assurance renewal, identified as #A3213-01, is approved for a four-year period, and will expire on May 31, 2009. (See DHHS letter of approval - pdf file).

Related Research Policy Handbook Documents:

1.4    Administrative Panels for Research Compliance
6.5   Changes In The University's Laboratory Animal
         Occupational Health Program (LAOHP)
8.2    Use of Vertebrate Animals in Teaching Activities
8.3    Responsibilities for the Humane Care
         and Use of Laboratory Animals
8.4   Transport, Care, and Use of Non-Stanford Owned
         Laboratory Animals on the Stanford Campus
8.5    Animal Care and Use Training and Education Program

SEE ALSO:  A-PLAC Home Page

Authority:

United States Public Health Service
Stanford Vice Provost and Dean of Research

Contact Person:

Research Compliance Administrator

The Leland Stanford Junior University, hereinafter referred to as "institution," hereby gives assurance that it will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as "PHS Policy."

 

   I.   Applicability

This Assurance is applicable to all research, research training, experimentation, biological testing, and related protocols, hereinafter referred to as "protocols," involving live, vertebrate animals, hereinafter referred to as "animals," supported by the Public Health Service (PHS) and conducted at this University, or at another institution as a consequence of the subgranting or subcontracting of a PHS conducted or supported activity by this institution. "Institution" includes the following branches and major components of the Leland Stanford Junior University:

  1. Stanford University School of Medicine

  2. Stanford University School of Humanities and Sciences

  3. Stanford Linear Accelerator Center

  4. Stanford University School of Engineering

  5. Lucile Salter Packard Children's Hospital at Stanford

  6. Howard Hughes Medical Institute (at Stanford University)

  7. Stanford Hospital and Clinics.

 

   II.   Institutional Policy

  1. This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.

  2. This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."

  3. This institution acknowledges and accepts responsibility for the care and use of animals involved in protocols covered by this Assurance. As partial fulfillment of this responsibility, this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.

  4. This institution has established and will maintain a program for protocols involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide).

 

   III.   Institutional Program for Animal Care and Use

  1. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are attached in Exhibit 1 and Exhibit 1a.

  2. The qualifications, authority, and percentage of time contributed by veterinarian(s) who participate in this program are summarized below:

    The veterinarians carry out their duties as part of the program of the Veterinary Service Center (VSC). The VSC is a division of the Department of Comparative Medicine (DCM). Therefore, as indicated in this Assurance, section IIA, the authority of the veterinarians is derived from the Board of Trustees, through the President, through the Provost, through the Dean of the Medical School, to the Chair of the Department of Comparative Medicine, to the veterinarians. The Chair of the Department of Comparative Medicine and the veterinarians also have a reporting relationship with the Associate Dean of Research, who reports to the Institutional Official.

         Chair, D.V.M., Texas A&M University, 1970; Ph.D. in Experimental Pathology, Washington State University, 1974; Diplomate, American College of Veterinary Pathologists, 1975; Professor, Department of Comparative Medicine, 1994; Chairman, Department of Comparative Medicine, 1994. Responsible for: 1) supervising the staff of the veterinary service center; 2) managing the research animal service center in a cost-effective manner; and 3) coordinating the education and training of protocol directors. Percentage of time contributed: 60%.

         Associate Professor, D.V.M., LSU, 1985; Ph.D. in Neuroscience, UC Davis, 1995; Diplomate American College Veterinary Internal Medicine, 1991, Assistant Professor, Department of Comparative Medicine, 1995. Associate Professor, Department of Comparative Medicine, 2001. Responsible for managing the critical care facility at the Veterinary Service Center and participates in protocol director and staff training programs. Percentage of time contributed: 75%.

         Associate Professor, Attending Veterinarian, D.V.M., University of Minnesota, 1987; Massachusetts Institute of Technology, 1987-1990; Diplomate, American College of Laboratory Animal Medicine, 1991. Assistant Professor, Department of Comparative Medicine, 1994. Associate Professor, Department of Comparative Medicine, 2001. Responsible for: 1) maintaining the research animal facilities in compliance with federal regulations and AAALAC accrediting standards; 2) coordinating all clinical and veterinary services for laboratory animals; 3) participating in the veterinary clinical care of animals in the research facility; 4) coordinating the review of IACUC protocols by veterinary faculty and staff; 5) participating in protocol director and staff training programs; and 6) coordinating occupational health and safety for the research animal facility. Percentage of time contributed: 85.4%.

         Associate Professor, D.V.M., Auburn University, 1987; Ph.D. in Molecular and Cellular Pathology, University of Alabama at Birmingham, 1994; Assistant Professor, Department of Comparative Medicine, 1997. Associate Professor, Department of Comparative Medicine, 2002. Responsible for clinical veterinary call and participates in protocol director training programs and coordinates the externship programs for laboratory animal medicine for veterinary students. Percentage of time contributed: 99.2%.

         Associate Professor, D.V.M., University of Tennessee, 1985; Ph.D. in Comparative and Experimental Medicine, University of Tennessee, 1995; Diplomate, American College of Veterinary Pathologists, 1996. Assistant Professor, Department of Comparative Medicine, 1997. Associate Professor, Department of Comparative Medicine, 2003. Director of Necropsy Services and provides diagnostic pathology support to the program and participates in protocol director training programs. Percentage of time contributed: 64.83%.

         Assistant Professor, D.V.M., University of Illinois at Champaign-Urbana, 1986; Ph.D. in Veterinary Pathobiology, University of Missouri - Columbia, 2000; Diplomate, American College of Laboratory Animal Medicine, 1997; Assistant Professor, Department of Comparative Medicine, 2000. Responsible for supporting the surgical and critical care programs and providing general clinical care as well as investigator training and consultation. Percentage of time contributed: 25%.

         Assistant Professor, D.V.M., University of California, Davis, 1994; Ph.D. in Endocrinology, University of California, Davis, 1998; Diplomate, American College of Laboratory Animal Medicine, 2002; Assistant Professor, Department of Comparative Medicine, 2001. Responsible for supporting the surgical and critical care programs and providing general clinical care as well as investigator training and consultation. Percentage of time contributed: 100%.

         Staff Veterinary Pathologist, D.V.M., University of California, Davis, 1984; Diplomate, American College of Veterinary Pathologists, 1996; Ph.D. in Comparative Pathology, University of California, Davis, 2001; Staff Veterinary Pathologist, Department of Comparative Medicine, 2002. Responsible for providing gross postmortem and histological examinations for diagnosis of spontaneous disease in the research colony and provides technical support for researchers. Percentage of time contributed: 100%.

         Staff Veterinarian, V.M.D., University of Pennsylvania; Staff Veterinarian, 2004. Responsible for supporting the clinical service functions of the Veterinary Service Center. Percentage of time contributed: 100%.

         Resident, Laboratory Animal Medicine, D.V.M., Cornell University, 2001; ACLAM Training Fellowship, 2003. Responsible for supporting the clinical service functions of the Veterinary Service Center. Percentage of time contributed: 100%.

  3. This institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures. The IACUC consists of at least five members, and its membership meets the composition requirements set forth in the PHS Policy at IV.A.3.b. Attached is a list of the names, degrees, position titles, specialties and institutional affiliations of the IACUC chair and other members. Exhibit 2.

  4. The IACUC will:

    D.1.

    Review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program evaluations are to:

    1. review semiannually the University's Program for Laboratory Animal Care and Use at a convened meeting;

    2. utilize the "Sample Semiannual Program and Facility Review," the Guide, the Policy, and as applicable, 9 CFR Chapter I, subchapter A, as a basis for evaluation during a convened meeting;

    3. categorize any program deficiencies as minor or significant and develop a plan and schedule for correction for any deficiencies.

    D. 2.

    Inspect at least once every six months all of the institution's animal facilities, including satellite facilities, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual facility inspections are to:

    1. iinspect every six months all of the University's animal facilities, including satellite facilities, using the Guide, the Policy, and as applicable, 9 CFR Chapter I, subchapter A, as a basis for evaluation, with at least two IACUC members inspecting all facilities;

    2. document inspection findings in a report to each facility director or protocol director with a schedule for correction if any deficiencies are found;

    3. require a response from the facility director or protocol director to the inspection report with a description of how the deficiency has been corrected;

    4. review and discuss a compilation of the facility inspection reports at a convened meeting of the IACUC.

    D. 3.

    Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional Official, the Vice Provost and Dean of Research. The IACUC process for developing reports and submitting them to the Institutional Official is to:

    1. prepare reports of the IACUC evaluations, addressing the requirements outlined in the "Sample Format for the Semiannual Report to the Institutional Official," and as applicable, 9 CFR Chapter I, subchapter A;

    2. describe the nature and extent of the institution's adherence to the Guide, PHS Policy, as applicable, 9 CFR Chapter I, subchapter A, and describe any newly approved exceptions or departures to existing standards and state the reason for each departure;

    3. distinguish significant deficiencies from minor deficiencies and assign reasonable and specific plans and schedule for correcting each deficiency;

    4. list the dates when program evaluation and facilities inspections were conducted and provide any minority views or a statement that there were no minority views;

    5. have the program evaluations signed by an IACUC quorum, and submit reports to the Associate Dean of Research, who then forwards the report to the Institutional Official.

    D. 4.

    Review concerns, i.e., reports or complaints of noncompliance with regulations or institutional policies involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are to:

    1. post the telephone number for reporting concerns anonymously in multiple locations throughout the main animal facilities, where the majority of animal users pass through;

    2. post the telephone number for reporting concerns anonymously within the protocol application;

    3. review all concerns with safeguards to protect the individual's identity, and if warranted, appoint a subcommittee to perform an IACUC investigation;

    4. review any subcommittee findings at a convened meeting and take appropriate action, if warranted, up to and including suspension of a protocol and notification of the Institutional Official, OLAW and the USDA.

    D. 5.

    Make written recommendations to the Institutional Official regarding any aspect of the institution's animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are to:

    1. evaluate, usually by subcommittee, a particular aspect of the University's animal program, facilities, or personnel training;

    2. review subcommittee reports at a convened meeting;

    3. write recommendations for review by the Associate Dean of Research, who then refers matters to the Institutional Official.

    D. 6.

    Review and approve, require modifications in (to secure approval), or withhold approval of those protocols related to the care and use of animals as set forth in the PHS Policy at IV.C. The IACUC procedures for protocol review are:

    D.6.a.   Review and Approval of protocols activities
    The IACUC Office will:

    1. Receive protocols in the IACUC office, review all protocols for completeness and provide applicable information on animal care to comply with federal regulations and University policies/practices to protocol directors;

    2. separate protocols into three categories:

      1. ADMINISTRATIVE REVIEW, e.g., title change, funding addition without procedural changes

      2. MINIMAL DISTRESS/PAIN; and

      3. GREATER THAN MINIMAL DISTRESS/PAIN;

    3. Review and record Category 1 protocols for administrative purposes;

    4. Within categories 2 and 3, select protocols to be assigned to full committee review;

    5. Any protocol not selected for full committee review shall be reviewed by at least one member of the IACUC, designated by the Chairperson (or his/her designee) and qualified to conduct the review. (In most cases, the Sr. IACUC Manager is the Chair's designee.) Protocols involving greater than minimal distress/pain are typically given to two designated reviewers. The reviewers shall review these protocols on behalf of the IACUC and have the authority to approve, require modifications (to secure approval) or request full committee review of those protocols, unless an IACUC member requests full committee review (as specified below).

    6. At least 5 days prior to the convened meeting, circulate to all IACUC members a list that includes all the protocols not assigned to full committee review. Written descriptions of these protocols shall be available to all IACUC members. Any member of the IACUC may request, no later than 5PM on the day prior to the convened meeting, full committee review of those protocols;

    7. Protocols selected for full committee review in step iv) or protocols for which full committee review has been requested by any member of the IACUC are assigned to one or two IACUC members (primary reviewers) based on their expertise or interest with the subject area. Protocols involving greater than minimal distress/pain are typically given to two primary reviewers. These protocols are presented and voted on at a convened meeting.

    D.6.b.   Required modifications to secure approval and outcome of review
    The IACUC Office will:

    1. Inform the protocol director in writing of any reviewer modifications, comments, questions, or concerns about the protocol and request a reply within a specified time;

    2. Circulate the protocol director's written responses to the reviewers;

    3. Repeat the process as necessary until one of the following steps is taken:

      1. Designated review process: reviewers are in agreement and approve the protocols, or request that the protocols be presented for full committee review at the next convened IACUC meeting;

      2. Full committee review process: the protocols are presented and voted on at a convened meeting. Approval requires an affirmative vote by a majority of the convened quorum. In the event that substantive questions prevent approval, the IACUC may wait until the next meeting for revisions to be reviewed by the full committee. Alternatively, the IACUC may decide to handle the resubmissions by the designated-member review process, with appropriate notation in the minutes. Under a full committee review, the IACUC members may also vote to withhold approval if they feel that the requirements of PHS Policy or other stipulations have not been satisfied

    D.6.c.   Description of the handling procedure for a typical animal use protocol from time of submission to time of approval

    1. Provide input and assistance to the protocol director in developing the protocol;

    2. Receive the protocol in the IACUC office and perform preliminary review for completeness through staff; process administrative review as appropriate; refer protocol to full committee review, or include in list of protocols for designated review to be circulated to all IACUC members at least 5 days prior to the convened meeting.

    3. Assign reviewers: protocols involving greater than minimal distress/pain are typically given to two designated reviewers or, when pre-assigned to full committee review, to two primary reviewers;

    4. Synthesize and send any reviewers' questions to the protocol director; require a reply within a specified time;

    5. Distribute the protocol directors' responses to reviewers and repeat the cycle as necessary;

    6. Circulate designated review list of protocols to all IACUC members at least five days prior to convened meeting;

    7. Present full committee review protocol at convened meeting.

    8. Determine approval process:

      1. A designated review protocol that was circulated on a list to all IACUC Members may be approved by the designated reviewer(s) provided that no IACUC member requested full committee review by 5PM on the day prior to the convened meeting. The designated reviewer(s) may also decide to refer the protocol to the convened meeting for full committee review.

      2. A protocol assigned to full committee review will be presented at a convened meeting by one of the primary reviewers or discussed collectively with direction from the Chair, prior to a vote to approve, withhold approval, or request modifications necessary for the approval of the protocol.

    9. Communicate any approval or disapproval or further questions to the protocol director. When approval is withheld, the protocol director shall have the opportunity to respond. Further review may be delegated to one or more qualified IACUC members designated by the Chair (or his/her designee) or presented for full committee review at a convened meeting.

    D.6.d.   Policies on Meeting Attendance and Voting on Protocols assigned to Full Committee Review
    The IACUC will:

    1. Require a quorum to conduct its business;

    2. Approve protocols assigned to full committee review only after review at a convened meeting with a quorum present and approval vote of a majority of the quorum present;

    3. Require members to decline participation in the IACUC review or voting of a protocol in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; a member who has a conflicting interest must leave the room and may not contribute to the constitution of a quorum;

    4. Invite consultants to assist in the review of complex protocols when necessary. Consultants may not vote unless they are officially appointed voting members on the IACUC.

    D.6.e.   Use of designated reviewers

    Use of designated reviewers is described in D.6.a., D.6.b. and D.6.c. above, as well as in D.7. below.

    D. 7.

    Designated reviewer process used for significant changes in on-going research projects

    The IACUC procedures for reviewing proposed significant changes that have been deemed by the Attending Veterinarian to be urgent in ongoing protocols are as follow:

    1. A Description of the proposed significant changes will be communicated to all IACUC members, who will have the opportunity to request, within a time frame determined according to the urgency, full committee review at a convened meeting;

    2. If no member requests full committee review, the IACUC Chair (or his/her designee) assigns the protocol in question to at least one designated reviewer qualified to review this specific protocol, who will approve the protocol, request additional information from the protocol director to approve it, or refer it for full committee review;

    3. The IACUC Office informs the protocol director in writing of any reviewer required modifications, comments, questions or concerns about the proposed significant change and requires timely clarification, modification, or elimination of concerns from the protocol director;

    4. The IACUC Office circulates the protocol director's written response to reviewers, and repeats process until reviewers are in agreement and approve the protocol or refer the significant change to full committee review at a convened IACUC meeting where it will be discussed and voted on.

    D. 8.

    Notify investigators and the institution in writing or via electronic posting of its decision to approve or withhold approval of those protocols related to the care and use of animals.

    The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are to:

    1. Notify protocol directors, in writing or via electronic posting, of the IACUC's decision regarding their protocols;

    2. Provide verification of laboratory animal approval to sponsoring agencies, as required;

    3. Post IACUC approval dates in University-wide laboratory animal database, and provide access to this information to the contracts and grants offices, Office of Postdoctoral Affairs, University Fellowship Office, Environmental Health & Safety, and Department of Comparative Medicine.

    D. 9.

    Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy at IV.C. 1-4 at least once every three years.

    The IACUC procedures for conducting complete continuing review are to:

    1. Require the protocol director to fill out a renewal application for the protocol on an annual basis;

    2. Review the renewal application with the initial protocol submission that conforms to the Guide, PHS Policy, and as applicable, 9CFR Chapter I, subchapter A;

    3. Perform the IACUC review as outlined above in Section D.6.

    D.10.

    Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.

    The IACUC procedures for suspending an approved activity are to:

    1. Suspend any protocol or approved activity involving animals after review of the matter at a convened meeting of a quorum of the IACUC and through a vote of a majority of the quorum present;

    2. Review the reasons for suspension with the Institutional Official and take appropriate corrective action;

    3. Submit a full report to the Institutional Official and for PHS supported research to OLAW, USDA and relevant Federal entities, as required.

    D.11.

    The institution's procedures for off site activities involving research animals are:

    1. Review of protocols for faculty located at the Palo Alto Veterans Administration Health Care System (PAVAHCS): this Institution and the PAVAHCS, located at 3801 Miranda Avenue, Palo Alto, California, 94304, have a general affiliation agreement and a specific memorandum of understanding relating to research animals. Many faculty of Stanford University are employed by and located at the PAVAHCS. The PAVAHCS has an Assurance of Compliance with PHS: Assurance #A3088-01. Protocol directors from this Institution who are located at the PAVAHCS submit proposed laboratory animal activities for review as outlined in the memorandum of understanding relating to the housing and use of animals; this Institution's IACUC accepts the review and approval of the PAVAHCS' IACUC. Exhibit 3

    2. Review of other off-site research or training protocols: institutional protocol directors conducting laboratory animal research or research training protocols at an off site facility not included in the Palo Alto Veterans Administration Health Care System must provide: a letter of approval from the host IACUC; proof of a currently approved PHS Assurance; and (if applicable) USDA registration number; certificate of registration from the State of California.

  5. The individual(s) authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals are: Research Compliance Director (Kathy McClelland), Associate Dean of Research (Ann Arvin), and Senior IACUC Manager (Valerie Fratus).


  6. The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is summarized below.

    F.1.

    The Laboratory Animal Occupational Health Program (LAOHP) is administered through Stanford's Department of Environmental Health & Safety (EH&S) in close cooperation with the Department of Comparative Medicine and the IACUC. The LAOHP provides information and safeguards for personnel working with laboratory animals and hazardous agents in the following underlined areas.

    F.2.

    PERSONNEL HYGIENE includes the provision or requirement of appropriate clothing depending on the area in which animal care personnel are working, or species working with, such as: ear protection, safety glasses or face shields; disposable gowns or jumpsuits, masks, gloves, hoods and booties, chemical resistant aprons, boots, and gloves, and steel mesh and/or gloves. Appropriate protective equipment and/or clothing is provided at the entrance to all biohazard containment rooms. Dedicated work clothing may be worn outside a facility in some circumstances if the employee is in transit to another campus facility, but work clothing is not be worn home or from home; no eating/drinking is allowed in any animal housing or procedure areas.

    F.3.

    HAZARDOUS AGENT HANDLING

    F.3.a.   Biohazardous Agent Use
    Oversight is provided by the Administrative Panel on Biosafety (APB) through the Biosafety Manager who is part of the University's EH&S program. The APB is responsible for the review of this institution's teaching projects, research activities and facilities involving the acquisition, use, storage and disposal of biohazardous agents. The Biosafety Manager and EH&S industrial hygiene professionals work closely with the veterinary staff to provide training in the safe handling and management of biological and chemical hazard agents used in studies with laboratory animals. Detailed biosafety requirements and safety procedures are contained in the Biosafety Manual (revised 2005) available on-line at the EH&S website or in hard copy. The Biosafety Manager is an IACUC member; the Attending Veterinarian serves on the APB to review the prospective use of hazardous agents and outline safeguards for affected personnel. Biohazardous projects can only be performed in areas approved by the Attending Veterinarian. This institution has special containment suites for projects involving specific biohazardous agents, and access to these facilities is granted only upon DCM approval of the appropriate protocols that detail how the biohazard agent will be handled and disposed of and what safeguards will be followed by research personnel.

    F.3.b.   Ionizing and Non-ionizing Radiation
    Possession and use of radioisotopes must be authorized under the radioactive materials license issued to Stanford University by the State of California. All machines that produce ionizing radiation for which State registration is required must be registered centrally. All projects must comply with pertinent regulations and relevant terms of licenses. The Administrative Panel on Radiological Safety (APRS) monitors compliance with regulations, license conditions and policies utilizing the Health Physics staff of EH&S. All regulated radiation activities are subject to approval by the APRS and are subject to inspection by the Health Physics staff. Detailed policies and procedures governing the acquisition, use and disposal of radiation sources are found in the Radiation Safety Manual (1997), available online or from Health Physics. The Manager of Health Physics, i.e., the Radiation Safety Officer (RSO), is designated in all licenses. The RSO may deny or withdraw approval to use a radiation source where an imminent threat to health and safety, non-compliance or unsafe practice is found, pending review by the APRS.

    F.3.c.   Chemical Agent Use
    Stanford has developed and implemented a written Chemical Hygiene Plan that is directed at controlling exposures to hazardous chemicals in laboratories. The Plan sets forth procedures, equipment, personal protective equipment, and practices that are capable of protecting employees from health hazards presented by hazardous chemicals used in laboratories and are capable of keeping chemical exposures below regulatory limits. The plan is administered through the Department of Environmental Health and Safety (EH&S). Supervisors of researchers and husbandry/cage washing staff are responsible, with assistance from EH&S, for evaluating the potential exposures risks of hazardous chemicals/drugs to staff during chemical preparation, animal dosing, and cage washing. Guidelines and operation specific exposure controls for occupational exposures to hazardous chemicals in chemical preparation, chemical administration, animal care and transport, and cage cleaning have been developed and are available on the EH&S webpage. Whenever agents administered to laboratory animals by research personnel are potentially hazardous, the Facility Operations Manager and/or the Attending Veterinarian discuss the aspects of safety and containment with both the research staff and the animal care staff.

    F.4.

    PERSONNEL PROTECTION for personnel working with laboratory animals includes the issuance of appropriate clothing either as part of their employment or, at their request, the provision of appropriate facilities for maintaining personal hygiene, first aid equipment, training in safe techniques including emergency responses in the event of an incident is also provided. This institution has policies in place for the use of biologic agents, chemical agents, physical agents, and are viewable via the EH&S website at http://www.stanford.edu/dept/EHS/prod/.

    F.5.

    PREEMPLOYMENT MEDICAL EVALUATION is required for all Veterinary Service Center employees as a condition of employment.

    F.6.

    REQUIRED IMMUNIZATIONS are managed by a board-certified occupational medicine physician who reviews LAOHP health questionnaires and determines what immunizations are necessary. Immunization requirements may include tetanus, hepatitis B, vaccinia virus, etc., depending upon the specific circumstances, identified risk factors and determined medical need. The occupational medicine physician reviews LAOHP questionnaires and determines what immunizations are necessary.

    F.7.

    PREVENTIVE MEDICINE PROGRAM is managed by a board-certified occupational medicine physician who reviews LAOHP questionnaires and determines what follow up is needed. A database in EH&S provides the ability to manage occupational health data for personnel and distribution of pertinent occupational health and safety information directly to the animal handler/users. In-service information and training on preventive medicine issues are also provided.

    F.8.

    ZOONOSIS SURVEILLANCE is managed by routinely screening animals for their ability to transmit zoonosis. This institution has appropriate quarantine facilities and procedures in place to prevent zoonosis. Personnel are provided with zoonosis information relevant to the species with which they are working.

    F.9.

    PROCEDURES FOR REPORTING AND TREATING INJURIES include instructing personnel involved in emergency situations to determine whether it is health threatening or not. If it is, they dial 911 and activate the nearest fire alarm if a phone is unavailable. Appropriate authorities, including protocol director, are notified. For a situation that isn't life threatening, medical treatment and follow-up are sought as needed. EH&S is consulted for clean-up assistance in instances involving hazardous materials. Personnel are instructed to report accidents/exposures to their supervisor as soon as possible. Injuries are treated by the occupational health physician or in the institution's emergency room. An investigation team consisting of an industrial hygienist, chemical safety specialist, chemical waste specialist, environmental specialist, Biosafety Officer, radiological safety specialist, and fire marshal is available.

    F.10.

    COVERED PERSONNEL are faculty, staff, students and visiting scholars who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas; the level of participation is dependent upon their level of risk through their assignment to Risk Category 1, (RC1), or Risk Category 2 (RC2). Risk Category 1 is considered higher risk and encompasses Veterinary Service Center employees, other dedicated animal care staff, and individuals who work with nonhuman primates (including unfixed tissue and bodily fluids), hoofed mammals (e.g., swine, goats, sheep, cows), wild rodents, and certain field studies. Specific risk factors are variable and dependent upon specific uses and handling identified in the animal care and use application. Personnel in RC1 must complete and submit a LAOHP questionnaire prior to IACUC approval of an individual to work on a protocol. Each LAOHP questionnaire will be evaluated by the occupational medical provider to determine the level of potential exposure and whether further steps are necessary. Risk Category 2 is for all individuals involved in protocols that do not fall within the RC1 participation group. All individuals in this group are provided with information, educational materials and periodic updates on health and safety issues associated with the particular animal species or research material with which they work. These individuals are strongly encouraged to complete the LAOHP questionnaire, but the LAOHP questionnaire submittal is optional for members of the RC2 participation group.

    F.11.

    PROCEDURES FOR HAZARD AND RISK ASSESSMENT involve input from: a board-certified occupational medicine physician who reviews the LAOHP questionnaires and performs the medical evaluation; the IACUC by review of the protocol; DCM by review of equipment, protective clothing and procedures; and EH&S by evaluation of specific and general risk factors.

    F.12.

    TRAINING OF PERSONNEL, e.g., on Zoonoses, Allergies, Hazards, Special Precautions for Pregnancy, Illness, Immune suppression, is provided through targeted in-service training and information programs, seminars and education programs by the occupational medicine physician and other specialized personnel. These programs, in additional to educational materials sent via email, emphasize the specific risks associated with different types of research with laboratory animals and provide guidance to research and support personnel on appropriate methods of exposure control and protection.

    F.13.

    SPECIAL PRECAUTIONS FOR PERSONNEL WORKING WITH NONHUMAN PRIMATES, e.g., Tuberculosis Screening, Training and Procedures for Bites and Scratches, and Education Regarding Cercopithecine herpesvirus 1 (Herpes B) are managed by requiring that personnel actively working with nonhuman primates be classified as RC1, be screened annually for tuberculosis, and participate in training specific to the prevention of illness/injury with this species. Each nonhuman primate housing area is equipped with injury/exposure kits. Follow up and treatment procedures specific to nonhuman primate exposure have also been developed and disseminated to personnel actively working with nonhuman primates.

  7. The total gross number of square feet in each animal facility (including each satellite facility), the species of animals housed therein and the average daily inventory of animals, by species, in each facility is provided in the attached table. Exhibit 4.


  8. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is summarized below.

    H.1.

    General

    Training in all topics in 9CFR, Part 2, Subpart c, section 2.32(c) is provided either as part of formal or organized training sessions described below or is available in the form of individualized training sessions given on an as-needed basis as indicated during the protocol review process.

    This institution provides faculty/staff/student access to AGRICOLA and the online resources available through AWIC/NAL. Trained librarians within the School of Medicine library are available to assist with literature searches, and advice can also be obtained from the faculty and staff of the Department of Comparative Medicine (DCM) who have experience with literature searches for alternatives.

    H.2.

    Specific Training Courses

    Module I
    Animal Care and Use

    A course is provided to individuals (protocol directors, research staff, animal care staff, students, etc.) who are directly involved with hands-on animal care and use at this institution. The format of the course will be lecture. The course will be presented on a routine basis, at least six times per year.

    The course outline is based, in part, on the 1991 Institute of Laboratory Animal Resources (ILAR) document entitled "Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs." The course outline is provided below:

    Introduction

    Lecture 1  -  Ethical Considerations
    (Estimated Presentation Time: 35 minutes)

    Lecture 2  -  Laws, Policies, and Standards Affecting the Care and Use of Animals in Research and Teaching
    Resources for Animal Research
    (Estimated Presentation Time: 25 minutes)

    Lecture 3  -  Animal Protocol Preparation and Review
    (Estimated Presentation Time: 25 minutes)

    Lecture 4  -  Zoonoses, Allergies and Occupational Health
    (Estimated Presentation Time: 25 minutes)

    Lecture 5  -  Biomethodology, Veterinary Care and Euthanasia
    (Estimated Presentation Time: 25 minutes)

    Lecture 6  -  Anesthesia, Surgery and Post-Operative Care
    (Estimated Presentation Time: 25 minutes)

    Lecture 7  -  Necropsy and Postmortem Sampling
    (Estimated Presentation Time: 10 minutes)

    The time for the course is 3 1/2 hours, including a 30 minute break. A course syllabus provided to all participants.

    Module 2
    Working Safely with Nonhuman Primates

    All individuals who come in contact with nonhuman primates and/or their tissues or body fluids as part of an animal research protocol will be asked to attend a presentation. The format of the course will be lecture and may be taught to small groups or individuals. The course outline is shown below:

    Bacterial, viral and protozoal pathogens that may infect humans

    Human diseases that can be anthroponotic

    Proper handling of non-human primates and appropriate personal protective equipment

    Procedure for dealing with a bite, scratch, needlestick or other exposure involving primates

    Proper waste disposal and decontamination procedures

    The time for the course is one hour. A course syllabus will be provided to all participants.

    Module 3
    Working Safely with Pregnant and Neonatal Sheep

    A small informal training session is given as needed to new members of research groups which have potential Q Fever exposure due to use of higher-risk sheep.

    H.3.

    Other Training Methods

    LABORATORY PARTNERS

    In 1998, the institution initiated an adjunctive method for communication and education. Approximately 80 laboratories have identified a laboratory partner; the other 130 laboratories have been assigned a laboratory partner (protocol director) by default. The laboratory partner and protocol director are responsible to provide other laboratory members with information.

    Informational updates are sent to the laboratory partner from the IACUC office via an email distribution list. In addition to these updates, web-based tutorials have been developed to provide personnel with information relevant to the use of animals and a means of assessing their own knowledge via self-tests.

    WORLD WIDE WEB PROGRAM FOR HOPKINS MARINE STATION PERSONNEL

    A web-based training program, consisting of educational information and tutorials for vertebrate animal users (predominantly fish), has been established for Hopkins Marine Station by one of its staff members. This web-based training program was developed to accommodate the need for training of vertebrate animal users at a remote location. The web-based training program is reviewed periodically by the IACUC.

    INDIVIDUAL TRAINING

    Individual (one-on-one) training is an integral component of the overall VSC training and education program. For example, an orientation session may be given to acquaint users with the procedures utilized for work with rodents housed in specific pathogen free colonies. In all cases this training will be documented and documentation will be kept by VSC.

    H.4.

    Training and Education for VSC Faculty and Staff

    In addition to the courses listed above, VSC staff will participate in a comprehensive training program using Standard Operating Procedures (SOPs). SOPs cover relevant VSC functions (i.e., animal husbandry, veterinary care, diagnostic and pathology procedures, administrative procedures, occupational health and safety, computer operations, etc.).

    All SOPs for the VSC will be centralized, both in hard copy and electronic form. Both current and historical files will be established, and complete records of training will be updated/created.

    H.5.

    Evaluation of Protocol Personnel Training

    All protocols submitted to the IACUC for review must describe experience/training personnel have had or will have with this specific animal model(s). The IACUC then performs an assessment of the personnel's ability to work humanely with animals. The IACUC may assign specific training to personnel as a condition of their approval.

    H.6.

    Additional Training Resources

    REFERENCE MATERIALS

    Reference materials (books, journals, newsletters, bibliographies, videos, brochures, etc.) will be maintained in DCM libraries. Items will be cataloged and available for review by DCM personnel and other individuals.

    WEB RESOURCES

    The Department of Comparative Medicine maintains a website (http://med.stanford.edu/compmed/) that includes VSC resource information, the DCM Newsletters, training information, occupational health and safety information, VSC guidelines, etc.

    The Office of the Dean of Research maintains a website (http://labanimals.stanford.edu) that provides information on institutional policies and practices.

    The Department of Environmental Health and Safety maintains a website (http://www.stanford.edu/dept/EHS) that provides information on safety, health and environmental practices and procedures.

    DCM NEWSLETTER

    The Department of Comparative Medicine publishes a periodic newsletter. The newsletter provides a range of information about current clinical problems, occupational health, and the spectrum of functions of the Veterinary Service Center. The newsletter is also available on the DCM web site.

    RESOURCE MANUAL

    The Resource Manual, which describes animal care and use-related policies, procedures, practices, etc., is available on the DCM website. The web site is routinely updated to maintain current information.

   IV.   INSTITUTIONAL STATUS

As specified in the PHS Policy at IV.A.2., as Category 1, all of this institution's programs and facilities (including satellite facilities) for protocols involving animals have been evaluated and accredited by The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). All of this institution's programs and facilities (including satellite facilities) for protocols involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months, in accord with IV.B.1. and 2. of the PHS Policy, and reports prepared in accord with IV.B.3. of the PHS Policy. All IACUC semiannual reports will include a description of the nature and extent of this institution's adherence to the Guide. Any departures from the Guide will be identified specifically and reasons for each departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC evaluations will be submitted to the Institutional Official. Semiannual reports of IACUC evaluations will be maintained by this institution and made available to the Office of Laboratory Animal Welfare (OLAW) upon request.

   V.   RECORD KEEPING REQUIREMENTS

  1. This institution will maintain for at least three years:

    1. A copy of this Assurance and any modifications thereto, as approved by PHS.

    2. Minutes of IACUC meetings, including records of attendance, protocols of the committee, and committee deliberations.

    3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.

    4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official.

    5. Records of accrediting body determinations.

  2. This institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing protocols reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.

  3. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

 

   VI.   REPORTING REQUIREMENTS

  1. At least once every 12 months, the IACUC, through the Institutional Official, will report in writing to OLAW:

    1. Any change in the status of the institution (e.g., if the institution becomes accredited by AAALAC or AAALAC accreditation is revoked), any change in the description of the institution's program for animal care and use as described in this Assurance, or any changes in IACUC membership. If there are no changes to report, this institution will provide OLAW with written notification that there are no changes.

    2. Notification of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to the Institutional Official.

  2. The IACUC, through the Institutional Official, will provide the OLAW promptly with a full explanation of the circumstances and actions taken with respect to:

    1. Any serious or continuing noncompliance with the PHS Policy,

    2. Any serious deviations from the provisions of the Guide, and

    3. Any suspension of an activity by the IACUC.

  3. Reports filed under VI.A. and VI.B. above shall include any minority views filed by members of the IACUC.

 

   VII.   INSTITUTIONAL ENDORSEMENT AND PHS APPROVAL

A.

Authorized Institutional Official

Name

Arthur Bienenstock, Ph.D.

Title

Vice Provost and Dean of Research and Graduate Policy

Address

Building 10, Stanford, CA 94305-2061

Phone

650 723-4550

Fax

650 725-8013

Signature

 

Date

 

 

B.

PHS Approving Official

Name

Denis J. Doyle

Title

Director, Division of Assurances, OLAW

Address

6705 Rockledge Drive, Bethesda, MD 20892-7982

Phone

301 496-7163

Fax

301 402-2803

Signature

 

Date

 

 

C.

Effective Date of Assurance:     April 12, 2005

D.

Expiration Date of Assurance:     May 31, 2009

 

Provider: Office of the Vice Provost and Dean of Research, Stanford University
Contact: Research Compliance Administrator
Last updated:September, 2005