Research Policy Handbook

Animal Welfare Assurance of Compliance (RPH 8.1)

Current version: May 18, 2009

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, 2013. (See DHHS letter of approval - pdf file).

The Leland Stanford Junior University, hereinafter referred to as "institution," by means of this document, provide assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as "PHS Policy. "

I. APPLICABILITY OF ASSURANCE

This Assurance is applicable to all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as activities, involving live vertebrate animals supported by the Public Health Service (PHS) and conducted at this Institution, 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 COMMITMENT

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 activities covered by this Assurance. As partial fulfillment of this responsibility, this Institution will 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 activities 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 as follows: Attachment one [ pdf file ].

2. The qualifications, authority, and percent of time contributed by veterinarian(s) who will participate in the program are as follows:

   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 IIIA, 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 Attending Veterinarian also have a reporting relationship with the Institutional Official.

   Professor and Chair, Director, 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 VSC; 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: 70%.

   Professor, D.V.M., LSU School of Veterinary Medicine, 1985; Ph.D. in Neurobiology, UC-Davis, 1995; Diplomate, American College of Veterinary Internal Medicine, 1992; Assistant Professor, Department of Comparative Medicine, 1995; Associate Professor, Department of Comparative Medicine, 2003; Professor, Department of Comparative Medicine, 2008; Director of Surgical Services; Associate Director of the Veterinary Service Center and Attending Veterinarian 2006-2008. Percentage of time contributed: 100%. Currently on sabbatical.

   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; Professor, Department of Comparative Medicine, 2008. Director of Necropsy and Clinical Diagnostic Services. Provides diagnostic pathology support to the Stanford researchers and participates in researcher training. Percentage of time contributed is: collaborative research - 56.5%, teaching - 18.5%, and clinical service - 25%.

   Dr. Stephen Felt, Assistant Professor, Attending Veterinarian, D.V.M., University of Wisconsin, 1989; MPH, Uniformed Services University, 2003; Diplomate, American College of Veterinary Preventive Medicine, 2003; Diplomate, American College of Laboratory Animal Medicine, 2005; Assistant Professor, Department of Comparative Medicine, 2008. Associate Director of the Veterinary Service Center (VSC) and responsibilities include: program authority, supervising personnel, training of investigative staff, assisting researchers with protocol preparation, protocol review, IACUC voting member and clinical care of animals. Attending Veterinarian also serves as the Director of Laboratory Animal Medicine Residency Program (currently three residents). Percentage of time contributed: 100%.

   Assistant Professor, Ph.D. in Ecology, University of California, Davis, 1979; D.V.M., University of Tennessee, 2004; Diplomate, American College of Laboratory Animal Medicine, 2008. Supervises Mouse Cryopreservation and Rederivation Program; supervises Rodent Sentinel Program; voting member of Administrative Panel on Laboratory Animal Care; alternate member of Administrative Panel of Biosafety; ex-officio member of Administrative Panel on Stem Cell Research Oversight; participates in Laboratory Animal Residency Program. Percentage of time contributed: 100%.

   Staff Veterinarian, D.V.M, Michigan State University, 1999; Ph.D. in Human Genetics, University of Michigan, 2007; Diplomate, American College of Laboratory Animal Medicine, 2008; Staff Veterinarian, Department of Comparative Medicine, 2007. Responsible for supporting the clinical service functions of the Veterinary Service Center, participates in protocol director training programs, participates in IACUC protocol review. Percentage of time contributed: 80%.

   Staff Veterinarian, D.V.M, University of California at Davis, 2003; Resident in laboratory animal medicine, UCLA, 2006; Diplomate, American College of Laboratory Animal Medicine, 2007. Responsible for supporting the clinical service functions of the Veterinary Service Center including animal health management, investigator training, IACUC activities, and resident training. Percentage of time contributed: 100%.

   Staff Veterinarian, DVM, University of Illinois 1993. Diplomate, American College of Laboratory Animal Medicine 1998. Clinical veterinarian supports clinical service functions of the Veterinary Service Center. Percentage of time contributed: 100%.

   Staff Veterinary Pathologist/Senior Research Scientist; BVSc, University of Sydney, 2000; Diplomate, American College of Veterinary Pathologists, 2007. Responsible for providing diagnostic pathology support to the Veterinary Services Center and participates in laboratory animal medicine resident training. Percentage of time contributed: 100%.

   Resident, Laboratory Animal Medicine, Stanford University; D.V.M., Ross University School of Veterinary Medicine 2001-2004; ACLAM Training Fellowship, Stanford University, 2008-2011. Responsible for supporting the clinical service functions of the Veterinary Service Center. Percentage of time contributed: 100%.

   Resident, Laboratory Animal Medicine, D.V.M., University of California, Davis, 2008; ACLAM Training Fellowship, Stanford University, 2008-2011. Responsible for supporting clinical services functions of the Veterinary Service Center. Percentage of time contributed: 100%.

   Resident Laboratory Animal Medicine, D.V.M., Tuskegee University, 2008; ACLAM Training Fellowship, 2008-2011. Responsible for supporting the clinical service functions of the Veterinary Service Center. Percentage of time contributed: 100%.

3. The Institutional Animal Care and Use Committee (IACUC) at this Institution is properly appointed in accordance with the PHS Policy IV.A.3. (the University President has delegated authority for IACUC appointments, specifically and in writing to the Institutional Official) and is qualified through the experience and expertise of its members to oversee the Institution's animal care and use program and facilities. The IACUC consists of at least five members, and its membership meets the composition requirements set forth in the PHS Policy, Section IV.A.3.b. Attached is a list of the chairperson and members of the IACUC and their degrees, profession, titles or specialties, and institutional affiliations. Attachment two.

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 as follows: the IACUC will review semiannually the University’s Program for Laboratory Animal Care and Use at convened meetings utilizing 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 their convened meetings; 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 as follows: inspect every six months all of the University’s animal facilities, including satellite holding facilities and areas in which surgical manipulations are performed, 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 where USDA-covered species are housed or used and IACUC members and/or ad hoc consultants inspecting where non-USDA covered species are housed or used. Facility inspection findings are presented at convened IACUC meetings. Any IACUC member can attend an inspection of any facility.
   D. 3.	Prepare reports of the IACUC evaluations as set forth in the PHS Policy IV.B.3 and submit the reports to the Institutional Official. The IACUC procedure for developing reports and submitting them to the Institutional Official are as follows: the IACUC develops 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; listing the dates when program evaluation and facilities inspections were conducted and provides any minority views or a statement that there were no minority views; the IACUC evaluations are reviewed and approved at an IACUC meeting; the IACUC submits reports to the Institutional Official via the IACUC office. the IACUC identifies and discusses departures from the Guide, the Policy, and as applicable, 9 CFR Chapter I, subchapter A, during their program evaluations, facilities inspections and protocol review, any departure is designated in IACUC records and if new, reported to the Institutional Official in the IACUC evaluations; the IACUC ensures through their facilities inspections and program evaluations processes that any deficiencies are characterized as significant or minor, and assigns reasonable and specific plans and schedules for the correction of each deficiency.
   D. 4.	Review concerns involving the care and use of animals at the Institution. The IACUC procedures for reviewing concerns are as follows: the IACUC facilitates and enables individuals’ abilities to report concerns involving animal care and use by posting the telephone number for reporting concerns anonymously in multiple locations throughout the main animal facilities, where the majority of animal users pass through; posting the telephone number for reporting concerns anonymously on the IACUC website; and providing information in the general animal care and use seminar on reporting concerns anonymously; the IACUC reviews all concerns with safeguards to protect the individual's identity, and if needed, appoints a subcommittee to perform an IACUC investigation; review any subcommittee investigation findings at a convened meeting and takes appropriate action, if warranted, up to and including suspension of a protocol; the IACUC reports concerns and related IACUC findings and recommendations, via the IACUC Chair, Attending Veterinarian or IACUC office to the Institutional Official.
   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 as follows: the IACUC will evaluate, usually by subcommittee, a particular aspect of the University’s animal program, facilities, or personnel training; review subcommittee reports at a convened meeting and vote to approve the report; submit written recommendations for review, via the IACUC Office, by the Institutional Official.
   D. 6.	In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require modifications in (to secure approval), or withhold approval of PHS-supported activities related to the care and use of animals. The IACUC procedures for protocol review are as follows: Receipt of protocols and pre-review: protocols are received in the IACUC office (on-line eProtocol system, eProtocol). IACUC staff pre-review all protocols for completeness and adherence to animal welfare standards, and write routine comments to comply with federal regulations and University policies/practices. Notification of members: IACUC members are notified of IACUC review by an auto-generated email from eProtocol when protocols are assigned to IACUC members (primary IACUC reviewers) and when the list of protocol activities is circulated to all IACUC members prior to any IACUC action by an auto-generated email list from eProtocol. Distribution: Protocol activities are distributed in eProtocol, for primary IACUC review as either: 1) full committee review; or 2) designated member review, (descriptions below under “Methods of Protocol Review”) based on established criteria. Only after all members have received a list of proposed research protocols, had written descriptions of those protocols available to them, and decided that full-committee review is not necessary, can the designated reviewers review and approve the protocols. Meetings and attendance requirements: The IACUC meets at least monthly; the IACUC proceedings are confidential. A quorum of the IACUC must be present to conduct its business. Alternates are encouraged to attend all meetings. All agendas and minutes are sent to all IACUC members, and a copy is sent to Institutional Official. Methods of protocol review Full committee review: Protocol activities that have been referred for Full Committee Review are assigned to IACUC primary reviewers, (a minimum of two IACUC members); the IACUC staff assigns other expert reviewers to protocols when applicable; Radiation Safety when a project involves radioisotope use and/or Biosafety when a project involves a biological agent or recombinant DNA vectors. The IACUC primary and expert reviewers review the protocol in the eProtocol system; IACUC reviewers submit their comments and requests for modification to the IACUC office within eProtocol. The IACUC office reviews all comments and requests for modification received for consistency and any duplication, and then sends the comments and requests for modification to the Protocol Directors. Protocol Directors are notified via an auto-generated email that comments have been sent on the protocol. All comments and requests for modification are sent without referencing the author of the comments and requests for modification, thus preserving IACUC reviewer anonymity. Comments and requests for modification are sent out with a request for response within three business days. Upon return-receipt of the Protocol Directors� responses to the comments and required modifications to the protocol, the IACUC staff reviews the responses and modifications, then forwards responses and modifications to the IACUC reviewers. Comments and modifications within the protocol are then reviewed by the reviewer. If additional questions arise or modifications need to be made, another round of comments is generated and sent to the Protocol Directors for responses. This process is repeated as often as necessary, until all reviewer questions have been answered and requested modifications to the protocol have been made. The protocol is then assigned to a convened IACUC meeting agenda. A protocol assigned to full committee review will be presented at a convened meeting by IACUC primary reviewers and/or discussed collectively at the meeting with direction from the IACUC Chair, prior to a vote to approve with or without further modifications to secure approval or withhold approval. If approval is withheld, the IACUC will provide written notification to the Protocol Director and provide the Protocol Director with an opportunity to respond in person and/or in writing. If substantive modifications are required, the IACUC will vote to return the modified protocol for full committee review or send the modified protocol for designated member review, as described below in the designated member review section. If designated member review is selected, then all IACUC members will have the revised research protocol available to them and the opportunity to call for full committee review prior to designated review and approval. At least 5 days prior to any convened meeting, a list of all protocol activities is sent to all IACUC members via an auto-generated email list. Complete written descriptions of these protocols are available to all IACUC members within the eProtocol system. Designated member review: Protocol activities referred for designated review are assigned by the IACUC Chair (or IACUC Chair designee) to IACUC primary reviewers, (a minimum of one IACUC member); the IACUC staff also assigns other expert reviewers to protocols when applicable, e.g., Radiation Safety when a project involves radioisotope use and/or Biosafety when a project involves a biological agent or recombinant DNA vectors. The IACUC designated and expert reviewers review the protocol in the eProtocol system. IACUC reviewers submit their comments and requests for modification to the IACUC office within eProtocol. The IACUC office reviews all comments and requests for modification received for consistency and any duplication, and then sends the comments and requests for modification to the Protocol Directors. Protocol Directors are notified via an auto-generated email that comments have been sent on the protocol. All comments and requests for modification are sent without referencing the author of the comments and requests for modification, thus preserving IACUC reviewer anonymity. Comments and requests for modification are sent out with a request for response within three business days. Upon return-receipt of the Protocol Directors' responses to the comments and required modifications to the protocol, the IACUC staff reviews the responses and modifications, then forwards responses and modifications to the IACUC reviewers. Comments and modifications within the protocol are then reviewed by the reviewer. If additional questions arise or modifications need to be made, another round of comments is generated and sent to the Protocol Directors for responses. This process is repeated as often as necessary, until all reviewer questions have been answered and requested modifications to the protocol have been made. Once this process has been concluded, the designated member can indicate the protocol activity is ready for approval or that full committee review is needed. Prior to designated member approval release, a list of all designated member protocol activities is sent to all IACUC members via an auto-generated email list. Complete written descriptions of these protocols are available to all IACUC members within the eProtocol system. Any member of the IACUC may request full committee review of those protocols that had been reviewed by designated member review. If full committee review of those protocols reviewed by designated members is not requested by the end of the predetermined time period, usually three days, then the protocol is considered approved by the designated member review process. In an emergency situation, the predetermined time period for review may be shortened, but the procedures for designated review as outlined above will be followed. CONFLICTS OF INTEREST Protocol activities that disclose a potential Investigator Conflict of Interest or potential Institutional Conflict of Interest are referred to the appropriate campus entities for follow up review. The IACUC requires members to decline participation in any type of IACUC review and/or voting, in which the member has a conflicting interest. The definition of Conflict of interest includes participation in the project, involvement in competing projects, a financial interest, a personal relationship, or other situation giving rise to a conflicting interest as defined in the Guidelines for A-PLAC Members on Conflict defined in �Guidelines for A-PLAC members on Conflicting Interests� (Stanford IACUC Handbook). Any member having a conflicting interest must leave the meeting during the discussion of and vote on the protocol. No member leaving the room because of a conflicting interest or any other reason will be counted as part of the quorum for any vote taking place while the member is out of the room. VOTING The IACUC requires a quorum to conduct its business. Voting occurs after IACUC review and deliberations at a convened meeting. An approval vote of a majority of the quorum present is needed for any IACUC action. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity of vote with the IACUC unless they are also members of the IACUC.
   D. 7.	Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are as follows: The IACUC processes significant changes for IACUC review under either: Full Committee Review or Designated Member Review, as described above.
   D. 8.	Notify investigators and the Institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy IV.C.4. The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are as follows: The IACUC notifies Protocol Directors and the Institutional Official by auto-generated email reports of IACUC decisions regarding protocol review.
   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 IV.C.1-4 at least once every three years. The IACUC procedures for conducting continuing reviews are as follows: The IACUC monitors ongoing activities through their post-approval monitoring program, including: Veterinary walk-throughs or veterinary assignments to animal use areas where protocol activities take place. Assignment of protocols (during protocol review process) for specific veterinary or IACUC inspection manager in-person monitoring. This monitoring is followed up by subsequent reporting during IACUC meetings. IACUC semiannual inspections and follow up inspections. The IACUC procedures for conducting complete review of continuing activities require at least annual review. Protocol Directors complete and submit a renewal protocol application annually (within the eProtocol system). The IACUC reviews the annual renewal application, along with the initial protocol submission and any subsequent revised versions of the protocol (within the eProtocol system) that conforms to the Guide, PHS Policy, and as applicable, 9CFR Chapter I, subchapter A, under either: Full Committee Review or Designated Member Review, as described above.
   D.10.	Be authorized to suspend an activity involving animals as set forth in the PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are as follows: Suspension of 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; Review of the reasons for suspension with the Institutional Official and implementation of appropriate corrective action; Submission of a full report to the Institutional Official, who then submits a written report to OLAW, for PHS supported research, USDA, and other relevant entities.
   D.11.	The institution's procedures for off site activities involving research animals are: PAVAHCS: 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. Off site research: off-site research, involving animal studies and institutional protocol directors conducting vertebrate animal research, teaching, 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; and, if applicable, proof of a currently approved PHS Assurance, a USDA registration number, or a certificate of registration from the State of California.

5. The occupational health and safety program for personnel workING in laboratory animal facilities or have frequent contact with animals is as follows:

   E.1.	The Laboratory Animal Occupational Health Program (LAOHP) is administered through Stanford’s Department of Environmental Health & Safety (EH&S) in the onsite Stanford University Occupational Health Center (SUOHC), in close cooperation with the Department of Comparative Medicine (DCM) and the IACUC. The LAOHP provides information and safeguards for personnel working with laboratory animals and hazardous agents in the following underlined areas.
   E.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/hair covers and booties, chemical resistant aprons, boots, and gloves, and steel mesh and/or gloves. Appropriate protective equipment and/or clothing are 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.
   E.3.	HAZARDOUS AGENT HANDLING E.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, SUOHC 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 2007) available on-line at the EH&S website, or in hard copy from the EH&S offices. Additionally, the Biosafety Manager is an IACUC member and 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. Stanford 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. E.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 through EH&S.; 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 (updated 2007), available on-line 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, noncompliance or unsafe practice is found, pending review by the APRS. E.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). Managers and supervisors of researchers, animal care technicians, and husbandry/cage washing staff are responsible, with assistance from SUOHC and 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.
   E.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 https://www.stanford.edu/dept/EHS/prod/.
   E.5.	PREEMPLOYMENT MEDICAL EVALUATION is required for all Veterinary Service Center employees as a condition of employment.
   E.6.	REQUIRED IMMUNIZATIONS is managed by the Medical Director of the SUOHC who reviews LAOHP health questionnaires and determines what immunizations are necessary. Immunization requirements may include tetanus, hepatitis B, rubeola, vaccinia virus, etc., depending upon the specific circumstances, identified risk factors and determined medical need.
   E.7.	PREVENTIVE MEDICINE PROGRAM is managed by the Medical Director of the SUOHC who reviews LAOHP questionnaires and determines what follow up is needed. A medical records database in EH&S provides the ability to manage occupational health information for personnel. Pertinent and specific occupational health and safety information can be distributed directly to the animal handler/users. In-service information and training on preventive medicine issues are also periodically provided.
   E.8.	ZOONOSIS SURVEILLANCE is managed by screening all animals for select pathogens during the procurement process and routine testing following arrival to our facility. This institution has appropriate quarantine facilities and procedures in place to prevent zoonoses. All personnel working with animals are provided general information on zoonotic agents and personnel working with higher-risk species (e.g., nonhuman primates, pregnant sheep) are required to receive additional species-specific training.
   E.9.	PROCEDURES FOR REPORTING AND TREATING INJURIES include instructing personnel involved in emergency situations to determine whether it is life 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 through the SUOHC. 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 SUOHC medical professionals during office hours (Monday-Friday 8:00 a.m. to 5:00 pm) or in the Stanford Hospital Emergency Room during weekends or nights. The Medical Director of SUOHC remains on-call to assist ER staff with the management of occupational illness/injuries as needed. An investigation team consisting of an industrial hygienist, chemical safety specialist, chemical waste specialist, environmental specialist, Biosafety Officer, radiological safety specialist, occupational health professional and fire marshal is available as appropriate for follow up.
   E.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. Personnel participate via a risk-based program. 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, and 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 health professional 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 risk 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 completion and submittal is optional for members of the RC2 participation group.
   E.11.	PROCEDURES FOR HAZARD AND RISK ASSESSMENT involves input from: the Medical Director of the SUOHC 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.
   E.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 SUOHC staff and other specialized personnel. These programs, in addition 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.
   E.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 in RC1 risk category, 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. Additionally, both the SUOHC and the Stanford Emergency Department have special and specific medical Standard Operating Procedures to follow for evaluation and treatment of nonhuman primate bites/scratches.

6. 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 Facility and Species Inventory table. Attachment three.

7. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:

   G.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.
   G.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 - Introduction 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 and resource material are 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: Overview of Biohazards Associated With Nonhuman Primates 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 and resource material is provided to all participants. Module 3 Working Safely with Pregnant and Neonatal Sheep All individuals who come in contact with pregnant or neonatal sheep 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: An introduction to Q Fever, its causative agent and the risk to human health Requirements for medical education and health surveillance of personnel Procedures for employees working in biohazardous areas Routine husbandry for pregnant or neonatal sheep Waste disposal and fomite containments in animal housing rooms and surgery areas Transport of animals Requirements of animal holding facilities Requirements of laboratories and surgical facilities Research Practices Procedures for collecting and handling placental tissue and amniotic fluid for PCR testing Procedures in the event a sheep tests positive for Q Fever or aborts The time for the course is one hour. A course syllabus and resource material is provided to all participants.
   G.3.	Other Training Methods LABORATORY PARTNERS In 1998, the institution initiated an adjunctive method for communication and education. Communications pertaining to veterinary review, anesthetic/analgesic agent updates, pathogen containment, chemical agent safety, etc. are emailed to laboratory partners (each animal laboratory on campus has at least one laboratory partner). The laboratory partner and protocol director are responsible to provide other laboratory members with information and updates from this program. 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.
   G.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 are centralized, both in hard copy and electronic form. Both current and historical files are established.
   G.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.
   G.6.	Additional Training Resources REFERENCE MATERIALS Reference materials (books, journals, newsletters, bibliographies, videos, brochures, etc.) are maintained in DCM libraries. Items are cataloged and available for review by DCM personnel and other individuals WEB RESOURCES The Department of Comparative Medicine maintains a website (https://med.stanford.edu/compmed/) that includes VSC resource information, training information, occupational health and safety information, VSC guidelines, etc. The Office of the Dean of Research maintains a website (https://labanimals.stanford.edu) that provides information on institutional policies and practices. The Department of Environmental Health and Safety maintains a website (https://www.stanford.edu/dept/EHS) that provides information on safety, health (including the Laboratory Animal Occupational Health Program) and environmental practices and procedures. 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. IACUC MEMBER TRAINING IACUC Members are provided with an orientation session to learn about IACUC membership responsibilities. There is an online IACUC member handbook that contains supplementary relevant policies, practices and procedures. IACUC meetings have a section reserved for ongoing IACUC member education. All IACUC members are encouraged to attend the Veterinary Service Center general training sessions. This Institution also supports IACUC member attendance at local and National IACUC-related meetings.

IV. INSTITUTIONAL PROGRAM EVALUATION AND ACCREDITATION

All of this Institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC within the past six months and will be re-evaluated by the IACUC at least once every six months thereafter, in accord with the PHS Policy IV.B.1-2. Reports have been and will continue to be prepared in accord with the PHS Policy IV.B.3. 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’s evaluations will be submitted to the Institutional Official. Semiannual reports of IACUC evaluations will be maintained by this Institution and made available to the OLAW upon request.

This Institution is Category One (1)�accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). As noted above, reports of the IACUC�s semiannual evaluations (program reviews and facility inspections) will be made available 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, activities 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, Vice Provost and Dean of Research.
   5. Records of accrediting body determinations.
2. This Institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities 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. This Institution’s reporting period is January 1 – December 31. The IACUC, through the Institutional Official, will submit an annual report to OLAW on January 31 of each year. The report will include:

   1. Any change in the accreditation status of the Institution (e.g,. if the Institution obtains accreditation 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 change in the IACUC membership. If there are no changes to report, this Institution will provide 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, Vice Provost and Dean of Research.

2. The IACUC, through the Institutional Official, will promptly provide OLAW 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.
   3. Any suspension of an activity by the IACUC.

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