THE MSU PUBLIC HEALTH SERVICE (PHS) ASSURANCE STATEMENT

1. Institutional Policy
2. Institutional Program for Animal Use and Care
3. Record Keeping
4. Reporting Requirements

I. 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, as well as with Federal and State Paperwork Reduction Acts.
   
   
2. This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals 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 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 activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide). Top

II. Institutional Program for Animal Use and Use:

1. This institution has established an the Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution's animal care program, facilities, and procedures.
   
   
2. The IACUC:
   
   1. Reviews at least once every 6 months the institution's program for humane care and use of animals, using the Guide as the basis for evaluation.
   
   2. Inspects at least once every six months all of the institution's animal facilities, (including satellite facilities) using the Guide as basis for evaluation.
   
   3. Prepares reports of the IACUC evaluations as set forth in the PHS Policy and submit the reports to the Assistant Vice President for Research and Graduate Studies.
   
   4. Reviews concerns involving the care and use of animals at the institution.
   
   5. Makes written recommendations to the Assistant Vice President for Research and Graduate Studies regarding any aspect of the institution's animal program, facilities, or personnel training.
   
   6. Reviews and approves, require modifications in (to secure approval), or withholds approval of those sections of applications or proposals to PHS and any other granting agencies related to the care and use of animals as set forth in the PHS Policy at IV.C.
   
   7. Reviews and approves, require modifications in (to secure approval), or withholds approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy.
   
   8. Notifies investigators and the institution in writing of its decision to approve or withhold approval of those sections of applications or proposals related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy.
   
   9. Is authorized to suspend an activity involving animals as set forth in the PHS Policy.
   
   
3. The procedures which the IACUC will follow to fulfill the requirements set forth in the PHS Policy at IV.B include:
   
   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.
    
   2. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as specified in PHS Policy at IV.C.  The IACUC meets at least once a month to review project descriptions (protocols) prepared by investigators or instructors prior to beginning research or teaching involving animals.
   
   3. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities:  Written updates on all approved protocols are required every 12 months. The Chairperson of the IACUC reviews and approves continuation of ongoing studies that have not changed significantly since the initial full committee review. If changes have occurred in the study that may affect the care and welfare of the animals involved, the Chairperson will request additional information, amendments or a revision of the protocol which will be reviewed by the full IACUC committee. The committee will review, approve, require modifications or withhold approval of the proposed changes regarding the use of animals in ongoing activities as deemed necessary by committee agreement. Generally, significant changes will require the filing of a new protocol. Such re-review will be conducted in conformance with all guidelines as set forth in section IV.C.
   
   4. 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 at IV.C.4." The committee will notify the investigator and the institution in writing of its decision to approve, require modifications before approval or its intent and reasons to disapprove a protocol usually within 7 days of the committee decision. The committee will not disapprove a protocol until the principal investigator has had an opportunity to respond to the committee in writing or at a convened meeting of the IACUC. The committee will inform, in writing, the Chancellor of all disapproved protocols and the reasons for said disapprovals. The investigator may appeal a disapproval action to the committee chairperson or the Institutional Official who may then ask for a re-review by the committee. No Institutional Official or non-committee member may override a committee decision related to protocol or grant proposal reviews.
   
   5. Be authorized to suspend activity involving animals in accord with specifications set forth in IV.C.6. The MSU IACUC has the authority to suspend activity involving animals as set forth in section IV.C.6. Such suspensions will also be in conformance with sections IV.C.7 and 8.
   
   
4. MSU has an occupational health program for personnel who work in laboratory animal facilities or have frequent contact with animals.
   
   
5. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment or use are:
   
   1. This Web Site provides information on current laws/regulations, university services and facilities for research animals, animal models, experimental techniques, anesthesia/analgesia, euthanasia, animal handling and manipulation, IACUC functions and policies, and other related subjects.
   
   2. In addition, audiovisual materials on the proper care and use of animals, individualized instruction by a veterinarian or animal technologist, and reference materials, relating to the humane care and use of animals in research are available. Top

III. Record Keeping:

1. This institution will maintain for at least five years:
   
   1. A copy of this assurance and any modifications 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 as forwarded to the Assistant Vice President for Research and Graduate Studies.
   
   5. Records of accrediting body (AAALAC), USDA and all Site Visit determinations.  All complete records of IACUC activities will be kept in the IACUC Office under the direction of the Chairperson of the IACUC. The institution will provide the Chairperson with adequate staff to fulfill these responsibilities.
   
   
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. Top

IV. Reporting Requirements

1. At least once every 12 months, the IACUC, through the Institutional Officer will report in writing to the Office of Laboratory Animal Welfare (OLAW):
   
   1. Any change in the status of the institution (e.g., if 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 the IACUC membership. If there are no changes to report, this institution will submit a letter to OLAW stating that there are no changes.
   
   2. Notification of the date that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to the Chancellor, UCHSC.
   
   
2. The IACUC, through the Institutional Official, will provide the OPRR 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.
   3. Any suspension of an activity by the IACUC.
   
   
3. Reports filed under IV.A.2. and IV.B above, shall include any minority visits filed by members of the IACUC. Top

Index of Program Overview