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Cleveland State University (CSU), 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.

IACUC(LABORATORY ANIMALS)FORMS

Applicability
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.

Institutional Policy
This Institution will comply with all applicable provisions of the Animal Welfare Act and other Federal Statutes and regulations relating to animals.

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

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 animals care and use.

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).

The Chairperson and members of the Institutional Animal Care and Use Committee are appointed directly by the President of the University. At CSU, the President is both the Chief Executive Officer and Institutional Official. The Committee is supported by staff under the supervision of the Director of Sponsored Programs and Research. Animal facilities at the University are under the direction of the Vice Provost for Research. The Consulting Veterinarian reports to the Vice Provost for Research, the Director of Sponsored Programs and Research, the Animal Care Facility Coordinator and the Committee on matters related to the day-to-day veterinary care of animals and policy matters related to the University's compliance with applicable federal regulations. The Animal Care Facility Coordinator reports directly to Director of Sponsored Programs and Research.

The qualifications and authority of the veterinarian who will participate in the program are available through the OSPR.

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 eleven (11) members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b. A list of members is available through OSPR.

The IACUC will:

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. 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.
3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3, and submit the reports to the President of the University.
4. Review concerns involving the care and use of animals at the Institution.
5. Make recommendations to the President regarding any aspect of the Institution's animal program, facilities, or personnel training.
6. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS policy at IV.C.
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 at IV.C.
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 at IV.C.R.
9. Conduct continuing review of each previously approve, ongoing activity covered by this 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.
10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.


The procedures which the IACUC will follow to fulfill the requirements set forth in the PHS Policy at IV.B. are:


11. The IACUC is scheduled to meet on a monthly basis; however, if there are no new applications/proposals or concerns that need to be addressed, the meeting may be canceled.
12. Every 6 months the IACUC reviews CSU's program for humane care and use of animals, and inspects CSU's animal facilities using the Guide as a basis for evaluation.
13. Reports of the IACUC evaluations, conducted as required by IV.B.1. and 2. of this policy, are submitted to the President. The reports contains a description of the nature and extent of the Institution's adherence to the Guide and this Policy, and identify specifically and departures from the provisions of the Guide and this Policy, and state the reasons for each departure. The reports distinguish significant deficiencies from minor deficiencies. Program or facility deficiencies are noted in the reports when applicable. The reports contain a reasonable and specific plan and schedule for correcting each deficiency.
14. Any comments referred to the Committee or received at other times will be addressed by the Committee in a timely manner.
15. All new applications or proposals to the PHS that include the use of animals in the proposed research will be reviewed by the Chairperson of the Institutional Animal Care and Use Committee. Those sections that relate to the care and use of animals shall also be available to all IACUC members, and any member of the IACUC may, upon request, obtain a full committee review of those sections. If full committee review is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, shall review those sections and have the authority to approve, require modifications (to secure approval) or request full committee review of those sections. If full Committee review is requested, approval of those sections may be granted only after review at a convened meeting of a quorum of the IACUC. The proposal shall not be reviewed by any member when the member has a conflicting interest (e.g. is personally involved in the project), except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
16. The IACUC shall conduct continuing review of applications and proposals covered by this policy at appropriate intervals as determined by the IACUC.
17. The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the applicable provision of the Animal Welfare Act, the Guide, or the Institution's Assurance. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.
    • If the IACUC suspends an activity involving animals, the President, in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action and report that action with a full explanation to the Office for Protection from Research Risks (OPRR).
    • Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the Institution. However, those officials may not approve those sections of an application or proposals related to the care and use of animals if they have not been approved by the IACUC.
    • Investigators are required to submit for IACUC review any proposed changes in the use of animals already submitted and approved. Such changes will be reviewed following the procedures outlined for new applications or proposals.

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 is the Chairperson of the IACUC.

The health program for personnel who work in laboratory animal facilities or have frequent contact with animals is available by contacting OSPR.

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, by species, of animals in each facility is available by contacting OSPR.

The University has the obligation to ensure that the qualifications of those performing animal research are adequate. High standards of professional conduct are expected of all faculty. Technicians and students, both graduate and undergraduate, must be trained in proper methods of animal anesthesia, surgery, or other experimental manipulations by regular faculty members. A formal course consisting of six one-hour workshops covering various aspects of animal laboratory care is presented annually by the Consulting Veterinarian. All faculty animal users must attend all 6 seminars within a two-year period and all students and technicians working with animals within University facilities must attend all 6 seminars within their first year of employment. For more specialized training involving hazardous biological or chemical agents, researchers may consult with the Institution's Director of Environmental Health and Safety, or may take special training at other universities or government laboratories.

All IACUC semiannual reports include a description of the nature and extent of the 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 and include a schedule for correcting each deficiency. Semiannual reports of the IACUC evaluations will be submitted to the Institution's President. Semiannual reports of IACUC evaluations will be maintained by the Institution and made available to the Office for Protection from Research Risks (OPRR) upon request.

Record keeping Requirements

This Institution will maintain for at least three years:

1. A copy of this Assurance and any modification 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 Institution's President.
5. Records of accrediting body determinations.

This Institution will maintain records that relate directly to applications, proposal, 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.

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

At least once every 12 months, the IACUC, through the Institutional Official, will report in writing to the Office for Protection from Research Risks (OPRR):

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 OPRR with written notification that there are not changes.
2. Notification of the date that the IACUC conducted its semiannual evaluations if the Institution's program and facilities (including satellite facility) and submitted the evaluation to the President.

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.