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Policy number: 10.9

Policy section: Research

Revised Date: January 2, 2019

1. Definitions

Definitions of capitalized terms are set forth in Appendix A.

2. Policy Statement

It is the policy of the University that the use of Animals in Research and instruction will conform to all applicable laws, rules, and regulations of the United States Government and the State of Texas. All such Research and instruction must be performed in compliance with the highest standards of ethics, practice, and conduct of each of the fields or disciplines involved in the specific Research projects or instructional activities.

3. Purpose

1. The purpose of this policy is to establish rules, requirements, and procedures that govern the humane conduct of Animal-based activities, to ensure compliance with external regulations and to establish roles and responsibilities of those individuals who are involved in the care and use of Animals in Research, testing and teaching.
2. The University is committed to the highest ethical standards of Animal care and use, and to ensuring compliance with all relevant laws, regulations, rules, and guidelines governing the humane care and use of Animals. All laws, regulations, rules, and guidelines, including, but not limited to, the PHS Policy, the Guide, the Animal Welfare Act, the Health Research Extension Act, and the U.S. Government Principles must be followed. Additional information on federal regulations, policies, and guidelines is provided in the Research Handbook.

4. General Policy Points

1. To ensure compliance with regulations regarding the humane care and use of Animals in Research and instruction, the President has delegated the responsibility as Institutional Official to the Assistant Vice President for Research Integrity and Operations. The Institutional Official has the legal, administrative, and operational authority to commit University resources to ensure compliance with the PHS Policy and other requirements. The Institutional Official signs the University’s PHS Animal Welfare Assurance.
2. In accordance with the Health Research Extension Act and the Animal Welfare Act, the University has established the IACUC to oversee Research using Animal subjects. The IACUC will consist of no fewer than five members with varying backgrounds who will be appointed by the Institutional Official. At least one member will be a licensed Doctor of Veterinary Medicine (Attending Veterinarian) and at least one member will be a person whose primary vocation is in a nonscientific area. One member will be unaffiliated with the University. Once appointed, the IACUC reports to and advises the Institutional Official.
3. The IACUC must exercise its responsibility and authority to approve, withhold approval of, require changes in, or suspend Research or instructional Protocols involving Animals in accordance with federal law, regulations, and federal and state agency guidelines. The acquisition or use of Animals in Research or instruction covered by this policy will not be permitted until the IACUC has reviewed and approved the Protocol. The IACUC will not normally consider any requests for retroactive approvals. The IACUC’s authority to review and approve Protocols is independent of the Institutional Official. The Institutional Official does not have the authority to overturn any IACUC decision. If the IACUC approves a Protocol, however, the University is not required or obligated to conduct the Research activity, nor is there a guarantee of Animal space in the Animal facility. The IACUC may also submit Protocols for additional institutional review by the Institutional Biosafety Committee, Radiation Safety Committee, or other University oversight committees as deemed appropriate by the IACUC.
4. The IACUC must perform semiannual program evaluations as a means of overseeing the Animal care and use program. In its semiannual reports the IACUC must advise the Institutional Official of the status of the University’s compliance, report plans and schedules for correcting deficiencies necessary to maintain or achieve compliance, and make recommendations to the Institutional Official regarding any aspect of the University’s Animal program, facilities, or personnel training.

5. Roles and Responsibilities: Institutional Official

1. The Institutional Official is responsible for oversight of the IACUC and serves as the signatory official on the University’s PHS Animal Welfare Assurance. The Institutional Official appoints IACUC members and ensures that the IACUC retains autonomy and remains free from undue influence.
2. The Institutional Official is responsible for maintaining regular communication with the IACUC, including reports of serious or continuing non-compliance with IACUC requirements and any other emergent issues. The Institutional Official will enable provision of adequate resources to the components of the IACUC to perform their respective functions.

6. Roles and Responsibilities: Institutional Animal Care and Use Committee

The IACUC reports to the Institutional Official. The IACUC is responsible for the general oversight, evaluation, and compliance of the University’s Animal care and use program. This responsibility includes, but is not limited to, the following:

1. reviewing at least once every six months the University’s program for humane care and use of Animals, using the Guide as a basis for evaluation;
2. inspecting at least once every six months all of the University’s Animal facilities, including satellite facilities, using the Guide as a basis for evaluation;
3. preparing written reports of the IACUC evaluations and submitting the reports to the Institutional Official;
4. ensuring that personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures;
5. conducting oversight of Animal activities to ensure the well-being of Animals and to provide opportunities for refinement of Research procedures;
6. reviewing concerns brought to its attention involving the care and use of Animals at the University;
7. making written recommendations to the Institutional Official regarding any aspect of the University’s Animal program, facilities, or personnel training;
8. reviewing and approving, requiring modifications in (to secure approval), or withholding approval of activities related to the care and use of Animals;
9. notifying Principal Investigators/Project Directors and the Institutional Official 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;
10. conducting yearly continuing review of each previously approved, ongoing activity related to the care and use of Animals at appropriate intervals as determined by the IACUC, including complete renewal of Protocols once every three years;
11. suspending an activity involving Animals if deemed necessary;
12. performing post approval monitoring of all previously approved activities; and
13. notifying Principal Investigators/Project Directors, the Institutional Official, and appropriate federal oversight agencies of any suspensions and the corrective actions taken when reinstatement of the approval occurs.

7. Roles and Responsibilities: Principal Investigator/Project Director

The Principal Investigator/Project Director is charged with:

1. completing necessary and appropriate forms for submission in accordance with the requirements of the University and any Sponsor ;
2. filing an Animal Use Protocol (“AUP”) form with the IACUC for prospective review and approval of all activities involving the use of teaching and Research Animals. Such uses include pilot projects and preliminary studies, whether or not they are part of a Sponsored Project. Approval may be granted for up to three years, Protocols must be reviewed annually, and amended to reflect any changes in Protocol, personnel or Animal species/numbers;
3. ensuring that IACUC approvals have been obtained, annual updates to the IACUC have been submitted, and any significant changes to the Protocol have been approved by the IACUC prior to implementation;
4. ensuring that the project is performed in accordance with the IACUC-approved Protocol;
5. preparing proposals for Funding that includes Animal projects in accordance with the requirements of the University and the Sponsor, and performing Sponsored Projects in accordance with Sponsor requirements and the associated IACUC-approved Animal use Protocol. All locations used to hold, house, or perform Research or teaching activities using Animals must be reported to and semi-annually inspected by the IACUC;
6. ensuring that no Animals are purchased or otherwise acquired without having an IACUC-approved Protocol;
7. ensuring that no Animals are sold, transferred, donated, or otherwise removed from the University without notification and approval of the IACUC;
8. taking responsibility for the appropriate training of their Research staff in the humane care and use of Animals, ensuring that they are qualified to perform their duties, and that they understand their obligations to comply with all relevant regulations and the specifics of the approved Protocol. Documentation of this training may be requested by regulatory and accrediting agencies and by the IACUC;
9. ensuring that specific requirements of federal regulatory agencies, including the PHS and the USDA/Animal and Plant Health Inspection Service (“USDA/APHIS”), are followed when Animal use takes place off èßäÊÓƵapp as a consequence of a sub-grant or subcontract (including the use of Animals in antibody production). Proof of an approved PHS Animal Welfare Assurance must be provided to the IACUC whenever PHS-supported Animal use activities are performed by an off-èßäÊÓƵapp entity. In addition, when certain species are utilized at an off-èßäÊÓƵapp site, that entity must be registered with the USDA and proof of that registration may be required by the IACUC.
10. ensuring that Animals are not housed for more than 12 hours outside designated housing areas without the prior review and approval of the IACUC. The IACUC will review any new housing requests in consultation with the Attending Veterinarian; and
11. performing all survival surgical procedures on non-rodent mammalian species in designated surgical suites approved by the IACUC in consultation with the Attending Veterinarian.

8. Roles and Responsibilities: Deans, Associate Deans, Assistant Deans, Directors and Department Chairs

Deans of colleges or schools, Associate Deans, Assistant Deans Directors and Department Chairs are responsible for:

1. reviewing and approving applications for use of vertebrate Animals in Research and instruction prior to their submission to the Office of Research and Graduate Studies for consideration by the IACUC;
2. reviewing Research Protocols for ethical considerations and for scientific and/or educational merit, through appropriate procedures established within their respective departments/units;
3. reporting promptly to the IACUC, in conjunction with the University Investigator, any serious or continuing non-compliance with the requirements of this policy or the determinations of the IACUC; and
4. attending IACUC meetings when requested by the IACUC to facilitate the review of Research and instructional Protocols.

9. Roles and Responsibilities: Director of Research Compliance

The Director of Research Compliance reports to the Assistant Vice President for Research Integrity and Operations and is responsible for:

1. developing, managing and evaluating policies and procedures that promote compliance with federal, state, and local regulations governing sponsored and University-funded Research including the Animal Welfare Act and the Health Research Extension Act. This responsibility includes monitoring changes in regulations and policies that relate to Animal Subjects care and use and overseeing all aspects of Research compliance;
2. advising the Institutional Official on key matters regarding Research at the University;
3. submitting, implementing, and maintaining an approved PHS Animal Welfare Assurance through the Institutional Official;
4. providing information to the Institutional Official regarding the needs and resources required for the Research compliance operations;
5. assisting Principal Investigators/Project Directors in their efforts to carry out the University’s Research mission;
6. reviewing initial and revised IACUC Protocols and related documents for completeness and accuracy prior to submitting to the IACUC for their review and approval;
7. in conjunction with the Laboratory Animal Resource Center manager, developing a training and education program as required and as appropriate for University Investigators, subcommittee members and Research staff, and ensuring that training is completed in a timely manner; and
8. serving as the primary contact and liaison at the University for communications with federal, state, and local regulatory agencies with respect to Animal Care and Use conducted under the University’s PHS Animal Welfare Assurance or under the oversight of the University’s IACUC.

10. Roles and Responsibilities: Institutional Biosafety Committee

The Institutional Biosafety Committee is responsible for ensuring that Research on Animals is conducted in a safe manner. The Committee is responsible for approving Research with biological agents conducted on Animals, promulgating procedures for doing such Research and generally ensuring that such Research complies with the Committee’s standards.

11. Roles and Responsibilities: Laboratory Animal Resource Center

The LARC is a University sponsored facility for Research and teaching activities conducted by Principal Investigators/Project Directors.

1. The LARC manager reports directly to the Director of Research Compliance, and
2. in collaboration with the Director of Research Compliance and the Institutional Official, allocates Research and teaching space within LARC, and
3. in consultation with the Attending Veterinarian and Director of Research Compliance develops and implements Standard Operating Procedures as needed for daily operations.

12. Related Policies, Statutes and Documents

• University Policy 10.1, Sponsored Research and Activities
• Research Handbook
• The Guide
• PHS Policy
• Animal Welfare Act
• Health Research Extension Act
• U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training

Appendix A: Definitions

“Animal” means any live or dead vertebrate animal used or intended for use in biomedical or behavioral Research, Research training, teaching or testing.

“Animal Welfare Act” means the Animal Welfare Act of 1966, as amended (7 U.S.C. 2131 et. seq.). It is the only federal law in the United States that regulates the treatment of Animals in Research, exhibition, transport, and by dealers.

“Attending Veterinarian” means the member of the IACUC who is a licensed Doctor of Veterinary Medicine as required by the Health Research Extension Act.

“Funding” means financial support for Research, including money, property, services, or anything of value in lieu of money. For purposes of this policy, Funding may be provided by an external Sponsored Project or by the University.

“The Guide” means the Guide for the Care and Use of Laboratory Animals, published by the National Research Council, 8th Edition, 2011, as amended or superseded from time to time.

“Health Research Extension Act” means the Health Research Extension Act of 1985 (Public Law 99-158), which provides the legislative mandate for the PHS Policy. It directs the Secretary of Health and Human Services to establish guidelines for the proper care and treatment of Animals used in Research, and for the organization and operation of institutional Animal care and use committees.

“IACUC” means the Institutional Animal Care and Use Committee appointed by the Institutional Official, which is charged with the responsibility of providing local review and oversight of Research and other scholarly activities using Animals.

“Institutional Official” means the University employee responsible for ensuring that activities using Animals at the University are humane and in compliance with all applicable laws, regulations, and University Policies relating to Animal care and use. The Institutional Official is sometimes referred to as the “IO”.

“LARC” means the Laboratory Animal Resource Center. LARC is the University supported resource for all research or teaching activities involving animal subjects.

“PHS” means the United States Public Health Service.

“PHS Animal Welfare Assurance” means the certification signed by the Institutional Official making a commitment on behalf of the University that the requirements of this policy will be met.

“PHS Policy” means the Public Health Service Policy on the Humane Care and Use of Laboratory Animals, published by the PHS, revised and reprinted 2015.

“Protocol” is a document (including subsequent amendments) that describes the Research design or methodology to be employed, the treatment regimen(s), and the proposed methods of analysis that will be performed on the data collected during performance of a Research project. Typically, a Protocol also gives the background and rationale for a Research activity involving Animal Subjects, but this information may be provided in other Protocol reference documents.

"Principal Investigator/Project Director” means the individual solely responsible for technical conduct of design, conduct or reporting of the Research or other educational activity, whether or not in connection with a Sponsored Project. "Principal Investigator” (PI) includes an individual designated as "Project Director" (PD), when performing the functions of a Principal Investigator, or other individuals performing the functions of a Principal Investigator. For purpose of this policy, “Principal Investigator/Project Director” includes any researcher responsible for the design, conduct or reporting of Research or other educational activity involving Animals. The IACUC may establish policies regarding eligibility criteria for Principal Investigators/Project Directors.

“Research” means, for the purposes of this policy, the use of live vertebrate animals for the systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions.

“Research Handbook” is a document maintained by the Office of Research and Graduate Studies specifying current procedures and requirements for the proposal, acceptance, execution, and oversight of Research.

"Sponsor” means any external entity that provides Funding to the University. Sponsors may be (i) governmental agencies (for example, federal, state, or local governments or their administrative organizations); (ii) nonprofit organizations (for example, universities, nonprofit corporations, foundations, or associations); (iii) for profit organizations (for example, corporations, partnerships, sole proprietorships, and other business entities); or (iv) individuals.

"Sponsored Projects” means all projects, programs, research, training, public service, and other activities that receive external Funding

“U.S. Government Principles” means the United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, published by the Office of Science and Technology Policy, 1985.

“University Investigator” is a faculty member, Principal Investigator/Project Director, research scientist, research associate, or other researcher responsible for the design, conduct or reporting of the research or other educational activity proposed for funding by a Sponsor or the University. This includes, but is not limited to, persons classified as University faculty, staff, and students.

“USDA” means the United States Department of Agriculture.

Revised: January 2, 2019

Adopted: January 15, 2015