Who is given institutional responsibility for deciding if an individual researcher is properly trained to perform animal procedures as required by law?
1. DefinitionsDefinitions of capitalized terms are set forth in Appendix A. Show
2. Policy StatementIt 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
4. General Policy Points
5. Roles and Responsibilities: Institutional Official
6. Roles and Responsibilities: Institutional Animal Care and Use CommitteeThe 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:
7. Roles and Responsibilities: Principal Investigator/Project DirectorThe Principal Investigator/Project Director is charged with:
8. Roles and Responsibilities: Deans, Associate Deans, Assistant Deans, Directors and Department ChairsDeans of colleges or schools, Associate Deans, Assistant Deans Directors and Department Chairs are responsible for:
9. Roles and Responsibilities: Director of Research ComplianceThe Director of Research Compliance reports to the Assistant Vice President for Research Integrity and Operations and is responsible for:
10. Roles and Responsibilities: Institutional Biosafety CommitteeThe 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 CenterThe LARC is a University sponsored facility for Research and teaching activities conducted by Principal Investigators/Project Directors.
12. Related Policies, Statutes and Documents
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. Who has the responsibility to ensure that all personnel working with live animals have been properly and appropriately trained?The IACUC has established some basic training requirements for all personnel (see below), and the IACUC Coordinator is responsible for verifying the completion and documentation of these requirements prior to any protocol personnel (including the PI) beginning to work with live animals. 3.
Which organization is responsible for monitoring institutional compliance with PHS Policy?The Office for Protection from Research Risks (OPRR) of the National Institutes of Health (NIH) develops, implements, and oversees compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (1).
Who is authorized to overturn a decision by an IACUC to suspend an activity involving animals quizlet?Terms in this set (3)
If the IACUC decides that any animal activities must be stopped to protect either animals or humans, it is given clear regulatory authority to do so.
Which of the following is a function of the IACUC?Responsibilities. The IACUC is responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide ).
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