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Animal Care and Use Policies
IU Animal Research Protections Program
The IU Animal Research Protections Program Policies and Standard Operating Procedures (SOPs) describe the requirements for conduct of animal subjects research. Research conducted by IU faculty, staff, and students or by employees and staff of IU-affiliate institutions that have contracted with the IU Institutional Animal Care and Use Committees (IACUCs) for review and oversight of animal subjects research must be conducted in accordance with IU IACUC Policies, as applicable. IU IACUC Policies apply the protections to animal research subjects outlined by the following regulations.
- Animal Welfare Regulations
- The Guide for the Care and Use of Laboratory Animals
- Public Health Service Policy on Humane Care and Use of Laboratory Animals
IU applies equivalent protections for animal subjects, with some minor differences to reduce administrative burden. Additional relevant requirements are based on other federal regulations, state law, accreditation standards, and institutional policy. IU IACUC policies are written, reviewed, and revised periodically by IU Animal Research Protection Office (ARPO) staff to ensure they accurately reflect research processes at IU. IU ARPO staff work with the IU IACUCs when policies or SOPs need to be updated. ARPO staff seek additional topic experts to assist in review and revision of policies and SOPs as necessary. The IU ARPO maintains a record of these Policies, and a copy of these Policies.
Below are definitions that outline the differences between IACUC and LAR/C Policies, SOPs, and Guidelines. These definitions serve as frameworks for decision-making and action within the Institutional Animal Care and Use Programs at Indiana University. These definitions are intended to provide clarity on the expected behaviors, responsibilities, and procedures of individuals involved in the IU Animal Care and Use Program.
Definitions
IACUC Policy refers to the formal, mandatory regulations and standards that govern the ethical and humane treatment of animals in research. These policies must be adhered to by all researchers within the institution. This is an institutional policy.
The IACIC Standard Operating Procedure (SOP) refers to the procedures that must followed to ensure compliance with federal, state, and institutional regulations for animal welfare. The SOPs are designed to uphold ethical standards in research while ensuring the health, safety, and well-being of animals
IACUC Guidelines consist of recommendations and best practices that help interpret and implement the policies and regulations effectively or provide information. This is an institutional guideline. Both ARPO polices and guidelines are enforced by the IACUC on behalf of IU.
The Lab Animal Resource/Center (LAR/C) Standard Operating Procedures (SOPs)are step-by-step instructions on a variety of topics written for use primarily by LAR/C employees. The core SOPs describe how procedures related to either animal care or equipment use are to be performed when working within the IU animal research animal facilities. Other types of SOPs focus on safety information, quality assurance, or administrative processes. These SOPs ensure consistency and compliance with IACUC policies, EHS requirements, and other relevant regulations. LAR/C SOPs are controlled documents which are required to be followed by LAR/C employees. The LAR/C SOPs are written, reviewed, maintained, and enforced by LAR/C. The LAR/C Director approves LAR/C SOPs.
- LAR/C Work Instructions are a sub-category of the LAR/C SOP system. They provide additional information to LAR/C staff, helping them understand and follow the SOPs by providing more detailed information to supplement SOPs. The LAR/C Work Instructions are controlled documents which are written, reviewed, maintained, and enforced by LAR/C. The LAR/C Director approves LAR/C Work Instructions
LAR/C Policy refers to the formal expectations that are applied by the LAR/C Director to certain aspects of operations and personnel management that are not covered under other mechanisms and with a primary goal of providing leadership and direction for the unit. LAR/C policy is driven and shaped by professional judgement and experience as well as the opinions and preferences of the Director but may or may not also be influenced by regulations or campus policy (depending on the topic). This may include, for example, HR-related decisions related to LAR/C-specific situations, such as how on-call assignment procedures may operate, operational preferences, or other similar issues that may benefit from having a standard approach for uniformity but fall outside of the scope of the LAR/C SOP system. LAR/C policy is more stringent than LAR/C guidelines, but the LAR/C Director sets LAR/C policy and can change the policy at any time if the need arises to do so such as if their opinion and/or preference changes on a subject given new information across time.
LAR/C Guidelines consist of recommendations, best practices, preferences, and instructions on a wide array of topics which are intended to communicate and share general information. Guidance documents (e.g. signs, postings, handouts) provide support, advice, or training information to researchers and/or LAR/C staff. Guidance documents can adapt to specific situations and be very detailed or may be broad and open-ended with a wide range of options. This guidance is flexible and can be easily changed or updated. Guideline documents are not controlled documents. They are considered informational and are not used for regulatory enforcement purposes through they may provide information and context relevant to explaining regulations as subject matter. LAR/C guidance documents are written, reviewed, and maintained by LAR/C. LAR/C guidance documents can be written by veterinarians, or non-veterinarian supervisors, managers, trainers, and others. The LAR/C Director can review/approve/sign-off on guidance documents, and might require this in some circumstances, but this is not a strict requirement and would depend on the topic as well as the intent and use of the information as a communication or teaching tool.
Indiana University Animal Research Protections Policies
The Indiana University IACUCs (Bloomington IACUC and Indianapolis IACUC) are working diligently to update their policies and SOPs. If you don’t see the updated policy or SOPs above, please click below to access IACUC policies or contact the ARPO office at ARPO@iu.edu.
Rules & Regulations
In its advisory role, the IACUC ensures that IU’s Animal Care & Use Program continues to operate in accordance with all applicable rules, regulations, policies, standards, and guidelines that govern the humane, responsible, and judicious use of vertebrate animals.
A brief summary of the federal rules and regulations governing the use of vertebrate animals in research, teaching, or testing activities is outlined below:
- Office of Laboratory Animal Welfare: The Office of Laboratory Animal Welfare (OLAW) is a division of the National Institutes of Health (NIH), and the regulating body for all activities funded by the federal government, including the NIH and National Science Foundation (NSF). OLAW’s primary standards are the Public Health Service Policy on Humane Care and Use of Laboratory Animals(PHS Policy), and the Guide for the Care and Use of Animals (The Guide).
- United States Department of Agriculture Animal and Plant Health Inspection Service: The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) oversees activities involving the use of vertebrate animals at government-registered research institutions. The USDA receives its authority through federal law (Code of Federal Regulations, Title 7 and 9). Veterinary Medical Officers enforcing the 7 and 9 CFRs inspect research organizations at least annually.
- The Institutional Animal Care and Use Committee (IACUC) Guidebookprovides comprehensive guidance on the ethical and humane use of animals in research, teaching, and testing. This guidebook, primarily intended for members of IACUCs, researchers, and institutional staff, offers a framework to ensure that institutions comply with U.S. regulations on animal welfare.
- Specific Funding Sources & Research Sponsors: Specific funding sources, such as the Department of Defense (ACURO), the S. Department of Veterans Affairs, and foundations, may require additional rules and regulations. Institutions receiving money from these organizations are responsible for following all other requirements for the humane care and treatment of any vertebrate animal used in field or laboratory research and educational training. The NIH Checklist for Grant Review of Vertebrate Animal Section describes the information that must be included in applications submitted to NIH for activities involving the care and use of animals.
Also see Indiana University Animal Research Facility Policies, Guidelines, and Formularies
- Bloomington LAR: http://lar.indiana.edu/
- Indianapolis LARC: https://indiana.sharepoint.com/sites/mednet-larc