Designated review may result in approval, a requirement for modifications (to secure approval), or referral to the full committee for review. [. (Note, clinically necessary procedures do not necessarily require review and approval by the IACUC in advance of the procedure.). If a protocol is assigned more than one designated reviewer, the reviewers must be unanimous in any decision. An institution may have a committee larger than the minimum required by federal policy. conduct full committee review and approval of a proposed project or of a significant change to a project, and. However, there are conflicting views regarding who has the obligation and, indeed, the right to carry out scientific merit review. In the comment section of the Animal Welfare Regulations, the USDA clearly states that it wishes ‘…to avoid any misunderstanding or implication that APHIS [Animal and Plant Health Inspection Service, a component of the USDA] intends to become involved in the evaluation of design outlines, guidelines, and scientific merit of proposed research’ ( USDA, 1989 ). data collection) are conducted. William & Mary has a properly constituted IACUC. Lifespan IACUC Manual, version 5, 11/2017 Page 6 of 58 (AWC) or Institutional Animal Care and Use Committee (IACUC) is charged with overseeing compliance with these federal regulations. Bad choices | Find, read and cite all the research you need on ResearchGate For guidance on what is considered a significant change, see FAQ D9. As noted in. Learn vocabulary, terms, and more with flashcards, games, and other study tools. The IACUC must ensure that protocol approvals are not allowed to expire or if they do expire, that no further animal activities (e.g., data collection) are conducted. it is frequently necessary to use non-pharmaceutical-grade substances such as investigational substances, pharmaceutical-grade substance is any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a recognized compendia (e.g., United States Pharmacopeia-National Formulary, U.S. Department of Health & Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, Guide for the Care and Use of Laboratory Animals (PDF), AVMA Guidelines for the Euthanasia of Animals (external PDF), IACUC Composition, Functions and Authority, Program Review and Inspection of Facilities, Openness and Transparency and Biomedical Research Oversight, Guidance on Significant Changes to Animal Activities, International Guiding Principles for Biomedical Research Involving Animals, Guide for the Care and Use of Laboratory Animals, The 2016 Vertebrate Animals Section, Grants Policy, and Congruence, Quick Reference Guide: 9 CFR, Part 2, Section 2.31(c)(2), AVMA Guidelines for the Euthanasia of Animals, https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research, ARENA OLAW Institutional Animal Care and Use Committee Guidebook, https://www.cdc.gov/coronavirus/2019-ncov/index.html, https://www.who.int/emergencies/diseases/novel-coronavirus-2019, https://medlineplus.gov/coronavirusinfections.html, https://distasterinfo.nlmnih.gov/pandemic-influenza, https://www.aalas.org/iacuc/iacuc_resources/disaster-preparedness#.VnrtDfkrJhE, https://medlineplus.gov/disasterpreparationandrecovery.html, PHS Policy on Humane Care and Use of Laboratory Animals, U.S. Department of Health and Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, 2015, a brief description of how those procedures are likely to affect the biology and ecology of the study animals by describing the relationship of that species to the habitat and to other species found in the study area (including the nature and duration of potential effects); and. Address familiarity of all involved personnel with behavioral/physiological/ anatomical characteristics of the selected species, and describe their experience with regard to the specific procedures to be applied to live animals. Similar guidance applies to surgical procedures. The objective is to anticipate and answer questions and concerns of the other panelists and to help the entire committee develop a clear understanding of the merit related issues of the research. According to the NIH's Office for Protection from Research Risks (OPRR), which is responsible for developing, implementing, and overseeing compliance with the PHS Policy, institutional consideration of Principle II should reflect scientific merit in the broad context ( Miller, 1991 ). The number of IACUC meetings may be reduced to as few as one every six months. OLAW expects Assured institutions to have policies and procedures in place that address the care or euthanasia of animals that hatch unexpectedly. Develop a crisis management plan that safeguards the institution, prepares it to respond with openness about the research being conducted, and educates employees on how to protect their families and their personal property. The egg-laying adult animal is covered by the Policy. 3.9 Review of Modifications to Approved P rotocols 19 . These actions are considered domestic terrorism by the FBI and are a source of serious concern for NIH and the awardee community. IACUC Approval Process . properly constituted according to PHS IV.A.3 and the: Guide. A quorum is required to conduct official business at a convened meeting. Annual Reports must represent the consensus of the Committee and include any minority views filed by members of the IACUC. 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