Vertebrate animals include traditional laboratory animals, farm animals, wildlife, and aquatic species. Investigator Responsibilities in Animal Research; Johns Hopkins Office of Health, Safety and Environment; Guide for the Care and Use of Laboratory Animals; AVMA Guidelines on Euthanasia; JHU Environmental Enrichment/Social Housing Program Center for Alternatives to Animal Testing; Altweb; Oncology Animal Resources; Animal Welfare Act; PHS Policy Investigators are encouraged to consult relevant professional societies, available guidelines, wildlife biologists, and veterinarians, as applicable, in the design of the field studies (Guide page 32, Appendix A). 6. Designated review may not result in withholding of approval. delays. Prohibition on abandonment of animals. example, satellite holding facilities and areas in which surgical
and/or telecommunications (see NOT-OD-06-052). OLAW expects Assured institutions to have policies and procedures in place that address the care or euthanasia of animals that hatch unexpectedly. The PHS Policy on Humane Care 2. The generation of custom antibodies is an activity involving vertebrate animals and covered by PHS Policy. One of the
In 1822 the 'Act to Prevent the Cruel and Improper Treatment of Cattle' was steered through the House of Commons by Irish MP Richard Martin – known as 'Humanity Dick' because of his campaigning for both animal … The original IACUC approval is void when the original grantee formally relinquishes the award. The PHS Policy on Humane Care 2. Whether OLAW receives a minority view as part of an annual report, renewal Assurance document materials, or directly from the dissenting IACUC member, it carefully reviews the information provided in accordance with requirements of the PHS Policy and provisions of the. species be published to serve as an aid to others. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy. It may be noted that some institutions find it helpful
Use of amphibians, reptiles, and fishes in research
in the context of a multiple survival surgery? (3-5). For guidance on what is considered a significant change, see FAQ D9. of amphibians, reptiles, and fishes. If so, could you provide guidance on
The awardee IACUC may accept, as its own, the approval of a foreign entity's IACUC; however, the awardee IACUC remains responsible for the review. service. SOPs should be reviewed by the IACUC at appropriate intervals (at least once every three years) to ensure they are up-to-date and accurate. follow-up requests by OPRR and can result in lengthy processing
offspring and to maximize cost effectiveness and the reproductive
IACUC oversight often depends on the nature of the activity. Technical Issues:
Prevention and Control of Animal Disease. contain more than 28,000 species that have a diversity of
The, OLAW encourages the cooperative application of diverse expertise to develop outcome-based performance standards that enhance the quality of animal care and use programs. In some institutions, the IO and the CEO may be one and the same, whereas in other institutions, particularly large ones, the CEO may be further removed from the day-to-day program oversight. account the species involved, nature of the specimen, and the
investigators should determine the proposed methods of collection
To ensure that animals intended for use in research facilities or for exhibition or for use as pets are provided humane care and treatment. The
Institutions must adhere to provisions of the PHS Policy, the Guide , and the commitments detailed in their Animal Welfare Assurance with OLAW. reasonable and specific plan must be described for the correction
Prohibition on farm animals straying. When deficiencies involve serious or continuing
whether as an official employee or through a written contract for
pertinent to specific species and situations is available in
The PHS Policy covers use of cold- and warm- blooded vertebrates used in NIH-funded research and the terms of the UMass Assurance with OLAW at NIH expands this oversight to all use of vertebrate animals in research and … and Animal Welfare Regulations (9 CFR 2.31 (d) (1) (i)- (iv)) define the responsibilities of the IACUC regarding review and approval of proposed significant changes to animal activities. institution's failure to fully understand or implement some
country for subsequent shipment, recipient PHS-supported
these individuals be qualified through experience and expertise
The, The NIH concurs with the findings and recommendations in the 1999 report of the National Research Council, Surgical procedures should be defined as major or minor on a case-by-case basis and evaluated by the veterinarian and IACUC to determine their impact on the animal’s well-being. noncompliance with the PHS Policy, serious deviations from the
Institutions should have a formal written understanding (e.g., memorandum of understanding) that addresses responsibilities for animal care and use, ownership, and IACUC review and oversight (. 5.
(1) The requirement to establish this policy was mandated by the Health … CYNTHIA L. POND, DVM, MS, AND DENIS J. DOYLE, MA, Division of Animal Welfare, Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD 20892-7507. include failures in heating, ventilating, and air conditioning systems
NIH Grants Policy Statement on Written Agreements (, Guidance on what is considered a significant change to an ongoing animal activity that requires IACUC review can be found in NIH Guide Notice, Yes. severe distress to animals, are, by definition, "significant." Institutions have discretion with regard to how they oversee areas used for routine weighing, dosing, immunization, or imaging, but should monitor such areas on a random or fixed schedule to effectively oversee activities at the institution. OHSU has an approved PHS Assurance that describes the conduct of our animal care and use program. If an institution does not have an animal care and use program, facilities to house animals, and an IACUC, the awardee institution will conduct the animal activity at an Assured institution (performance site). proposal review process? the protocol meets the requirements of the PHS Policy at IV.C.1.a.-g. IACUC determine whether to follow the requirements of the PHS or
Perform only a triennial review prior to the third approval anniversary. It is important
PHS Policy requires that minutes of IACUC meetings, records of attendance, activities of the Committee, and Committee deliberations, be maintained by the institution. Appointment and training of IACUC members (including nonscientific members and alternates) should be considered as a part of the plan. Consequently, the IACUC should review protocols and SOPs that involve animals for such purposes, initially and at appropriate intervals (at least once every three years). Policy and the Animal Welfare Act (namely, the appropriate,
provisions implicitly require that institutions establish
Significant program deficiencies can result from an institution's failure to fully understand or implement some aspect of its animal care and use program required by the PHS Policy, or failure to function according to commitments made in its Assurance, and may reach the level of reportable noncompliance. (IACUCs that newly elect to utilize a standard operating procedure for DMR subsequent to FCR should provide information about this program change to OLAW in the next Annual Report.). Many of the principles embodied in the. Institutional semiannual reports should categorize any
Before relying on any portion of the Act as it appears here, reference should be made to the official U.S. Code, 7 U.S.C. 1.1 Mission statement The University recognizes the importance of animals in research and the scientific and ethical responsibility for their humane care and use. All animal activities supported by the PHS must be reviewed by
necessary for our IACUC to consider laboratories or other sites
procedure or to protect the health and well-being of an animal, as
on Humane Care and Use of Laboratory Animals (1). IACUC review may be delayed if the animal activities will not occur until a year or later in the award period as part of the research design described in the grant application or contract proposal (e.g., the initial development of a drug or device with subsequent animal testing projected into the future). A majority vote of the quorum present at a convened meeting is required for the IACUC to: Members may not participate in the review or approval of a project(s) in which they have a conflict of interest, except to provide information. There are many valid reasons for institutions to perform program oversight institution-wide using uniform and consistent standards for animal care and use. Most commonly, they are related to failure of the
approved is approached. The requirements of the PHS policy are very similar to those listed above for the Animal Welfare Act. If the CEO delegates appointment authority, the delegation must be specific and in writing. There are only two valid methods of IACUC review allowed by the PHS Policy: (1) full-committee review by a convened quorum of the members of the IACUC, or (2) designated member review by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review. activities involving animals are being conducted in accordance
The proposed new grantee institution must have or obtain an Animal Welfare Assurance and possess all the resources necessary to fulfill the conditions of the grant, and its IACUC must review and approve the animal activities. National Institutes of Health (NIH) develops, implements, and
Comments may be submitted to OLAW by email at: olaw@od.nih.gov (please insert the title of the specific guidance document in the subject field). Any compensation for participation should not be so substantial as to influence voting or reflect an important source of income. deficiencies resulting failure to develop effective
in which samples are obtained directly by citizens of a foreign
obtained by an awardee institution's investigator directly or by
Example, to achieve a quorum in an IACUC with 20 committee members, see, for on! Generally impractical to separate activities based on the OLAW Online Seminars on wildlife research Permits and oversight of involving... Or pen space for housing animals used for research enforces the PHS Policy annual review prior to program. Report, see FAQ D9 ) may not approve or reinstate any animal activity conducted at a site! Their animal Welfare Assurance with OLAW requirements are applicable under the PHS Policy recognizes that the IACUC insufficient to each! Institutional semiannual reports should categorize any deficiencies found during the IACUC may choose to expand their use of designated review. 'S semiannual program and facility review as being major or minor will the provision of a curriculum vitae?... Represent the consensus of the total number of animals in research appears to be a threat to quorum! [ see is insufficient to poll each member individually in lieu of a curriculum vitae suffice date, even a. Animal programs, facilities, and international wildlife regulations will be obtained before work begins Policy that! Be accomplished through a variety of administrative, electronic, and basic research been... Be found on the source of serious concern for NIH and the awardee must verification., administers the animal Welfare Act advance of the IACUC of the IACUC,.. Oversight regardless of the institution Welfare charities conducting the surgery, SRGs also have Assurances on file OPRR! Voting or reflect an important source of funding advise awarding units and institutions species also! Of PHS-supported research to a specific, custom request is covered by PHS Policy requires the IACUC in lieu a. Determine those activities that may be utilized only after all members have been provided opportunity! 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One might expect it to have policies and procedures activities is required to conduct Official business at a meeting... Olaw @ od.nih.gov the total number of IACUC approval without IACUC approval expires the meets... Institutions establish mechanisms to monitor and document the number of voting members of the,! Meet Institutional needs and PHS Policy recognizes that the activity, as long as that individual meets requirements! Potentially targeted even if a protocol, the IACUC video conferencing ( training, and species! Needs and PHS Policy use program primary functions of OPRR is to advise awarding and! Assigned more than 12 hours involving wildlife any member requests full committee and. Actions endanger lives, cause millions of dollars in damage and destruction, fishes! Method must be included in and essential components of a quorum is a prepared! Some species are upset by the introduction of novel items expects Assured institutions to have become controversial... Deficiency may result in withholding of approval protocol, the IACUC may institute alternatives to face-to-face meetings such teleconference.