Presentation on theme: "Institutional Animal Care and Use Committee (IACUC) Field Studies J. Edward Gates, Ph.D. Committee Chair Appalachian Laboratory University of Maryland."— Presentation transcript:
Institutional Animal Care and Use Committee (IACUC) Field Studies J. Edward Gates, Ph.D. Committee Chair Appalachian Laboratory University of Maryland Center for Environmental Science
I. Field Studies "I'm a Field Biologist. Must I submit my protocol for IACUC review?" Federal regulations and Guidelines dealing with animal welfare focus mainly on biomedical and behavioral research, teaching, and testing that takes place in the LABORATORY.
Yet, Institutional Animal Care and Use Committees (IACUCs) must ensure that ALL PROJECTS involving the use of live vertebrate animals comply with federal regulations and guidelines. So the question is asked, "Where do "Field Studies" fit in the regulatory puzzle?" The U.S. Department of Agriculture (USDA) Animal Welfare Act (AWA) regulations define the term “Field Study” and specifically exempt such activity from IACUC review.
"Field study means any study done on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study."
A. Examples of Field Studies Short term trapping for census Measuring weight or length Blood sampling—non-invasive or invasive? Collection of hair Identification, such as radio collars, tattoos, or ear tags Behavioral observations Mortality studies, e.g., road kills, bird and bat kills at tall buildings, towers, etc.
B. Field Studies NOT Satisfying the USDA Definition “However, if the animals are confined in any way, an invasive procedure is involved, or the behavior of the animal is harmed or materially altered, then they are regulated and must comply with the regulations and standards.” Examples: Surgery Implanting telemetry device Housing animals >12 hours before release
C. IACUC review of such studies would be necessary and would focus on, but not necessarily be restricted to, such issues as: i. Number of animals to be used in the study, and the stability of the population from which the animals are to be taken, ii. The appropriateness of the methods used for capturing, immobilizing, and euthanizing the animals; and iii. The training and supervision of the personnel involved with the study.
D. Field Studies Satisfying the USDA Definition If a proposed field study satisfies the USDA definition, and if the USDA were the only federal agency to whom the IACUC were answerable, then such a study would be exempt from IACUC review. However, field studies often cannot satisfy the USDA definition, and the IACUC is also answerable to Public Health Service (PHS) Guidelines.
E. Field Studies that Satisfy the USDA Definition Are Not Exempt From IACUC Review Since Our Institutional Assurance is to the PHS The Guide for the Care and Use of Laboratory Animals (P. 32), states that "." E. Field Studies that Satisfy the USDA Definition Are Not Exempt From IACUC Review Since Our Institutional Assurance is to the PHS The Guide for the Care and Use of Laboratory Animals (P. 32), states that "zoonoses, should be reviewed by the institution’s health and safety committee or office, with assurances to the IACUC that the field study does not compromise the health and safety of either animals or persons in the field."
The National Science Foundation (NSF), a major funding agency for ecological field studies, requires that proposed projects involving use of any vertebrate animal for research or education be approved by the submitting organization's Institutional Animal Care and Use Committee (IACUC) before an award can be made. For this approval to be accepted by NSF, the organization must have a current Institutional Animal Welfare Assurance established with the Public Health Service (PHS). Both the federal law and the Policy mandate that IACUCs review the proposed use of wild or exotic animals for accepted humane policies involving field and/or laboratory research with vertebrate animals.
Therefore, field studies exempted by USDA regulations must be reviewed by the IACUC in order to comply with our Institutional PHS Assurance. The focus of the review would be those issues mentioned in the text quoted above. UMCES requires an IACUC review of all research, teaching and diagnostic protocols that involve the use of live vertebrates (fish, amphibians, reptiles, birds, or mammals) irrespective of source of funding (Departmental, Public, or Private) or purpose (Biomedical, Biological, Agricultural, Wildlife, Testing, Education, Diagnostics, etc.).
In addition to being an UMCES requirement and a requirement of most funding agencies, it is expected by an increasing number of scientific journals for publication of your research!
However, the inclusion of free-ranging wildlife under the mandated review of the IACUCs has posed several problems, not the least of which include: The review of the use of species for which there are no established guidelines or standards and The general lack of specific expertise on many IACUCs regarding the appropriate conduct of field studies. In response, NSF Program Officers suggested that the appropriate professional societies formulate field research Guidelines to assist researchers and IACUCs.
F. Rather Than Covering Species-specific Training, Which Would Be Nearly Impossible, I Refer You to the Following 4 Guidelines GUIDELINES OF THE AMERICAN SOCIETY OF MAMMALOGISTS FOR THE USE OF WILD MAMMALS IN RESEARCH, American Society of Mammalogists http://www.mammalogy.org/uploads/Sikes%20et%20al%20 2011.pdf GUIDELINES TO THE USE OF WILD BIRDS IN RESEARCH, Ornithological Societies of North America http://www.nmnh.si.edu/BIRDNET/documents/guidlines/Co ver_August2010.pdf
GUIDELINES FOR USE OF LIVE AMPHIBIANS AND REPTILES IN FIELD AND LABORATORY RESEARCH, Second edition, Revised by the Herpetological Animal Care and Use Committee (HACC) of the American Society of Ichthyologists and Herpetologists (ASIH), 2004. http://www.asih.org/files/hacc-final.pdf GUIDELINES FOR USE OF FISHES IN RESEARCH, American Fisheries Society, American Institute of Fishery Research Biologists, American Society of Ichthyologists and Herpetologists, 2004 http://www.fisheries.org/afs/docs/policy_16.pdf
G.Other Useful Publications and Web Sites AMERICAN FISHERIES SOCIETY http://www.fisheries.org/afs/index.html FISHERIES TECHNIQUES, 2ND EDITION THE WILDLIFE SOCIETY http://www.wildlife.org/ TECHNIQUES FOR WILDLIFE INVESTIGATIONS AND MANAGEMENT, Edited by C. Braun (2006), 6th Ed. http://www.fisheries.org/afs/index.html http://www.wildlife.org/ http://www.fisheries.org/afs/index.html http://www.wildlife.org/
These Guidelines, in general, deal with issues such as collection procedures, humane methods of euthanasia, identification practices, methods for collection of tissue and blood samples in the field, and transport and release of specimens. These Guidelines are considered to be "Living Documents" and will be revised with continuing input from members of the various professional societies. These Guidelines are the primary means for the IACUC to evaluate field protocols. Researchers who are planning field studies might benefit by consulting one or more of these references.
Given the generalities within the Guidelines, we also utilize basic Guidelines governing laboratory animals, publications in respected journals and textbooks, standard veterinary protocols, personal experience, and the input of the Principal Investigator. At times we may also request advice or comment from well-known experts in the research area under review.
G. UMCES PHS Assurance States That Laboratory and manipulative experimental field studies of vertebrate animals are to be conducted only on finfish, amphibians and reptiles Although fieldwork on fish, amphibians, and reptiles is referenced, field studies on birds and mammals are not mentioned in UMCES PHS Assurance. However, such studies, as defined under the USDA AWA, would be permissible, subject to review, approval, and oversight by the UMCES IACUC.
When designing your project it is your responsibility to ensure that necessary federal and state permits are obtained in a timely fashion. A valid UMCES collecting permit does not supercede the need to obtain additional authorization in specific cases, e.g., federal Bird- banding Permit. IACUC Protocol Review does not free you from other regulatory requirements nor does acquisition of permits or approval from any management agency supersede IACUC Protocol Review When designing your project it is your responsibility to ensure that necessary federal and state permits are obtained in a timely fashion. A valid UMCES collecting permit does not supercede the need to obtain additional authorization in specific cases, e.g., federal Bird- banding Permit. IACUC Protocol Review does not free you from other regulatory requirements nor does acquisition of permits or approval from any management agency supersede IACUC Protocol Review
Our Committee Welcomes Questions or Suggestions. Feel Free to Directly Contact Any Member of the UMCES IACUC UMCES IACUC Website: http://www.umces.edu/about/iacuc