Presentation on theme: "The University of Texas Arlington IACUC and Field Research"— Presentation transcript:
1 The University of Texas Arlington IACUC and Field Research Institutional Animal Care and Use Committee
2 Field Studies“Why are field biologists required to submit a protocol for IACUC review?”Field research that involves SOLELY invertebrates, or the salvage of dead vertebrates, does not need to be reviewed by the Institutional Animal Care and Use Committee (IACUC). In this presentation, “animal” refers to live vertebrates.The majority of Federal regulations and guidelines involving animal welfare focus mainly on biomedical and behavioral research, teaching, and testing that takes place in the laboratory. However, there are several Federal agencies with oversight involving animal research and each has its own regulations.In order to assure institutional compliance with these regulations and guidelines, the IACUC must review ALL projects involving the use of live vertebrates.UTA, the Animal Care Facility (ACF), and the IACUC are subject to regular performance audits by external reviewers, and departures from regulations or guidelines can endanger funding from sources such as NSF, NIH, and others.
3 Guidelines and Regulations “What guidelines and regulations are involved?”More than you might think! For example, the U.S. Dept. of Agriculture (USDA) Animal Welfare Act (AWA) regulations define Field Research as:“… 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.”“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 [the field studies] are regulated and must comply with the regulations and standards.”Public Health Service (PHS), of which NIH is a part, in its Guide for the Care and Use of Laboratory Animals (p. 5) states that:“ Zoonoses and occupational health and safety issues should be reviewed by the IACUC to ensure that field studies do not compromise the health and safety of other animals or persons working in the field.”NSF requires funded investigators to comply with PHS policies.Other considerations are involved; for example, euthanasia of specimens may be affected by the Euthanasia Guidelines of the American Veterinary Medical Association. Or, if animals are confined for study, the research may in part be regulated by the NIH Office of Laboratory Animal Welfare (OLAW).
4 Funding Sources “What funding sources require IACUC review?” Essentially, ALL of them. Sources such as NSF and NIH have already been mentioned. And most other federal sources such as US Geological Survey (USGS), Bureau of Land Management (BLM), US Forest Service (USFS), etc. defer to NSF standards. But because many different funding sources exist for field biologists, UTA (like other such institutions) must provide formal Assurance that research with live vertebrates is reviewed. An Assurance is a formal legal document filed with major granting agencies. It contains very specific requirements for institutional oversight of ALL live vertebrate research conducted under the auspices of the institution, regardless of funding source.In addition to being a UTA requirement and a requirement of most funding agencies, review is expected by an increasing number of scientific journals for publication of your research. Thus, it is increasingly required that scientists provide an IACUC review number for the research as part of the manuscript acceptance process.
5 IACUC Review “Doesn’t this pose problems for the IACUC?” Inclusion of field studies of free-ranging wildlife, as well as studies that combine field study with captive housing/care for behavioral study, postoperative care (as after transmitter implant), species inventories, etc. poses several challenges for the IACUC, not the least of which include:The use of species for which there are no established guidelines or standards;The differing approaches of scientists to studies of the vast range of vertebrate species;Different field research practices for the different Classes of vertebrates.These challenges are not new. In the mid-1980s, when NSF first accepted the political desirability, as one consequence of increasing animal welfare activist demands, of IACUC review of live vertebrate field research, NSF Program Officers suggested that the appropriate professional societies formulate discipline-specific research Guidelines to assist scientists and IACUCs.The societies, seeing this as a means of being part of the coming regulatory process, prepared detailed Guidelines that were “rolled out” at a NSF-sponsored meeting in Guidelines are revised periodically.
6 Society Guidelines Links to Society Guidelines The IACUC strongly adheres to, and advises observance of, these Professional Society Guidelines.Links to Society GuidelinesGuidelines for the Capture, Handling, and Care of Mammals, American Society of Mammalogists.Guidelines to the Use of Wild Birds in Research, Ornithological Societies of North America.Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research, Second ed., Revised by the Herpetological Animal Care and Use Committee (HACC) of the American Society of Ichthyologists and Herpetologists, 2004.Guidelines for Use of Fishes in Research, American Institute of Fishery Research Biologists, American Society of Ichthyologists and Herpetologists, 2004.Also useful is the publication:Guidelines for Proper Care and Use of Wildlife in Field Research, The Wildlife Society: National Wildlife Federation.
7 These Guidelines deal with issues such as collection procedures, humane methods of euthanasia, identification practices, tissue collection methods, and transport and release of specimens.While these Guidelines are the primary means for the UTA IACUC to evaluate field protocols, from time to time as needed we may utilize publications in respected journals and texts, standard veterinary protocols for wildlife, personal experience of field biologists serving on the IACUC, and the input of the Principal Investigator.On occasion, we may also request advice or comment from well-known experts in the research area under review.In all instances, the goal of the IACUC is to fulfill its charge of assuring university compliance with funding agency requirements.
8 “If everything in field research is regulated, what am I to do if I am afield and observe some interesting behavior, wish to document it, and have not filed a Statement with the IACUC?”We recognize the importance of fortuitous observation to the process of science in all research fields, and nothing in IACUC policies would hamper publication of such observations. Were you to afterward decide to design a field investigation to explore this fortuitous find in greater detail, IACUC review would be required.Similarly, a manager of a field station facing a pest control problem involving, for example, rodents or introduced fish would not need to seek IACUC approval of control measures. This same principle applies to the University’s on-campus pest control activities. Use of certain chemical control agents, or control of some species, may be subject to State and/or Federal regulations with which field station managers must comply.
9 “So, what do I have to do?” Requirements for Field Research Approval To secure IACUC approval, a Field Research Application must be completed and submitted to the Office of Research Administration. The new protocol application will be reviewed at the following monthly IACUC meeting.The process has been simplified for studies that involve solely the observation of animals (i.e., the animals are not handled— if they are trapped or netted, handling is involved), as might be the case in many studies such as bird or amphibian censuses conducted by call monitoring, observation of mammals from a blind, photographic censuring, etc.Completion of the Health Assessment form is required for all types of study. The form is used to fulfill the IACUC’s responsibility to the mandated PHS guidelines, and asks that persons check off items relevant to their general health and allergy history. This latter can be of particular importance to persons conducting field research, as certain hyperallergic responses can result in anaphylaxis and death.
10 Fulfillment of IACUC requirements does not free you from other regulatory requirements that may bear upon your study, such as: acquisition of applicable local, state or federal permits; regulations imposed by international entities such as CITES; requirements of the USA and other countries regarding export/import of specimens collected.Similarly, acquisition of permits or approval of your project from any management agency does not supercede IACUC protocol review. These are entirely separate, though related, processes.Finally, in all field research Principal Investigators are required to be familiar with the Professional Society Guidelines applicable to the study (which may be ALL of them for some faunal inventory studies), and also are responsible for certifying that all project participants are familiar with these Guidelines.