The University of Texas Arlington IACUC and Field Research

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

IACUC EVALUATIONS Program Reviews & Facility Inspections William R. Parlett, Jr., DVM, DACLAM Compliance Officer (Contractor) Office of Laboratory Animal.
Institutional Animal Care and Use Committee (IACUC)
Guidance on Significant Changes to Animal Activities
Responsible Conduct in Research
Field Studies. "I'm a Field Biologist. Must I submit my protocol for IACUC review?" Federal regulations and Guidelines dealing with animal welfare focus.
Managing and Coordinating the Semi- annual Site Visit Process.
Adapted from ISEF webpage Society for Science and the Public “Roles and Responsibilities of students and adults” Roles and Responsibilities of students.
Preparation for AAALAC Sylvia J. Singletary, DVM DACLAM.
TEXAS SOUTHERN UNIVERSITY OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR DEPARTMENT OF RESEARCH ENHANCEMENT AND COMPLIANCE SERVICES.
Institutional Animal Care and Use Committee (IACUC) Field Studies J. Edward Gates, Ph.D. Committee Chair Appalachian Laboratory University of Maryland.
TEXAS SOUTHERN UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE PROGRAM WORKSHOP OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR RESEARCH ENHANCEMENT.
Responsible Conduct of Research & Research Compliance Adam J. Rubenstein, Ph.D. Director of Research Compliance Old Dominion University Office of Research.
IACUC and Compliance Overview and Updates
Public and Private Interests in Animal Research LAT Chapter 1.
Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.
Office of the Vice President for Research
The University of New Mexico & The Office of Animal Research, Ethics, Care, and Compliance present New Researcher Training A learning module developed.
Office of the Campus Veterinarian Preparing Your Lab for an IACUC or AAALAC Inspection.
Post Approval Monitoring Program Presented by Carolyn Malinowski Manager, Quality Assurance and Training.
Overview of the Howard University Animal Care and Use Program (IACUC) Regulatory/Oversight Agencies OLAW (Office of Laboratory Animal Welfare) USDA (United.
What are the Issues with Animal Research Bill Greer IACUC Administration The Office for Research Protections.
 IACUCs are animal research analogs of IRBs.  They are designed to assure that regulations about the appropriate use of animals in research are upheld.
Historical Perspectives of Research Animal Protection Dr. Susan Wilson-Sanders.
A Review of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals Created by Marc S. Hulin, DVM, Dipl. ACLAM.
MANDY FAIR, IACUC ADMINISTRATOR ANIMAL CARE AND USE.
Caring for Research Animals
Balancing Compliance and Flexibility Dr. Nancy Marks Director of the IACUC Office.
Use and Care of Vertebrate Animals: What Researchers Need to Know Brian Greene IACUC Chair and Associate Professor of Biology Missouri State University.
ASUJ: IACUC Guidelines Malathi Srivatsan Chair, IACUC.
The ASU Animal Use Program A three-legged stool Institutional Official - Jon Harrison Institutional Official - Jon Harrison Institutional Animal Care.
Research Ethics BIO 594. Ethics Morality Ethics - Rules that govern personal behavior - Rules that govern professional behavior.
Institutional Animal Care and Use Committee (IACUC) The IACUC provides internal oversight of animal: - husbandry - facilities - use in teaching & research.
Institutional Animal Care and Use Committee. IACUC  Required by AWA, PHS, AAALAC  Is appointed by the President of the UA  The Institutional Official.
THE UNIVERSITY OF TEXAS AT TYLER Institutional Animal Care and Use Committee Education General Overview *Note: Content not specific to UT Tyler is from.
The Role and Responsibilities of Those Using Animals in Research and Teaching College’s obligation to the AWA Reasonable and professional commitment to.
Institutional Animal Care and Use Committee (IACUC) at Ross University Bernard Grevemeyer.
We have reviewed this material in accordance with U.S. Copyright Law and have tried to maximize your ability to use, share, and adapt it. The citation.
Animals in Research Donald B. Casebolt, DVM, MPVM, DACLAM.
Use of Animals in Research: IACUC's, Animal Care Requirements and More Panel members: William Ray Stricklin, PhD IACUC Chair Douglas Powell, DVM, ACLAM.
Research Compliance: An Overview of the Players and Issues Involved in Emory’s Research Compliance Programs.
 Good care is important to the research process as a whole  Animals that are treated well provide the normal biological and behavioral responses researchers.
Animal Research at Princeton Prepared by Stuart Leland Director, Research Integrity and Assurance For use and distribution by the Princeton University.
DOMESTIC AND FOREIGN SUBCONTRACTS/SUBAWARDS CITI Training.
Compliance, how does your institution interpret the “Gray Area” – Total Risk Aversion? Bill Greer Penn State University.
Institutional Animal Care and Use Committee (IACUC) Field Studies J. Edward Gates, Ph.D. Committee Chair Appalachian Laboratory University of Maryland.
Who Monitors the Use of Animals in Research? United States Department of Agriculture United States Department of Agriculture -Animal and Plant Health Inspection.
Caring for Research Animals Biomedical Research. Caring for Animals Used in Research Public is concerned with how animals are treated Animals that are.
Animals in Research: Navigating the Animal Protocol Approval Process Summer Seminar Series Susan Warren IACUC Chair.
Regulations. PHS and USDA PHS Policy on Humane Care and Use of Laboratory Animals NIH - OLAW oversees animal welfare for vertebrates Guide for The Care.
Research Protections Office University of Vermont Change to Procedures for Committee Review of Resubmissions of Grant Applications.
LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER NEW ORLEANS.
Paul Kelly Facility Research Compliance Officer for the Ralph H. Johnson VA Medical Center.
 Welcome ◦ Amanda Athey, Director, Graduate School  Student Experience  Funding Opportunities ◦ Rebecca Drake, Research Administrator, Office of Research.
R EGULATORY A GENCIES What are regulatory issues? Types of agencies How they affect you Top 10 regulatory issues.
INTERNATIONAL SCIENCE AND ENGINEERING FAIR Rules and Guidelines 2016.
Middle/High School Science Fair Information Session GSEF/ISEF Rules and Guidelines Changes and Modifications.
Institutional Animal CARe and use committee - IACUC
Patricia Brown, VMD, MS, DACLAM Director, OLAW, NIH April 14, 2016 ORI Workshop Research with… Animals.
Regulatory Agencies What are regulatory issues? Types of agencies How they affect you Top 10 regulatory issues.
Institutional Animal Care and Use Committee
A-State IACUC Guidelines
Office of Animal Welfare Assurance (OAWA) Janna Barcelo, BA, CPIA
The Animal Research Environment
Office of Animal Care Compliance (OACC)
Institutional Animal CARe and use committee - IACUC
CARING FOR RESEARCH ANIMALS
Who Monitors the Use of Animals in Research?
Sponsored Programs at Penn
Care of Research Animals
Presentation transcript:

The University of Texas Arlington IACUC and Field Research Institutional Animal Care and Use Committee

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.

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).

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.

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 1987. Guidelines are revised periodically.

Society Guidelines Links to Society Guidelines The IACUC strongly adheres to, and advises observance of, these Professional Society Guidelines. Links to Society Guidelines Guidelines 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.

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.

“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.

“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.

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.