Panel II: Options/Opportunities to Address Regulatory/Administrative Burden

Wednesday, March 21
9:30 AM - 10:45 AM
Location: Regency Ballroom

This panel will provide a discussion on the options and opportunities for institutions and the biomedical research community to address issues related to regulatory/administrative burden. Under the auspices of the Federal Demonstration Project, the Compliance Unit Standard Procedure (CUSP) Project offers an option to address administrative burden at the institutional level. The goal of this project is to create a repository where participating institutions can share standard substances information and procedures used in animal care and use protocols with the broader animal welfare compliance community. The language contained in Section 2034 of the 21st Century Cures Act directs leadership of NIH, USDA, and the FDA to “complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.” The review is to be completed within two years of the bill’s enactment. This bill provides the biomedical research community with a unique opportunity to have input into the process and, to that end, the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), and the Council on Governmental Relations (COGR), with the assistance of the National Association for Biomedical Research (NABR), prepared a report, in part, in response to the language in the 21 st Century Cures Act with recommendations on how to reduce the regulatory/administrative burden on animal care and use programs. This panel will consist of three presentations: an overview of the CUSP Project; an overview of the AAMC, FASEB, COGR, and NABR report; and an update on the work being done by the NIH, USDA, and FDA in response to the mandate in the 21st Century Cures Act.

B. Taylor Bennett, DVM, PhD, DACLAM, DACAW

Senior Scientific Advisor
National Association for Biomedical Research

B. Taylor Bennett, DVM, PhD, DACLAM, DACAW, currently serves as the senior scientific advisor for the National Association for Biomedical Research. He spent 36 years at the University of Illinois at Chicago overseeing their animal care and use program, and spent the last 10 years there as the associate vice chancellor for research resources, where he was responsible for 14 campus-wide core research support services. Dr. Bennett has been active in a variety of professional organizations, and currently serves on the Board of Directors of the Scientist Center for Animal Welfare and as chair of the Board of Directors of the American Society of Laboratory Animal Practitioners Foundation. Dr. Bennett obtained his DVM from Auburn University and his PhD from the University of Illinois Medical School. Dr. Bennett is a member of the 2018 IACUC Conference Planning Committee.

Presentation(s):

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Patricia A. Brown, VMD, MS, DACLAM

Director, Office of Laboratory Animal Welfare
NIH

Patricia A. Brown, VMD, MS, DACLAM, is the director of Office of Laboratory Animal Welfare (OLAW) at NIH. OLAW oversees the use of animals in research supported by NIH, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Health and Human Services, the Veterans Administration, the National Aeronautics and Space Administration, and the National Science Foundation. Using the animal welfare standards required by the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy), OLAW monitors compliance with the PHS Policy; evaluates allegations or indications of noncompliance with federal animal welfare requirements; and supports educational programs that further the humane care and use of research animals. Dr. Brown joined NIH in 1986, and served in clinical and management positions in the NIH intramural program before joining OLAW in 2006 as the director. She received her Bachelor of Science degree in animal science from The Pennsylvania State University and her VMD from the University of Pennsylvania. She served in the United States Air Force and, while on active duty, completed a residency and Master of Science degree in laboratory animal medicine from the Penn State Milton S. Hershey Medical Center.

Presentation(s):

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Joseph R. Haywood, PhD

Professor, Pharmacology and Toxicology, Assistant Vice President for the Office of Regulatory Affairs
Michigan State University

Dr. Joseph R. Haywood is the Assistant Vice President for Regulatory Affairs and Professor of Pharmacology and Toxicology at Michigan State University (MSU). He joined MSU as the Chair of Pharmacology and Toxicology, a position he held for 9 years. Through his career, he has published over 80 papers investigating central nervous system control of blood pressure and mechanisms of hypertension. He has been active in science policy, especially with respect to the use of animals in research and education. Dr. Haywood is a past member of the Council on Accreditation of the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and served on its Board of Trustees. He served on the Board of Governors for the International Council for Laboratory Animal Science (ICLAS) and co-chaired the revision of the ICLAS-CIOMS “International Guiding Principles for Biomedical Research Involving Animals”. He also served as chair of the American Physiological Society Animal Care and Experimentation Committee, chair of the Science Policy Committee, and a member of the society’s governing council. Dr. Haywood has served on the Board of Directors for the Federation of American Societies for Experimental Biology and as Vice President for Science Policy and President of the society. He has served on two National Academy of Science panels related to animals in research and regulatory burden. Recently, he participated in the discussion and preparation of the “Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden” report.

Presentation(s):

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Sally Thompson-Iritani, DVM, PhD, CPIA

Director, Office of Animal Welfare
University of WashingtonAssociate Director, Washington National Primate Research Center

Sally Thompson-Iritani, DVM, PhD, CPIA, is the director of the Office of Animal Welfare (OAW) at the University of Washington (UW), and Associate Director for the Washington National Primate Research Center (WaNPRC). Current projects in OAW include novel ways to decrease regulatory burden while supporting welfare and compliance and Compassion Fatigue (CF) support. OAW has undergone several transitions to increase its alignment and move forward with technology and customer service while maintaining regulatory compliance. The office recently completed an overhaul and conversion to a fully integrated electronic database system for IACUC management. As OAW converted to the on-line database UW developed a library of standard procedures and pursued an opportunity to make these nationally available by partnering with the Federal Demonstration Partnership (FDP) via a program now referred to as CUSP (Compliance Unit Standard Procedures). In addition, in her new role as AD of the primate center she is involved in the oversight of the daily care and support of the animals, research, and animal caregivers that work at the center. Special areas of interest in the WaNPRC are behavior management and the utilization of positive reinforcement training when working with research animals. Dr. Thompson-Iritani is a member of the 2018 IACUC Conference Planning Committee.

Presentation(s):

Send Email for Sally Thompson-Iritani


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