Description

In the United States, two major federal laws apply to vertebrate animals used in laboratory research. The first of these two statutes, the Animal Welfare Act (AWA, under the US Department of Agriculture), celebrated its fiftieth anniversary in 2016. The second statute, the Health Research Extension Act of 1985 (also referred to as the Public Health Services Act, or PHS Act), which is similar to the AWA, applies specifically to work funded by the US Public Health Service (i.e., agencies under the Department of Health and Human Services). Understanding laboratory animal law is necessary and fundamental for all researchers relying on results from animal research, laboratory animal veterinarians, institutional officials, Institutional Animal Care and Use Committee (IACUC) members and veterinarians in training. They require familiarity with both the scope and particulars of these laws. Different parties interested in or impacted by laboratory animal laws can have significantly different perspectives about the scope or efficiency of the regulations or their implementation.

The Roundtable on Science and Welfare in Laboratory Animal Use of the Institute for Laboratory Animal Research, the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and the Animal Law and Policy Program of Harvard Law School convened this pre-workshop webcast and a workshop to discuss the future of federal laboratory animal law in the United States.

Pre-Workshop Webcast

Laws and Regulations Governing the Care and Use of Laboratory Animals: An Overview

Presenter: Professor Margaret Foster Riley, University of Virginia School of Law

Margaret (Mimi) Foster Riley teaches food and drug law, health law, animal law, bioethics, regulation of clinical research and public health law. Riley has written and presented extensively about health care law, biomedical research, genetics, reproductive technologies, stem cell research, animal biotechnology, health disparities and chronic disease. She serves as chair of UVA’s Embryonic Stem Cell Research Oversight Committee and as legal advisor to the Health Sciences Institutional Review Board, which is responsible for reviewing all human subject research at UVA involving medically invasive procedures. She served on the National Research Council Committee on Revisions to the Common Rule for the Protection of Human Subjects and has advised numerous committees of the Institute of Medicine and the Virginia Bar. Before coming to Virginia, Riley was an associate with Pepper Hamilton & Scheetz in Philadelphia, where she worked primarily in complex securities, commercial and mass tort litigation. Prior to that position, she was a litigation associate with Rogers & Wells in New York. Riley received her law degree from Columbia University and her bachelor of arts from Duke University.

AVAILABLE NOW ONLINE.

Workshop: Future Directions for Laboratory Animal Law in the United States

Laws and Regulations Governing the Care and Use of Laboratory Animals: An Overview

January 26, 2018

This workshop examined such topics as how technological advances, such as CRISPR/Cas9, may impact the current legal framework and the ability to sustainably support laboratory animal welfare.

Agenda

8:30 – 9:00am, Registration

9:00 – 9:15am, Welcoming Remarks

• Lida Anestidou, Institute for Laboratory Animal Research, National Academies of Sciences, Engineering and Medicine
• Carmel Shachar, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
• Chris Green, Animal Law and Policy Program, Harvard Law School; organizing committee member

9:15 – 10:00am, Keynote Presentation

• Bernadette Juarez, US Department of Agriculture – Animal and Plant Health Inspection Services
• Moderator: Chris Green, Animal Law and Policy Program, Harvard Law School; organizing committee member

10:00 – 11:00am, Revision

The laws, regulations, and policies that govern the use of animals in laboratories create a complex and not always consistent system. In this panel, we heard different perspectives about how this system currently operates, and how it might be changed. As we look to the future, what aspects of federal laws should or could be changed? Do the goals as currently set out in federal laws need to be changed? If so, to what and how?

• Richard Born, Harvard Medical School
• Delcianna J. Winders, PETA Foundation & Elisabeth Haub School of Law at Pace University
• Moderator: Anne DesChamps, Federation of American Societies for Experimental Biology; organizing committee member

11:00 – 11:15am, Break

11:15am – 12:15pm, Reach: Application of Laboratory Animal Laws

Part 1: Expanding Laboratory Animal Laws to Other Species and Other Research Purposes

This session addressed whether current federal laws, regulations, and policies addressing animals in research setting should be expended to cover currently exempted species, including animals in agricultural research. Speakers also discussed the possible impact on the resources required for implementation of such laws, regulations, and/or policies.

• Steven M. Niemi, Harvard University; organizing committee co-chair
• Lawrence B. Schook, University of Illinois
• Moderator: Chris Green, Animal Law and Policy Program, Harvard Law School; organizing committee member

12:15 – 1:15pm, Lunch

1:15 – 2:15pm, Reach: Application of Laboratory Animal Laws

Part 2: Expanding Laboratory Animal Laws to New Technologies and Organizations and Other Animal Owners

• Lisa Moses, Angell Animal Medical Center & Harvard Medical School
• Kenneth Oye, MIT
• Moderator: Elizabeth Heitman, University of Texas Southwestern Medical Center; organizing committee member

2:15 – 3:15pm, Resolution

This session addressed significant and/or interesting potential legal conflicts related to laboratory animals that may arise in coming years.

• Jerrold Tannenbaum, UC Davis School of Veterinary Medicine
• Nathan W. Herschler, New England Anti-Vivisection Society
• Moderator: Richard L. Cupp, Pepperdine University School of Law; organizing committee member

3:15 – 4:00pm, Closing Comments and General Discussion

• Paul A. Locke, Johns Hopkins University; organizing committee co-chair

Learn More

• Richard Born, “Animal Law: The PI’s* Perspective”
• Nathan W. Herschler, “Resolving Upcoming Conflicts in the Laboratory Animal Law System”
• Lisa Moses, “Expanding Laboratory Animal Laws to Other Animal Owners: The Ethical Implications of Using Pets as Research Subjects”
• Steven M. Niemi, “Expanding US Laboratory Animal Laws to Other Species”
• Kenneth A. Oye, “Gene Drives: Mechanisms, Applications and Risk Governance Issues”
• Lawrence B. Schook, “Future Directions for Laboratory Animal Law in the United States: Workshop”
• Jerrold Tannenbaum, “Should federal law allow or require IACUCs to engage in ethical review of animal research projects?”
• Delcianna J. Winders, VP & Deputy GC, Captive Animal Law Enforcement PETA Foundation

Recording

Couldn’t join us in person for the January 26 workshop? Join the conversation online @theNASEM @PetrieFlom #ILAR

This event was cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. With support from the Oswald DeN. Cammann Fund at Harvard University.