Full Title Name:  Brief Summary of Medical Research Animals

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Nikki Leung Place of Publication:  Michigan State University College of Law Publish Year:  2014 Primary Citation:  Animal Legal & Historical Center Country of Origin:  United States
Summary: This brief summary examines various federal regulations on animal biomedical testing within the United States as well as the industry’s standards and trends. The application of the federal Animal Welfare Act and regulations issued by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are discussed. The importance of self-regulation mainly through the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) is also outlined.

Animal research has long been a topic of controversy both within the worlds of cosmetic and medical research. Animal use in biomedical research usually arises in terms of preclinical trials, trials that must be completed for products to be determined to be safe enough to progress to trials in humans, known as clinical trials.

There are currently several different sources for regulation in animal testing. From the federal regulatory level, both the United States Department of Agriculture (USDA) and Food and Drug Administration (FDA) influence animal testing standards. The Animal Welfare Act (AWA) represents a large body of federal regulatory laws encompassing the use of laboratory animals and is enforced by the USDA’s Animal and Plant Health Inspection Services (APHIS). However, a large issue with the AWA in terms of laboratory animal protection is the fact that the AWA excludes coverage of mice and rats, species which make up an overwhelming majority of research animals used today.

For facilities funded by Public Health Services (PHS) organizations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals acts as an additional motivator for facilities to follow animal care standards since routine violations may result in a withdrawal of funds.

Most compliance between research facilities and agency regulations is maintained through a relationship of trust and self-reporting, although the USDA and FDA may both conduct unannounced inspections. Additional industry-regulated accreditation programs have also arisen to boost the reputation and credibility of individual research facilities, the most notable of which is the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Although these standards are adopted voluntarily and hold no force of law, there is still strong incentive for facilities to remain accredited, especially if they rely on client sponsors for business.

Given that most existing regulation is enforced through a self-reporting system and additional animal care and use standards are voluntarily adopted, it is hoped that the current state of animal use regulation within the laboratory today can be understood by studying the reasoning that may drive the behavior of research facilities today.

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