Government Relations Update

APA recommends against proposed federal lab animal research policy

Public Health Service is urged not to adopt 8th edition of the Guide.

By Sangeeta Panicker, PhD

Earlier this year, the Institute for Laboratory Animal Research of the National Research Council (a component of the National Academies) published the eighth edition of the Guide for the Care and Use of Laboratory Animals (known in the animal research community as the Guide). Subsequently, the Office for Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) published a call for public comments (PDF, 180KB) concerning adoption of the newly revised Guide as Public Health Service (PHS) policy.  OLAW is charged with regulatory oversight of all PHS-supported research, testing, and training that involves laboratory animals, and has adopted previous editions of The Guide for evaluation of laboratory animal research programs.   (The PHS is an umbrella organization within the U.S. Department of Health and Human Services that includes the NIH, Centers for Disease Control and Prevention, Food and Drug Administration, and other agencies.)

Based on an extensive review of the new Guide, the American Psychological Association (APA) has submitted comments expressing concerns about multiple aspects of the revision and recommending that the seventh edition of the Guide (published in 1996) remain PHS policy while the eighth edition is used as a reference.  APA’s comments were developed primarily by the APA Committee on Animal Research and Ethics (CARE) with input from other psychological scientists who conduct research with laboratory animals.

Many of APA’s concerns regarding the new Guide are shared by other scientific societies that have also submitted comments, including the American College of Neuropsychopharmacology, American Society for Pharmacology and Experimental Therapeutics, Association for Behavior Analysis International, College on Problems of Drug Dependence, and National Association for Biomedical Research.

The main concern raised by APA and other organizations is that the recommendations in the new Guide are written in a manner that makes them de facto regulations, rather than as guidelines as they are supposed to be treated by the PHS according to current law. Moreover, some of the recommendations are problematic because they constrain the exercise of scientific and professional judgment by researchers and laboratory animal veterinarians.  It is argued that if the recommendations are indeed going to be viewed and implemented as regulations rather than as guidance, then the research community should be given the opportunity to comment on them in a substantive manner.

Furthermore, the new Guide is highly prescriptive and calls for significant changes in institutional laboratory animal research programs’ standard operating procedures, the physical environment and housing of various laboratory animal species, and the level of veterinary care and oversight. Compliance with these new standards will greatly increase the cost of conducting research with laboratory animals with no evidence of a commensurate improvement in animal welfare.

OLAW is expected to respond later this year to the public comments about its proposed adoption of the eighth edition of the Guide. APA and its partner scientific organizations will continue to communicate and work with OLAW concerning the roles of both the seventh and eight editions of the Guide in the management of laboratory animal research, with the goal of ensuring that policies for laboratory animal welfare are ethical and evidence-based.

 

Sangeeta Panicker, PhD, is director of the APA Research Ethics Office and serves as staff liaison to the Committee on Animal Research and Ethics.