ILAR Journal Online, Volume 37(2) 1995: Laboratory Animal Care Policies and Regulations

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ILAR Journal V37(2) 1995
Laboratory Animal Care Policies and Regulations

Call for Comments

Permitting Issues and the Costs of Animal Research

The costs of doing research have long been of concern to the scientific community. They have also recently become the focus of Congressional inquiry. In a June 6, 1995 letter to the Government Accounting Office (GAO), Congressmen John Porter (R-IL and Dan Miller (R-FL) expressed their concern for the amount of money being spent on "funding excess paperwork and additional staff due to excessive regulations'' governing research.

ILAR is currently focusing on two aspects of the cost issue--the collection and importation of biologics for research and education, and how various costs associated with animal research affect scientific progress. To assist in our work on these two issues, we are seeking comments and examples from the scientific, regulatory, and funding communities regarding problems encountered in these two areas.

PERMITS FOR THE COLLECTION AND IMPORTATION OF BIOLOGICS FOR RESEARCH AND EDUCATION

Biological research often requires the collection and movement of sera, cells, and other specimens as well as whole plants, animals, and fossils from one country to another or from the field to a laboratory. Collection, transport and disposition of such material are closely regulated and often require permits. Four major permitting agencies regulate these activities: the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture, the National Marine Fisheries Service of the National Oceanographic and Atmospheric Administration, the Fish and Wildlife Service of the Department of Interior, and the Centers for Disease Control and Prevention of the Department of Health and Human Services. Components of other agencies also have a role, such as the Department of Transportation, U.S. Post Office, U.S. Customs, Food and Drug Administration, Bureau of Land Management, and the National Park Service. Scientists from both the biomedical and biodiversity sciences, in academe and industry, are affected by the permitting process.

Two goals frequently clash during the permitting process. On the one hand, science requires the use and exchange of biological material and live organisms. On the other, the natural resources of the country and the health of the public must both be protected. The rules and regulations on permitting are complex and can lead to problems for both scientists and regulators. Complying with the laws is time-consuming and can cause delays in the movement of materials. An investigator might have to obtain permits from as many as four or five agencies before collecting or moving biological specimens. Several institutions have full-time staff whose job is to deal with permits. Nonetheless, many investigators are unaware of the regulations or choose to ignore them. Many of the problems might be solved by simplifying the permitting process, streamlining the administration of the granting of permits, 'and by better communication between scientists and regulators.

ILAR held two meetings in 1994, attended by both regulators and scientists, to plan a series of workshops on permitting issues. Some of the topics identified were

effects of the permitting process on biomedical and toxicological research requiring the use of live and dead plants and animals; biological materials such as sera, cell lines, DNA, and microorganisms,
impact of the permitting process on biodiversity research including planned, opportunistic, and existing collections and field research,
international laws and regulations (such as NAFTA and GATT), and packaging and shipping requirements,
cataloguing and harmonizing import/export documents used by various agencies to administer the regulations, with a goal of producing a resource handbook and electronic database, and
examining whether permitting policies could be improved by basing them more explicitly on scientific risk-assessment.

To assist in developing the proposed workshop series and to help foster communication between regulators and scientists, we seek examples and comments from the scientific and regulatory communities regarding problems encountered in obtaining or issuing permits necessary for collection, transport, export, or import of biologic materials, including animals, plants, biologic specimens, cell cultures and reagents, and museum or archaeologic specimens.

THE COSTS OF ANIMAL RESEARCH: IMPACTS ON SCIENTIFIC PROGRESS

In recent years, ILAR has heard increasing concerns from many researchers that high and rising costs of conducting research with animals are impeding scientific progress. Various causes for cost increases have been cited, including the purchase and maintenance of specialized stocks and strains; the regulatory oversight imposed on research institutions by federal, state, and local regulations and policies; requirements for facility safety and security; and various internal policies of research institutions. Differences in the ways that institutions handle cost components can lead to substantial differences in the costs of performing animal research at different institutions.

Federal requirements have a major impact on costs. Chief among them are the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. They impose wide-ranging controls and oversight over animal-based research, including review of protocols by institution-based animal care and use committees (IACUCs); cage-size requirements; occupational health and safety programs; facility designs; and heating, ventilation, and air-conditioning requirements. Office of Management and Budget (OMB) directive A-21 prohibits recovery of indirect costs for animal housing since it is a cost center whose use can be assigned to specific investigators. That requirement has caused some institutions to charge very high direct costs to cover heating, ventilation, and cooling; housekeeping; maintenance; and other such indirect costs. Others are finding ways to redefine animal facilities and research space, and still others are decentralizing the animal facilities.

ILAR is exploring the above and related issues to determine what, if any, action the institute should take to help address those issues and how to prioritize those that need to be addressed. The ILAR Council is considering questions such as the following:

What are the major sources of cost for research involving animals? What factors affect those costs?
To what extent is it possible to evaluate what impacts those costs have on scientific progress?
Is there any evidence that the funding success of research proposals in which animals are used is related to the costs associated with their use? To what extent is it known whether interinstitutional variability of direct and indirect costs for animal research affects funding success?
How might the costs identified be reduced, or at least contained, without sacrificing animal welfare, safety, and other goals?

To help ILAR identify and address concerns about the costs of animal research, we seek comments and examples relating to the above and related questions.

HOW COMMENTS WILL BE USED

The examples and comments we obtain on permitting issues and the cost of animal research will be used internally by ILAR in planning activities that provide advice to the government and the scientific community and foster communication between them. A summary of the information received may be published in a future issue of ILAR Journal, but neither contributing individuals nor their institutions would be identified without permission.

Please send comments and examples by letter, fax, or email to: Editor, ILAR Journal, Institute of Laboratory Animal Resources, 2101 Constitution Avenue, NW, Washington, DC 20418, Fax: 202-334-1687, E-mail: ilarj@ nas.edu.