5
Regulatory Concerns

The Institutional Animal Care and Use Committee (IACUC) plays a critical role in an institution through review and approval of research protocols and semiannual review of the institution's facilities and programs for the humane care and use of laboratory animals. It is important to note the interactive relationships of the IACUC and the animal research program in the assurance of high-quality care. The IACUC has responsibility for oversight of all components of laboratory animal management, so poorly managed or chronically undersupported animal research facilities and programs not only erode the research mission and cooperation of investigators, but also require an extraordinary commitment of time and effort on the part of the IACUC. Ill-advised reduction in support of research animal program administration could result in a degradation of the program and increased expenditures related to regulation. Personal communications from several financial officers at academic institutions have indicated that the magnitude of IACUC costs is underestimated by many institutions because the institution fails to account for the cost of faculty time spent on IACUC activities. For those reasons, most institutions rely on strong leadership of the animal care and use program to diminish costs of IACUC program oversight

Institutions acknowledge the importance of maintaining viable regulatory compliance, but researchers and administrators at universities have complained for many years about the high cost and time required to comply with federal and state regulation of the use of animals in research. However, compliance cost has been difficult to estimate. In 1995, seven



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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES 5 Regulatory Concerns The Institutional Animal Care and Use Committee (IACUC) plays a critical role in an institution through review and approval of research protocols and semiannual review of the institution's facilities and programs for the humane care and use of laboratory animals. It is important to note the interactive relationships of the IACUC and the animal research program in the assurance of high-quality care. The IACUC has responsibility for oversight of all components of laboratory animal management, so poorly managed or chronically undersupported animal research facilities and programs not only erode the research mission and cooperation of investigators, but also require an extraordinary commitment of time and effort on the part of the IACUC. Ill-advised reduction in support of research animal program administration could result in a degradation of the program and increased expenditures related to regulation. Personal communications from several financial officers at academic institutions have indicated that the magnitude of IACUC costs is underestimated by many institutions because the institution fails to account for the cost of faculty time spent on IACUC activities. For those reasons, most institutions rely on strong leadership of the animal care and use program to diminish costs of IACUC program oversight Institutions acknowledge the importance of maintaining viable regulatory compliance, but researchers and administrators at universities have complained for many years about the high cost and time required to comply with federal and state regulation of the use of animals in research. However, compliance cost has been difficult to estimate. In 1995, seven

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES major research universities tried to estimate the cost of complying with pertinent federal regulations (Greger 1995). The University of Wisconsin-Madison in 1995 employed eight full-time equivalents (FTEs) to support the efforts of college and all-campus IACUCs. These people (including veterinarians part of the time) processed protocols, attended IACUC meetings, performed animal facility site visits, and educated faculty, other researchers, and IACUC members on animal care and federal compliance issues. Faculty serving on IACUCs contributed the equivalent of 4,000 hours/year (2 FTEs) in reviewing protocols, attending IACUC meetings, and participating in semiannual facility inspections. On the average, the faculty and staff spent 19 hours per protocol to meet compliance recommendations. No attempt was made to estimate the amount of time that investigators spent in preparing and revising protocols. The costs of animal care staff, veterinarians, and institutional review board members to attend national and regional training was not estimated. Future surveys should gather information regarding these costs as an overall assessment of training costs. All seven universities agreed that the amount of faculty and staff time spent on compliance with animal use regulations was large and did not necessarily reflect the quality of animal care programs. Some types of protocol took more time to review—those involving international collaborators, those with complex and multiple procedures, and especially “less developed” protocols. Accordingly, the seven institutions recommended “just-in-time” review of human and animal use protocols with no review of protocols submitted to the National Institutes of Health (NIH) and “considered unfundable” by a study section. Depending on the institution, this would eliminate the need to review 10 to 50% of protocols submitted for NIH funding. However, this recommendation would not reduce the IACUC's workload for proposals submitted to industry, the National Science Foundation, or the US Department of Agriculture (USDA), because their grant review differs from that of NIH. During the next 3 years, the so-called regulatory burden was often mentioned but never analyzed successfully. However, the House of Representatives Committee on Appropriations (House Report 105–205, p. 98) in the FY 1998 budget report mandated that NIH conduct a study of regulatory burden. The mandate extended the study to “regulations governing use of animal and human subjects in research and regulations covering the use and disposal of hazardous and radioactive materials. ” NIH convened a focus group of researchers, IACUC members and staff, and laboratory animal veterinarians to assess animal care and use issues. The resulting report (NIH 1999) cited the following as major categories of problems:

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES Redundancy of program review and inspections. Inconsistency in yearly reports required by the Office for Protection from Research Risks (OPRR), USDA, and the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Inconsistency between USDA and OPRR on protocol review. Outdated or poorly conceived USDA requirements, including those dealing with caging of animals. Inconsistency in interpretation of regulation and policies by oversight groups. Complexity of regulations governing the transportation of animals and materials derived from nonhuman primates. No estimate was made of the cost of complying with the redundant or inconsistent policies. However, the Animal Care and Use Workgroup noted that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation review of hospitals occurs every 3 years. In contrast, “IACUCs are required by the Health Research Extension Act and the Animal Welfare Act to conduct both an in-depth review of the institution's program for the humane care and use of animals, and an inspection of its facilities every 6 months. In addition, current law also requires that the USDA inspect every facility once a year. Furthermore AAALAC conducts a full accreditation site visit every 3 years for those institutions that voluntarily seek accreditation ” (NIH 1999). As a result the animal care programs and facilities at an institution are reviewed at least 3 times per year. Some experts in the regulatory work group think that reducing redundancy and inconsistency of efforts would allow faculty and staff to spend their time more efficiently in producing high-quality research with well-tended research animals. This committee is not aware of studies documenting the costs of training investigators in writing protocols and training required before procedures are performed as well as the costs of training research staff in record keeping and the proper use of animals. However, if properly done, these training costs must be considerable. A potential benefit would be that well-trained staff perform more efficiently. The 1999 ARS demonstrated that the costs of supporting IACUC functions are substantial, even apart from faculty time, and are a frequent recipient of institutional subsidy. Of 48 institutions that responded, 31 reported that their IACUCs had an annual budget in excess of $50,000 (range, $0–301,260) (Table 29, Appendix C); and in 27 of 51 institutions that responded, the IACUC budget was funded in whole or in part by the institution (Table 26b, Appendix C). The 1999 ARS was not designed to address the regulatory burden

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES issue, but it yielded some insights into the topic, especially with regard to the relative burden for small and large research programs. The 14 institutions with large animal use programs (group 3) invested more in the management of regulatory compliance than the 23 institutions with smaller programs (group 1) (Table 29, Appendix C). They were more apt to have a program for monitoring animal experimentation apart from the mandated semiannual IACUC inspections (92% versus 70%), had more faculty and staff serving on IACUCs (21 versus 14 members), and budgeted more for IACUCs ($164,000/year versus $63,000/year). However, the cost of compliance as a percentage of research dollars received was generally higher for smaller programs (Tables 21b and 29, Appendix C). The proposal to require USDA to regulate the use of rats, birds, and mice in research—as well as other species—will increase the regulatory burden in all institutions. However, the burden will be especially heavy in smaller institutions that have had no previous regulatory experience and in institutions that depend on difficult to obtain state funds and state approval for renovation of facilities. The 1999 ARS also provided insights into the issues that most concerned laboratory animal veterinarians and users of research animal facilities. They ranked their concerns in descending order as high per diem rates, inadequacy of space available for animal housing, and burdensome regulatory compliance and inadequate institutional support for the facility (tied) (Table 31, Appendix C). Some noted that the large investment that institutions must make to support regulatory compliance reduces the funds available for renovation and expansion of animal facilities or reduction of per diem rates. Although that might not be true in all cases, 13 of 52 researchers perceived institutional funding of animal research to be inadequate. Perhaps the biggest shortfall is in funds for upgrading of animal facilities. This is due to at least 4 factors: Most research institutions have delayed maintenance of their research facilities. Thus, funds for renovations are used for both repairs and upgrade. Transgenic animals and modern research techniques require ever larger and more sophisticated animal facilities. NCRR has a small budget for upgrading animal facilities. NIH Research and Program (R and P) series grants provide little support for facility renovation. Universities are relying more on donations for facility upgrades, but animal facilities are less appealing to donors than other facilities (partially because of the activities of animal-rights activists.)

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES The result of the costs of complying with regulations is that institutions and researchers have tried to become more efficient in all aspects of animal research. Most experts think that reducing the regulatory burden on animal use is one way to make animal care more efficient. SUMMARY In summary, the major findings and opinions expressed in this chapter are as follows: Costs of regulatory compliance are usually underestimated because costs of faculty time for IACUC activities, and for writing protocols as well as costs of training are rarely assessed. Just-in-time protocol review might reduce costs somewhat. Some regulations governing use of animals in research are redundant and inconsistent; this leads to increased costs. The IACUC annual budget was greater than $50,000 for 65% of institutions responding to the 1999 ARS survey. The budget was somewhat higher, when calculated as a percentage of animal research dollars, for smaller institutions. The proposal to require USDA to regulate rats, mice, and birds will be especially burdensome for smaller institutions. This and previous items would suggest forming independent IACUCs to handle the compliance needs of smaller institutions.