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: