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Regulatory Concerns
Pages 48-52

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From page 48...
... 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.
From page 49...
... 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.
From page 50...
... 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 highquality 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.
From page 51...
... 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.
From page 52...
... 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. fuss-in-time protocol review might reduce costs somewhat.


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