between the regulatory community and the scientific research community. Sessions like this workshop will contribute to closing that gap.

One of the suggestions from the study to help reduce regulatory burden was to prereview policies and regulations before implementation or commentary period. There should be discussion within the broad scientific community that includes investigators, IACUC coordinators, and laboratory animal veterinarians, all of whom will be affected by the policies or regulations.

In addition, there should be a sunset review of all policies and regulations that have been implemented. Every 5 or 10 years, policies and regulations should be reviewed by an external body to determine whether the policy has been effective and whether it should be revised.

The last aspect of what can contribute to regulatory burden is changing standards of compliance. In an environment where the rules keep changing, it becomes a constant challenge to remain in compliance, especially when there is no mechanism to directly inform investigators about the changes. Perhaps the rate of change should decrease so that everyone can understand what the standards are at this point in time.

If the factors I have described are the causes of regulatory burden, then what is the result of regulatory burden? What impact does regulatory burden have? Unfortunately, the impact is difficult to quantitate. However, issues such as lack of cooperation, feeling of distrust, and a general cynicism about the process can undermine the progress that has been made for animals.

Perhaps the most adverse effect of regulatory burden is the cost to the public. This cost is incurred with respect to financial loss due to reduced productivity as well as a loss of research. The burden of unnecessary regulations results in less research accomplished, fewer advances in health care, and fewer lives saved. Institutions and investigators have a shared responsibility with the regulatory agencies to minimize regulatory burden so that advances in health care can be made.


The second message today is that any change in pain and distress definitions, categories, or reporting requirements must adhere to the dictum “keep it simple.” Compliance is facilitated by keeping regulations and policy simple.

The Animal Welfare Act contains the following very simple statement: “The Secretary shall promulgate standards for animal care, treatment and practices in experimental procedures to insure that animal pain and distress are minimized, including adequate veterinary care with appropriate use of anesthetic, analgesic, or tranquilizing drugs or euthanasia.” This simple statement has been made more complex than necessary.

The most effective means of minimizing pain and distress in research animals is not by federal regulation, but by an emphasis on the shared responsibility

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