I would like to make just a few comments about the Pain and Distress Initiative of the Humane Society of the United States. I doubt whether anyone in this audience favors increased pain and distress. Most of us are quite comfortable with the hope that some day it may be possible to achieve all scientific aims without pain and distress or, better yet, that we will have solved all of the medical problems that have relied on the use of animals so their use will become unnecessary. I think there is at least philosophical agreement on that point.
One of the concepts mentioned in the HSUS proposal, which I believe deserves discussion, is the idea of minimal risk. One of the HSUS proposals to USDA for altering the pain and distress categories is to establish certain thresholds below which particular levels of IACUC review may or may not apply. I have taken the liberty of extending that proposal perhaps beyond the point they had intended.
We do have a degree of flexibility now in the application of the designated versus the full review process. The parallel on the human subjects side for review, institutional review board (IRB) review, is a category called minimal risk. If carefully applied, this approach could free the IACUC's time to focus on much higher risk issues. However, neither the PHS policy nor the USDA regulations have provisions for minimal risk. Again, rulemaking would be required to implement such a suggestion. I believe the idea has some potential.
The current PHS policy and the USDA regulation, in contrast to the HSUS proposals, already require the minimization of pain and distress. The entire biomedical research community has already accepted this concept through the adoption of ethical principles by scientific professional societies, through journal editorial policies, and through commitments made as a condition for eligibility to receive PHS support. The concept of eliminating pain and distress is not very new. From the PHS perspective and expectation, it does not have to wait for 20 years.
In closing, I think the questions listed below cover some of the important public policy issues that I hope will be discussed further today and considered in the ongoing process of change in the regulations:
Will proposed changes benefit animals?
Are they consistent with statutes/regulations?
Do they “harmonize” agency standards?
Do they achieve goals while minimizing burdens?
NRC [National Research Council]. 1996. Guide for the Care and Use of Laboratory Animals. 7th ed. Washington, D.C. National Academy Press.