Pain, Distress, and Reporting Requirements: PHS Policy Perspective

Nelson Garnett

Director, Office of Laboratory Animal Welfare

National Institutes of Health

Rockville, Md.

It is my pleasure to be here with you this morning to talk about some very important public policy issues that are before us. Pain and distress (and especially distress, as we have heard) have been topics of several recent meetings, which have all contributed greatly to our understanding of these issues.

NIH is a partial sponsor of this workshop for several reasons. One reason is that Congress has raised a concern, which NIH has addressed through the commissioning of a study on regulatory burden. The study is associated with a variety of federal requirements, including not only animal welfare but also human subjects and hazardous waste disposal and many other things that have an impact on research institutions. Another reason is our recognition of the continuing need to harmonize the requirements of federal agencies. Harmonization is especially important in our application of existing animal welfare laws, regulations, and policies from the different oversight agencies involved. An additional reason is that obviously, it is important for us to “get it right ” for the benefit of animal welfare as well as science.

INTERRELATED ISSUES

Although the real focus today is on pain and distress and the USDA Policy 11, which defines these, it is really impossible to separate Policy 11 and look at it independently from some other current initiatives because these issues are all interrelated. Each issue is very important in its own right but also because it has significant potential for unintended outcomes and burdens if not looked at along with others in an integrated fashion. I will comment briefly on some of these issues.



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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Pain, Distress, and Reporting Requirements: PHS Policy Perspective Nelson Garnett Director, Office of Laboratory Animal Welfare National Institutes of Health Rockville, Md. It is my pleasure to be here with you this morning to talk about some very important public policy issues that are before us. Pain and distress (and especially distress, as we have heard) have been topics of several recent meetings, which have all contributed greatly to our understanding of these issues. NIH is a partial sponsor of this workshop for several reasons. One reason is that Congress has raised a concern, which NIH has addressed through the commissioning of a study on regulatory burden. The study is associated with a variety of federal requirements, including not only animal welfare but also human subjects and hazardous waste disposal and many other things that have an impact on research institutions. Another reason is our recognition of the continuing need to harmonize the requirements of federal agencies. Harmonization is especially important in our application of existing animal welfare laws, regulations, and policies from the different oversight agencies involved. An additional reason is that obviously, it is important for us to “get it right ” for the benefit of animal welfare as well as science. INTERRELATED ISSUES Although the real focus today is on pain and distress and the USDA Policy 11, which defines these, it is really impossible to separate Policy 11 and look at it independently from some other current initiatives because these issues are all interrelated. Each issue is very important in its own right but also because it has significant potential for unintended outcomes and burdens if not looked at along with others in an integrated fashion. I will comment briefly on some of these issues.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Similarity of Initiatives The underlying principles for the USDA Animal Welfare Act and the Department of Health and Human Services Health Research Extension Act are remarkably similar, especially on the pain and distress issues. I discuss the specific elements of these documents below. Principle IV. US Government Principle IV is a good example: “Proper use of animals including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative.” I believe that statement is the simplest way of describing the “Three Rs” and the concept of alternatives. The principle continues with that familiar anthropomorphic statement, which provides the starting point for making the necessary pain and distress assessments before determining how to avoid or minimize them. According to the statement, unless the contrary is established, investigators should consider that procedures that cause pain and distress in human beings may cause pain or distress in animals. It proceeds to address sedation, euthanasia, and other important points. Another PHS policy (also NIH grants policy) that is not often mentioned is the requirement for investigators to address five very specific animal-related points in the vertebrate animal section of the NIH grant application. Study sections are expected to evaluate this information along with other components of the application. Applications without this information are considered incomplete. In the statement at D, the principal investigator is asked to describe “procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research....” These are just two of the dozens of references to pain and distress in the PHS policy and in the Guide for the Care and Use Of Laboratory Animals (NRC 1996). I mention them because they are not very different from the intended outcome of the USDA requirement to consider alternatives, that is, the infamous Policy 12. Policy 12. Although far more prescriptive, the USDA language in Policy 12 calls for essentially the same assurances that are required in an NIH grant application. Dr. DeHaven and I have had this discussion, and I believe the revised Policy 12 reflects a more appropriate focus on what will be done to minimize pain and distress and what steps will be taken or were taken to learn about the availability of various alternative systems. On this subject, some of you may be aware that our office is cosponsoring the production of an alternative search engine, working with the Johns Hopkins Center for Alternatives to Animal Testing and a number of other project team members. This search engine is now at the beta test stage, and we are very excited about its prospects. It is designed and intended to provide useful tools for

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 investigators and IACUCs to make this process of considering alternatives not only much easier but also considerably more effective. We are looking forward to that development. Policy 11. Dr. DeHaven has provided an excellent description of the possible changes to Policy 11. Of course, the definitions are extremely important because they determine not only what is reported, and where and how it is reported, but they determine also when Policy 12 might apply and play a role in decisions. I do want to emphasize, as did Dr. DeHaven, a fairly major problem with the current Column E definition in which animals are assigned to Column E based on whether anesthetics or analgesics were withheld because they would interfere with the aims of the study. A very literal, technical application of this definition does not include the more important issue of whether the animal actually experienced pain or distress. I believe this area is of common concern for most of the participants in this discussion. Another issue is that the current definition does not take into account the availability of many methods to alleviate pain and distress that are not classified as analgesics or anesthetics. For example, if a disease state is the cause of a painful or distressful condition, the effective treatment of that condition could obviously alleviate it. Alternatively, if a behavioral approach were used to alleviate anxiety or distress through something like training, conditioning, social housing, or simply comforting by a trusted caretaker, these methods of pain and distress alleviation would not count because they are not anesthetics or analgesics. The same description applies to other classes of drugs such as anti-inflammatory agents or antihistamines; they do not count for the purpose of reporting. This issue should be addressed so that the full range of pain alleviation methods can be credited. Unfortunately, some of these problems are embedded in the language of the regulations and may require a rule making to correct. I believe this area requires attention along with the changing definition and reporting requirements. RATS, MICE, AND BIRDS Another favorite topic is that of rats, mice, and birds. Dr. DeHaven has already alluded to this topic. You probably ask what this has to do with pain and distress. The PHS policy already covers all vertebrates, so there should be little change in the day-to-day care of these animals as a result of USDA coverage, at least at PHS-supported institutions. Our main public comment to USDA on this issue is that we seek consistency with the existing PHS standards and the Guide for the Care and Use of Laboratory Animals (NRC 1996). However, if one factors in modified reporting requirements, Policy 12 requirements, and possible definition changes for pain and distress, the sheer numbers involved could increase the administrative load on institutions very significantly.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 HSUS PAIN AND DISTRESS INITIATIVE 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. CONCLUSION 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? REFERENCE NRC [National Research Council]. 1996. Guide for the Care and Use of Laboratory Animals. 7th ed. Washington, D.C. National Academy Press.