by Amy Davis , Senior Director for Programs and Publications

During the final series of breakout sessions at the 2013 IACUC Conference there was a discussion of the Implementation of the Institute of Medicine (IOM) Report on the Use of Chimpanzees in Biomedical and Behavioral Research. Hope Ferdowsian, MD, MPH, moderated the discussion which featured Tom Beauchamp, PhD; Margaret Landi, VMD, MS, DACLAM; and David Wendler, MA, PhD.

Dr. Landi set the stage by presenting a summary of the 2011 IOM report, explaining that the committee’s charge was to develop a report on whether and under what circumstances it was necessary to use chimpanzees in either biomedical or behavioral research. (For more information, view the report here.)

For biomedical research, research with chimpanzees is justified only when the following conditions are met:

1. There is no other suitable model available, such as in vitro, nonhuman in vivo, or other models, for the research in question, and
2. The research in question cannot be performed ethically on human subjects, and
3. Forgoing the use of chimpanzees for the research in question will significantly slow or prevent important advancements to prevent, control and/or treat life-threatening or debilitating conditions.

The use of chimpanzees for behavioral research is justified only when:

1. Studies provide otherwise unattainable insight into comparative genomics, normal and abnormal behavior, mental health, emotion, or cognition, and
2. All experiments are performed on acquiescent animals, in a manner that minimizes pain and distress, and is minimally invasive.

Applying these criteria to current practices, the IOM Committee concluded in 2011 that while the chimpanzee has been a valuable model in the past, there is decreasing need for such studies given the increasing availability of alternative models and technologies.

Dr. Beauchamp continued the discussion by pointing out the challenges of developing a report under the conditions established by the National Institutes of Health for the project, which included the single animal model and the instruction not to consider the ethical issues. In spite of these limitations, the IOM Committee succeeded in producing a significant report that changes the landscape of chimp research by establishing comparatively restrictive criteria for justifying such research. As an example, he pointed out the criterion that limits behavioral research to “acquiescent” animals, establishing a relatively high level of respect for the chimpanzee.

Dr. Beauchamp criticized the IOM report’s lack of consideration of the “moral costs” of using chimpanzees in research. He sees a need for a new standard defining a pain threshold. Given the increasing difficulty to justify such research, Dr. Beauchamp predicts its imminent cessation.

Dr. Wendler focused on the question of whether an ethical framework for conducting animal research could be modeled after the existing framework for conducting human research. He presented three areas of inquiry for analyzing the question:  research value, level of risk, and assent/dissent.

1. Research value: Human subjects research is justified only when the risks are reasonable in relation to the potential benefits. Most research using chimpanzees is solely for the benefit of humans, not chimpanzees. Dr. Wendler asked whether we can justify non-beneficial research on sentient beings, particularly ones who cannot consent to such research? The IOM principles are relevant to the question of research value in that they limit research with chimpanzees to studies necessary for advancing a public health goal that could not be otherwise accomplished. The question remains, however, whether such research should be further limited by requiring potential benefit for the animal subjects.

 

1. Level of risk: Dr. Wendler asked whether animal research ethics framework should include a risk threshold. Under the human research regulations risk is measured against a comparator. Are the risks of the research greater or less than those of daily life activities?  Dr. Wendler presented the standards for permissible research involving children as a useful model for research involving chimpanzees given the comparably limited capacity to consent to such research. For research involving children, federal regulations present different requirements for potential benefit depending on the level of risk to the child subjects. Dr. Wendler wondered whether this framework could be adapted to some extent to animal research by establishing a range of “burden” levels based on potential for pain and suffering. In general, observational studies would be considered minimally burdensome, while some pain and suffering would be considered moderately burdensome, and prolonged pain, suffering would be considered highly burdensome.  Each level would require increasing potential for benefit.

 

1. Assent/Dissent: Finally, Dr. Wendler examined the applicability of the assent requirement in research with children to research with animals. With children and other populations who do not have the capacity to consent, researchers consider the preferences of potential subjects. The IOM report referred to “acquiescence” as a requirement for behavioral research with chimpanzees. Is acquiescence too passive a standard? Should there be an effort to assess “assent?” Should researchers consider the animals’ expression of dissent as they would in a child? And then where do you draw the line for this requirement? While it might be possible to discern assent in a chimp, it may not be for a rabbit, for example. 

Given advances in technology and the decreasing need for certain animal models, is now the time to develop an ethical framework for conducting all animal research? What do you think? Please share your opinions below.