Establishing a Necessity-Based Approach to the Use of Chimpanzees - PowerPoint PPT Presentation

Establishing a Necessity-Based Approach to the Use of Chimpanzees in Research Jeffrey Kahn, PhD, MPH Andreas C. Dracopoulos Director Johns Hopkins Berman Institute of Bioethics

Background  2010  ~950 chimpanzees in US research colonies  US and Gabon only countries with captive research populations  Approx. 2/3 are owned or supported by the NIH  Animals from Alamogordo (NM) colony slated to be moved to other research colonies  10 yr. contract expired  NM senators and former Gov. Bill Richardson, Sen. Tom Harkin objected, and requested expert review by NRC/IOM  Committee on the Use of Chimpanzees in Biomedical and Behavioral Research formed in April 2011 (report issued Dec. 2011)  “Explore contemporary and anticipated biomedical research questions to determine if chimpanzees are or will be necessary [my italics] for research discoveries and to determine the safety and efficacy of new prevention or treatment strategies.” – statement of task

Why Have Chimpanzees Been Used? (many answers are unique to them)  Similarity to humans  Genetic  Immunological  Physiological/morphological  Behavior  No other applicable animal model  Infectious disease  Studies of specific behavior  Unethical to perform proposed research on humans  Long-lived in captivity (up to 70 yrs)  No euthanasia policy (CHIMP Act, 2000)  Available resource, high cost to maintain  Some of these are different from because they are necessary

Assessing the Necessity of Existing Research  Reviewed literature for all NIH-funded research involving chimpanzees over previous 10 years  Asked whether research question asked could have been addressed using other animal or non- animal model, either at the time or at present  If yes, then chimpanzees not necessary  If no, then while chimpanzees may have been required for research in question, was the research itself necessary?

Chimpanzee research supported by the NIH 60 50 Colony Maintenance 40 Other Number of Projects Malaria Immunology 30 Behavior AIDS/HIV Neuroscience 20 Comparative Genomics Hepatitis 10 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year

Ethical Considerations • “The committee felt ethics was at the core of any discussion about the necessity of continued use of chimpanzees in research. While the committee was not sufficiently constituted to take on the ethics of research on chimpanzees, its considerations were suffused with an awareness of the moral cost of such research. These concerns were manifest in the very high level of justification the committee required to support the necessity of chimpanzee research in the specific areas of research it examined and assessed.” • The scientific reasons for using chimpanzees are what creates ethical concerns, ie they are close to us in many ways • And their availability allows us to do research on them rather than humans • Presumption that research on at least some animals is acceptable

Principles and Criteria • The committee was guided by the following three principles: 1.The knowledge gained must be necessary to advance the public’s health, and 2.There must be no other research model by which the knowledge could be obtained, and the research cannot be ethically performed on human subjects, and 3.The animals used in the proposed research must (a) acquiesce to research, and (b) be maintained in either ethologically appropriate physical and social environments or in natural habitats. • Criteria were crafted from these principles

General Conclusions  The chimpanzee has been a valuable animal model.  There is no uniform set of criteria currently used to assess the necessity of the chimpanzee in NIH-funded biomedical and behavioral research.  Application of the committee’s criteria would provide a framework to assess scientific necessity to guide the future use of chimpanzees in biomedical, comparative genomics, and behavioral research.  The trajectory indicates a decreasing scientific need for chimpanzee studies due to the emergence of non- chimpanzee models and technologies.  Hep C vaccine development and mAb could be necessary under the criteria  Development of non-chimpanzee models requires continued support by the NIH.

Recommendations  The NIH should limit the use of chimpanzees in research to those studies that meet the recommended criteria  The criteria set forth in the report are intended to guide not only current research policy, but also decisions regarding potential use of the chimpanzee in future research.  The committee believes that the assessment of the necessity of the chimpanzee in all grant renewals and future research projects would be strengthened and the process made more credible by establishing an independent oversight committee.

Lessons for Connecting Recommendations to Ethics  Among the most important features of the IOM Committee’s recommendations was that arguments from necessity should be rendered coherent with arguments and perceptions about ethics.  Such alignment made for well-grounded conclusions that met with support from a diverse range of stakeholders, despite their potentially divergent perspectives, and contributed to the significant policy impact of the Committee’s work.

Congressional Response “The IOM report recommends the National Institutes of Health adopt strict criteria for evaluating future proposals to use chimpanzees in biomedical, genomics, or behavioral research programs. These criteria would significantly reduce the need for chimpanzees in health research. We ask you to promptly adopt these recommendations .” – Senator Bingaman and Senator Udall

NIH Response “ I have considered the report carefully and have decided to accept the IOM committee recommendations. NIH is in the process of developing a complete plan for implementation of the IOM’s guiding principles and criteria. I am grateful to the IOM for their careful and thoughtful assessment of this important and sensitive topic. ” – NIH Director Francis Collins, on the day of the report’s public release

Summary  Review of proposed research involving chimpanzees changed in significant ways  Much higher bar for justification  Presumption changed to avoiding use of chimpanzees unless criteria are met  Implementation  NIH Director’s Working group released its report and recommendations in Jan. 2013 (IOM report Dec. 2011)  Reduce to 50 total in research population; revisit every 3-5 yrs  No breeding  Ethologically appropriate housing  Allow “autonomous choice to participate” [acquiescence]  NIH decision to discontinue funding for any research involving chimpanzees, and retire remaining captive population to sanctuary — Nov. 2015