In many countries the approval of animal research projects depends on the decisions of Animal Ethics Committees (AEC’s), which review the projects. An animal ethics review is performed as part of the authorization process and therefore performed routinely, but comprehensive information about how well the review system works is not available. This paper reviews studies that assess the performance of animal ethics committees by using Donabedian’s structure-process-outcome model. The paper points out that it is well recognised that AECs differ in structure, in their decision-making methods, in the time they take to review proposals and that they also make inconsistent decisions. On the other hand, we know little about the quality of outcomes, and to what extent decisions have been incorporated into daily scientific activity, and we know almost nothing about how well AECs work from the animal protection point of view. In order to emphasise this viewpoint in the assessment of AECs, the paper provides an example of measures for outcome assessment. The animal suffering is considered as a potential measure for outcome assessment of the ethics review. Although this approach has limitations, outcome assessment would significantly increase our understanding of the performance of AECs.
References
[1]
de Greeve, P.; de Leeuw, W. Ethics Committees in Europe—An overview. In Handbook of Animal Models of Infection Experimental Models in Antimicrobial Chemotherapy; Zak, O., Sande, M., Eds.; Academic Press: London, UK, 1999; pp. 13–28.
[2]
Wagman, B.A.; Liebman, M. A Worldview of Animal Law; Carolina Academic Press: Durham, NC, USA, 2011; pp. 185–255.
[3]
Principles and Practice in Ethical Review of Animal Experiments across Europe; Federation of European Laboratory Animal Science Associations: London, UK, 2007.
[4]
The European Parliament and The Council of The European Union. Directive 2010/63/EU of the European Parliament and of The Council of 22 September 2010 on the Protection of Animals Used for Scientific Purposes; European Union: Bruxelles, Belguim, 2010; Volume 2010/63/EU.
[5]
Australian Code of Practice for the Care and Use of Animals for Scientific Purposes; National Health and Medical Research Council: Canberra, Australia, 2004.
[6]
Donabedian, A. Evaluating the quality of medical care. Milbank Mem. Fund Q. 1996, 44 (Suppl.), 166–206.
[7]
American Physical Therapy Association Outcomes Assessment in Physical Therapy Education. Available online: http://www.apta.org/OutcomesAssessment/ (accessed on 29 August 2013).
[8]
Champagne, F.; Contandriopoulos, A.-P.; Pineault, R. A health care evaluation framework. Health Manag. Forum 1986, 7, 57–65.
[9]
Schuppli, C.A.; Fraser, D. Factors influencing the effectiveness of research ethics committees. J. Med. Ethics 2007, 33, 294–301, doi:10.1136/jme.2005.015057.
[10]
Hansen, L.A.; Goodman, J.R.; Chandna, A. Analysis of Animal Research Ethics Committee Membership at American Institutions. Animals 2012, 2, 68–75, doi:10.3390/ani2010068.
[11]
Physicians Committee for Responsible Medicine (PCRM). Animal Care and Use Committees: Structural Problems Impair Usefulness. Available online: http://www.pcrm.org/pdfs/research/testing/exp/ae_iacuc.pdf (accessed on 30 August 2013).
[12]
Silverman, J.; Baker, S.P.; Lidz, C.W. A Self-Assessment Survey of the Institutional Animal Care and Use Committee, Part 2: Structure and organizational functions. Lab Anim. (NY) 2012, 41, 289–294, doi:10.1038/laban1012-289.
[13]
Silverman, J.; Baker, S.P.; Lidz, C.W. A self-assessment survey of the Institutional Animal Care and Use Committee, Part 1: Animal welfare and protocol compliance. Lab Anim. (NY) 2012, 41, 230–235, doi:10.1038/laban0812-230.
[14]
Houde, L.; Dumas, C.; Leroux, T. Ethics: Views from IACUC members. ATLA 2009, 37, 291–296.
[15]
Graham, K. A study of three IACUCs and their views of scientific merit and alternatives. J. Appl. Anim. Welf. Sci. 2002, 5, 75–81, doi:10.1207/S15327604JAWS0501_7.
[16]
Ideland, M. Different views on ethics: How animal ethics is situated in a committee culture. J. Med. Ethics 2009, 35, 258–261, doi:10.1136/jme.2008.026989.
[17]
Houde, L.; Dumas, C.; Leroux, T. Animal ethical evaluation: An observational study of Canadian IACUCs. Ethics Behav. 2003, 13, 333–350, doi:10.1207/S15327019EB1304_2.
[18]
Nordgren, A.; R？cklinsberg, H. Genetically modified animals in research: an analysis of applications submitted to ethics committees on animal experimentation in Sweden. Anim. Welf. 2005, 14, 239–248.
[19]
Schuppli, C.A. Decisions about the Use of Animals in Research: Ethical Reflection by Animal Ethics Committee Members. Anthrozoos: A Multidiscip. J. Interact. People Anim 2011, 24, 409–425, doi:10.2752/175303711X13159027359980.
[20]
Mann, M.D.; Prentice, E.D. Verification of IACUC approval and the just-in-time PHS grant process. ILAR J. 2007, 48, 12–28, doi:10.1093/ilar.48.1.12.
[21]
Kolar, R.; Ruhdel, I. A survey concerning the work of ethics committees and licensing authorities for animal experiments in Germany. ALTEX 2007, 24, 326–334.
[22]
Dresser, R. Developing Standards in Animal Research Review. J. Am. Vet. Med. Assoc. 1989, 194, 1184–1191.
[23]
Plous, S.; Herzog, H. Animal research. Reliability of protocol reviews for animal research. Science 2001, 293, 608–609, doi:10.1126/science.1061621.
[24]
Voipio, H.-M.; Kaliste, E.; Hirsj？rvi, P.; Nevalainen, T.; Ritskes-Hoitinga, M. Nordic-European Workshop on Ethical Evaluation of Animal Experiments. Scand. J. Lab. Anim. Sci. 2004, 31, 251–267.
[25]
Ingham, K.M.; Goldberg, J.A.; Klein, H.J.; Johnson, R.G.; Kastello, M.D. A novel approach for assessing the quality and effectiveness of IACUC oversight in investigator compliance. Contemp Top. Lab. Anim. Sci. 2000, 39, 28–31.
[26]
Hagelin, J.; Hau, J.; Carlsson, H.E. The refining influence of ethics committees on animal experimentation in Sweden. Lab. Anim. 2003, 37, 10–18, doi:10.1258/002367703762226656.
[27]
Hau, J.; Carlsson, H.E.; Hagelin, J. Animal research. Ethics committees have influenced animal experiments in Sweden. BMJ 2001, 322, 1604.
[28]
International Council for Laboratory Animal Science (ICLAS). International harmonization of guidance on the ethical review of proposals for the use of animals, and on the education and training of animal users in science. Available online: http://www.iclas.org/harmonization.htm (accessed on 21 March 2011).
[29]
Coleman, C.H.; Bouesseau, M.C. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med. Ethics 2008, 9, doi:10.1186/1472-6939-9-6.
[30]
Abbott, L.; Grady, C. A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. J. Empir. Res. Hum. Res. Ethics 2011, 6, 3–19.
[31]
Edwards, S.J.; Ashcroft, R.; Kirchin, S. Research ethics committees: Differences and moral judgement. Bioethics 2004, 18, 408–427.
[32]
Prentice, E.; Jameton, A.; Antonson, D.; Zucker, I. Prior ethical review of animal versus human subjects research. Invest. Radiol. 1988, 23, 695–697.
[33]
Schneiderman, L.J.; Gilmer, T.; Teetzel, H.D.; Dugan, D.O.; Blustein, J.; Cranford, R.; Briggs, K.B.; Komatsu, G.I.; Goodman-Crews, P.; Cohn, F.; Young, E.W. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: A randomized controlled trial. JAMA 2003, 290, 1166–1172, doi:10.1001/jama.290.9.1166.
[34]
Taylor, K.; Gordon, N.; Langley, G.; Higgins, W. Estimates for worldwide laboratory animal use in 2005. Altern. Lab. Anim. 2008, 36, 327–342.
[35]
Ethical Principles and Guidelines for Experiments on Animals; Swiss Academy of Medical Sciences (SAMS), Swiss Academy of Sciences (SCNAT): Basel, Switzerland, 2005.
[36]
Act on Welfare and Management of Animals; The Government of Japan: Tokyo, Japan, 1973.
[37]
Guideline on Humane Treatment of Laboratory Animals; Ministry of Science and Technology of China: Beijing, China, 2006.
[38]
CCAC Guidelines on Animal Use Protocol Review (1997); The Canadian Council on Animal Care (CCAC): Ottawa, Canada, 1997.
[39]
Guide for the Care and Use of Laboratory Animals; Institute for Laboratory Animal Research, US National Research Council: Washington, DC, USA, 2010.
[40]
Institutional Animal Care and Use Committee Guidebook, 2nd ed. ed.; Office of Laboratory Animal Welfare (OLAW): Bethesda, MD, USA, 2002.
[41]
Weary, D.; Lee Niel, L.; Flower, F.; Fraser, D. Identifying and preventing pain in animals. Appl. Anim. Behav. Sci. 2006, 100, 64–76, doi:10.1016/j.applanim.2006.04.013.
[42]
Haywood, J.R.; Greene, M. Avoiding an overzealous approach: A perspective on regulatory burden. ILAR J. 2008, 49, 426–434, doi:10.1093/ilar.49.4.426.
[43]
Spellecy, R.; May, T. More than cheating: Deception, IRB shopping, and the normative legitimacy of IRBs. J. Law Med. Ethics 2012, 40, 990–996.
[44]
Klein, H.J.; Bayne, K.A. Establishing a culture of care, conscience, and responsibility: Addressing the improvement of scientific discovery and animal welfare through science-based performance standards. ILAR J. 2007, 48, 3–11, doi:10.1093/ilar.48.1.3.
