Critical Analysis of Assessment Studies of the Animal Ethics Review Process †
Abstract
:Simple Summary
Abstract
1. Introduction
Component to be evaluated | Evaluation approach | Explanation |
---|---|---|
Resource input | Evaluation of Structure | Structure assessment relates to the organization of ethics committees, the number, training and competency of staff, the comprehensiveness of services, and the accessibility of services. The link to outcome assessment is based on the assumption that the better the structure, the better the process and outcomes. |
Service rendered | Evaluation of Process | This addresses issues related to what committees do, how they do it and the interaction they have with each other/researchers. |
Outcome achieved | Evaluation of Outcome | Outcome assessment relate specifically to the program’s objectives. Narrow and measurable objectives are needed. |
2. “Assessment Studies” in the Literature
Goals | References | |
---|---|---|
Evaluation of Structure | Evaluation of committee composition and dynamics, recruitment of members, workload, participation level and member turnover | [9,10,11,12,13] |
Evaluation of members’ opinion on structure, organization function and performance | ||
Evaluation of Process | Attitude of committee members towards ethics review | [13,14,15,16] |
Decision making process (individual and group) | [17,18,19] | |
Policy implementation and variation in time for review | [19,20,21] | |
Examination of variation among AECs in evaluation of hypothetical or real cases | [22,23,24] | |
Evaluation of Outcome | Compliance of investigators | [25] |
Approval rate | [21,26,27] |
2.1. Evaluation of Structure
2.2. Evaluation of Process
2.3. Evaluation of Outcome
2.4. Summary of the Different Evaluation Studies
Authors (Year) Title [citation number] | ||
---|---|---|
Affiliation | ||
Funding | Conflict of interest | |
Method | ||
Dresser, R., (1989) Developing standards in animal research review [22] | ||
School of Law, Case Western Reserve University, Cleveland, USA | ||
Not specified | Not specified | |
Protocol evaluation, protocol review form analysis | ||
Graham, K. (2002) A study of three IACUCs and their views of scientific merit and alternatives [15] | ||
Center for Animals and Public Policy, Tufts University School of Veterinary Medicine, USA | ||
Not specified | Not specified | |
Survey and interview | ||
Hau, J., Carlsson, H. E. Hagelin, J. (2001) Animal research. Ethics committees have influenced animal experiments in Sweden [27] | ||
Division of Comparative Medicine, Department of Physiology Uppsala University, Uppsala, Sweden | ||
Not specified | Not specified | |
Review of minutes of meetings | ||
Hagelin, J., Hau, J. and Carlsson, H. E. (2003) The refining influence of ethics committees on animal experimentation in Sweden [26] | ||
Department of Physiology, Division of Comparative Medicine, Uppsala University, Sweden. | ||
Helge Axson Johnsons Stiftelse, Magn. Bergwalls Stiftelse, CF Lundstroms Stiftelse and CFN (grant. no. 02-72) | Not specified | |
Review of minutes of meetings | ||
Hansen, L. A., (1), Goodman, J. R. (2), Chandna, A. (3) (2012) Analysis of Animal Research Ethics Committee Membership at American Institutions [10] | ||
1 Departments of Neurosciences and Pathology, University of California San Diego, USA; 2 People for the Ethical Treatment of Animals, Washington, DC 20036, USA; 3 Department of Sociology and Criminal Justice, Marymount University, USA | ||
Not specified | none | |
Membership review | ||
Houde, L., Dumas, C. (1) Leroux, T. (2), (2003) Animal ethical evaluation: an observational study of Canadian IACUCs [17] | ||
1 Département de psychologie, Université du Québec à Montréal, Montréal, QC, Canada, H3C 3P8.; 2 Centre de recherche en droit public Université de Montréal | ||
Not specified | Not specified | |
Observation | ||
Houde, L., Dumas, C. (1) Leroux, T. (2), (2009) Ethics: views from IACUC members [14] | ||
1 Département de Psychologie, Université du Québec à Montréal, Canada; 2 Centre de Recherche en Droit; Public, Université de Montréal, Canada | ||
Not specified | Not specified | |
Interview | ||
Ideland, M. (2009) Different views on ethics: how animal ethics is situated in a committee culture [16] | ||
School of Teacher Education, Malmö University, Malmö, Sweden. | ||
Not specified | Not specified | |
Interview | ||
Ingham, K. M., Klein, H. J., Kastello, M. D. (1), Goldberg, J. A., (2) Johnson, R. G. (3), (2000) A novel approach for assessing the quality and effectiveness of IACUC oversight in investigator compliance [25] | ||
1 Department of Laboratory Animal Resources, Merck Research Laboratories, USA 2 Management Development Systems, Inc., Hillsborough, NJ, USA 3 Chiron Vaccines, Emeryville, CA, USA | ||
Not specified | Not specified | |
Interview and survey | ||
Kolar, R. and Ruhdel, I. (2007) A survey concerning the work of ethics committees and licensing authorities for animal experiments in Germany [21] | ||
Animal Welfare Academy (Akademie für Tierschutz), German Animal Welfare Federation (Deutscher Tierschutzbund), Neubiberg, Germany | ||
Not specified | Not specified | |
Survey | ||
Mann, M. D. , Prentice, E. D., (2007) Verification of IACUC approval and the just-in-time PHS grant process [20] | ||
University of Nebraska Medical Center, Omaha, NE, USA. | ||
Not specified | Not specified | |
Survey | ||
Nordgren, A. (1) Röcklinsberg, H. (2), (2005) Genetically modified animals in research: an analysis of applications submitted to ethics committees on animal experimentation in Sweden [18] | ||
1 Centre for Applied Ethics, Linköping University, SE–581 83 Linköping, Sweden; 2 Centre for Theology and Religious Studies, Lund University, Allhelgona Kyrkogata 8, SE–223 62 Lund, Sweden. | ||
Swedish Foundation for Strategic Research (the ELSA Program) and the Knut and Alice Wallenberg Foundation (Program of ethics research in connection to Swegene and WCN). | Not specified | |
Protocol evaluation | ||
Plous, S. (1) Herzog, H. (2), (2001) Animal research. Reliability of protocol reviews for animal research [23] | ||
1 Department of Psychology, Wesleyan University, Middletown, CT 06459-0408, USA. 2 Department of Psychology, Western Carolina University, Cullowhee, NC 28723, USA. | ||
Not specified | Not specified | |
Protocol evaluation | ||
Schuppli, Catherine A., (2011) Decisions about the Use of Animals in Research: Ethical Reflection by Animal Ethics Committee Members [19] | ||
Animal Welfare Program, Faculty of Land and Food Systems, University of British Columbia, Canada | ||
International Foundation for Ethical Research (IFER) through a postgraduate fellowship; by the UBC Animal Welfare Program that is funded by the Natural Sciences and Engineering Research Council of Canada; the BCSPCA; the BC Veterinary Medical Association; and sponsors listed on the programme website | Not specified | |
Observation and interview | ||
Schuppli, C. A. and Fraser, D., (2007) Factors influencing the effectiveness of research ethics committees [9] | ||
Animal Welfare Program, Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada | ||
The International Foundation for Ethical Research (IFER) through a postgraduate fellowship; by the UBC Animal Welfare Program that is funded by the Natural Sciences and Engineering Research Council of Canada; the BCSPCA; the BC Veterinary Medical Association; and other sponsors listed on the programme website at www.landfood.ubc.ca/animalwelfare/. | none | |
Interview | ||
Silverman, J. (1), Baker, S. P. (2), Lidz, C. W. (3), (2012) A self-assessment survey of the Institutional Animal Care and Use Committee, part 2: structure and organizational functions [12] | ||
1 Department of Animal Medicine, University of Massachusetts Medical School, Worcester, MA. 2 Departments of Quantitative Health Sciences, Cell Biology, and Information Services, University of Massachusetts Medical School, Worcester, MA. 3 Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA.; USA | ||
Not specified | none | |
Survey | ||
Silverman, J. (1), Baker, S. P. (2), Lidz, C. W. (3), (2012) A self-assessment survey of the Institutional Animal Care and Use Committee, Part 1: animal welfare and protocol compliance [13] | ||
1 Department of Animal Medicine, University of Massachusetts Medical School, Worcester, MA, USA 2 Departments of Quantitative Health Sciences, Cell Biology, and Information Services, University of Massachusetts Medical School, Worcester, MA, USA 3 Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA | ||
Not specified | none | |
Survey | ||
Voipio, H.-M., (1), Kaliste, E., Nevalainen, T. (2), Hirsjärvi, P.,(3) Ritskes-Hoitinga, M.(4), (2004) Nordic-European Workshop on Ethical Evaluation of Animal Experiments [24] | ||
1 Laboratory Animal Centre, University of Oulu, Oulu, Finland; 2 National Laboratory Animal Center, University of Kuopio, Kuopio, Finland; 3 Department of Social and Moral Philosophy, University of Helsinki, Helsinki, Finland; 4 Biomedical Laboratory, University of Southern Denmark, Odense C, Denmark | ||
The workshop was organized by the Cooperation Group for Laboratory Animal Sciences of the Finnish Ministry of Education and made possible through funding by the Academy of Finland, the Finnish Ministry of Education and Agriculture and Forestry, NOVA University and the Finnish Society for the Protection of Animals. | Not specified | |
Protocol evaluation | ||
Physicians Committee for Responsible Medicine (PCRM), (1994) Animal Care and Use Committees: Structural Problems Impair Usefulness [11] | ||
Physicians Committee for Responsible Medicine (PCRM), USA | ||
Not specified | Not specified | |
Interview |
3. Why is it Challenging to Study the Outcome of AECs’ Decisions?
3.1. An Example of Measures for Outcome Assessment
Principles | Objectives | Sources |
---|---|---|
Applying 3Rs | Reducing number of experimental animals keeping scientific value of research | [4,5,36,37,38,39,40] |
Reducing animals’ suffering by refinement such as anaesthesia, humane endpoints, euthanasia | ||
Replacing animals to non animal tools and use of less sensitive animals | ||
Severity assessment | Recognizing severity of procedures | [4,5,38,40] |
Scientific relevance | Reviewing the merit and value of research under review | [4,5,38,39] |
Maximizing benefit | ||
Ethical justification | Ensuring that the benefits of research outweighs the risks (harm-benefit analysis) | [4,5,38,39] |
Giving extra protection to certain species such as non-human primate research | ||
Preventing duplication of experiments | ||
Expertise of researchers | Well trained personal is involved in experiments | [4,5,38,39,40] |
Appropriate design | Methodological rigour of the research is necessary | [4,5,38,39,40] |
Statistical soundness | ||
Selected species can be scientifically justified |
4. Conclusions
Acknowledgments
Conflicts of Interest
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Varga, O. Critical Analysis of Assessment Studies of the Animal Ethics Review Process. Animals 2013, 3, 907-922. https://doi.org/10.3390/ani3030907
Varga O. Critical Analysis of Assessment Studies of the Animal Ethics Review Process. Animals. 2013; 3(3):907-922. https://doi.org/10.3390/ani3030907
Chicago/Turabian StyleVarga, Orsolya. 2013. "Critical Analysis of Assessment Studies of the Animal Ethics Review Process" Animals 3, no. 3: 907-922. https://doi.org/10.3390/ani3030907