Information Resources for Institutional Animal Care and Use Committees 1985-1999 *************************

Protocol Review




Federal Criteria for Granting IACUC Approval


(From the ARENA/NIH IACUC Guidebook)

Activities Must be in accord with USDA Regulations/PHS Policy.
Pain/Distress Must avoid/minimize discomfort, distress, and/or pain. If pain/distress is caused, appropriate sedation, analgesia or anesthesia will be used. Attending veterinarian must be involved in planning. Use of paralytics without anesthesia is prohibited. Animals with chronic/severe unrelievable pain will be painlessly killed.
Surgery Must meet requirements for sterile surgery and pre/postoperative care. Cannot use one animal for several major operative procedures from which it will recover, without meeting specified conditions.
Euthanasia Euthanasia method must be consistent with USDA Regulations/AVMA recommendations.
Housing/Health Animal living conditions must be consistent with standards of housing, feeding and care directed by veterinarian or scientist with appropriate expertise.
Alternatives There must be considered alternatives to painful procedures; also must document consideration of alternatives if animals experience pain or suffering.
Rationale and Methods Must provide written narrative of methods/sources.
Duplication Must provide assurance that activities do not unnecessarily duplicate previous efforts.
Qualifications Personnel must be appropriately qualified.
Deviations from Requirements Must be justified for scientific reasons, in writing.



























Bibliography


Cohen, J.M. (1987). Protocol preview and review. Laboratory Animal Science 37(special issue): 57-58.
NAL call number: 410.9 P94
Descriptors: animal experiments, institutions, animal welfare, ACUC.

de Cock Buning, T. and E. Theune (1994). A comparison of three models for ethical evaluation of proposed animal experiments. Animal Welfare 3(2): 107-128.
NAL call number: HV4701 A557
Descriptors: hypothetical case studies, quality of animal experiment, research goals, potential to achieve objective, animal species, number of animals, quality of animal care, discomfort, duration of discomfort, significance of discomfort, credentials of investigators, decision trees, animal welfare, cost-benefit analysis, animal experiments.

Dresser, R. (1987). Refining the IACUC process: Policies and procedures. SCAW Newsletter 9(1): 3-6.
NAL call number: QL55.N48
Descriptors: animal welfare, animal experiments, pain, stress, institutions, ACUC.

Dresser, R. (1989). Developing standards in animal research review. Journal of the American Veterinary Medical Association 194(9): 1184-1191.
NAL call number: 448.9 Am37
Descriptors: animal welfare, laboratory animals, protocols, standards, United State Public Health Service.

Everitt, J. and W. Griffin (1995). Proposed IACUC guidelines for the review of rodent toxicology studies. Contemporary Topics in Laboratory Animal Science 34 (3): 72-74.
NAL call number: SF405.5.A23
Descriptors: laboratory animals, rodents, toxicology, committees, guidelines, animal

Gillett, C.S. (1986). Animal use protocol review is here now. Laboratory Animal Science 36(5): 579.
NAL call number: 410.9 P94
Descriptors: abstract, educational materials, ACUC.

Hart, L.A. (1995). The animal subjects protocol process: Applying the 3Rs. Lab Animal 24(5): 40-43.
NAL call number: QL55 A1L33
Descriptors: protocol preparation, protocol review, investigator's responsibilities, IACUC responsibilities, importance of animal wellbeing, alternatives, reducing sources of discomfort, approaches for the investigator, review of the literature, literature searching.

Hughes, H.G. (1989). An effective industrial animal care and use committee. In Science and Animals: Addressing Contemporary Issues H.N. Guttman, J.A. Mench, and R.C. Simmonds (eds.), Bethesda, Maryland: Scientists Center for Animal Welfare, pp. 49-50.
NAL call number: HV4704 S33 1988
Descriptors: ethics, protocols, drug development.

Johnston, N.E. (1994). Is a second, independent-review animal ethics committee of real benefit. In Welfare and Science: Proceedings of the Fifth Symposium of the Federation of European Laboratory Animal Science Associations, 8-11 June 1993, Brighton, UK. London: Royal Society of Medicine Press, pp. 281-282.
NAL call number: QL55.F43 1993
Descriptors: animal welfare, committees, university research, standards, regulations

Knauff, D.R. (1987). Animal research review in an industrial facility. Laboratory Animal Science 37(special issue): 129-131.
NAL call number: 410.9 P94
Descriptors: animal welfare regulations, animal experiments, ACUC.

Ledney, G.D., C.L. Hadick, and R.H. Weichbrod (1996). The IACUC process: facilitating science in a well-managed animal care and use program. Animal Welfare Information Center Newsletter 7(1): 1-2, 14-15.
NAL call number: aHV4701.A952
Descriptors: animal welfare, committees, communication, legislation, protocol review.

Moreland, A.F. (1987). Animal research protocol review in the Veterans Administration. Laboratory Animal Science 37(special issue): 137-139.
NAL call number: 410.9 P94
Descriptors: animal experiments, policy, regulations, medical research.

Mueller, R. and M.E. Landi (1989).An effective industrial animal care and use committee. In Science and Animals: Addressing Contemporary Issues H.N. Guttman, J.A. Mench, and R.C. Simmonds (eds.), Bethesda, Maryland: Scientists Center for Animal Welfare, pp. 123- 124.
NAL call number: HV4704 S33 1988
Descriptors: protocol, Good Laboratory Practices, training.

Oki, G.S.F., E.D. Prentice, N.L. Garnett, D.F. Schwindaman, and C.Y. Wigglesworth (1996). Model for performing institutional animal care and use committee: continuing review of animal research. Contemporary Topics in Laboratory Animal Science 35 (5):53-56.
NAL call number: SF405.5.A23
Descriptors: animal experiments, laboratory animals, animal welfare, regulations, reviews.

Orlans, F.B. (1987). Review of experimental protocols: Classifying animal harm and applying 'refinements'. Laboratory Animal Science 37(special issue): 50-56.
NAL call number: 410.9 P94
Descriptors: animal welfare, ethics, injuries, animal testing alternatives, ACUC.

Orlans, F.B. (1987). Case studies of ethical dilemmas. Laboratory Animal Science 37(special issue): 59-64.
NAL call number: 410.9 P94
Descriptors: laboratory animals, animal experiments, animal welfare, ACUC.

Orlans, F.B. (1987). Research protocol review for animal welfare. Investigative Radiology 22: 253-258.
Descriptors: ACUC, animal use in research, alternatives, humane treatment of animals.

Orlans, F.B. (1987). Pioneering in-house policies on animal procedures. Laboratory Animal Science 37(4): 512-513.
NAL call number: 410.9 P94
Descriptors: laboratory animals, ACUC.

Prentice, E., A. Jameton, D. Antonsen, and I. Zucker (1988). Prior ethical review of animal versus human subjects research. Investigative Radiology 23(9): 695-697.
Descriptors: ACUC, institutional review board.

Prentice, E.D., D.A. Crouse, and R.W. Rings (1990). Approaches to increasing the ethical consistency of prior review of animal research. Investigative Radiology 25(3): 271-4.
Descriptors: animal testing alternatives, legislation, ethics.

Prentice, E.D., D.A. Crouse, and M.D. Mann (1992). Scientific merit review: The role of the IACUC. ILAR News 34 (1/2): 15-19.
NAL call number: QL55.A1I43
Descriptors: laboratory animals, scientific merit review, committees, animal welfare.

Prentice, E.D. and I. Zucker (1987). Protocol review at the University of Nebraska Medical Center. SCAW Newsletter 9(4): 5-6,9.
NAL call number: QL55.N48
Descriptors: ACUC, animal review committee, expedited process, full committee review.

Protocol Review

This is a regular column in the magazine Lab Animal (NAL call number: QL55 A1L33). The column coordinator is Jerald Silverman, DVM, who describes a hypothetical IACUC scenario and has members of the research community resolve the issue. Below is a partial list of column references.

Rowan, A.N. (1990). Ethical review and the animal care and use committee. Hastings Center Report 20(3 Supp.): 19-24.
NAL call number: R724 H27
Descriptors: Laboratory Animal Welfare Act of 1966, social aspects, Animal Welfare Act of 1970, ethics, animal experimentation, research institutes, standards.

Russow, L-M. (1995). Protocol Review: Too much paperwork? In "Current Issues and New Frontiers in Animal Research, K.A.L. Bayne, M. Greene, and E.D. Prentice, eds., Greenbelt, Maryland: Scientists Center for Animal Welfare, pp. 15-18.
NAL call number: HV4913 C87 1995
Descriptors: information required by IACUC, development of protocol forms, ethics, roles of IACUC members.

Stafleu, F.R., B.D. Baarda, F.R. Heeger, and A.C. Beynen (1993). The influence of animal discomfort, human interest and scientific quality on the ethical acceptability of a projected animal experiment as assessed with questionnaires. Alternatives to laboratory animals: ATLA 21 (2): 129-137.
NAL call number: Z7994.L3A5
Abstract: This study attempts to assess to what extent three selected variables (animal discomfort, scientific quality and human interest) determine the ethical acceptability of a projected animal experiment, as judged by animal experimenters. Two levels of each of the three variables were incorporated into otherwise identical protocols of a hypothetical animal experiment. Thus, there were eight different protocols with various combinations of the variables. In a postal survey, animal experimenters were asked to assign an acceptability score to the projected animal experiment described and to give a short written justification of their score. Human interest had the greatest influence on acceptability scores, followed by animal discomfort and scientific quality. Arguments concerning scientific quality played a major role in determining acceptability scores. At high levels of animal discomfort, the projected experiment was considered acceptable when both human interest and scientific quality were high. Thus, it remains questionable whether, in practice, a well-designed experiment with significant, expected human interest would be dismissed because of a high or moderate degree of anticipated animal discomfort.
Descriptors: animal experiments, animal welfare, bioethics.

Staflue, F.R., B.D. Baarda, F.R. Heeger, and A.C. Beynen (1994). The influence of animal discomfort and human interest on the ethical acceptability of projected animal experiments. In Welfare and science: proceedings of the Fifth Symposium of the Federation of European Laboratory Animal Science Associations, 8-11 June 1993, Brighton, London: Royal Society of Medicine Press, pp. 278-280.
NAL call number: QL55.F43 1993
Descriptors: laboratory animals, animal experiments, ethics, pain, animal welfare, questionnaires, man, health protection.

Steneck, N.H. (1997). Role of the institutional animal care and use committee in monitoring research. Ethics Behavior 7(2): 173-184.
Descriptors: animal care, ethics, committees, regulation.

Tomson, F.N. (1989). Approving the use of animals in medical education. Theoretical Medicine 10(1): 35-42.
Descriptors: animal welfare, laboratory animals, standards, attitude of health personnel.


Useful World Wide Web Sites


Protocol Review Procedures
http://iacuc.tennessee.edu/
This site is provided by the University of Tennessee at Knoxville Institutional Animal Care and Use Committee. Click on protocol review procedures.

Review of Protocols, National Institutes of Health, Office for Protection from Research Risks
http://grants.nih.gov/grants/olaw/references/pubartindex.htm
The following articles can be viewed from this site: