title: Decision Making and the IACUC: Part 1- Protocol Information Discussed at Full-Committee Reviews.
abstract: IACUC protocols can be reviewed by either the full committee or designated members. Both review methods use the principles of the 3 Rs (reduce, refine, replace) as the overarching paradigm, with federal regulations and policies providing more detailed guidance. The primary goal of this study was to determine the frequency of topics discussed by IACUC during full-committee reviews and whether the topics included those required for consideration by IACUC (for example, pain and distress, number of animals used, availability of alternatives, skill and experience of researchers). We recorded and transcribed 87 protocol discussions undergoing full-committee review at 10 academic institutions. Each transcript was coded to capture the key concepts of the discussion and analyzed for the frequency of the codes mentioned. Pain and distress was the code mentioned most often, followed by the specific procedures performed, the study design, and the completeness of the protocol form. Infrequently mentioned topics were alternatives to animal use or painful or distressful procedures, the importance of the research, and preliminary data. Not all of the topics required to be considered by the IACUC were openly discussed for all protocols, and many of the discussions were limited in their depth.
authors.affiliation: Department of Animal Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA; Department of Pathology, University of Massachusetts Medical School, Worcester, Massachusetts, USA. Jerald.silverman@umassmed.edu.
authors.forename: Jerald
authors.initials: J
authors.lastname: Silverman
authors.affiliation: Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
authors.forename: Charles W
authors.initials: CW
authors.lastname: Lidz
authors.affiliation: Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Clayfield
authors.affiliation: Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Murray
authors.affiliation: Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
authors.forename: Lorna J
authors.initials: LJ
authors.lastname: Simon
authors.affiliation: Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Rondeau
mesh_terms: D000698:Analgesia / Q000662:veterinary; D035661:Animal Care Committees; D032761:Animal Experimentation / Q000592:standards*; D000827:Animal Welfare / Q000331:legislation & jurisprudence / Q000592:standards*; D000818:Animals; D003657:Decision Making; D012107:Research Design