| Preface |
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xvii | |
| Introduction |
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xix | |
| Acknowledgments |
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xxi | |
| Authors |
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xxiii | |
| Acronyms and Common Terms |
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xxv | |
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Chapter 1 An Introduction to Best Practices Meetings |
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1 | (6) |
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1 | (1) |
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History of Best Practices Meetings |
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2 | (2) |
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4 | (1) |
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Limitations of the Meeting Format |
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4 | (1) |
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IACUC Administrators' Association |
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4 | (1) |
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5 | (2) |
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Chapter 2 The IACUC Administrator's Office Structure |
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7 | (14) |
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7 | (1) |
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8 | (1) |
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Research Compliance Office |
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8 | (1) |
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Administration through the Director of the ARP |
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8 | (1) |
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How Many Full-Time Employees Does It Take to Effectively Operate an IACUC Administrative Office? |
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9 | (1) |
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10 | (1) |
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The Variable for Number of Animal Users |
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11 | (1) |
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The "Other Factors" Variable |
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11 | (1) |
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11 | (1) |
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AAALAC International Accreditation |
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12 | (1) |
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13 | (1) |
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13 | (1) |
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14 | (1) |
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Hiring IACUC Administrative Staff Members t |
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15 | (1) |
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Credentials: What Is Important? |
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15 | (1) |
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16 | (1) |
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16 | (1) |
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Conducting Reference Checks |
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17 | (1) |
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Reporting Lines: Who Reports to Whom? |
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17 | (1) |
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17 | (1) |
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18 | (1) |
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19 | (1) |
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Improving Efficiency and Working Smart |
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19 | (2) |
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Chapter 3 The IACUC Administrator's Role and Responsibilities |
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21 | (20) |
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21 | (2) |
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23 | (1) |
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The IACUC Administrator's Experience and Background |
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23 | (1) |
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The Regulatory Role of the IACUC Administrator |
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24 | (1) |
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The IACUC Administrator and the IACUC |
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24 | (1) |
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The IACUC Administrator and the AV |
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25 | (1) |
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The IACUC Administrator and the IO |
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26 | (1) |
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The IACUC Administrator and Other Administrative Units |
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26 | (1) |
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The IACUC Administrator and Regulatory Agencies |
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27 | (1) |
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The IACUC Administrator and AAALAC International |
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27 | (1) |
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The IACUC Administrator and Principal Investigators |
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28 | (1) |
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Should the IACUC Administrator Be a Voting Member? |
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28 | (1) |
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What Are the Common Duties of the IACUC Administrator? |
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28 | (1) |
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Coordinate and Conduct Protocol Prescreening and Reviews |
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28 | (2) |
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Organize and Schedule Meetings, Inspections, and Program Reviews |
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30 | (1) |
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Prepare and Distribute Reports |
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30 | (2) |
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32 | (1) |
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OLAW (PHS) Assurance, USDA Registration, and AAALAC Accreditation |
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32 | (2) |
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Conduct Training and Orientations for IACUC Members and Pis |
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34 | (1) |
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Oversee Training Programs and Maintain Training Records |
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35 | (1) |
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Advise the IACUC and IO on Relevant Regulations and Policies |
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35 | (1) |
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Assist PIs with Preparing Protocols and Satisfying Regulatory Requirements |
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36 | (1) |
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36 | (1) |
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Informational Resource to the AV, IACUC Chair, IO, and Pis |
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37 | (1) |
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Serve as Long-Term IACUC Participant and Provide "Institutional Memory" |
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37 | (1) |
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Manage IACUC Investigations |
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38 | (1) |
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Program/Facility Deficiencies and Corrections |
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39 | (1) |
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Conduct Protocol and Grant Congruency Reviews |
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39 | (1) |
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Develop and Maintain IACUC SOPs and Policies |
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39 | (1) |
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Develop and Maintain Websites |
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39 | (1) |
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Author and Distribute Newsletters |
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39 | (1) |
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Monitor Animal Rights Activism and Initiate Appropriate Responses |
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40 | (1) |
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Serve as a Point of Contact for USDA Officers and AAALAC Visitors |
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40 | (1) |
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Develop and Maintain Emergency Disaster Programs |
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40 | (1) |
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Chapter 4 The Animal Care and Use Program |
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41 | (16) |
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41 | (2) |
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Regulatory Requirements and Guidance Documents |
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43 | (1) |
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43 | (2) |
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Key Members of the Organization's Animal Care and Use Program |
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45 | (3) |
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48 | (1) |
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48 | (1) |
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49 | (1) |
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50 | (1) |
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Properly Constituted IACUC and Quorum |
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50 | (1) |
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51 | (1) |
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52 | (1) |
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52 | (1) |
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53 | (1) |
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54 | (1) |
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54 | (2) |
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Expectation of Member Confidentiality |
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56 | (1) |
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Chapter 5 Protocol Review and Approval |
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57 | (16) |
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57 | (2) |
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Regulatory Requirements and Resources |
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59 | (1) |
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Prescreening Protocols (Administrative and Veterinary Reviews) |
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59 | (1) |
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IACUC Administrator Pre-Review |
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59 | (1) |
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60 | (1) |
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Initiating the IACUC Review Process |
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61 | (1) |
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Full Committee Review Process |
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62 | (1) |
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The Use of a Primary Reviewer |
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62 | (1) |
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Consultation with the PI during the FCR |
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63 | (1) |
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Table the Submission after the Next Full Committee Meeting |
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63 | (1) |
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The Use of a Designated Member Reviewer |
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63 | (1) |
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Designated Member Review Process |
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64 | (1) |
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Assigning the Designated Member Reviewer |
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65 | (1) |
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Benefits of Using the Designated Member Review Process |
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65 | (1) |
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Potential Pitfalls of the Designated Member Review Process |
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66 | (1) |
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Conducting Protocol Reviews Using Video and Teleconferencing |
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66 | (1) |
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Full Committee versus Designated Member Review |
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67 | (1) |
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Receiving Proposed Animal Activities |
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67 | (1) |
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Using Approved SOPs as Part of the Protocol |
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67 | (1) |
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68 | (1) |
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Significant versus Nonsignificant (or Minor) Modifications |
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69 | (1) |
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69 | (1) |
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Annual and De Novo Reviews |
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70 | (1) |
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70 | (1) |
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Reviewing Proposals for Custom Antibody Production |
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71 | (1) |
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Reviewing a Protocol for Scientific Merit |
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71 | (2) |
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Chapter 6 Protocol Noncompliance |
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73 | (8) |
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73 | (1) |
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Regulatory Requirements and Resources |
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74 | (1) |
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Investigating and Reporting Animal Welfare Concerns |
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75 | (1) |
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Conducting Investigations |
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75 | (1) |
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75 | (1) |
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76 | (1) |
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76 | (1) |
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77 | (1) |
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78 | (3) |
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Chapter 7 Protocol and Grant Congruency |
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81 | (10) |
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81 | (1) |
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Regulatory Requirements and Guidance Documents |
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82 | (1) |
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83 | (1) |
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84 | (1) |
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Collaborations and Protocol and Grant Congruency |
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85 | (1) |
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86 | (1) |
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86 | (1) |
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87 | (1) |
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88 | (1) |
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How Does a Grant Modification Affect the IACUC Approval? |
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88 | (1) |
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Oversight at Collaborating Organizations |
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89 | (2) |
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Chapter 8 Animal Care and Use Program Review |
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91 | (12) |
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91 | (1) |
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Regulatory Requirements and Resources |
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92 | (1) |
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93 | (1) |
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Preparing for the Program Review |
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93 | (1) |
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Proposed Best Practices for Conducting Program Reviews |
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94 | (1) |
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Program Review Best Practice 1 |
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94 | (3) |
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Program Review Best Practice 2 |
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97 | (2) |
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Program Review Best Practice 3 |
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99 | (1) |
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Illustrating the Animal Care and Use Program Review Process |
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100 | (2) |
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Documenting the Program Review |
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102 | (1) |
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Chapter 9 Semiannual Facility Inspection |
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103 | (18) |
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103 | (1) |
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Regulatory Requirements and Reference Resources |
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104 | (1) |
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104 | (1) |
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What Facilities Must Be Inspected Semiannually by the IACUC? |
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105 | (1) |
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105 | (1) |
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105 | (1) |
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Specialized Animal Laboratories |
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106 | (1) |
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106 | (1) |
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106 | (1) |
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HVAC and Emergency Monitoring Systems |
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106 | (1) |
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Preparing for the Program Review |
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107 | (1) |
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Training/Refresher Training |
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107 | (1) |
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Establishing the Inspection Schedule |
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107 | (1) |
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Coordinating the Inspections |
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108 | (1) |
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Who Should Serve on the Inspection Teams? |
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108 | (2) |
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The Size of the Inspection Teams |
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110 | (1) |
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Announcing the Inspection |
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110 | (1) |
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Preparing for the Inspections |
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111 | (1) |
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Conducting Semiannual Inspections |
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111 | (1) |
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Inspecting Animal Housing Areas |
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111 | (1) |
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Laboratory Animal Facilities |
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112 | (3) |
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Agriculture Animal Facilities |
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115 | (1) |
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116 | (1) |
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Cage Wash and Support Areas |
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116 | (1) |
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Procedure and Specialized Areas |
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117 | (1) |
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Survival and Nonsurvival Surgery Suites |
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117 | (1) |
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117 | (1) |
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118 | (1) |
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Controlled Drug Storage Areas |
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118 | (1) |
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Identifying, Documenting, and Correcting Deficiencies |
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118 | (1) |
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119 | (2) |
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Chapter 10 Monitoring the Animal Care and Use Program |
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121 | (14) |
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121 | (1) |
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Regulatory Requirements and Guidance Documents |
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122 | (1) |
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122 | (1) |
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Monitoring Approved IACUC Protocols |
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123 | (1) |
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Developing a Monitoring Program to Complement the Program |
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124 | (1) |
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A Simple Method for Conducting Focused Assessments |
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124 | (2) |
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Establishing a Postapproval Monitoring Program |
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126 | (1) |
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126 | (1) |
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Identifying and Training the Compliance Liaisons |
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127 | (1) |
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Reporting Lines and the Compliance Liaison's Relationship with the IACUC |
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128 | (1) |
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Policy and Standard Operating Procedure Development |
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129 | (1) |
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129 | (1) |
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129 | (1) |
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130 | (1) |
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Postassessment Activities (Follow-Ups) |
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131 | (1) |
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132 | (1) |
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132 | (3) |
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Chapter 11 Facilitating Communication |
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135 | (6) |
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135 | (2) |
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137 | (1) |
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Communications among Groups Administering the Program |
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137 | (1) |
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Communicating with the IO |
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138 | (1) |
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Communicating with the AV and Veterinary Staff |
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139 | (1) |
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Communicating with Principal Investigators |
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140 | (1) |
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Communicating with the IACUC |
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140 | (1) |
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141 | (10) |
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141 | (1) |
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Regulatory Requirements and Resources |
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142 | (1) |
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IACUC Review of Field Studies |
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143 | (1) |
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Field Studies: What Information Does the IACUC Need? |
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144 | (1) |
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Protocol Review and IACUC Oversight |
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145 | (1) |
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146 | (1) |
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Vertebrate Animals as Bait in Field Studies |
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146 | (1) |
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Accounting for Animals Used in Invasive Research Field Studies |
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147 | (1) |
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Accounting for Animals Used in Noninvasive Research Field Studies |
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147 | (1) |
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148 | (1) |
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149 | (1) |
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What Should IACUC Administrators Know about Permitting Requirements? |
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149 | (1) |
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Providing Guidance to the PI |
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149 | (1) |
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149 | (1) |
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150 | (1) |
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Chapter 13 Personnel Qualifications and Training Programs |
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151 | (18) |
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151 | (1) |
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152 | (1) |
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Establishing a Training Program |
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152 | (1) |
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Common Training Employed by Organizations Using Animals |
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153 | (1) |
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Training for Individuals Handling Animals |
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153 | (5) |
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158 | (2) |
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160 | (1) |
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160 | (2) |
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162 | (1) |
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A Web-Based Training Module |
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162 | (1) |
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163 | (1) |
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164 | (1) |
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Continuing Education for IACUC Members |
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165 | (1) |
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Additional Training Programs Frequently Developed for Animal Users |
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166 | (1) |
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Evaluating the Effectiveness of Training Programs |
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167 | (1) |
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Final New Member Actions before New Members Go to Work |
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167 | (2) |
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Chapter 14 Tracking Animal Use on Protocols |
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169 | (6) |
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169 | (1) |
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Regulatory Requirements and Guidance Documents |
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169 | (1) |
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170 | (1) |
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Identifying Use When Transferring Animals between Research Proposals |
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170 | (1) |
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Agricultural Production Animals |
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170 | (1) |
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171 | (1) |
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172 | (1) |
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Methodologies for Tracking the Number of Animals Used on Each Protocol |
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172 | (1) |
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172 | (1) |
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173 | (1) |
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De Novo Reviews and Animal Numbers |
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173 | (2) |
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Chapter 15 Veterinary Care Programs |
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175 | (8) |
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175 | (2) |
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177 | (1) |
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The Veterinary Care Program |
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178 | (1) |
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Evaluating the Veterinary Care Program |
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179 | (1) |
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180 | (1) |
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Using Research Animals in More Than One Project |
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180 | (1) |
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181 | (1) |
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Pharmaceutical versus Reagent Grade Drugs |
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182 | (1) |
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Chapter 16 Whistle-Blower Policy |
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183 | (8) |
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183 | (1) |
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Regulatory Requirements and Resources |
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183 | (1) |
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184 | (1) |
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184 | (1) |
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184 | (1) |
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Reporting Noncompliance or the Misuse of Animals |
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184 | (1) |
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Sample Policy 1 Advantages and Disadvantages |
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185 | (1) |
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185 | (1) |
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GEU's Whistle-Blower Policy |
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185 | (1) |
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186 | (1) |
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Sample Policy 2 Advantages and Disadvantages |
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186 | (1) |
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Investigating Whistle-Blower Policy Reports |
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187 | (1) |
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187 | (1) |
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IACUC Investigation of Reports |
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188 | (1) |
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Whistle-Blower Policy (Reporting Animal Welfare Concerns) Checklist |
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189 | (2) |
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Chapter 17 Occupational Health and Safety Program |
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191 | (12) |
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191 | (1) |
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Regulatory References and Guidance Documents |
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191 | (2) |
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The OHSP and Accreditation |
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193 | (1) |
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The IACUC Administrator's Role |
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193 | (1) |
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193 | (1) |
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Hazard Identification and Analysis |
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194 | (1) |
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Identifying Environmental Hazards |
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194 | (1) |
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194 | (2) |
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196 | (1) |
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Ongoing Hazard Identification and Assessment |
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197 | (1) |
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197 | (1) |
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197 | (1) |
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Quantifying Identified Environmental Hazards |
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198 | (1) |
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Personal Dispositions (Personal Risk Assessments) |
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198 | (2) |
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Risk Protection and Mitigation |
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200 | (1) |
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200 | (1) |
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What Constitutes Participation in the Occupational Health and Safety Program? |
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200 | (3) |
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Chapter 18 Emergency Disaster Plans |
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203 | (8) |
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203 | (1) |
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Regulatory Requirements and Guidance Documents |
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204 | (1) |
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Developing an Emergency Disaster Plan |
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205 | (1) |
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Identifying Potential Disasters |
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205 | (1) |
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The EDP Program Structure |
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206 | (1) |
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206 | (1) |
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207 | (1) |
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208 | (1) |
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208 | (1) |
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209 | (1) |
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Evaluating and Testing Emergency Disaster Plans |
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209 | (1) |
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Continuing Program Business during a Disaster |
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210 | (1) |
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Chapter 19 The Role of a Primary Grantee |
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211 | (10) |
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211 | (1) |
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211 | (1) |
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212 | (1) |
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212 | (1) |
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PHS Assurance Ramifications |
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212 | (1) |
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213 | (1) |
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Securing Animal Welfare Assurance Coverage |
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213 | (1) |
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213 | (3) |
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Interinstitutional Assurance |
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216 | (1) |
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217 | (1) |
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Collaborations and Contracts |
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217 | (1) |
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Collaborations When Research Is Funded through a PHS Agency |
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217 | (2) |
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AAALAC International Accreditation and Collaborations |
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219 | (1) |
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219 | (1) |
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International Collaborations |
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220 | (1) |
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Chapter 20 FOIA, Sunshine Laws, and Confidential Information |
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221 | (4) |
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221 | (1) |
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Freedom of Information Act |
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222 | (1) |
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Responding to FOIA Requests |
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223 | (1) |
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223 | (1) |
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Institutional Access to Information |
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223 | (2) |
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Chapter 21 DOD and VA Regulations---Know the Differences |
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225 | (12) |
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225 | (1) |
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Regulatory References and Guidance Documents |
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225 | (1) |
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Federal Funding and PHS Assurance |
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226 | (1) |
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227 | (1) |
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227 | (1) |
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228 | (1) |
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229 | (1) |
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Semiannual Review Processes |
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229 | (1) |
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230 | (1) |
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230 | (1) |
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230 | (1) |
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230 | (1) |
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231 | (1) |
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231 | (1) |
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231 | (1) |
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232 | (1) |
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Unique Aspects of VA and DOD Programs |
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232 | (1) |
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232 | (1) |
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233 | (1) |
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VA Memorandum of Understanding |
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234 | (1) |
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VA Models and Relationship to Sister Civilian Animal Care and Use Progams |
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235 | (1) |
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235 | (1) |
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235 | (1) |
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235 | (1) |
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235 | (2) |
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Chapter 22 Data Management and Electronic Systems |
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237 | (14) |
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237 | (1) |
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Regulatory Guidance on the Use of Electronic Communications |
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238 | (1) |
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Methods of Telecommunications |
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238 | (1) |
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E-mail as a Method of Communication |
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239 | (1) |
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Appropriate and Effective Use of E-mail |
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239 | (1) |
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Inappropriate Use of E-mail |
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239 | (2) |
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Use of Video Conferencing Equipment |
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241 | (1) |
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242 | (1) |
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242 | (1) |
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243 | (1) |
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243 | (1) |
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243 | (2) |
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Commercial Off-the-Shelf Systems |
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245 | (1) |
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245 | (1) |
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245 | (1) |
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245 | (1) |
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Meeting Minutes: What Must They Contain? |
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246 | (1) |
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Animal Care and Use Protocol Records |
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246 | (1) |
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Duration of Record Maintenance |
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247 | (1) |
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Using Electronic Systems for the Protocol Review Process |
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247 | (1) |
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247 | (1) |
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Organization-Specific Electronic Processes |
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248 | (3) |
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Chapter 23 Policies, Guidelines, and Standard Operating Procedures |
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251 | (8) |
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251 | (2) |
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Policies, SOPs, and Guidelines---What Is the Difference? |
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253 | (1) |
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254 | (1) |
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Standard Operating Procedure |
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254 | (1) |
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255 | (1) |
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256 | (1) |
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256 | (1) |
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256 | (1) |
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Use of Hazardous Materials in Conjunction with Animal Activities Policy |
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257 | (2) |
| Appendix 1 |
|
259 | (2) |
| Appendix 2 |
|
261 | (2) |
| Appendix 3 |
|
263 | (2) |
| Appendix 4 |
|
265 | (2) |
| Appendix 5 |
|
267 | (2) |
| Appendix 6 |
|
269 | (2) |
| Appendix 7 |
|
271 | (2) |
| Appendix 8 |
|
273 | (2) |
| Appendix 9 |
|
275 | (2) |
| Appendix 10 |
|
277 | (2) |
| Appendix 11 |
|
279 | (2) |
| Index |
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281 | |