Exam 1 Study Guide Flashcards

1
Q

4 steps of biomedical research progress

A
  1. computer modeling
  2. in vitro research
  3. animal research
  4. human clinical trials
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2
Q

3R’s

A

replacement
reduction
refinement

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3
Q

what kinds of animals are used in research

A

rodents, swine, dogs, cats, rabbits, fish, NHPs

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4
Q

most commonly used animals in research

A

rodents

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5
Q

how many animals are used in research each year

A

20 million

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6
Q

how many animals are slaughtered for food production each year

A

9 billion

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7
Q

where do lab animals come from

A

breeding colonies specifically for research
dealers raised specifically for research

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8
Q

what happens to an animal once the study is completed

A
  1. euthanasia
  2. additional studies
  3. adopted
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9
Q

innovations leading to reduction in number of animals used in research

A

increased use of genetically manipulated mice, rats, and zebrafish

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10
Q

some areas of research that use animals

A
  1. education and training
  2. medical product development
  3. safety testing
  4. procedure development
  5. disease investigation
  6. basic science research
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11
Q

who must be registered under AWA

A
  1. research facilities with covered animals
  2. zoos
  3. dealers
  4. exhibitors
  5. roadside exhibitions/zoos
  6. circuses/animal acts
  7. educational exhibits
  8. petting zoos
  9. public walk-in aviaries
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12
Q

who is excluded under AWA

A
  1. retail pet stores
  2. shelters
  3. breeders with face-to-face sales
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13
Q

why was the AWA created

A

prevent pet theft and regulate humane care

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14
Q

AWA date of origin

A

1966

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15
Q

who enforces the AWA

A

USDA via APHIS

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16
Q

animal definition under AWA

A

warm-blooded animals live/dead EXCEPT birds, mice of mus, rat of rattus BRED for use in research

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17
Q

how is AWA compliance ensured

A

annual reports, unannounced inspections, IACUC

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18
Q

major updates to AWA

A

birds are covered

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19
Q

avian coverage criteria flowchart

A

refer to slideshow

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20
Q

who must follow the Guide

A

institutions who want federal funding

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21
Q

orgs used for Guide compliance

A

OLAW, AAALAC

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21
Q

Guide first publication

A

1963

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22
Q

Guide most current publication

A

2011

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23
Q

difference from AWA and PHS

A

PHS includes rodents

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24
Q

the Guide purpose

A

basis for care and use of lab animals; basis for standards, program reviews, inspections

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25
Q

what regulations are IACUC required by

A

AWA and PHS

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26
Q

IACUC responsibilities

A

oversees program, procedures, and facilities through inspection, review, and evaluation

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27
Q

IACUC goal

A

ensure compliance with AWA, Guide, and AVMA Guidelines for Euthanasia

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28
Q

IACUC makeup

A
  1. institutional official
  2. chairperson
  3. vet with LAS experience
  4. non-affiliated member
  5. scientist with LAS experience
  6. non-scientist member
  7. public member
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29
Q

types and frequencies of IACUC inspections

A
  1. new location - prior to housing animals
  2. semi-annual - at least every 6 months
  3. unannounced - if any concerns
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30
Q

IACUC 3 areas of focus

A

record keeping
expiration dates
human and animal safety and health

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31
Q

IACUC 3 locations

A

animal facility
where animal work is completed
where items related to work is stored

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32
Q

IACUC post inspection process

A
  1. discuss during inspection
  2. fix immediately if possible
  3. IACUC reviews and discusses
  4. submit findings
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33
Q

who must follow PHS

A

all institutions using animals in research

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34
Q

when was PHS first published

A

1971

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35
Q

PHS is enforced by what agency

A

OLAW

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36
Q

PHS animal definition

A

any live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes

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37
Q

OLAW enforces which guidelines

A

PHS and the Guide

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38
Q

species covered under OLAW

A

all live, vertebrate animals used in research

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39
Q

does OLAW do inspections

A

yes, through IACUC

40
Q

is OLAW voluntary or involuntary

A

involuntary

41
Q

OLAW standards not met

A

approval/funding is suspended

42
Q

AAALAC evaluates which 3 programs

A
  1. Guide
  2. Ag Guide
  3. European Guide
43
Q

AAALAC 2 standards to be met in USA

A

PHS and AVMA Guidelines

44
Q

AAALAC inspections?

A

yes

45
Q

AAALAC volunatry or involuntary

A

voluntary

46
Q

AAALAC standards not met

A

accreditation revoked

47
Q

Nuremberg Code

A

after WWII
results of Nazis
human experiments must be done on animals first

48
Q

Declaration of Helsinki

A

1964 by 18th World Medical Assembly
human research must be done on animals first

49
Q

what is AALAS

A

national org dedicated to humane care and treatment of lab animals

50
Q

lab animal research team members

A
  1. principal investigator - coordinates research
  2. co-investigators/research technicians - perform research tasks
  3. lab animal vets - maintenance of animals
  4. lab animal techs - perform animal care functions
51
Q

animal welfare

A

treat animals with compassion and provide for their humane treatment

52
Q

animal rights

A

animals should have the same rights as humans

53
Q

why improve study designs?

A

improve data quality, reach more people, save time/funds, save animals

54
Q

what is a pilot study

A

preliminary information
small

55
Q

what is an exploratory study

A

provide data to generate new hypotheses

56
Q

what is a confirmatory study/hypothesis test

A

formal hypothesis stated
study conducted
results compared to hypothesis

57
Q

what is the gold standard for confirmatory studies

A

double-blind, randomized, placebo-controlled

58
Q

what is an “uncontrolled” study

A

no comparison between groups

59
Q

what is a regression and correlation study

A

estimates relationship between variables

60
Q

what is the experimental unit

A

physical entity assigned randomly to a treatment group

61
Q

what is a subject

A

the individual whose response is studied in the experiment

62
Q

N

A

the set of all individuals or experimental units of interest

63
Q

n

A

a subset of individuals or experimental units selected from the population

64
Q

what is a crossover study

A

subject receives two or more treatments, one after another in a random sequence

65
Q

what is teratology

A

study of abnormal fetal development

66
Q

what is bias

A

systemic differences between treated and control groups

67
Q

what is blind assessment

A

investigator does not know if subject belongs to experimental or control group

68
Q

what is randomization

A

process of assigning subjects to groups to that any difference between groups is due to chance alone

69
Q

what are Type I errors and how to avoid them

A

false positives, rejecting null when it is true
avoid by estimating probability of false positive and making assumptions when appropriate

70
Q

what is the null hypothesis

A

states that there is no difference between the means

71
Q

how does power analysis help control stat errors

A

mathematical relationship between:
1. Type I
2. Type II
3. sample size
4. signal
5. noise
if you have 4, you can predict the 5th

72
Q

how does signal/noise affect study

A

magnitude of response to the treatment likely to be scientific, includes standard deviation

73
Q

how does the power of the proposed experiment affect study

A

1-B where B is probability of Type II error

74
Q

how does the sidedness of the test affect study

A

which direction a difference is being tested in

75
Q

how does the significance level affect study

A

how often a Type I error is expected to occur

76
Q

how does the sample size affect study

A

number of subjects in each group

77
Q

how to determine sample size by power analysis

A
  1. alternative hypothesis
  2. significance of use
  3. what power to use based on consequences
  4. estimate noise
  5. estimate signal of interest
78
Q

what is the resource equation model

A

backup for signal-noise ratio
E=N-B-T
N = experimental unit - 1
B = blocks - 1
T = treatment/control groups - 1

79
Q

outbred strains

A

mating unrelated animals in a closed colony

80
Q

inbred strains

A

animals developed by breeding related individuals for many generations (>20)

81
Q

mutants

A

animals with an accidental genetic mutation

82
Q

genetically modified strains

A

animals with purposefully modified genetics

83
Q

benefits of controlling variability

A

lowers sample sizes needed

84
Q

completely randomized design

A

subjects/experimetnal units assigned to treatments at random

85
Q

randomized block design

A

ranks on blocking factors such as body weight, pen location, or treatment day

86
Q

factorial design

A

multiple factors with each factor having 2+ levels

87
Q

what does statistical analysis reveal

A

estimate the magnitude of any differences between the means of the treatment groups for an outcome variable

88
Q

parametric stat analysis

A

estimates mean and standard deviations, performs hypothesis tests

89
Q

non-parametric stat analysis

A
  1. Wilcoxon test
  2. Mann-Whitney test
  3. Kruskal-Wallis test
  4. Friedman test
    uses when data/transformation fails to meet parametric assumptions
90
Q

standard deviation

A

describes variability of data

91
Q

standard error

A

describes variability of the mean

92
Q

confidence interval

A

indicates the range within which we can reasonably be sure the true mean lies

93
Q

what is a mean

A

average

94
Q

what is a median

A

middle point

95
Q

what are the ARRIVE Guidelines

A

list 10 essential and 11 additional items that need to be taken into account when writing a paper involving lab animal use

96
Q

10 essential ARRIVE Guidelines

A
  1. study design
  2. sample size
  3. inclusion and exclusion criteria
  4. randomisation
  5. binding/masking
  6. outcome measures
  7. stat methods
  8. experimental animals
  9. experimental procedures
  10. results
97
Q

what makes a good study

A
  1. correct number of animals
  2. consult statistician
  3. randomisation
  4. blind assessment of outcomes
  5. reduced variability
98
Q

what is variation, how does it affect study

A

differences between groups/standard deviation
increases signal/noise ratio, reduces samples size, increases power, detect smaller responses