Exam 1 Study Guide Flashcards
1
Q
4 steps of biomedical research progress
A
- computer modeling
- in vitro research
- animal research
- human clinical trials
2
Q
3R’s
A
replacement
reduction
refinement
3
Q
what kinds of animals are used in research
A
rodents, swine, dogs, cats, rabbits, fish, NHPs
4
Q
most commonly used animals in research
A
rodents
5
Q
how many animals are used in research each year
A
20 million
6
Q
how many animals are slaughtered for food production each year
A
9 billion
7
Q
where do lab animals come from
A
breeding colonies specifically for research
dealers raised specifically for research
8
Q
what happens to an animal once the study is completed
A
- euthanasia
- additional studies
- adopted
9
Q
innovations leading to reduction in number of animals used in research
A
increased use of genetically manipulated mice, rats, and zebrafish
10
Q
some areas of research that use animals
A
- education and training
- medical product development
- safety testing
- procedure development
- disease investigation
- basic science research
11
Q
who must be registered under AWA
A
- research facilities with covered animals
- zoos
- dealers
- exhibitors
- roadside exhibitions/zoos
- circuses/animal acts
- educational exhibits
- petting zoos
- public walk-in aviaries
12
Q
who is excluded under AWA
A
- retail pet stores
- shelters
- breeders with face-to-face sales
13
Q
why was the AWA created
A
prevent pet theft and regulate humane care
14
Q
AWA date of origin
A
1966
15
Q
who enforces the AWA
A
USDA via APHIS
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
17
Q
how is AWA compliance ensured
A
annual reports, unannounced inspections, IACUC
18
Q
major updates to AWA
A
birds are covered
19
Q
avian coverage criteria flowchart
A
refer to slideshow
20
Q
who must follow the Guide
A
institutions who want federal funding
21
Q
orgs used for Guide compliance
A
OLAW, AAALAC
21
Q
Guide first publication
A
1963
22
Q
Guide most current publication
A
2011
23
Q
difference from AWA and PHS
A
PHS includes rodents
24
the Guide purpose
basis for care and use of lab animals; basis for standards, program reviews, inspections
25
what regulations are IACUC required by
AWA and PHS
26
IACUC responsibilities
oversees program, procedures, and facilities through inspection, review, and evaluation
27
IACUC goal
ensure compliance with AWA, Guide, and AVMA Guidelines for Euthanasia
28
IACUC makeup
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
29
types and frequencies of IACUC inspections
1. new location - prior to housing animals
2. semi-annual - at least every 6 months
3. unannounced - if any concerns
30
IACUC 3 areas of focus
record keeping
expiration dates
human and animal safety and health
31
IACUC 3 locations
animal facility
where animal work is completed
where items related to work is stored
32
IACUC post inspection process
1. discuss during inspection
2. fix immediately if possible
3. IACUC reviews and discusses
4. submit findings
33
who must follow PHS
all institutions using animals in research
34
when was PHS first published
1971
35
PHS is enforced by what agency
OLAW
36
PHS animal definition
any live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes
37
OLAW enforces which guidelines
PHS and the Guide
38
species covered under OLAW
all live, vertebrate animals used in research
39
does OLAW do inspections
yes, through IACUC
40
is OLAW voluntary or involuntary
involuntary
41
OLAW standards not met
approval/funding is suspended
42
AAALAC evaluates which 3 programs
1. Guide
2. Ag Guide
3. European Guide
43
AAALAC 2 standards to be met in USA
PHS and AVMA Guidelines
44
AAALAC inspections?
yes
45
AAALAC volunatry or involuntary
voluntary
46
AAALAC standards not met
accreditation revoked
47
Nuremberg Code
after WWII
results of Nazis
human experiments must be done on animals first
48
Declaration of Helsinki
1964 by 18th World Medical Assembly
human research must be done on animals first
49
what is AALAS
national org dedicated to humane care and treatment of lab animals
50
lab animal research team members
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
animal welfare
treat animals with compassion and provide for their humane treatment
52
animal rights
animals should have the same rights as humans
53
why improve study designs?
improve data quality, reach more people, save time/funds, save animals
54
what is a pilot study
preliminary information
small
55
what is an exploratory study
provide data to generate new hypotheses
56
what is a confirmatory study/hypothesis test
formal hypothesis stated
study conducted
results compared to hypothesis
57
what is the gold standard for confirmatory studies
double-blind, randomized, placebo-controlled
58
what is an "uncontrolled" study
no comparison between groups
59
what is a regression and correlation study
estimates relationship between variables
60
what is the experimental unit
physical entity assigned randomly to a treatment group
61
what is a subject
the individual whose response is studied in the experiment
62
N
the set of all individuals or experimental units of interest
63
n
a subset of individuals or experimental units selected from the population
64
what is a crossover study
subject receives two or more treatments, one after another in a random sequence
65
what is teratology
study of abnormal fetal development
66
what is bias
systemic differences between treated and control groups
67
what is blind assessment
investigator does not know if subject belongs to experimental or control group
68
what is randomization
process of assigning subjects to groups to that any difference between groups is due to chance alone
69
what are Type I errors and how to avoid them
false positives, rejecting null when it is true
avoid by estimating probability of false positive and making assumptions when appropriate
70
what is the null hypothesis
states that there is no difference between the means
71
how does power analysis help control stat errors
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
how does signal/noise affect study
magnitude of response to the treatment likely to be scientific, includes standard deviation
73
how does the power of the proposed experiment affect study
1-B where B is probability of Type II error
74
how does the sidedness of the test affect study
which direction a difference is being tested in
75
how does the significance level affect study
how often a Type I error is expected to occur
76
how does the sample size affect study
number of subjects in each group
77
how to determine sample size by power analysis
1. alternative hypothesis
2. significance of use
3. what power to use based on consequences
4. estimate noise
5. estimate signal of interest
78
what is the resource equation model
backup for signal-noise ratio
E=N-B-T
N = experimental unit - 1
B = blocks - 1
T = treatment/control groups - 1
79
outbred strains
mating unrelated animals in a closed colony
80
inbred strains
animals developed by breeding related individuals for many generations (>20)
81
mutants
animals with an accidental genetic mutation
82
genetically modified strains
animals with purposefully modified genetics
83
benefits of controlling variability
lowers sample sizes needed
84
completely randomized design
subjects/experimetnal units assigned to treatments at random
85
randomized block design
ranks on blocking factors such as body weight, pen location, or treatment day
86
factorial design
multiple factors with each factor having 2+ levels
87
what does statistical analysis reveal
estimate the magnitude of any differences between the means of the treatment groups for an outcome variable
88
parametric stat analysis
estimates mean and standard deviations, performs hypothesis tests
89
non-parametric stat analysis
1. Wilcoxon test
2. Mann-Whitney test
3. Kruskal-Wallis test
4. Friedman test
uses when data/transformation fails to meet parametric assumptions
90
standard deviation
describes variability of data
91
standard error
describes variability of the mean
92
confidence interval
indicates the range within which we can reasonably be sure the true mean lies
93
what is a mean
average
94
what is a median
middle point
95
what are the ARRIVE Guidelines
list 10 essential and 11 additional items that need to be taken into account when writing a paper involving lab animal use
96
10 essential ARRIVE Guidelines
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
what makes a good study
1. correct number of animals
2. consult statistician
3. randomisation
4. blind assessment of outcomes
5. reduced variability
98
what is variation, how does it affect study
differences between groups/standard deviation
increases signal/noise ratio, reduces samples size, increases power, detect smaller responses
