RESEARCH DESIGN and ETHICS

Question 1

a true experimental design in which subjects are randomly assigned to at least two comparison groups

Answer 1

randomized controlled trial

Question 2

list the three essential characteristics of an experiment

Answer 2

1. independent variable must be manipulated by researcher
2. a control group must be incorporated into the design
3. subjects must be randomly assigned to groups

Question 3

experimental trials that examine the effect of interventions on patient or community populations; either therapeutic or preventative

Answer 3

clinical trials

Question 4

pre-clinical research

Answer 4

in vitro
animal research
design drug delivery or surgical methods
if successful seek approval to begin human trials

Question 5

phase 1

Answer 5

purpose is determining safety
small number of subjects
data on dosage, timing, side effects

Question 6

phase II

Answer 6

demonstrate effectiveness
small samples several years
should be better than current protocol to continue

Question 7

phase 3

Answer 7

compares new therapy to standard treatment or procedure
- randomized, controlled, blinded trial
large scale, many subjects
- if successful, seek FDA approval

Question 8

phase 4

Answer 8

• patients followed after FDA approval
  -evaluate effects in other populations
• if problems are found, drug may be taken off market

Question 9

aka one way design
one independent variable with any number of levels
- may have one or more dependent variables
-compares 2 or more groups randomly assigned

Answer 9

single factor experiment independent groups

Question 10

factorial designs incorporates two or more independent variables; looks for main effects and the interaction effect of variables a and b together

Answer 10

multi factor designs for independent groups

Question 11

example of a multi factor design for independent groups

Answer 11

analyzed by 2 or 3 way anova

Question 12

one group, repeated measurements “within subjects” design
- each subject is its own control
- controls for individual differences because most factors remain constant throughout trials

Answer 12

repeated measures design

Question 13

one independent variable (with levels), one group
- each subject is exposed to every level of the independent variable
-crossover design

Answer 13

one way repeated measure design

Question 14

this is an example of:
each subject has eyesight measured with contacts and glasses and without any aid

Answer 14

one way repeated measures design

Question 15

groups are selected on the basis of whether or not they have the disorder under study; PURPOSE IS TO DETERMINE WHY CASES HAVE THE DISEASE AND CONTROLS DO NOT

Answer 15

case-control study

Question 16

two groups are chosen, one which has been exposed to a clinical intervention or agent, by chance or choice; ESTABLISH RELATIONSHIP BETWEEN EXPOSURE AND RISK OF DEVELOPING A PARTICULAR DISEASE

Answer 16

cohort study

Question 17

description of new, interesting, and unique clinical cases as a means of sharing special information to professional colleagues

Answer 17

case studies
DESCRIPTIVE RESEARCH DESIGNS

Question 18

description of developmental change and sequencing of behaviors over time

Answer 18

developmental studies

Question 19

observation of different age or developmental groups at one point in time

Answer 19

cross-sectional study

Question 20

called “Self reports” meaning that the researcher does not directly observe the behaviors but only records the respondents report of them

Answer 20

interviews and questionnaires

Question 21

can be used under any classification of research, but they are most commonly used as methods for collecting descriptive data

Answer 21

surveys

Question 22

these are the objectives that delineate what the researcher is trying to find out

Answer 22

formulation of guiding questions

Question 23

detailed outline listing each item of information needed to answer guiding questions

Answer 23

questionnaire outline

Question 24

find out if there is a similar questionnaire out there that can be used with modification; doesn’t necessarily have to be in the same field.

Answer 24

review of existing surveys

Question 25

write a series of questions that address each components of the guiding questions; questions can be grouped by category or topic

Answer 25

preliminary draft

Question 26

after draft is ready, pass out questionnaire to about 5-10 people to see if they understand it

Answer 26

pilot testing and revisions

Question 27

verify the questionnaire measures what it is intended to measure

Answer 27

validity

Question 28

should be looking friendly with uncluttered pages, nice print, looks good. includes some type of introduction or cover letter to describe the purpose of the study with instructions

Answer 28

final draft

Question 29

must have an accessible population identified; anonymous; administered in person, phone, mail; may have to follow up to get better response

Answer 29

administration of survey

Question 30

allow the respondent to express themseles

Answer 30

open ended questions

Question 31

ask respondents to select an answer from among several choices provided to them

Answer 31

closed ended questions

Question 32

a series of statements is presented expressing a viewpoint and respondents are asked to choose an appropriately ranked response

Answer 32

likert scales

Question 33

statements are presented that reflect increasing intensity of the characteristic being measured

Answer 33

guttman scale

Question 34

how are systematic reviews different from classical literature reviews

Answer 34

clinical decision vs updating the field

Question 35

what are the “subjects” in a systematic review?

Answer 35

studies - papers

Question 36

examining data from papers (similar topic or hypothesis) to put forth a new conclusion

Answer 36

meta analysis

Question 37

how are studies in a systematic review evaluated for validity or methodological quality?

Answer 37

stats- peer review- rating scales

Question 38

science is built on a foundation of trust and honesty

Answer 38

scientific integrity

Question 39

list underlying motives for scientific fraud

Answer 39

1. career/ academic pressure
2. belief that you know the answer and take shortcuts to get there
3. some experiments yield data that are not precisely reproducible

Question 40

what is not misconduct

Answer 40

proposing hypotheses that ultimately turn out to be false
offering conflicting interpretations
making erroneous observations and analyses

Question 41

usually done by senior members of the scientific community

Answer 41

peer reviews

Question 42

an individual exploits, or appears to exploit their position for personal gain or for the profit of a member of their immediate family or household

Answer 42

conflict of interest

Question 43

editors delaying publication of competitor. reviewers not being sufficiently critical of a friends manuscript/grant

Answer 43

scientific conflict of interest

Question 44

types of intellectual property and ownership

Answer 44

trade secrets
trademarks
copyrights
patents

Question 45

protect expression/ presentation of idea; not idea itself

Answer 45

copyrights

Question 46

blastomere separation and somatic cell nuclear transfer to create a copied organism

Answer 46

reproductive cloning

Question 47

one member must be a veterinarian
- practicing scientsis with experience in animal research
non scientist
non institutional affiliated individual

Answer 47

institutional animal care and use committees

Question 48

list components of belmont report

Answer 48

respect for persons: dignitiy and autonomy
beneficence: max benefits, min risks
justice: distributed benefits and burdens of research

Question 49

reviews all research proposals relating to human research determines risk to benefit ratio

Answer 49

IRB institutional review board