General Methodological Concepts of Research

Question 1

What are the two subcategories of Quantitative research design? Explain the differences.

Answer 1

Interventional: Researcher intervenes to force participants in various groups

Observational: Researcher does not intervene or force participants in groups. More common for ethics studies. More Natural. Uses Phases.

Question 2

What are common study designs for observational studies?

Answer 2

Cross-Sectional
Case-Control
Cohort

Question 3

Every study design as its own ___ and ___

Answer 3

Strengths

Weaknesses

Question 4

What are the three statistical perspectives for Null Hypothesis?

Answer 4

Superiority
Non-inferiority
Equivalency

Question 5

What is the appropriate null hypothesis from the superiority perspective?

Answer 5

My drug will not be superior to placebo

Question 6

What is the appropriate null hypothesis from the non-inferiority perspective?

Answer 6

My drug is worse than placebo

Question 7

What is the appropriate null hypothesis from the equivalence perspective?

Answer 7

My drug is not equal to placebo.`

Question 8

Simple Random Sampling

Answer 8

Assign random numbers and select in order/non-order

Question 9

Systematic Random Sampling

Answer 9

Assign random numbers, randomly sort them then select “middle 50”, “top 10” or “bottom 10”

Question 10

Stratified Simple Random Sampling

Answer 10

Separate by desired characteristics for equableness in each group and then use simple randomizing for the appropriate sample size. Stratify for gender for example.

Question 11

Stratified Disproportionate Random Sampling

Answer 11

Sampling of certain groups are not equal or desirable to other groups so we decide to add more weight to the under-represented OR over sample in that specific category

Question 12

Multi-Stage Random Sampling

Answer 12

Using simple random sampling at different stages (country then state then county)

Question 13

Cluster Multi Stage Random Sampling

Answer 13

Just like multi-stage but various regions, hospital are cluster in one region

Question 14

What is the one non-probability sampling scheme?

Answer 14

Quasi-Systematic or Convenience Sampling

Question 15

Quasi-Systematic or Convenience Sampling

Answer 15

Not Random, “first 10”

Question 16

What is Equipoise?

Answer 16

Genuine confidence that an intervention may be worthwhile(risk vs. benefit) in order to use it in humans

Question 17

What are the 4 principles of bioethics?

Answer 17

Autonomy
Justice
Beneficience
Nonmaleficence

Question 18

Belmont Report

Answer 18

1978, issued by National Commission for protection of human subjects of biomedical and behavioral research

Question 19

3 guidelines of Belmont Report

Answer 19

Respect for persons
Beneficence
Justice

Question 20

Consent vs. Assent

Answer 20

Over 18 versus under 18

“agreement to participate, based on being fully and completely informed.”

Question 21

IRB or “___” have an intention to ____ (before/after study)

Answer 21

1. Institutional Review Board or
2. Ethics Board
3. Protect human subjects
4. Before

Question 22

OHRP has a role to _____

Answer 22

Office of Human Research Protections

Administers and enforces the regulations

Question 23

What are the three levels of IRB review?

Answer 23

Full Board
Expedited
Exempt

Question 24

Who is the DSMB? When do they interfere?

Answer 24

Data Safety and Monitoring Board, during the study

Question 25

Type I Error

Answer 25

False-Positive

Rejecting null hypothesis when should not have

Question 26

Type II Error

Answer 26

False Negative

Not rejecting Null Hypothesis when should have