General Methodological Concepts of Research

Question 1

What type of study has the highest strength of evidence?

Answer 1

Meta-analyses

Question 2

What is internal validity?

Answer 2

Validity of the techniques used in the experiment.

Question 3

What is external validity?

Answer 3

Validity of inferences made on general population based on data findings.

Question 4

What is a null hypothesis?

Answer 4

A research perspective which states there is NO difference between groups compared.

Question 5

What is the difference between noninferior and equivalent hypotheses?

Answer 5

Noninferior suggests that one things will not be superior. Equivalency suggests that the things will be equal.

Question 6

What is a type I error?

Answer 6

The null hypothesis is rejected, even though it is true.

Question 7

What is a type II error?

Answer 7

The null hypothesis is not rejected, even though it is false. (The experimental hypothesis is true).

Question 8

What is an observational design?

Answer 8

A design that considered “natural.” Researchers observe subject elements occurring in a natural state. There is NO researcher-forced group allocation.

Question 9

What is an intervention design?

Answer 9

A design that is considered “experimental”; there is researcher-forced group allocation, which is sometimes randomized.

Question 10

If a researcher allocates people into groups, what kind of study is it?

Answer 10

Interventional

Question 11

What are the phases of interventional studies?

Answer 11

pre-clinical, phases 1 - 4.

Question 12

What is the most effective type of observational study?

Answer 12

cohort studies

Question 13

What is the population in a human study?

Answer 13

All individuals making up a common group from which a smaller set is obtained.

Question 14

What is a sample in a human study?

Answer 14

A subset or portion of the full, complete population.

Question 15

What is a study population based on?

Answer 15

A hypothesis, inclusion/exclusion criteria, ethics and equipoise.

Question 16

What is equipoise?

Answer 16

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

Question 17

What are the 4 key principles of bioethics?

Answer 17

autonomy, beneficence, justice, and non-maleficence

Question 18

What does autonomy in a study refer to?

Answer 18

Participants must have full understanding of the risks and benefits of a study.

Question 19

What is the Belmont Report?

Answer 19

A report issued by the National Commission for Protection of Human Subjects of Biomedical and Bheavioral Research. It contains 3 important guidelines for studies.

Question 20

What are the 3 guidelines in the Belmont Report?

Answer 20

respect for persons, beneficence (research risks are justified by risks), and justice (risks and benefits equally distributed).

Question 21

What is consent?

Answer 21

Agreement to participate, based on being fully and completely informed; includes being mentally capable and being 18 or older.

Question 22

What is assent?

Answer 22

Agreement to participate, based on being informed (mentally capable), but being under age 18.

Question 23

Who determines ethical conduct of research?

Answer 23

Institutional Review Board (IRB); all human studies MUST be approved by them.

Question 24

What does the Office of Human Research Protections do?

Answer 24

administers and enforces regulations from the IRB and DHHS (department of health and human services).

Question 25

What is the IRB full board review used for?

Answer 25

Studies with more than minimial/no risk to patients; it includes all medication-related studies.

Question 26

What are the IRB expedited and exempt reviews used for?

Answer 26

For studies with minimal risk or no patient identifiers

Question 27

What does the Data Safety and Monitoring Board (DSMB) do?

Answer 27

Reviews studies as the studies progress to assess for ethical issues, risks, etc. If a group is excessively benefiting or being harmed from a study, it can be stopped.