General Methodological Concepts of Research Flashcards
What type of study has the highest strength of evidence?
Meta-analyses
What is internal validity?
Validity of the techniques used in the experiment.
What is external validity?
Validity of inferences made on general population based on data findings.
What is a null hypothesis?
A research perspective which states there is NO difference between groups compared.
What is the difference between noninferior and equivalent hypotheses?
Noninferior suggests that one things will not be superior. Equivalency suggests that the things will be equal.
What is a type I error?
The null hypothesis is rejected, even though it is true.
What is a type II error?
The null hypothesis is not rejected, even though it is false. (The experimental hypothesis is true).
What is an observational design?
A design that considered “natural.” Researchers observe subject elements occurring in a natural state. There is NO researcher-forced group allocation.
What is an intervention design?
A design that is considered “experimental”; there is researcher-forced group allocation, which is sometimes randomized.
If a researcher allocates people into groups, what kind of study is it?
Interventional
What are the phases of interventional studies?
pre-clinical, phases 1 - 4.
What is the most effective type of observational study?
cohort studies
What is the population in a human study?
All individuals making up a common group from which a smaller set is obtained.
What is a sample in a human study?
A subset or portion of the full, complete population.
What is a study population based on?
A hypothesis, inclusion/exclusion criteria, ethics and equipoise.
What is equipoise?
Genuine confidence that an intervention may be worthwhile (risk v. benefit) in order to use it in humans.
What are the 4 key principles of bioethics?
autonomy, beneficence, justice, and non-maleficence
What does autonomy in a study refer to?
Participants must have full understanding of the risks and benefits of a study.
What is the Belmont Report?
A report issued by the National Commission for Protection of Human Subjects of Biomedical and Bheavioral Research. It contains 3 important guidelines for studies.
What are the 3 guidelines in the Belmont Report?
respect for persons, beneficence (research risks are justified by risks), and justice (risks and benefits equally distributed).
What is consent?
Agreement to participate, based on being fully and completely informed; includes being mentally capable and being 18 or older.
What is assent?
Agreement to participate, based on being informed (mentally capable), but being under age 18.
Who determines ethical conduct of research?
Institutional Review Board (IRB); all human studies MUST be approved by them.
What does the Office of Human Research Protections do?
administers and enforces regulations from the IRB and DHHS (department of health and human services).
What is the IRB full board review used for?
Studies with more than minimial/no risk to patients; it includes all medication-related studies.
What are the IRB expedited and exempt reviews used for?
For studies with minimal risk or no patient identifiers
What does the Data Safety and Monitoring Board (DSMB) do?
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.
