Class 15 General Methodological Concepts of Research Flashcards
Study design selection is based on the following (6):
Perspective of research question (hypothesis)
Ability/Desire to force group allocation (randomization)
Ethics of methodology
Efficiency and Practicality (time/resource commitment)
Costs
Validity of acquired information (internal & external)
Define Null Hypothesis
A research perspective which states there will be no (true) difference between the groups being compared
Research either accept or reject
Define Alternative Hypothesis
A research perspective which states there will be a (true) difference between the groups being compared
What type of Study Design is Described Below?
Researchers observe subject elements occurring naturally or selected by individuals (naturally or freely)
Observational
True or False:
Most observational study designs are NOT able to prove causeation
TRUE
True or False:
In observational study designs, there is researcher-forced group allocation
FALSE
There is NO researcher-forced group allocation in an observational study design
What type of study design is considered experimental?
Interventional study design
Does researcher-forced group allocation occur in observational or interventional study design?
Interventional study design
Define Population in terms of study subjects
All individuals making up a common group, from which a sample (smaller set) can be obtained if desired
Not to be confused with “study population”
Define Sample in terms of study subjects
A subset or portion of the full, complete population (“representatives”)
Study population selection is based on:
Research Hypothesis/Question
Inclusion & exclusion selection criteria (interventional studies)
Case/Control or Exposed/Non-exposed group selection criteria (obs. studies)
Ethics
Equipoise
Define Equipoise
Genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use it in human
What are the four key principles of bioethics?
Autonomy
Beneficence
Justice
Nonmaleficence
Define Autonomy
Self-rule/Self-determination. Participants must..
full and complete understanding of risks/benefits
decide for one-self, w/o outside influence
Define Beneficence
To benefit, or do good for, the patient (not society)
Define Justice
Equal and Fair treatment regardless of patient characteristics
Nonmaleficence
Do no harm. Researchers must not…
withhold info
provide false info
exhibit profesional incompetence
What three guiding principles does the Belmont Report contain?
Respect for persons
Beneficence
Justice
What is the difference between Consent and Assent?
Consent - Agreement to participate by mentally-capable individuals of legal consenting age
Assent - Agreement to participate given by mentally-capable individuals NOT able to give legal consent
Who is responsible for ethical determination?
Institutional Review Board (IRB)
aka “Ethics Committee”
What is the IRB’s role?
To Protect Human Subjects from undue risk
True or False:
Only studies regarding those under the age of 18 must be reviewed by an IRB prior to study initiation
FALSE
All human subject studies must be reviewed by an IRB prior to study initiation
Who regulates and develops IRBs
Regulated by Federal statutes developed by the Department of Health and Human Services
What is the name of the agency that administers and enforces the Common Federal Rules?
The Office of Human Research Protections (OHRP)
What are the levels of IRB review?
Full Board
Expedited
Exempt
When is Full Board review used?
Used for ALL interventional trials with more than minimal/no risk to patients (all medication-related studies)
When is Expedited review used?
Minimal risk and/or no patient identifiers
When is Exempt review used?
No patient identifiers, low/no risk, deidentified dataset analysis, environmental studies, use of existing data/specimens (de-identified)
What semi-independent committee is charged with reviewing study data as a study progresses, but is not involved with the conduct of the study?
Data Safety & Monitoring Board
What are the two methodologies of study in human studies?
Outcomes
Internal Validity
