Research Studies Flashcards
IRB Exemption
-chair gives exemptions
-pose little risk
-does not involve a sensitive topic or population
-educational
IRB Expedited
-subset of board reviews it
-minimal risk (surveys, healthhy pops, non invasive, existing data)
-no interventions
IRB Full
-entire board reviews
-more than minimal risk
-sensitive topic or populations
-any research with an intervention
IRB Application Contents
-additional questions about study plans
-informed consent
-apropriate management of data
Informed Consent
-informed
-can opt out
-lay language (6th grade)
-answet questions
-contact info
-sign
-voluntary
Evidence Based Practice
integration of:
-evidence
-clinical expertise
-patient values
PubMed
-access to medline
-best source for RCT
Medline
-National library of medicine’s database
Primary Sources
-only clinical trials
-RCT, cohort, case control
-current but must read it all
Cochrane
-database for systematic reviews
Hierarchies of Evidence
-1a-5
-A-F
Systematic Reviews of RCT
-1a
-review or meta analysis of RCT
Randomized Control Trials
-1b
-group randomized into experiemental groups
-narrow confidence interval
All or None
-1c
-all Pt died before but some lived after
-some pt died before but none died after
Systematic Review of Cohort Studies
-2a
-review or meta analysis of cohort studies
Cohort Studies
-2b
-already in a group and compare different treatments
Outcomes Research
-2c
-how much value does it give to the pt
-not experimental