Research: lecture 1 Flashcards
(49 cards)
-involve more than just minimal risks to the participants
-involve a sensitive topic
-involve minors or other vulnerable populations (fetus, prisoner)
ex: most prospective research that includes an intervention requires a full review
Entire Board reviews
full
research definition
any manipulation, observation or other study of a human being… some with the intent of developing new knowledge
T/F:: research requires IRB approval prior to beginning any data collection or participant recruitment
T
T/F: you can go back and use old medical records that were standard of care and publish the data without IRB approval
F
How can you avoid having to do a dual review for IRB approval?
do an institutional IRB agreement between the two universities
what are the three levels of IRB review
full
expedited
exempt
-involve minimal risks to the participants
-sub-set of the board review
expedited
-pose little risks to the partipants
- do not involve a sensitive topic
-do not involve vulnerable populations
exempt
elements of informed consent
fully informed
confidential and anonymous as much as possible
6th grade lvl
researcher must offer to answer questions throughout study
no penalty for withdrawing
contact info provided
Participants must sign every page and get a copy
voluntary
T/F: you can be an author on the manuscript even if your name wasn’t in the IRB
T
evidence based practice is the integration of
-best research evidence
-clinical expertise
-patient values/ situation
what does PICO stand for
Patient or problem
Intervention
Comparison intervention
Outcomes
this is a common way to develop a research question
PICO
what does FINER stand for
Feasible
Interesting
Novel
Ethical
Relevant
CEBM levels hierarchy
1a - systematic RCT
1b
1c
2a
2b
2c
3a
3b
4
5 - expert opinion
1a
systemic reviews of RCTs
1b
RCT with narrow CI
1c
all or none
all pts died before a rx became available, now some live
some patients dies before rx became available, now none dies
2a
systematic review of cohort studies
2+ groups (cohorts) of pts, one which did receive the exposure of interest (or has risk factor) and one that didnt, and following these cohorts forward for the outcome of interest
2b
cohort study or low quality RCT
One group (cohort), followed over time
2c
outcomes research
focused on what is of value for the patient (effectiveness). does the intervention make a difference in the eyes of the patient?
3a
systematic review of case control studies
case control: finding people who already have a condition and people who dont and then looking back in time to see what might have caused it
3b
individual case-control study
4
case reports, small case series