Lecture 15 Flashcards
Describe interventional study design
Study designs considered “experimental”:
o Investigator-selects interventions (exposure)
There IS researcher-forced group allocation
• Randomization processes commonly utilized to accomplish this step
Describe observational study design
Study designs considered “natural”:
o Researchers “observe” subject-elements occurring
naturally or selected by individual (naturally or freely)
Useful for unethical study designs using forced interventions
o Most observational study designs not able to prove
Causation
There is NO researcher-forced group allocation
Describe research studies pyramid in increasing order of evidence
- In vitro bench research
- Animal research
- Case reports
- Case series
- Ecological
- Cross-sectional
- Case-control
- Cohort
- Interventional/Pragmatic studies
- Systematic reviews
- Meta-analyses
Describe interventional study designs in increasing order of evidence
- Pre-clinical (phase 0 )
- Phase 1
- Phase 2
- Phase 3
- Phase 4
Describe observational study designs in increasing order of evidence
- Case reports/series
- Cross-sectional
- Ecological
- Case-control
- Cohort
Type I error
- False positive (rejecting null hypothesis when it is true)
Type II error
- False negative (not rejecting null hypothesis when it is false)
Define equipose
- Genuine confidence that an intervention
may be worthwhile (risk vs. benefit) in order to use it in
humans
List 4 principles of bioethics
- Autonomy
- Beneficence
- Justice
- Nonmaleficence
Autonomy
Self-rule/Self-determination. Participants must…
• Decide for ones-self, without outside influences
• No coercion, reprisal, financial manipulation
• Have full & complete understanding of the risks and benefits
• No misinformation, incomplete information, or ineffectively-conveyed information (language or education level)
Beneficence
To benefit, or do good for, the patient (not society)
Justice
Equal & Fair treatment regardless of patient characteristics
Nonmaleficence
Do no harm. Researchers must not…
• Withhold information
• Provide false information
• Exhibit professional incompetence
What is the Belmont Report
1978; issued by National Commission for Protection of Human Subjects of Biomedical and Behavioral Research
o Contains 3 guiding principles:
Respect for persons
• research should be voluntary, subjects autonomous
Beneficence
• research risks are justified by potential benefits
Justice
• risks and benefits of the research are equally distributed
Define IRB
o Ethical (& safe; protections in place) determination
performed by Institutional Review Board (IRB)
Sometimes referred to internationally as the “Ethics
Committee”
IRB’s role is to protect human subjects from undue risk (research not complying with principles of bioethics)
ALL human subject studies MUST be reviewed by an IRB prior to study initiation
• Observational and Interventional studies (all use humans)
o IRBs are regulated by Federal statutes (laws &
regulations) developed by the Department of Health
and Human Services (DHHS)
Rules are referred to by CFR (Common Federal Rules)
Applies to all studies funded by federal government;
standards also usually apply to studies reviewed by an IRB
The Office of Human Research Protections (OHRP) is agency that administers and enforces the regulations
