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Ethics and Study Design - Introductory
Clinical research can be defined more or less broadly. For our purposes we define it to be any study that requires IRB approval. These include:
- Data from living individuals
- Biological material from living individuals
- Interaction or intervention with a living individual
- Use of a non-FDA approved, drug, device or biological
Such research includes:
- Physiological or behavioral studies of normal individuals or those with a specific condition.
- Review of data from large populations (Health Services Research) or from selected populations (chart review)
- Epidemiological studies of populations with or without an intervention.
- The study of human tissue either fresh or from repositories such as Banks or Pathology departments
- Interventional studies
Types of studies include
Phase 1: Toxicity (small number of individuals)
Phase 2: Efficacy, may include pharmacodynamics (small number of individuals)
Many studies are mixed Phase 1 and 2.
Phase 3: Efficacy and safety of unapproved drug, device or biological (tend to be large studies)
Phase 4: Efficacy and safety of approved drugs, devices or biologicals, or a comparison between interventions.
Each of these types of study requires the appropriate design to reach scientifically sound conclusions while protecting the participants and their identifiable human information.
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Chapter 3
Quick Links
Ethics and Study Design
Introductory
Ethics Design
Appropriate Risk to Benefit Ratio
Selection of Subject Populations
Cases
Bibliography
Chapter 3 Download (PDF)
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