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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:
  1. Data from living individuals
  2. Biological material from living individuals
  3. Interaction or intervention with a living individual
  4. Use of a non-FDA approved, drug, device or biological
Such research includes:
  1. Physiological or behavioral studies of normal individuals or those with a specific condition.
  2. Review of data from large populations (Health Services Research) or from selected populations (chart review)
  3. Epidemiological studies of populations with or without an intervention.
  4. The study of human tissue either fresh or from repositories such as Banks or Pathology departments
  5. 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
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Ethics and Study Design


Ethics Design

Appropriate Risk to Benefit Ratio

Selection of Subject Populations



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