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HSP Module 3: Minimizing probability of harm and increasing the possibility of benefit in human subject research
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HSP Module 3: Minimizing probability of harm and increasing the possibility of benefit in human subject research
Overview
Principles
Guidance
Protocol Design - Identification and Quantification of Research Risk
Protocol Design - Minimization of Risk
Assessment of Benefits
Protocol Design - Assessment of the Risk-Benefit Relationship
General Guidance - Conducting the Study
General Guidance - Post-Study
Specific Guidance
Placebo-Controlled Trials
Use of a Less-Effective Comparator When Conducting Clinical Trials in Developing Countries (copied in large part from Council for International Organizations of Medical Sciences)
Conducting Studies During Early Phases of Testing Non-Validated Drugs, Devices, or Interventions
Regulations
Resources
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