clinical trial and informed consent (연구윤리, 임상실험, 임상실험 동의서)

목차

1. Historical introduction
2. Comparative Effectiveness Research
3. 3 options for CE RCTs
4. Comparing Models

본문내용

Historical Introduction
• Prior to mid 1960s, RCTs routinely conducted without informed consent
• Streptomycin Trial (1947) : Patients not informed that they were participating in a clinical trial
• Sham Surgery Trial: No mention of randomization or use of sham procedure to evaluate real surgery
• 1962: Congress directed FDA to require IC for studies of “investigational new drugs”
• 1966: based on research scandals, NIH mandated IC to clinical research and oversight by Institutional Review Boards (IRBs)
• IC with detailed written consent documents became standard practice for RCTs

참고 자료

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