Table of Contents:
  • 1. Introduction
  • 2. A Systematic approach to human research participant protection programs
  • 3. Back to basics: scientific, conflict of interest, and ethical review of research protocols
  • 4. The Participant-investigator interface
  • 5. Improving protection through oversight and data and safety monitoring
  • 6. Improving human research participant protection program performance and clarifying roles
  • 7. Improving an evolving national human research participant protection system.