Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: ORGANIZATION OF THE REPORT
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Introduction, Background, and Definitions
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
Principle 7, the Nuremberg Code
The protection of individuals who volunteer to participate in research is essential to the ethical conduct of research. Such protections were not explicitly and systematically addressed in the United States, however, until the late 1940s, when scientists and policy makers recognized the need to respond to crimes committed by Nazi scientists during World War II. Since then national and international policies have evolved to create a system of protections requiring the involvement of investigators, research sponsors, research institutions, health care providers, federal agencies, and patient and consumer groups. This evolution is worth tracking to appreciate what brings this report to the forefront at this time; that is, how can this complex system of protections be assessed in a reliable and valid way to ensure that it is effective, efficient, and accountable—that “proper preparations ” have been made and that “adequate facilities” have been provided to protect the experimental subjects of research?
ORGANIZATION OF THE REPORT
Before beginning the discussion leading to the recommendations contained within this report, the committee notes that this document focuses narrowly on
