Choice Reflection

Distinguishing Research from Human Subjects Research

Abstract

IRBs have suffered mission creep, moving from assessing dangers presented to participants in research (human subjects) to becoming de facto assessors of research. This brief essay traces engagement with the IRB, tracing understanding of human subjects research review through interactions with the committee over two decades and through numerous configurations and reconfigurations of the committee, its members, its focus, and its understanding of its role in the research process.