IRB

Running a basket trial operationally requires infrastructure that treats each tumor type cohort as a distinct operational unit within a shared governance framework: cohort-specific site selection (not study-level), a central [...]

A well-governed basket or umbrella trial requires four explicitly designed governance bodies: a Steering Committee with defined decision authority over major protocol changes, an IDMC chartered specifically for adaptive review [...]

Explore the history of human subjects research, from unethical experimentation to modern protections like IRBs, the Belmont Report, and global research ethics.