WHEN HISTORY WENT WRONG
Q: The 18-year-old research participant whose death reshaped modern clinical trial oversight in the U.S.
A: Who is Jesse Gelsinger?
Q: The approximate settlement amount paid in response to the Trovan trial litigation and related claims.
A: What is $75 million?
Q: The federal framework that governs human subjects protections in U.S. research.
A: What is the Common Rule?
Q: The disease outbreak during which a controversial drug trial took place in Nigeria in 1996.
A: What is meningitis?
Q: FDA actions taken to pause studies when serious safety concerns or compliance failures are identified.
A: What are clinical holds?
Q: This oversight body reviews protocols, monitors risk, and enforces participant protections at the institutional level.
A: What is the IRB?
Q: The pharmaceutical company responsible for the Trovan trial during that outbreak.
A: What is Pfizer?
Q: The process that requires prompt disclosure of serious and unexpected adverse events to regulators and oversight bodies.
A: What is safety reporting?
Q: A regulated disclosure intended to prevent financial interests from influencing study design, conduct, or reporting.
A: What is Financial Conflict of Interest?