The protocols are in place so that we know that there is a plan. If there is an adverse event and something does happen, there is an entire reporting structure within the universities. Those things are often there for lab-based events, but most of it, from a qualitative end, is more around...and by lab-based I mean more biological science lab-based adverse events, to report a structure that way if there is an adverse event report. But there are processes and balances and checks in place within ethics, and all researchers are trained around the ethical guidelines and their duty to report anything that deviates from the protocol that's been agreed upon.
On November 17th, 2016. See this statement in context.