
From Nuremberg to E6(R3): The Ethical Imperative Behind Informed Consent
Traces the ethical history of informed consent from the Nuremberg Code through the Belmont Report to ICH E6(R3), establishing the moral foundation for the consent process.
The form that is not a form
Picture this. A new coordinator arrives at a study site on a Monday morning, ready for a first week in clinical research. The study binder is thick. The training checklist is long. And somewhere near the top of that list sits a task that looks straightforward enough: "Observe informed consent process."