Exception from Informed Consent Requirements for Emergency Research
Posted by Michael Jay on Wed, Jun 01, 2011
RxTrials welcomes Gretchen Bowker with Pearl IRB as a guest blogger who wrote the below post:
In March 2011 FDA finalized guidance on exception of informed consent requirements for emergency research. Emergency research involves the most vulnerable population of study subjects, i.e., a population with no capacity to control what happens to them and no capacity to consent, in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject’s legally authorized representative. more...