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. One can imagine how important, yet how difficult, it is to generate this kind of data. For example, take the issues of community consultation and public disclosure prior to and after the study. One could propose many forums for community consultation. The trick is to get the right people with a voiced opinion together.