Well, while we freely admit to muttering under our breath about some FDA research requirements, we want to take this opportunity to shout from the rooftops about a new FDA guidance indicating the agency will not object to the IRB waiving or altering informed consent requirements in some minimal risk research.
This guidance — which was released without so much as a public comment period, the FDA wants us to know — marks a pretty significant change from previous FDA practice. In the past, there was very little flexibility in the FDA’s consent requirements. If you had an FDA-regulated study that involved human subjects, you had to get informed consent from participants, in almost all cases. Now, however, the FDA is indicating in this guidance that it will not object to a study in which the IRB waives or alters consent requirements, providing certain conditions are met. Those conditions are on page 4 of the new guidance, and they’ll look familiar, as they are based on those in the Common Rule, and are similar to those in UAMS IRB Policy 15.3.