FDA regulations allow a waiver of informed consent only under very specific circumstances, and unlike the Common Rule, there is no provision for alteration of the informed-consent requirements. For research governed by FDA regulations (21 CFR 50.23), informed consent may be waived in an individual circumstance only if deemed “infeasible” for all of the following reasons: a life-threatening situation exists, necessitating the use of the test article; the potential subject is unable to consent due to his or her inability to communicate; there is insufficient time to obtain the consent of a legally authorized representative; and no alternative approved therapy exists that is equally or more effective at saving the life of the subject. The test article may be a drug (including a biological product), medical device, or electronic device. Within five working days of the use of the test article, both the investigator and a nonparticipating physician (i.e., one not involved in the research) must certify in writing that all of the conditions described above existed prior to the treatment, procedure, or intervention. This written documentation must be submitted to the IRB, again within five working days.
There are also FDA regulations (21 CFR 50.24) exempting certain planned emergency research from informed consent requirements. Please see the Yale University HRPP policy for further information regarding this type of research.