The USF Compliance News will be posted on the USF Office of Research web site. 1999 Researchers from the Colleges of Medicine, Nursing and Public Health display abstracts of their research throughout Health Sciences Center ground-floor corridors. The USF Division of Compliance Services publishes USF Compliance News monthly. Although the mission can be clearly stated, confusion sometimes exists as to what the regulations require in these circumstances. It is a life-threatening situation.
Subject is unable to provide consent.
There is insufficient time to obtain consent from the subject's legal representative. There is no available alternative method of treatment. In addition, the DHHS does not offer a waiver on Informed Consent unless the research presents no more than minimal risk. In light of these regulations and as a result of the University's Multiple Project Assurance Document on file with the DHHS, any emergency use action initiated without prior full IRB review and approval may not be used as research data. In addition, if the emergency use entails the use of a FDA test article, all FDA regulations must be met.