A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met.

Aim: To determine IRB members' experience reviewing research protocols using emergency exception to informed consent.

Does the emergency exception from informed consent process protect research subjects?

Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define "protection"; therefore, it is not currently known whether or not subjects are protected under the current rules.

Cerebral infarcts in a pediatric patient secondary to phenylpropanolamine, a recalled medication.

Phenylpropanolamine (PPA) recently has been publicly implicated as a cause of stroke and other neurologic events. In November of 2000, the Food and Drug Administration (FDA) requested a voluntary recall of the product from all manufacturers. However, medications containing PPA still can be found in many homes of those unaware of the voluntary recall.