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THE PERFORMANCE of clinical research under emergency circumstances, when the patient is unable to give consent, has come to a virtual halt. Where it is still being done, it is in danger of being seriously compromised.
The situation is of concern to researchers, review bodies, and regulators. To discuss the problem and try to resolve the issues, the Food and Drug Administration (FDA) and National Institutes of Health (NIH) convened a public forum in January.
While hardly new, the situation has surfaced only relatively recently because of two principal developments. The first is the appearance of several new and potentially useful treatments for lifethreatening conditions such as stroke, cardiac arrest, and traumatic injury. These treatments require evaluation for clinical effectiveness.
The second is that both the NIH and FDA—the two agencies mainly responsible for overall review of clinical research studies—have recently stopped or otherwise curtailed a number of clinical studies
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