Impact of the Final Rule on the rate of clinical cardiac arrest research in the United States

Abstract

Background: The federal government placed a moratorium on human emergency resuscitation research in 1993 due to concerns related to informed consent. In 1996, the Food and Drug Administration introduced the Final Rule in order to allow clinical resuscitation research to proceed in special cases without prospective informed consent. It is unclear, however, how this change has impacted the performance of this research.

Objectives: To measure the potential impact of the Final Rule by determining the number of clinical cardiac arrest studies performed in the United States (US) before and after 1993, and to compare it with the number of studies performed in the European Union (EU) during the same periods.

Methods: A MEDLINE search was performed for cardiac arrest studies that were prospective, interventional, randomized, and performed in the US or EU from 1983 through 2003.

Results: Of the 3,115 cardiac arrest publications identified, 66 (2%) met inclusion criteria. Of the 40 studies conducted in the US, 24 (60%) were published prior to or during 1993, whereas of the 27 studies conducted in the EU, six (22%) were published prior to or during 1993 (odds ratio = 0.5; 95% confidence interval = 0.3 to 0.8).

Conclusions: There has been a significant decrease in the number of published clinical cardiac arrest trials in the US since 1993. In contrast, there has been a significant increase in the number of published EU trials since 1993. The current informed consent requirements may have reduced the number of clinical cardiac arrest studies performed in the US.