Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research?

摘要: Abstract Introduction: Research in patients with life-threatening illness such as cardiac arrest is challenging since they can not consent. The Food and Drug Administration addressed research under emergency conditions by publishing new criteria for exception from informed consent 1996. We systematically reviewed randomized trials over a 10-year period to assess the impact of these regulations. Methods: Case–control study published (cases) atrial fibrillation (controls.) Studies were identified using structured searches MEDLINE EMBASE 1992 2002. Included studies random allocation humans or prior enrollment. Excluded duplicate publications. Number American trials, foreign proportion origin compared regression analysis. Changes versus calculated risk differences. Results: Of 4982 studies, 57 (1.1%) trials. number decreased 15% (95% CI: 8, 22%) annually (P=0.05). 16% 10, (P=0.006). 5596 197 (3.5%) difference between being significantly (annual −5.8% −10, −0.1%), P=0.03). Interpretation: Fewer during last decade, when federal requirements changed. Regulatory clinical may inhibit improvements care threaten public health.