Impracticability of Informed Consent in the Registry of the Canadian Stroke Network
Tu, Jack V.
Willison, Donald J.
Silver, Frank L.
Richards, Janice A.
Kapral, Moira K.
New England Journal of Medicine 2004 April 1; 350(14): 1414- 1421
BACKGROUND: Government legislators and research ethics boards in some jurisdictions require all patients to give written informed consent before enrollment in clinical registries. However, the effect of such a requirement on the use of clinical registries and the extent to which registry data can be generalized remain uncertain. METHODS: We examined the effectiveness of a comprehensive attempt to obtain informed consent between June 2001 and December 2002 on the overall participation rate and the characteristics of participating patients in the Registry of the Canadian Stroke Network, a prospective registry based at 20 major stroke centers across Canada. RESULTS: The overall participation rate (i.e., the consent rate among all potential participants) was 39.3 percent of 4285 eligible patients during phase 1 of the project (June 2001 through February 2002) and 50.6 percent of 2823 eligible patients during phase 2 (June 2002 through December 2002), despite the presence of neurologic research nurse coordinators at each site. Many patients died or left the hospital before they could be approached for consent. Major selection biases were found; the in-hospital mortality rate was much lower among patients who were enrolled (6.9 percent) than among those who were not enrolled (21.7 percent) (relative risk of in-hospital death, 3.13; 95 percent confidence interval, 2.65 to 3.70; P
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Variation in Recruitment Across Sites in a Consent-Based Clinical Data Registry: Lessons From the Canadian Stroke Network Willison, Donald J.; Kapral, Moira K.; Peladeau, Pierrot; Richards, Janice R.A.; Fang, Jiming; Silver, Frank L. (2006)Background : In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent ...