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Previous Volume 350:1414-1421 April 1, 2004 Number 14 Next

	Full Text PDF PDA Full Text Editorial by Ingelfinger, J. R. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

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<0.001). We estimate that approximately $500,000 (Canadian dollars) was spent on consent-related issues during the first two years of the registry.

Conclusions Obtaining written informed consent for participation in a stroke registry led to important selection biases, such that registry patients were not representative of the typical patient with stroke at each center. These findings highlight the need for legislation on privacy and policies permitting waivers of informed consent for minimal-risk observational research.

Source Information

From the Institute for Clinical Evaluative Sciences, Toronto (J.V.T., J.F., J.A.R., A.L., M.K.K.); the Division of General Internal Medicine, Sunnybrook and Women's College Health Sciences Centre, Toronto (J.V.T., A.L.); the Center for Evaluation of Medicines, St. Joseph's Hospital, and the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ont. (D.J.W.); the Department of Medicine, University of Toronto, Toronto (J.V.T., F.L.S., A.L, M.K.K.); and the Divisions of Neurology (F.L.S.) and General Internal Medicine (M.K.K.), University Health Network, Toronto — all in Canada.

Address reprint requests to Dr. Tu at the Institute for Clinical Evaluative Sciences, G106-2075 Bayview Ave., Toronto, ON M4N 3M5, Canada, or at tu{at}ices.on.ca.

Full Text of this Article

Related Letters:

Registries and Informed Consent
Clark A. M., Jamieson R., Findlay I. N., McKenna M. T., Wingo P., Gibson J. J., Haidinger G., Vutuc C., Maier M., Tu J. V., Silver F. L., Kapral M. K.
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N Engl J Med 2004; 351:612-614, Aug 5, 2004. Correspondence

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