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Dal-Ré R, Avendaño C, Gil-Aguado A, et al. When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process. Clin Pharmacol Ther. 2007;83(5):788-93doi: 10.1038/sj.clpt.6100357.
Dal-Ré, R., Avendaño, C., Gil-Aguado, A., Gracia, D., & Caplan, A. L. (2008). When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process. Clinical pharmacology and therapeutics, 83(5), 788-93. https://doi.org/10.1038/sj.clpt.6100357
Dal-Ré, R, et al. "When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process." Clinical pharmacology and therapeutics vol. 83,5 (2008): 788-93. doi: https://doi.org/10.1038/sj.clpt.6100357
Dal-Ré R, Avendaño C, Gil-Aguado A, Gracia D, Caplan AL. When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process. Clin Pharmacol Ther. 2008 May;83(5):788-93. doi: 10.1038/sj.clpt.6100357. Epub 2007 Sep 19. PMID: 17882160.
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Clin Pharmacol Ther. 2008 May;83(5):788-93. doi: 10.1038/sj.clpt.6100357. Epub 2007 Sep 19.

When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process.

Clinical pharmacology and therapeutics

R Dal-Ré, C Avendaño, A Gil-Aguado, D Gracia, A L Caplan

Affiliations

  1. Medical Department, GlaxoSmithKline SA, Tres Cantos, Madrid, Spain. [email protected]

PMID: 17882160 DOI: 10.1038/sj.clpt.6100357

Abstract

Investigators, sponsors, and institutional review boards have to decide when re-consent of clinical trials' participants must be obtained when new information becomes available. We present an algorithm to help in the decision-making process, which takes into consideration the kind of new information, the risk of exposure (patients could be on the treatment or in the follow-up phases), and the possibility of managing the case. Re-consent should be obtained in three of the eight possible situations.

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