title: When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process.
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.
authors: Medical Department, GlaxoSmithKline SA, Tres Cantos, Madrid, Spain. rafael.dal-re@gsk.com
authors: R
authors: R
authors: Dal-Ré
authors: C
authors: C
authors: Avendaño
authors: A
authors: A
authors: Gil-Aguado
authors: D
authors: D
authors: Gracia
authors: A L
authors: AL
authors: Caplan
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards