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When Should Re‐consent of Subjects Participating in a Clinical Trial Be Requested? A Case‐Oriented Algorithm to Assist in the Decision‐Making Process
Author(s) -
DalRé R,
Avendaño C,
GilAguado A,
Gracia D,
Caplan AL
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100357
Subject(s) - informed consent , clinical decision making , process (computing) , clinical trial , algorithm , computer science , medicine , psychology , family medicine , alternative medicine , pathology , operating system
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. Clinical Pharmacology & Therapeutics (2008); 83 , 5, 788–793. doi: 10.1038/sj.clpt.6100357