When Should Re-consent of Subjects Participating in a Clinical Trial Be Requested? A Case-Oriented Algorithm to Assist in the Decision-Making Process

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...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2008-05, Vol.83 (5), p.788-793
Main Authors: Dal‐Ré, R, Avendaño, C, Gil‐Aguado, A, Gracia, D, Caplan, AL
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical Trials as Topic - ethics
Clinical Trials as Topic - standards
Humans
Informed Consent - ethics
Informed Consent - standards
Medical sciences
Pharmacology. Drug treatments
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Summary: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
ISSN:0009-9236
1532-6535
DOI:10.1038/sj.clpt.6100357