When Should Re-consent of Subjects Participating in a Clinical Trial Be Requested? A Case-Oriented Algorithm to Assist in the Decision-Making Process
- 19 September 2007
- journal article
- Published by Wiley in Clinical Pharmacology & Therapeutics
- Vol. 83 (5), 788-793
- https://doi.org/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.Keywords
This publication has 1 reference indexed in Scilit:
- Consent for Continuing Research Participation: What Is It and When Should It Be Obtained?Ethics & Human Research, 2002