Journal Article

The dilemma of data-safety monitoring: provision of significant new data to research participants

Buss, William G, Godley, Paul A, Fost, Norm, Peppercorn, Jeffery

2008

Overview

1 Several research ethics codes reiterate the necessity for informed consent throughout the research process.'s Although the quality of information provided to potential participants at the time of trial initiation has received much attention,6-8 there has been relatively little discussion, and no consensus, about the delivery and adequacy of information provided to individuals after their enrolment.9 This concern applies particularly to large randomised controlled trials, in which consideration of new information is often delegated to a data-monitoring committee. Whether statistical significance (valued by the committee in the finasteride study) represents an acceptable threshold for sharing information of potential importance (as promised in US federal regulations) is not self-evident.\\n Other reports highlight the extent to which decisions to disclose information, or to stop a trial early, can be controversial.17,20 Although the data-monitoring committee is expected to have to make difficult decisions, consideration should be given to creation of a mechanism for consultation with outside experts for advice, recommendation, or decision when the appointed members (or a substantial minority of members) feel there is sufficient disagreement within the group.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Clinical trials / Clinical Trials Data Monitoring Committees - ethics / Committees / Decision Making / Ethics, Research / Federal regulation / Humans / Informed Consent / Internal Medicine / Medical ethics / Medical research / Prostate cancer / Randomized Controlled Trials as Topic - ethics / Research ethics / Research Subjects