Webinar-Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study
Copernicus Group IRB will be leading a webinar “Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study,” This is a free educational webinar run by Copernicus Group IRB and Duke University.
Date: October 18, 2011
Time: 11 am EST
Click here to download a recording of this Webinar
In a recent announcement of the proposed revisions to existing federal regulations governing human research subjects, the US Department of Health and Human Services (HHS) acknowledged, “There is very little evidence that having multiple IRBs review the same study is increasing protections to subjects,” according to an HHS publication on the recent proposed changes to the review and conduct of human. “By diffusing responsibility for that review, it might actually be leading to weakened protections.”
Goals
The goals of this presentation are to provide clarity on the rationale for this proposed change to the federal regulations; to discuss the potential impact on sponsors, CROs, and academic institutions; to dispel some of the myths regarding the independent review board model and to provide a case study of the collaborative relationship between the Duke University and Copernicus Group IRB in the review and conduct of clinical trials.